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Carboplatin +/- Nivolumab in Metastatic Triple Negative Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03414684
Recruitment Status : Active, not recruiting
First Posted : January 30, 2018
Results First Posted : January 26, 2023
Last Update Posted : January 12, 2024
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Sara Tolaney, MD, Dana-Farber Cancer Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Drug: Carboplatin
Drug: Nivolumab
Enrollment 78
Recruitment Details The first patient was enrolled on February 12, 2018, and the last patient was enrolled on September 23, 2020.
Pre-assignment Details 96 patients were assessed for eligibility, and 18 were found to be ineligible. A total of 78 patients were enrolled and randomized.
Arm/Group Title Arm A: Carboplatin + Nivolumab Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion
Hide Arm/Group Description
  • Nivolumab is administered every three weeks intravenously
  • Nivolumab dosage is 360mg
  • Carboplatin is administered every three weeks intravenously
  • Carboplatin dosage is AUC 6
  • Carboplatin is administered every three weeks intravenously

  • Carboplatin dosage is AUC 6

    • Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) before the protocol amendment continued to receive nivolumab monotherapy after the amendment, rather than nivolumab plus nab-paclitaxel
Period Title: First-course Treatment
Started 39 [1] 39 [2]
Started Treatment 37 38
Completed 0 [3] 0 [3]
Not Completed 39 39
Reason Not Completed
Complete response             0             1
Intercurrent illness             1             0
Progressive Disease             31             32
Adverse Event             1             2
Physician Decision             0             1
Withdrawal by Subject             0             1
"Patient proceeded with chest wall excision"             1             0
"Participant needed palliative radiation, which is not permitted on study"             0             1
Still on treatment             3             0
Never started protocol therapy             2             1
[1]
39 patients were randomized to Arm A
[2]
39 patients were randomized to Arm B
[3]

There was no completion of treatment, per protocol. Patients were to remain on treatment until:

  • Disease progression
  • Complete response (and treated for at least 24 weeks, with at least two treatments occurring beyond the date when the initial CR was declared)
  • Intercurrent illness
  • Unacceptable adverse event(s)
  • Withdrawal of consent
  • General/specific changes in the patient's condition that render the patient unacceptable for further treatment
Period Title: Crossover Treatment
Started 0 18
Completed 0 0 [1]
Not Completed 0 18
Reason Not Completed
Progressive disease             0             12
Adverse Event             0             3
Physician Decision             0             1
Still on treatment             0             2
[1]

There was no completion of treatment, per protocol. Patients were to remain on treatment until:

  • Disease progression
  • Complete response (and treated for at least 24 weeks, with at least two treatments occurring beyond the date when the initial CR was declared)
  • Intercurrent illness
  • Unacceptable adverse event(s)
  • Withdrawal of consent
  • General/specific changes in the patient's condition that render the patient unacceptable for further treatment
Arm/Group Title Arm A: Carboplatin + Nivolumab Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion Total
Hide Arm/Group Description
  • Nivolumab is administered every three weeks intravenously
  • Nivolumab dosage is 360mg
  • Carboplatin is administered every three weeks intravenously
  • Carboplatin dosage is AUC 6
  • Carboplatin is administered every three weeks intravenously

  • Carboplatin dosage is AUC 6

    • Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel
 Total of all reporting groups
Overall Number of Baseline Participants 37 38 75
Hide Baseline Analysis Population Description
78 patients were enrolled and randomized, but only 75 patients started protocol therapy. The primary analysis population is the treated population, thus baseline characteristics are shown for the 75 patients that started protocol therapy.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 37 participants 38 participants 75 participants
59.1
(27.9 to 75.8)
59.1
(25.4 to 75.5)
59.1
(25.4 to 75.8)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Age, years Number Analyzed 37 participants 38 participants 75 participants
<40
1
   2.7%
4
  10.5%
5
   6.7%
40-59
19
  51.4%
16
  42.1%
35
  46.7%
>=60
17
  45.9%
18
  47.4%
35
  46.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 38 participants 75 participants
Female
37
 100.0%
38
 100.0%
75
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 38 participants 75 participants
Hispanic or Latino
2
   5.4%
0
   0.0%
2
   2.7%
Not Hispanic or Latino
33
  89.2%
36
  94.7%
69
  92.0%
Unknown or Not Reported
2
   5.4%
2
   5.3%
4
   5.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 38 participants 75 participants
Asian
1
   2.7%
0
   0.0%
1
   1.3%
Black or African American
2
   5.4%
3
   7.9%
5
   6.7%
Caucasian
30
  81.1%
34
  89.5%
64
  85.3%
More than one race
1
   2.7%
1
   2.6%
2
   2.7%
Other
3
   8.1%
0
   0.0%
3
   4.0%
Germline BRCA Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 38 participants 75 participants
gBRCA1 mutation
1
   2.7%
2
   5.3%
3
   4.0%
gBRCA2 mutation
0
   0.0%
1
   2.6%
1
   1.3%
Non-gBRCA1/2 carrier
36
  97.3%
35
  92.1%
71
  94.7%
Programmed death-ligand 1 (PD-L1) immunohistochemistry (IHC) Status -- Local  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 38 participants 75 participants
Positive
6
  16.2%
6
  15.8%
12
  16.0%
Negative
11
  29.7%
12
  31.6%
23
  30.7%
Not done
20
  54.1%
20
  52.6%
40
  53.3%
Programmed death-ligand 1 (PD-L1) immunohistochemistry (IHC) Status -- Central, SP142  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 38 participants 75 participants
Positive (>=1% IC)
14
  37.8%
14
  36.8%
28
  37.3%
Negative (<1% IC)
23
  62.2%
24
  63.2%
47
  62.7%
Stromal tumor-infiltrating lymphocytes (sTILs)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 38 participants 75 participants
0%
1
   2.7%
0
   0.0%
1
   1.3%
1-9%
23
  62.2%
19
  50.0%
42
  56.0%
10-49%
11
  29.7%
17
  44.7%
28
  37.3%
>=50%
1
   2.7%
1
   2.6%
2
   2.7%
Unknown
1
   2.7%
1
   2.6%
2
   2.7%
Eastern Cooperative Oncology Group (ECOG) Performance Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 38 participants 75 participants
0-Fully active, able to carry on pre-disease performance without restriction
28
  75.7%
28
  73.7%
56
  74.7%
1-Restricted in strenuous physical activity but able to perform work of a light or sedentary nature
9
  24.3%
10
  26.3%
19
  25.3%
Inflammatory breast cancer  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 38 participants 75 participants
Yes
1
   2.7%
3
   7.9%
4
   5.3%
No
36
  97.3%
35
  92.1%
71
  94.7%
Prior anthracycline in neoadjuvant/adjuvant setting  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 38 participants 75 participants
Yes
1
   2.7%
4
  10.5%
5
   6.7%
No
36
  97.3%
34
  89.5%
70
  93.3%
Prior taxane in neoadjuvant/adjuvant setting  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 38 participants 75 participants
Yes
9
  24.3%
10
  26.3%
19
  25.3%
No
28
  75.7%
28
  73.7%
56
  74.7%
Prior platinum in neoadjuvant/adjuvant setting  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 38 participants 75 participants
Yes
4
  10.8%
3
   7.9%
7
   9.3%
No
33
  89.2%
35
  92.1%
68
  90.7%
Number of lines of prior chemotherapy for advanced disease  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 38 participants 75 participants
0
32
  86.5%
30
  78.9%
62
  82.7%
1
5
  13.5%
8
  21.1%
13
  17.3%
Baseline lactate dehydrogenase (LDH)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 38 participants 75 participants
<= Upper Limit of Normal
23
  62.2%
24
  63.2%
47
  62.7%
> Upper Limit of Normal
10
  27.0%
14
  36.8%
24
  32.0%
Unknown
4
  10.8%
0
   0.0%
4
   5.3%
1.Primary Outcome
Title Progression-free Survival
Hide Description Defined as the time from randomization to the earlier of progression or death due to any cause. Participants alive without disease progression are censored at date of last disease evaluation
Time Frame Assessed from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, up to 3.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
The primary efficacy analysis was conducted in the intention-to-treat (ITT) population, which denotes the 62 patients who had 0 prior lines of treatment for advanced disease prior to enrollment.
Arm/Group Title Arm A: Carboplatin + Nivolumab Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion
Hide Arm/Group Description:
  • Nivolumab is administered every three weeks intravenously
  • Nivolumab dosage is 360mg
  • Carboplatin is administered every three weeks intravenously
  • Carboplatin dosage is AUC 6
  • Carboplatin is administered every three weeks intravenously

  • Carboplatin dosage is AUC 6

    • Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel
Overall Number of Participants Analyzed 32 30
Median (95% Confidence Interval)
Unit of Measure: months
4.2
(2.7 to 11.5)
5.5
(4.4 to 19.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A: Carboplatin + Nivolumab, Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.88
Comments [Not Specified]
Method Log Rank
Comments stratified log rank test
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.95
Confidence Interval (2-Sided) 95%
0.49 to 1.84
Estimation Comments Reference level is Arm B, such that hazard ratio corresponds to the effect of treatment on Arm A
2.Secondary Outcome
Title Objective Response Rate by Response Evaluation Criteria in Solid Tumours (RECIST) 1.1
Hide Description Defined as the percentage of patients achieving a complete response (complete disappearance of all target and non-target lesions; no new lesions) or partial response (at least 30% decrease in the sum of the diameters of target lesions; persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits [i.e., "non-CR/non-PD" in non-target lesions]; and no new lesions) based on RECIST 1.1
Time Frame Assessed from the start of treatment until disease progression, complete response (after at least 24 weeks of treatment), intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 3.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
The primary efficacy analysis was conducted in the intention-to-treat (ITT) population, which denotes the 62 patients who had 0 prior lines of treatment for advanced disease prior to enrollment.
Arm/Group Title Arm A: Carboplatin + Nivolumab Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion
Hide Arm/Group Description:
  • Nivolumab is administered every three weeks intravenously
  • Nivolumab dosage is 360mg
  • Carboplatin is administered every three weeks intravenously
  • Carboplatin dosage is AUC 6
  • Carboplatin is administered every three weeks intravenously

  • Carboplatin dosage is AUC 6

    • Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel
Overall Number of Participants Analyzed 32 30
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent of patients
25.0
(11.5 to 43.4)
23.3
(9.9 to 42.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A: Carboplatin + Nivolumab, Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.09
Confidence Interval (2-Sided) 95%
0.29 to 4.18
Estimation Comments Reference level is Arm B, such that the odds ratio corresponds to the effect of treatment on Arm A
3.Secondary Outcome
Title Objective Response Rate by Immune-Related Response Criteria (irRC)
Hide Description Defined as the proportion of patients achieving an immune-related complete response (complete disappearance of all target and non-target lesions; no new measurable/unmeasurable lesions) or immune-related partial response (a decrease of the immune-related sum of product diameters [irSPD] of 50% or greater) based on irRC
Time Frame Assessed from the start of treatment until disease progression, complete response (after at least 24 weeks of treatment), intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 3.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
First-course objective response rate by irRC was only evaluated in the 32 patients that received immunotherapy (on Arm A) in the ITT population. Because of this, statistical testing by arm was not performed.
Arm/Group Title Arm A: Carboplatin + Nivolumab Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion
Hide Arm/Group Description:
  • Nivolumab is administered every three weeks intravenously
  • Nivolumab dosage is 360mg
  • Carboplatin is administered every three weeks intravenously
  • Carboplatin dosage is AUC 6
  • Carboplatin is administered every three weeks intravenously

  • Carboplatin dosage is AUC 6

    • Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel
Overall Number of Participants Analyzed 32 0
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent of patients
28.1
(13.7 to 46.7)
4.Secondary Outcome
Title Overall Survival
Hide Description Defined as the time from randomization to death due to any cause, or censored at date last known alive
Time Frame Assessed from date of randomization until the date of death from any cause, up to 3.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
The primary efficacy analysis was conducted in the intention-to-treat (ITT) population, which denotes the 62 patients who had 0 prior lines of treatment for advanced disease prior to enrollment.
Arm/Group Title Arm A: Carboplatin + Nivolumab Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion
Hide Arm/Group Description:
  • Nivolumab is administered every three weeks intravenously
  • Nivolumab dosage is 360mg
  • Carboplatin is administered every three weeks intravenously
  • Carboplatin dosage is AUC 6
  • Carboplatin is administered every three weeks intravenously

  • Carboplatin dosage is AUC 6

    • Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel
Overall Number of Participants Analyzed 32 30
Median (95% Confidence Interval)
Unit of Measure: months
16.8 [1] 
(10.4 to NA)
11.1
(8.2 to 24.4)
[1]
Upper bound inestimable due to insufficient number of events
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A: Carboplatin + Nivolumab, Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.49
Comments [Not Specified]
Method Log Rank
Comments stratified log rank test
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.80
Confidence Interval (2-Sided) 95%
0.43 to 1.50
Estimation Comments Reference level is Arm B, such that the hazard ratio corresponds to treatment on Arm A
5.Secondary Outcome
Title Clinical Benefit Rate
Hide Description Defined as the proportion of patients achieving a complete response or partial response by RECIST 1.1, or stable disease lasting greater than or equal to 24 weeks
Time Frame Assessed from the start of treatment until disease progression, complete response (after at least 24 weeks of treatment), intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 3.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
The primary efficacy analysis was conducted in the intention-to-treat (ITT) population, which denotes the 62 patients who had 0 prior lines of treatment for advanced disease prior to enrollment.
Arm/Group Title Arm A: Carboplatin + Nivolumab Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion
Hide Arm/Group Description:
  • Nivolumab is administered every three weeks intravenously
  • Nivolumab dosage is 360mg
  • Carboplatin is administered every three weeks intravenously
  • Carboplatin dosage is AUC 6
  • Carboplatin is administered every three weeks intravenously

  • Carboplatin dosage is AUC 6

    • Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel
Overall Number of Participants Analyzed 32 30
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent of patients
34.4
(18.6 to 53.2)
33.3
(17.3 to 52.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A: Carboplatin + Nivolumab, Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.05
Confidence Interval (2-Sided) 95%
0.32 to 3.43
Estimation Comments Reference level is Arm B, such that the odds ratio corresponds to treatment on Arm A
6.Secondary Outcome
Title Duration of Response
Hide Description Defined as the time measurement criteria are met for CR or PR by RECIST 1.1 (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. Patients without events reported are censored at the last disease evaluation.
Time Frame Assessed from the time measurement criteria are met for CR or PR by RECIST 1.1 (whichever is first recorded) to the time of first progression, up to 2.75 years
Hide Outcome Measure Data
Hide Analysis Population Description
Duration of response was analyzed among the total 15 patients who achieved objective response in the ITT population.
Arm/Group Title Arm A: Carboplatin + Nivolumab Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion
Hide Arm/Group Description:
  • Nivolumab is administered every three weeks intravenously
  • Nivolumab dosage is 360mg
  • Carboplatin is administered every three weeks intravenously
  • Carboplatin dosage is AUC 6
  • Carboplatin is administered every three weeks intravenously

  • Carboplatin dosage is AUC 6

    • Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel
Overall Number of Participants Analyzed 8 7
Median (95% Confidence Interval)
Unit of Measure: months
19.3 [1] 
(16.8 to NA)
7.7 [1] 
(2.7 to NA)
[1]
Upper bound inestimable due to insufficient number of events
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A: Carboplatin + Nivolumab, Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.36
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.53
Confidence Interval (2-Sided) 95%
0.13 to 2.12
Estimation Comments Reference level is Arm B, such that the hazard ratio corresponds to treatment on Arm A
7.Secondary Outcome
Title Time to Objective Response
Hide Description Defined as the time from randomization to the date of the first documented CR or PR by RECIST 1.1, whichever is first recorded
Time Frame Assessed from randomization to the time of first response, up to 3.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
The primary efficacy analysis was conducted in the intention-to-treat (ITT) population, which denotes the 62 patients who had 0 prior lines of treatment for advanced disease prior to enrollment.
Arm/Group Title Arm A: Carboplatin + Nivolumab Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion
Hide Arm/Group Description:
  • Nivolumab is administered every three weeks intravenously
  • Nivolumab dosage is 360mg
  • Carboplatin is administered every three weeks intravenously
  • Carboplatin dosage is AUC 6
  • Carboplatin is administered every three weeks intravenously

  • Carboplatin dosage is AUC 6

    • Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel
Overall Number of Participants Analyzed 32 30
Median (95% Confidence Interval)
Unit of Measure: months
4.6 [1] 
(4.0 to NA)
11.2 [1] 
(4.7 to NA)
[1]
Upper bound inestimable due to insufficient number of events
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A: Carboplatin + Nivolumab, Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.68
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.24
Confidence Interval (2-Sided) 95%
0.43 to 3.43
Estimation Comments Reference level is Arm B, such that the hazard ratio corresponds to treatment on Arm A
8.Secondary Outcome
Title Progression-free Survival Among PD-L1-positive Patients
Hide Description

PFS defined as the time from randomization to the earlier of progression or death due to any cause; participants alive without disease progression are censored at date of last disease evaluation.

PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1.
Time Frame Assessed from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, up to 3.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 24 patients were PD-L1-positive in the ITT population.
Arm/Group Title Arm A: Carboplatin + Nivolumab Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion
Hide Arm/Group Description:
  • Nivolumab is administered every three weeks intravenously
  • Nivolumab dosage is 360mg
  • Carboplatin is administered every three weeks intravenously
  • Carboplatin dosage is AUC 6
  • Carboplatin is administered every three weeks intravenously

  • Carboplatin dosage is AUC 6

    • Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel
Overall Number of Participants Analyzed 13 11
Median (95% Confidence Interval)
Unit of Measure: months
8.3 [1] 
(2.5 to NA)
4.7 [1] 
(1.6 to NA)
[1]
Upper bound inestimable due to insufficient number of events
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A: Carboplatin + Nivolumab, Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.27
Comments [Not Specified]
Method Log Rank
Comments stratified log rank test
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.54
Confidence Interval (2-Sided) 95%
0.18 to 1.62
Estimation Comments Reference level is Arm B, such that the hazard ratio corresponds to treatment on Arm A
9.Secondary Outcome
Title Objective Response Rate by RECIST 1.1 Among PD-L1-positive Patients
Hide Description

ORR defined as the proportion of patients achieving a complete response (complete disappearance of all target and non-target lesions; no new lesions) or partial response (at least 30% decrease in the sum of the diameters of target lesions; persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits [i.e., "non-CR/non-PD" in non-target lesions]; and no new lesions) based on RECIST 1.1.

PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1.
Time Frame Assessed from the start of treatment until disease progression, complete response (after at least 24 weeks of treatment), intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 3.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 24 patients were PD-L1-positive in the ITT population.
Arm/Group Title Arm A: Carboplatin + Nivolumab Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion
Hide Arm/Group Description:
  • Nivolumab is administered every three weeks intravenously
  • Nivolumab dosage is 360mg
  • Carboplatin is administered every three weeks intravenously
  • Carboplatin dosage is AUC 6
  • Carboplatin is administered every three weeks intravenously

  • Carboplatin dosage is AUC 6

    • Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel
Overall Number of Participants Analyzed 13 11
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent of patients
23.1
(5.0 to 53.8)
27.3
(6.0 to 61.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A: Carboplatin + Nivolumab, Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.81
Confidence Interval (2-Sided) 95%
0.08 to 7.78
Estimation Comments Reference level is Arm B, such that the odds ratio corresponds to treatment on Arm A
10.Secondary Outcome
Title Objective Response Rate by irRC Among PD-L1-positive Patients
Hide Description

ORR by irRC defined as the proportion of patients achieving an immune-related complete response (complete disappearance of all target and non-target lesions; no new measurable/unmeasurable lesions) or immune-related partial response (a decrease of the immune-related sum of product diameters [irSPD] of 50% or greater) based on irRC.

PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1.
Time Frame Assessed from the start of treatment until disease progression, complete response (after at least 24 weeks of treatment), intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 3.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 13 patients were treated with immunotherapy (on Arm A) and were PD-L1-positive in the ITT population. Because first-course irORR was only assessed for patients on Arm A, no statistical testing by arm was performed.
Arm/Group Title Arm A: Carboplatin + Nivolumab Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion
Hide Arm/Group Description:
  • Nivolumab is administered every three weeks intravenously
  • Nivolumab dosage is 360mg
  • Carboplatin is administered every three weeks intravenously
  • Carboplatin dosage is AUC 6
  • Carboplatin is administered every three weeks intravenously

  • Carboplatin dosage is AUC 6

    • Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel
Overall Number of Participants Analyzed 13 0
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent of patients
30.8
(9.1 to 61.4)
11.Secondary Outcome
Title Overall Survival Among PD-L1-positive Patients
Hide Description

OS defined as the time from randomization to death due to any cause, or censored at date last known alive.

PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1.
Time Frame Assessed from date of randomization until the date of death from any cause, up to 3.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 24 patients were PD-L1-positive in the ITT population.
Arm/Group Title Arm A: Carboplatin + Nivolumab Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion
Hide Arm/Group Description:
  • Nivolumab is administered every three weeks intravenously
  • Nivolumab dosage is 360mg
  • Carboplatin is administered every three weeks intravenously
  • Carboplatin dosage is AUC 6
  • Carboplatin is administered every three weeks intravenously

  • Carboplatin dosage is AUC 6

    • Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel
Overall Number of Participants Analyzed 13 11
Median (95% Confidence Interval)
Unit of Measure: months
17.6 [1] 
(4.9 to NA)
10.7 [1] 
(6.7 to NA)
[1]
Upper bound inestimable due to insufficient number of events
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A: Carboplatin + Nivolumab, Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.61
Comments [Not Specified]
Method Log Rank
Comments stratified log rank test
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.75
Confidence Interval (2-Sided) 95%
0.26 to 2.16
Estimation Comments Reference level is Arm B, such that the hazard ratio corresponds to treatment on Arm A
12.Secondary Outcome
Title Clinical Benefit Rate Among PD-L1-positive Patients
Hide Description

CBR defined as the proportion of patients achieving a complete response or partial response by RECIST 1.1, or stable disease lasting greater than or equal to 24 weeks.

PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1.
Time Frame Assessed from the start of treatment until disease progression, complete response (after at least 24 weeks of treatment), intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 3.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 24 patients were PD-L1-positive in the ITT population.
Arm/Group Title Arm A: Carboplatin + Nivolumab Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion
Hide Arm/Group Description:
  • Nivolumab is administered every three weeks intravenously
  • Nivolumab dosage is 360mg
  • Carboplatin is administered every three weeks intravenously
  • Carboplatin dosage is AUC 6
  • Carboplatin is administered every three weeks intravenously

  • Carboplatin dosage is AUC 6

    • Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel
Overall Number of Participants Analyzed 13 11
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent of patients
30.8
(9.1 to 61.4)
36.4
(10.9 to 69.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A: Carboplatin + Nivolumab, Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.79
Confidence Interval (2-Sided) 95%
0.10 to 5.93
Estimation Comments Reference level is Arm B, such that the odds ratio corresponds to treatment on Arm A
13.Secondary Outcome
Title Duration of Response Among PD-L1-positive Patients
Hide Description

DOR defined as the time measurement criteria are met for CR or PR by RECIST 1.1 (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. Patients without events reported are censored at the last disease evaluation.

PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1.
Time Frame Assessed from the time measurement criteria are met for CR or PR by RECIST 1.1 (whichever is first recorded) to the time of first progression, up to 2.75 years
Hide Outcome Measure Data
Hide Analysis Population Description
Duration of response was assessed only among the 6 PD-L1-positive patients in the ITT population who achieved objective response. Due to insufficient sample size, statistical testing by arm was not performed.
Arm/Group Title Arm A: Carboplatin + Nivolumab Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion
Hide Arm/Group Description:
  • Nivolumab is administered every three weeks intravenously
  • Nivolumab dosage is 360mg
  • Carboplatin is administered every three weeks intravenously
  • Carboplatin dosage is AUC 6
  • Carboplatin is administered every three weeks intravenously

  • Carboplatin dosage is AUC 6

    • Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel
Overall Number of Participants Analyzed 3 3
Median (95% Confidence Interval)
Unit of Measure: months
16.8 [1] 
(NA to NA)
4.9 [2] 
(2.0 to NA)
[1]
Bounds inestimable due to insufficient sample size/number of events
[2]
Upper bound inestimable due to insufficient sample size/number of events
14.Secondary Outcome
Title Time to Objective Response Among PD-L1-positive Patients
Hide Description

TTOR defined as the time from randomization to the date of the first documented CR or PR by RECIST 1.1, whichever is first recorded.

PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1.
Time Frame Assessed from randomization to the time of first response, up to 3.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 24 patients were PD-L1-positive in the ITT population.
Arm/Group Title Arm A: Carboplatin + Nivolumab Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion
Hide Arm/Group Description:
  • Nivolumab is administered every three weeks intravenously
  • Nivolumab dosage is 360mg
  • Carboplatin is administered every three weeks intravenously
  • Carboplatin dosage is AUC 6
  • Carboplatin is administered every three weeks intravenously

  • Carboplatin dosage is AUC 6

    • Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel
Overall Number of Participants Analyzed 13 11
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(3.4 to NA)
NA [1] 
(3.0 to NA)
[1]
Median and upper bound inestimable due to insufficient number of responses
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A: Carboplatin + Nivolumab, Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.73
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.75
Confidence Interval (2-Sided) 95%
0.14 to 3.89
Estimation Comments Reference level is Arm B, such that the hazard ratio corresponds to treatment on Arm A
15.Secondary Outcome
Title Second-course Progression-free Survival Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab
Hide Description PFS defined as the time from the start of crossover treatment to the earlier of progression (on crossover therapy) or death due to any cause; participants alive without disease progression are censored at date of last disease evaluation.
Time Frame Assessed from the start of crossover therapy to the date of first documented progression on crossover therapy or the date of death from any cause, whichever came first, up to 2.8 years
Hide Outcome Measure Data
Hide Analysis Population Description
10 patients in the ITT population who were initially randomized to Arm B (carboplatin monotherapy) crossed over to receive nab-paclitaxel plus nivolumab
Arm/Group Title Arm A: Carboplatin + Nivolumab Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion
Hide Arm/Group Description:
  • Nivolumab is administered every three weeks intravenously
  • Nivolumab dosage is 360mg
  • Carboplatin is administered every three weeks intravenously
  • Carboplatin dosage is AUC 6
  • Carboplatin is administered every three weeks intravenously

  • Carboplatin dosage is AUC 6

    • Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel
Overall Number of Participants Analyzed 0 10
Median (95% Confidence Interval)
Unit of Measure: months
4.1 [1] 
(1.9 to NA)
[1]
Upper bound inestimable due to insufficient sample size / number of events
16.Secondary Outcome
Title Second-course Objective Response Rate by RECIST 1.1 Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab
Hide Description ORR defined as the proportion of patients achieving a complete response (complete disappearance of all target and non-target lesions; no new lesions) or partial response (at least 30% decrease in the sum of the diameters of target lesions; persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits [i.e., "non-CR/non-PD" in non-target lesions]; and no new lesions) based on RECIST 1.1., during crossover therapy
Time Frame Assessed from the start of crossover treatment until disease progression, intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 2.8 years
Hide Outcome Measure Data
Hide Analysis Population Description
10 patients in the ITT population initially randomized to Arm B (carboplatin monotherapy) crossed over to receive nab-paclitaxel plus nivolumab
Arm/Group Title Arm A: Carboplatin + Nivolumab Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion
Hide Arm/Group Description:
  • Nivolumab is administered every three weeks intravenously
  • Nivolumab dosage is 360mg
  • Carboplatin is administered every three weeks intravenously
  • Carboplatin dosage is AUC 6
  • Carboplatin is administered every three weeks intravenously

  • Carboplatin dosage is AUC 6

    • Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel
Overall Number of Participants Analyzed 0 10
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent of patients
20.0
(2.5 to 55.6)
17.Secondary Outcome
Title Second-course Objective Response Rate by irRC Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab
Hide Description ORR by irRC defined as the proportion of patients achieving an immune-related complete response (complete disappearance of all target and non-target lesions; no new measurable/unmeasurable lesions) or immune-related partial response (a decrease of the immune-related sum of product diameters [irSPD] of 50% or greater) based on irRC, during second-course therapy
Time Frame Assessed from the start of crossover treatment until disease progression, intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 2.8 years
Hide Outcome Measure Data
Hide Analysis Population Description
10 patients in the ITT population initially randomized to Arm B (carboplatin monotherapy) crossed over to receive nab-paclitaxel plus nivolumab
Arm/Group Title Arm A: Carboplatin + Nivolumab Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion
Hide Arm/Group Description:
  • Nivolumab is administered every three weeks intravenously
  • Nivolumab dosage is 360mg
  • Carboplatin is administered every three weeks intravenously
  • Carboplatin dosage is AUC 6
  • Carboplatin is administered every three weeks intravenously

  • Carboplatin dosage is AUC 6

    • Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel
Overall Number of Participants Analyzed 0 10
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent of patients
20.0
(2.5 to 55.6)
18.Secondary Outcome
Title Second-course Clinical Benefit Rate Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab
Hide Description CBR defined as the proportion of patients achieving a complete response or partial response by RECIST 1.1, or stable disease lasting greater than or equal to 24 weeks, during second course therapy
Time Frame Assessed from the start of crossover treatment until disease progression, intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 2.8 years
Hide Outcome Measure Data
Hide Analysis Population Description
10 patients in the ITT population initially randomized to Arm B (carboplatin monotherapy) crossed over to receive nab-paclitaxel plus nivolumab
Arm/Group Title Arm A: Carboplatin + Nivolumab Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion
Hide Arm/Group Description:
  • Nivolumab is administered every three weeks intravenously
  • Nivolumab dosage is 360mg
  • Carboplatin is administered every three weeks intravenously
  • Carboplatin dosage is AUC 6
  • Carboplatin is administered every three weeks intravenously

  • Carboplatin dosage is AUC 6

    • Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel
Overall Number of Participants Analyzed 0 10
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent of patients
30.0
(6.7 to 65.2)
19.Secondary Outcome
Title Second-course Duration of Response Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab
Hide Description DOR defined as the time measurement criteria are met for second-course CR or PR by RECIST 1.1 (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented thereafter. Patients without events reported are censored at the last disease evaluation.
Time Frame Assessed from the time measurement criteria are met for CR or PR by RECIST 1.1 (whichever is first recorded) on crossover therapy to the time of first progression on crossover therapy, up to 2.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
10 patients in the ITT population initially randomized to Arm B (carboplatin monotherapy) crossed over to receive nab-paclitaxel plus nivolumab, and only 2 of these patients achieved objective response
Arm/Group Title Arm A: Carboplatin + Nivolumab Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion
Hide Arm/Group Description:
  • Nivolumab is administered every three weeks intravenously
  • Nivolumab dosage is 360mg
  • Carboplatin is administered every three weeks intravenously
  • Carboplatin dosage is AUC 6
  • Carboplatin is administered every three weeks intravenously

  • Carboplatin dosage is AUC 6

    • Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel
Overall Number of Participants Analyzed 0 2
Median (95% Confidence Interval)
Unit of Measure: months
1.81 [1] 
(1.81 to NA)
[1]
Upper bound inestimable due to insufficient sample size
20.Secondary Outcome
Title Second-course Time to Objective Response Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab
Hide Description TTOR defined as the time from start of crossover treatment to the date of the first documented CR or PR by RECIST 1.1 on second-course therapy, whichever is first recorded
Time Frame Assessed from the start of crossover therapy to the time of first response on crossover therapy, up to 2.8 years
Hide Outcome Measure Data
Hide Analysis Population Description
10 patients in the ITT population initially randomized to Arm B (carboplatin monotherapy) crossed over to receive nab-paclitaxel plus nivolumab
Arm/Group Title Arm A: Carboplatin + Nivolumab Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion
Hide Arm/Group Description:
  • Nivolumab is administered every three weeks intravenously
  • Nivolumab dosage is 360mg
  • Carboplatin is administered every three weeks intravenously
  • Carboplatin dosage is AUC 6
  • Carboplatin is administered every three weeks intravenously

  • Carboplatin dosage is AUC 6

    • Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel
Overall Number of Participants Analyzed 0 10
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(3.5 to NA)
[1]
Median and upper bound inestimable due to insufficient number of responses
21.Secondary Outcome
Title Second-course Overall Survival Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab
Hide Description Second-course OS defined as the time from the start of crossover treatment to death due from any cause, or censored at date last known alive.
Time Frame Assessed from the start of crossover therapy until the date of death from any cause, up to 2.8 years
Hide Outcome Measure Data
Hide Analysis Population Description
10 patients in the ITT population who were initially randomized to Arm B (carboplatin monotherapy) crossed over to receive nab-paclitaxel plus nivolumab
Arm/Group Title Arm A: Carboplatin + Nivolumab Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion
Hide Arm/Group Description:
  • Nivolumab is administered every three weeks intravenously
  • Nivolumab dosage is 360mg
  • Carboplatin is administered every three weeks intravenously
  • Carboplatin dosage is AUC 6
  • Carboplatin is administered every three weeks intravenously

  • Carboplatin dosage is AUC 6

    • Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel
Overall Number of Participants Analyzed 0 10
Median (95% Confidence Interval)
Unit of Measure: months
12.9 [1] 
(6.4 to NA)
[1]
Upper bound inestimable due to insufficient number of events
22.Secondary Outcome
Title Progression-free Survival Among BRCA-mutant Patients
Hide Description

PFS defined as the time from randomization to the earlier of progression or death due to any cause; participants alive without disease progression are censored at date of last disease evaluation.

BRCA-mutant patients were those having BRCA1 or BRCA2 mutations.
Time Frame Assessed from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, up to 3.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 2 patients in the ITT population had BRCA1 or BRCA2 mutations.
Arm/Group Title Arm A: Carboplatin + Nivolumab Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion
Hide Arm/Group Description:
  • Nivolumab is administered every three weeks intravenously
  • Nivolumab dosage is 360mg
  • Carboplatin is administered every three weeks intravenously
  • Carboplatin dosage is AUC 6
  • Carboplatin is administered every three weeks intravenously

  • Carboplatin dosage is AUC 6

    • Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel
Overall Number of Participants Analyzed 0 2
Median (95% Confidence Interval)
Unit of Measure: months
4.74 [1] 
(4.74 to NA)
[1]
Upper bound inestimable due to insufficient sample size/number of events
23.Secondary Outcome
Title Objective Response Rate by RECIST 1.1 Among BRCA-mutant Patients
Hide Description

ORR defined as the proportion of patients achieving a complete response (complete disappearance of all target and non-target lesions; no new lesions) or partial response (at least 30% decrease in the sum of the diameters of target lesions; persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits [i.e., "non-CR/non-PD" in non-target lesions]; and no new lesions) based on RECIST 1.1.

BRCA-mutant patients were those with BRCA1 or BRCA2 mutations.
Time Frame Assessed from the start of treatment until disease progression, complete response (after at least 24 weeks of treatment), intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 3.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 2 patients in the ITT population had BRCA1 or BRCA2 mutations.
Arm/Group Title Arm A: Carboplatin + Nivolumab Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion
Hide Arm/Group Description:
  • Nivolumab is administered every three weeks intravenously
  • Nivolumab dosage is 360mg
  • Carboplatin is administered every three weeks intravenously
  • Carboplatin dosage is AUC 6
  • Carboplatin is administered every three weeks intravenously

  • Carboplatin dosage is AUC 6

    • Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) before the protocol amendment continued to receive nivolumab monotherapy after the amendment, rather than nivolumab plus nab-paclitaxel
Overall Number of Participants Analyzed 0 2
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent of patients
50.0
(1.3 to 98.7)
24.Secondary Outcome
Title Objective Response Rate by irRC Among BRCA-mutant Patients
Hide Description

ORR by irRC defined as the proportion of patients achieving an immune-related complete response (complete disappearance of all target and non-target lesions; no new measurable/unmeasurable lesions) or immune-related partial response (a decrease of the immune-related sum of product diameters [irSPD] of 50% or greater) based on irRC.

BRCA-mutant patients were those with BRCA1 or BRCA2 mutations.
Time Frame Assessed from the start of treatment until disease progression, complete response (after at least 24 weeks of treatment), intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 3.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
There were 0 patients treated with immunotherapy (on Arm A) and had BRCA1 or BRCA2 mutations in the ITT population.
Arm/Group Title Arm A: Carboplatin + Nivolumab Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion
Hide Arm/Group Description:
  • Nivolumab is administered every three weeks intravenously
  • Nivolumab dosage is 360mg
  • Carboplatin is administered every three weeks intravenously
  • Carboplatin dosage is AUC 6
  • Carboplatin is administered every three weeks intravenously

  • Carboplatin dosage is AUC 6

    • Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) before the protocol amendment continued to receive nivolumab monotherapy after the amendment, rather than nivolumab plus nab-paclitaxel
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
25.Secondary Outcome
Title Overall Survival Among BRCA-mutant Patients
Hide Description

OS defined as the time from randomization to death due to any cause, or censored at date last known alive.

BRCA-mutant patients were those with BRCA1 or BRCA2 mutations.
Time Frame From date of randomization until the date of death from any cause, assessed up to 3.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 2 patients in the ITT population had BRCA1 or BRCA2 mutations.
Arm/Group Title Arm A: Carboplatin + Nivolumab Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion
Hide Arm/Group Description:
  • Nivolumab is administered every three weeks intravenously
  • Nivolumab dosage is 360mg
  • Carboplatin is administered every three weeks intravenously
  • Carboplatin dosage is AUC 6
  • Carboplatin is administered every three weeks intravenously

  • Carboplatin dosage is AUC 6

    • Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) before the protocol amendment continued to receive nivolumab monotherapy after the amendment, rather than nivolumab plus nab-paclitaxel
Overall Number of Participants Analyzed 0 2
Median (95% Confidence Interval)
Unit of Measure: months
24.4 [1] 
(NA to NA)
[1]
Bounds inestimable due to insufficient sample size/number of events
26.Secondary Outcome
Title Clinical Benefit Rate Among BRCA-mutant Patients
Hide Description

CBR defined as the percentage of patients achieving a complete response or partial response by RECIST 1.1, or stable disease lasting greater than or equal to 24 weeks.

BRCA-mutant patients were those with BRCA1 or BRCA2 mutations.
Time Frame Assessed from the start of treatment until disease progression, complete response (after at least 24 weeks of treatment), intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 3.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 2 patients in the ITT population had BRCA1 or BRCA2 mutations.
Arm/Group Title Arm A: Carboplatin + Nivolumab Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion
Hide Arm/Group Description:
  • Nivolumab is administered every three weeks intravenously
  • Nivolumab dosage is 360mg
  • Carboplatin is administered every three weeks intravenously
  • Carboplatin dosage is AUC 6
  • Carboplatin is administered every three weeks intravenously

  • Carboplatin dosage is AUC 6

    • Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) before the protocol amendment continued to receive nivolumab monotherapy after the amendment, rather than nivolumab plus nab-paclitaxel
Overall Number of Participants Analyzed 0 2
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent of patients
50.0
(1.3 to 98.7)
27.Secondary Outcome
Title Duration of Response Among BRCA-mutant Patients
Hide Description

DOR defined as the time measurement criteria are met for CR or PR by RECIST 1.1 (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. Patients without events reported are censored at the last disease evaluation.

BRCA-mutant patients were those with BRCA1 or BRCA2 mutations.
Time Frame Assessed from the time measurement criteria are met for CR or PR by RECIST 1.1 (whichever is first recorded) to the time of first progression, up to 3.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Only 1 patient in the ITT cohort that had a BRCA1 or BRCA2 mutation also achieved objective response.
Arm/Group Title Arm A: Carboplatin + Nivolumab Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion
Hide Arm/Group Description:
  • Nivolumab is administered every three weeks intravenously
  • Nivolumab dosage is 360mg
  • Carboplatin is administered every three weeks intravenously
  • Carboplatin dosage is AUC 6
  • Carboplatin is administered every three weeks intravenously

  • Carboplatin dosage is AUC 6

    • Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) before the protocol amendment continued to receive nivolumab monotherapy after the amendment, rather than nivolumab plus nab-paclitaxel
Overall Number of Participants Analyzed 0 1
Median (95% Confidence Interval)
Unit of Measure: months
2.04 [1] 
(NA to NA)
[1]
Bounds inestimable due to insufficient sample size/number of events
28.Secondary Outcome
Title Time to Objective Response Among BRCA-mutant Patients
Hide Description

TTOR defined as the time from randomization to the date of the first documented CR or PR by RECIST 1.1, whichever is first recorded.

BRCA-mutant patients were those with BRCA1 or BRCA2 mutations.
Time Frame Assessed from randomization to the time of first response, up to 3.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 2 patients in the ITT population had BRCA1 or BRCA2 mutations.
Arm/Group Title Arm A: Carboplatin + Nivolumab Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion
Hide Arm/Group Description:
  • Nivolumab is administered every three weeks intravenously
  • Nivolumab dosage is 360mg
  • Carboplatin is administered every three weeks intravenously
  • Carboplatin dosage is AUC 6
  • Carboplatin is administered every three weeks intravenously

  • Carboplatin dosage is AUC 6

    • Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) before the protocol amendment continued to receive nivolumab monotherapy after the amendment, rather than nivolumab plus nab-paclitaxel
Overall Number of Participants Analyzed 0 2
Median (95% Confidence Interval)
Unit of Measure: months
3.2 [1] 
(3.2 to NA)
[1]
Upper bound inestimable due to insufficient sample size/number of events
Time Frame Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years.
Adverse Event Reporting Description

An SAE is any untoward medical occurrence that:

  • results in death
  • is life-threatening (i.e., participant was at risk of death at the time of the event)
  • requires hospitalization or prolongs existing hospitalization
  • results in persistent/significant disability/incapacity
  • is a congenital anomaly/birth defect
  • is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)
 
Arm/Group Title Arm A: Carboplatin + Nivolumab Arm B: Carboplatin Arm B: Carboplatin -- Crossover
Hide Arm/Group Description
  • Nivolumab is administered every three weeks intravenously
  • Nivolumab dosage is 360mg
  • Carboplatin is administered every three weeks intravenously
  • Carboplatin dosage is AUC 6
  • Carboplatin is administered every three weeks intravenously

  • Carboplatin dosage is AUC 6

    • Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel
  • Carboplatin is administered every three weeks intravenously

  • Carboplatin dosage is AUC 6

    • Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel
All-Cause Mortality
Arm A: Carboplatin + Nivolumab Arm B: Carboplatin Arm B: Carboplatin -- Crossover
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   24/37 (64.86%)   17/38 (44.74%)   10/18 (55.56%) 
Hide Serious Adverse Events
Arm A: Carboplatin + Nivolumab Arm B: Carboplatin Arm B: Carboplatin -- Crossover
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   10/37 (27.03%)   11/38 (28.95%)   6/18 (33.33%) 
Blood and lymphatic system disorders       
Anemia † 1  2/37 (5.41%)  1/38 (2.63%)  0/18 (0.00%) 
Cardiac disorders       
Atrial fibrillation † 1  1/37 (2.70%)  0/38 (0.00%)  0/18 (0.00%) 
Pericardial effusion † 1  0/37 (0.00%)  1/38 (2.63%)  0/18 (0.00%) 
Gastrointestinal disorders       
Colitis † 1  2/37 (5.41%)  0/38 (0.00%)  0/18 (0.00%) 
Diarrhea † 1  1/37 (2.70%)  0/38 (0.00%)  0/18 (0.00%) 
Vomiting † 1  0/37 (0.00%)  1/38 (2.63%)  0/18 (0.00%) 
Enterocolitis † 1  0/37 (0.00%)  0/38 (0.00%)  1/18 (5.56%) 
Small intestinal obstruction † 1  0/37 (0.00%)  0/38 (0.00%)  1/18 (5.56%) 
General disorders       
Fever † 1  1/37 (2.70%)  0/38 (0.00%)  0/18 (0.00%) 
Infusion related reaction † 1  1/37 (2.70%)  0/38 (0.00%)  0/18 (0.00%) 
Fatigue † 1  0/37 (0.00%)  1/38 (2.63%)  0/18 (0.00%) 
Pain † 1  0/37 (0.00%)  2/38 (5.26%)  1/18 (5.56%) 
Flu like symptoms † 1  0/37 (0.00%)  0/38 (0.00%)  1/18 (5.56%) 
Immune system disorders       
Allergic reaction † 1  1/37 (2.70%)  0/38 (0.00%)  0/18 (0.00%) 
Infections and infestations       
Infections and infestations - Other, specify † 1  1/37 (2.70%)  0/38 (0.00%)  0/18 (0.00%) 
Joint infection † 1  1/37 (2.70%)  0/38 (0.00%)  0/18 (0.00%) 
Lung infection † 1  1/37 (2.70%)  1/38 (2.63%)  1/18 (5.56%) 
Sepsis † 1  1/37 (2.70%)  0/38 (0.00%)  1/18 (5.56%) 
Urinary tract infection † 1  1/37 (2.70%)  0/38 (0.00%)  0/18 (0.00%) 
Upper respiratory infection † 1  0/37 (0.00%)  1/38 (2.63%)  0/18 (0.00%) 
Injury, poisoning and procedural complications       
Fall † 1  1/37 (2.70%)  0/38 (0.00%)  0/18 (0.00%) 
Spinal fracture † 1  0/37 (0.00%)  0/38 (0.00%)  1/18 (5.56%) 
Investigations       
Blood bilirubin increased † 1  1/37 (2.70%)  0/38 (0.00%)  1/18 (5.56%) 
Neutrophil count decreased † 1  2/37 (5.41%)  1/38 (2.63%)  0/18 (0.00%) 
Platelet count decreased † 1  3/37 (8.11%)  1/38 (2.63%)  2/18 (11.11%) 
White blood cell decreased † 1  1/37 (2.70%)  0/38 (0.00%)  0/18 (0.00%) 
Metabolism and nutrition disorders       
Hyperglycemia † 1  0/37 (0.00%)  1/38 (2.63%)  0/18 (0.00%) 
Musculoskeletal and connective tissue disorders       
Back pain † 1  0/37 (0.00%)  1/38 (2.63%)  0/18 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify † 1  2/37 (5.41%)  1/38 (2.63%)  0/18 (0.00%) 
Nervous system disorders       
Cognitive disturbance † 1  1/37 (2.70%)  0/38 (0.00%)  0/18 (0.00%) 
Psychiatric disorders       
Confusion † 1  1/37 (2.70%)  0/38 (0.00%)  0/18 (0.00%) 
Reproductive system and breast disorders       
Breast pain † 1  1/37 (2.70%)  0/38 (0.00%)  0/18 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Dyspnea † 1  1/37 (2.70%)  2/38 (5.26%)  0/18 (0.00%) 
Hypoxia † 1  2/37 (5.41%)  2/38 (5.26%)  1/18 (5.56%) 
Cough † 1  0/37 (0.00%)  1/38 (2.63%)  0/18 (0.00%) 
Pleural effusion † 1  0/37 (0.00%)  1/38 (2.63%)  1/18 (5.56%) 
Pneumonitis † 1  0/37 (0.00%)  0/38 (0.00%)  1/18 (5.56%) 
Vascular disorders       
Hypotension † 1  1/37 (2.70%)  0/38 (0.00%)  0/18 (0.00%) 
1
Term from vocabulary, CTCAE (4.0)
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm A: Carboplatin + Nivolumab Arm B: Carboplatin Arm B: Carboplatin -- Crossover
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   37/37 (100.00%)   38/38 (100.00%)   18/18 (100.00%) 
Blood and lymphatic system disorders       
Anemia † 1  25/37 (67.57%)  20/38 (52.63%)  8/18 (44.44%) 
Blood and lymphatic system disorders - Other, specify † 1  3/37 (8.11%)  4/38 (10.53%)  2/18 (11.11%) 
Cardiac disorders       
Atrial fibrillation † 1  2/37 (5.41%)  2/38 (5.26%)  0/18 (0.00%) 
Sinus tachycardia † 1  0/37 (0.00%)  2/38 (5.26%)  0/18 (0.00%) 
Ear and labyrinth disorders       
Tinnitus † 1  2/37 (5.41%)  4/38 (10.53%)  0/18 (0.00%) 
Endocrine disorders       
Hypothyroidism † 1  11/37 (29.73%)  3/38 (7.89%)  2/18 (11.11%) 
Eye disorders       
Blurred vision † 1  2/37 (5.41%)  0/38 (0.00%)  0/18 (0.00%) 
Gastrointestinal disorders       
Abdominal pain † 1  3/37 (8.11%)  2/38 (5.26%)  3/18 (16.67%) 
Colitis † 1  3/37 (8.11%)  0/38 (0.00%)  0/18 (0.00%) 
Constipation † 1  18/37 (48.65%)  14/38 (36.84%)  4/18 (22.22%) 
Diarrhea † 1  11/37 (29.73%)  7/38 (18.42%)  9/18 (50.00%) 
Gastroesophageal reflux disease † 1  4/37 (10.81%)  3/38 (7.89%)  2/18 (11.11%) 
Hemorrhoids † 1  2/37 (5.41%)  0/38 (0.00%)  0/18 (0.00%) 
Mucositis oral † 1  5/37 (13.51%)  0/38 (0.00%)  0/18 (0.00%) 
Nausea † 1  21/37 (56.76%)  26/38 (68.42%)  7/18 (38.89%) 
Vomiting † 1  5/37 (13.51%)  8/38 (21.05%)  3/18 (16.67%) 
Dry mouth † 1  0/37 (0.00%)  3/38 (7.89%)  0/18 (0.00%) 
General disorders       
Chills † 1  4/37 (10.81%)  0/38 (0.00%)  0/18 (0.00%) 
Edema limbs † 1  3/37 (8.11%)  5/38 (13.16%)  0/18 (0.00%) 
Fatigue † 1  28/37 (75.68%)  28/38 (73.68%)  11/18 (61.11%) 
Fever † 1  5/37 (13.51%)  5/38 (13.16%)  5/18 (27.78%) 
Infusion related reaction † 1  8/37 (21.62%)  0/38 (0.00%)  0/18 (0.00%) 
Localized edema † 1  3/37 (8.11%)  0/38 (0.00%)  3/18 (16.67%) 
Non-cardiac chest pain † 1  2/37 (5.41%)  0/38 (0.00%)  0/18 (0.00%) 
Pain † 1  10/37 (27.03%)  13/38 (34.21%)  4/18 (22.22%) 
Infections and infestations       
Infections and infestations - Other, specify † 1  2/37 (5.41%)  0/38 (0.00%)  2/18 (11.11%) 
Lung infection † 1  4/37 (10.81%)  0/38 (0.00%)  0/18 (0.00%) 
Sinusitis † 1  2/37 (5.41%)  0/38 (0.00%)  0/18 (0.00%) 
Skin infection † 1  2/37 (5.41%)  3/38 (7.89%)  0/18 (0.00%) 
Upper respiratory infection † 1  2/37 (5.41%)  3/38 (7.89%)  0/18 (0.00%) 
Urinary tract infection † 1  4/37 (10.81%)  0/38 (0.00%)  0/18 (0.00%) 
Vaginal infection † 1  2/37 (5.41%)  0/38 (0.00%)  0/18 (0.00%) 
Injury, poisoning and procedural complications       
Bruising † 1  2/37 (5.41%)  0/38 (0.00%)  0/18 (0.00%) 
Injury, poisoning and procedural complications - Other, specify † 1  0/37 (0.00%)  2/38 (5.26%)  0/18 (0.00%) 
Fall † 1  0/37 (0.00%)  0/38 (0.00%)  2/18 (11.11%) 
Investigations       
Alanine aminotransferase increased † 1  6/37 (16.22%)  3/38 (7.89%)  2/18 (11.11%) 
Alkaline phosphatase increased † 1  6/37 (16.22%)  3/38 (7.89%)  2/18 (11.11%) 
Aspartate aminotransferase increased † 1  7/37 (18.92%)  3/38 (7.89%)  3/18 (16.67%) 
Blood bilirubin increased † 1  2/37 (5.41%)  0/38 (0.00%)  0/18 (0.00%) 
Creatinine increased † 1  2/37 (5.41%)  0/38 (0.00%)  2/18 (11.11%) 
Investigations - Other, specify † 1  2/37 (5.41%)  0/38 (0.00%)  0/18 (0.00%) 
Lymphocyte count decreased † 1  6/37 (16.22%)  5/38 (13.16%)  2/18 (11.11%) 
Neutrophil count decreased † 1  20/37 (54.05%)  21/38 (55.26%)  7/18 (38.89%) 
Platelet count decreased † 1  29/37 (78.38%)  20/38 (52.63%)  5/18 (27.78%) 
Weight loss † 1  4/37 (10.81%)  2/38 (5.26%)  2/18 (11.11%) 
White blood cell decreased † 1  10/37 (27.03%)  8/38 (21.05%)  3/18 (16.67%) 
Cholesterol high † 1  0/37 (0.00%)  2/38 (5.26%)  0/18 (0.00%) 
INR increased † 1  0/37 (0.00%)  2/38 (5.26%)  0/18 (0.00%) 
Metabolism and nutrition disorders       
Anorexia † 1  9/37 (24.32%)  6/38 (15.79%)  5/18 (27.78%) 
Dehydration † 1  4/37 (10.81%)  0/38 (0.00%)  0/18 (0.00%) 
Hyperglycemia † 1  7/37 (18.92%)  6/38 (15.79%)  3/18 (16.67%) 
Hypoalbuminemia † 1  4/37 (10.81%)  0/38 (0.00%)  3/18 (16.67%) 
Hypocalcemia † 1  3/37 (8.11%)  0/38 (0.00%)  0/18 (0.00%) 
Hypokalemia † 1  7/37 (18.92%)  5/38 (13.16%)  3/18 (16.67%) 
Hypomagnesemia † 1  12/37 (32.43%)  7/38 (18.42%)  0/18 (0.00%) 
Hyponatremia † 1  3/37 (8.11%)  2/38 (5.26%)  2/18 (11.11%) 
Hypophosphatemia † 1  5/37 (13.51%)  0/38 (0.00%)  2/18 (11.11%) 
Metabolism and nutrition disorders - Other, specify † 1  2/37 (5.41%)  0/38 (0.00%)  0/18 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia † 1  6/37 (16.22%)  2/38 (5.26%)  0/18 (0.00%) 
Back pain † 1  7/37 (18.92%)  6/38 (15.79%)  0/18 (0.00%) 
Bone pain † 1  5/37 (13.51%)  2/38 (5.26%)  0/18 (0.00%) 
Chest wall pain † 1  2/37 (5.41%)  3/38 (7.89%)  0/18 (0.00%) 
Generalized muscle weakness † 1  2/37 (5.41%)  2/38 (5.26%)  0/18 (0.00%) 
Myalgia † 1  8/37 (21.62%)  4/38 (10.53%)  5/18 (27.78%) 
Neck pain † 1  2/37 (5.41%)  0/38 (0.00%)  0/18 (0.00%) 
Pain in extremity † 1  4/37 (10.81%)  2/38 (5.26%)  0/18 (0.00%) 
Musculoskeletal and connective tissue disorder - Other, specify † 1  0/37 (0.00%)  3/38 (7.89%)  0/18 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Tumor pain † 1  0/37 (0.00%)  0/38 (0.00%)  3/18 (16.67%) 
Nervous system disorders       
Dizziness † 1  6/37 (16.22%)  4/38 (10.53%)  0/18 (0.00%) 
Headache † 1  10/37 (27.03%)  10/38 (26.32%)  5/18 (27.78%) 
Nervous system disorders - Other, specify † 1  2/37 (5.41%)  0/38 (0.00%)  0/18 (0.00%) 
Peripheral sensory neuropathy † 1  15/37 (40.54%)  11/38 (28.95%)  6/18 (33.33%) 
Tremor † 1  2/37 (5.41%)  0/38 (0.00%)  0/18 (0.00%) 
Dysgeusia † 1  0/37 (0.00%)  3/38 (7.89%)  2/18 (11.11%) 
Paresthesia † 1  0/37 (0.00%)  2/38 (5.26%)  0/18 (0.00%) 
Peripheral motor neuropathy † 1  0/37 (0.00%)  3/38 (7.89%)  0/18 (0.00%) 
Psychiatric disorders       
Anxiety † 1  11/37 (29.73%)  7/38 (18.42%)  0/18 (0.00%) 
Depression † 1  5/37 (13.51%)  3/38 (7.89%)  0/18 (0.00%) 
Insomnia † 1  10/37 (27.03%)  5/38 (13.16%)  0/18 (0.00%) 
Reproductive system and breast disorders       
Breast pain † 1  5/37 (13.51%)  0/38 (0.00%)  0/18 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Cough † 1  11/37 (29.73%)  7/38 (18.42%)  4/18 (22.22%) 
Dyspnea † 1  15/37 (40.54%)  17/38 (44.74%)  7/18 (38.89%) 
Epistaxis † 1  2/37 (5.41%)  0/38 (0.00%)  2/18 (11.11%) 
Nasal congestion † 1  4/37 (10.81%)  0/38 (0.00%)  2/18 (11.11%) 
Pneumonitis † 1  2/37 (5.41%)  0/38 (0.00%)  4/18 (22.22%) 
Sore throat † 1  2/37 (5.41%)  2/38 (5.26%)  0/18 (0.00%) 
Wheezing † 1  2/37 (5.41%)  0/38 (0.00%)  0/18 (0.00%) 
Hypoxia † 1  0/37 (0.00%)  2/38 (5.26%)  0/18 (0.00%) 
Pleural effusion † 1  0/37 (0.00%)  3/38 (7.89%)  0/18 (0.00%) 
Allergic rhinitis † 1  0/37 (0.00%)  0/38 (0.00%)  2/18 (11.11%) 
Hoarseness † 1  0/37 (0.00%)  0/38 (0.00%)  3/18 (16.67%) 
Skin and subcutaneous tissue disorders       
Alopecia † 1  4/37 (10.81%)  0/38 (0.00%)  5/18 (27.78%) 
Dry skin † 1  2/37 (5.41%)  2/38 (5.26%)  0/18 (0.00%) 
Pruritus † 1  5/37 (13.51%)  0/38 (0.00%)  2/18 (11.11%) 
Rash acneiform † 1  2/37 (5.41%)  2/38 (5.26%)  0/18 (0.00%) 
Rash maculo-papular † 1  3/37 (8.11%)  0/38 (0.00%)  5/18 (27.78%) 
Skin/subcutaneous tissue disorders; Other, specify † 1  4/37 (10.81%)  2/38 (5.26%)  0/18 (0.00%) 
Vascular disorders       
Flushing † 1  2/37 (5.41%)  0/38 (0.00%)  0/18 (0.00%) 
Hot flashes † 1  5/37 (13.51%)  0/38 (0.00%)  0/18 (0.00%) 
Hypertension † 1  10/37 (27.03%)  6/38 (15.79%)  0/18 (0.00%) 
Lymphedema † 1  2/37 (5.41%)  2/38 (5.26%)  2/18 (11.11%) 
Thromboembolic event † 1  0/37 (0.00%)  2/38 (5.26%)  0/18 (0.00%) 
1
Term from vocabulary, CTCAE (4.0)
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Sara Tolaney, MD, MPH
Organization: Dana-Farber Cancer Institute
Phone: 617-632-5743
EMail: Sara_Tolaney@dfci.harvard.edu
Layout table for additonal information
Responsible Party: Sara Tolaney, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT03414684    
Other Study ID Numbers: 17-512
CA209-9JX ( Other Identifier: Bristol-Myers Squibb )
First Submitted: December 1, 2017
First Posted: January 30, 2018
Results First Submitted: November 11, 2022
Results First Posted: January 26, 2023
Last Update Posted: January 12, 2024