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Testing the Addition of Radiation Therapy to Immunotherapy for Merkel Cell Carcinoma

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: NCT03304639
Recruitment Status : Active, not recruiting
First Posted : October 9, 2017
Results First Posted : February 8, 2024
Last Update Posted : March 25, 2024
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Advanced Merkel Cell Carcinoma
Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8
Clinical Stage IV Cutaneous Merkel Cell Carcinoma AJCC v8
Metastatic Merkel Cell Carcinoma
Pathologic Stage III Cutaneous Merkel Cell Carcinoma AJCC v8
Pathologic Stage IIIA Cutaneous Merkel Cell Carcinoma AJCC v8
Pathologic Stage IIIB Cutaneous Merkel Cell Carcinoma AJCC v8
Pathologic Stage IV Cutaneous Merkel Cell Carcinoma AJCC v8
Interventions Biological: Pembrolizumab
Radiation: Stereotactic Body Radiation Therapy
Enrollment 9
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group I (Pembrolizumab) Group II (Pembrolizumab, SBRT)
Hide Arm/Group Description

Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.>

> Pembrolizumab: Given IV

Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo SBRT for 3 doses during cycle 1.> > Pembrolizumab: Given IV>

> Stereotactic Body Radiation Therapy: Undergo SBRT
Period Title: Overall Study
Started 4 5
Completed 4 5
Not Completed 0 0
Arm/Group Title Group I (Pembrolizumab) Group II (Pembrolizumab, SBRT) Total
Hide Arm/Group Description

Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.>

> Pembrolizumab: Given IV

Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo SBRT for 3 doses during cycle 1.> > Pembrolizumab: Given IV>

> Stereotactic Body Radiation Therapy: Undergo SBRT

 Total of all reporting groups
Overall Number of Baseline Participants 4 5 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 5 participants 9 participants
76.0  (9.7) 69.0  (9.2) 72.1  (9.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 5 participants 9 participants
Female
0
   0.0%
1
  20.0%
1
  11.1%
Male
4
 100.0%
4
  80.0%
8
  88.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 5 participants 9 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
4
 100.0%
5
 100.0%
9
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 5 participants 9 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
4
 100.0%
5
 100.0%
9
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Progression-free Survival (PFS)
Hide Description Will compare PFS in non-radiated lesion(s) of patients receiving either (a) stereotactic body radiation therapy (SBRT) + pembrolizumab compared to (b) pembrolizumab alone in patients with advanced Merkel cell carcinoma. Kaplan- Meier curves will be constructed and median PFS times will be calculated for each arm. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Time Frame From randomization to either disease progression or death (without progression), assessed up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group I (Pembrolizumab) Group II (Pembrolizumab, SBRT)
Hide Arm/Group Description:

Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

>

> Pembrolizumab: Given IV

Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo SBRT for 3 doses during cycle 1.

>

> Pembrolizumab: Given IV

>

> Stereotactic Body Radiation Therapy: Undergo SBRT
Overall Number of Participants Analyzed 4 5
Median (95% Confidence Interval)
Unit of Measure: months
7.5 [1] 
(1.6 to NA)
5.5 [1] 
(3.7 to NA)
[1]
Insufficient number of participants with events
2.Secondary Outcome
Title PFS Among All Response Evaluation Criteria in Solid Tumors Lesions
Hide Description Same as the primary endpoint, but includes both irradiated and non-radiated lesions. It is a time to event endpoint and will be evaluated using the Kaplan- Meier method. Median PFS times will be calculated for each arm and a cox proportional hazards model will be constructed to determine if there is a PFS benefit for patients receiving SBRT + pembrolizumab compared to pembrolizumab alone.
Time Frame From randomization to either evidence of disease progression or death (without evidence of progression), assessed up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group I (Pembrolizumab) Group II (Pembrolizumab, SBRT)
Hide Arm/Group Description:

Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

>

> Pembrolizumab: Given IV

Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo SBRT for 3 doses during cycle 1.

>

> Pembrolizumab: Given IV

>

> Stereotactic Body Radiation Therapy: Undergo SBRT
Overall Number of Participants Analyzed 4 5
Median (95% Confidence Interval)
Unit of Measure: months
7.5 [1] 
(1.6 to NA)
NA [1] 
(5.5 to NA)
[1]
Insufficient number of participants with events
3.Secondary Outcome
Title Overall Response Rate
Hide Description Defined as partial response (PR) on 2 consecutive evaluations. Response rates will be calculated and compared across treatment arms utilizing a chi-square test.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group I (Pembrolizumab) Group II (Pembrolizumab, SBRT)
Hide Arm/Group Description:

Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

>

> Pembrolizumab: Given IV

Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo SBRT for 3 doses during cycle 1.

>

> Pembrolizumab: Given IV

>

> Stereotactic Body Radiation Therapy: Undergo SBRT
Overall Number of Participants Analyzed 4 5
Measure Type: Count of Participants
Unit of Measure: Participants
1
  25.0%
2
  40.0%
4.Secondary Outcome
Title Progression-free Survival
Hide Description The rates of success will be calculated and compared across treatment arms utilizing a chi-square test.
Time Frame At 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group I (Pembrolizumab) Group II (Pembrolizumab, SBRT)
Hide Arm/Group Description:

Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.>

> Pembrolizumab: Given IV

Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo SBRT for 3 doses during cycle 1.> > Pembrolizumab: Given IV>

> Stereotactic Body Radiation Therapy: Undergo SBRT
Overall Number of Participants Analyzed 4 5
Measure Type: Count of Participants
Unit of Measure: Participants
1
  25.0%
2
  40.0%
5.Secondary Outcome
Title Incidence of Adverse Events
Hide Description Graded according to National Cancer Institute's Common Terminology Criteria for Adverse Events, version 5.0. Maximum grade adverse events will be summarized by treatment arm in a tabular setting.
Time Frame Up to 3 months
Outcome Measure Data Not Reported
6.Secondary Outcome
Title PFS for Lesions Chosen for Radiation Prior to Randomization
Hide Description The protocol irradiated tumors are considered to be controlled if they have no evidence of progression. No evidence of progression is defined as complete response, PR, or stable disease. Local control of the protocol-irradiated tumor will be described using the Kaplan-Meier technique.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Group I did not receive radiation per protocol.
Arm/Group Title Group I (Pembrolizumab) Group II (Pembrolizumab, SBRT)
Hide Arm/Group Description:

Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

>

> Pembrolizumab: Given IV

Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo SBRT for 3 doses during cycle 1.

>

> Pembrolizumab: Given IV

>

> Stereotactic Body Radiation Therapy: Undergo SBRT
Overall Number of Participants Analyzed 0 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
7.Secondary Outcome
Title Delivered Radiation Dose Using Cone-beam Computed Tomography (CT) Images
Hide Description Radiation doses will be summarized descriptively and compared to the planned dose.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Group I did not receive radiation per protocol.
Arm/Group Title Group I (Pembrolizumab) Group II (Pembrolizumab, SBRT)
Hide Arm/Group Description:

Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

>

> Pembrolizumab: Given IV

Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo SBRT for 3 doses during cycle 1.

>

> Pembrolizumab: Given IV

>

> Stereotactic Body Radiation Therapy: Undergo SBRT
Overall Number of Participants Analyzed 0 5
Median (Full Range)
Unit of Measure: cGY
Planned Dose Cycle 1 Number Analyzed 0 participants 5 participants
24
(8 to 24)
Actual Dose Cycle 1 Number Analyzed 0 participants 5 participants
24
(8 to 24)
Planned Dose Cycle 2 Number Analyzed 0 participants 2 participants
16
(8 to 24)
Actual Dose Cycle 2 Number Analyzed 0 participants 2 participants
16
(8 to 24)
Time Frame Up to 5 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group I (Pembrolizumab) Group II (Pembrolizumab, SBRT)
Hide Arm/Group Description Pembrolizumab: Given IV Stereotactic Body Radiation Therapy: Undergo SBRT
All-Cause Mortality
Group I (Pembrolizumab) Group II (Pembrolizumab, SBRT)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)      0/5 (0.00%)    
Hide Serious Adverse Events
Group I (Pembrolizumab) Group II (Pembrolizumab, SBRT)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/4 (0.00%)      0/5 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group I (Pembrolizumab) Group II (Pembrolizumab, SBRT)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/4 (100.00%)      5/5 (100.00%)    
Blood and lymphatic system disorders     
Anemia † 1  1/4 (25.00%)  28 1/5 (20.00%)  33
Cardiac disorders     
Myocardial infarction † 1  0/4 (0.00%)  0 1/5 (20.00%)  1
Sinus bradycardia † 1  0/4 (0.00%)  0 1/5 (20.00%)  4
Ear and labyrinth disorders     
Tinnitus † 1  1/4 (25.00%)  1 0/5 (0.00%)  0
Endocrine disorders     
Hypothyroidism † 1  1/4 (25.00%)  22 1/5 (20.00%)  8
Eye disorders     
Blurred vision † 1  0/4 (0.00%)  0 1/5 (20.00%)  4
Eye disorders - Other, specify † 1  0/4 (0.00%)  0 1/5 (20.00%)  4
Watering eyes † 1  0/4 (0.00%)  0 1/5 (20.00%)  8
Gastrointestinal disorders     
Abdominal pain † 1  0/4 (0.00%)  0 1/5 (20.00%)  1
Constipation † 1  0/4 (0.00%)  0 1/5 (20.00%)  2
Diarrhea † 1  1/4 (25.00%)  1 4/5 (80.00%)  27
Flatulence † 1  1/4 (25.00%)  1 0/5 (0.00%)  0
Gastroesophageal reflux disease † 1  1/4 (25.00%)  1 1/5 (20.00%)  1
Nausea † 1  1/4 (25.00%)  1 2/5 (40.00%)  23
Pancreatitis † 1  0/4 (0.00%)  0 1/5 (20.00%)  7
General disorders     
Edema limbs † 1  1/4 (25.00%)  2 2/5 (40.00%)  28
Fatigue † 1  1/4 (25.00%)  1 2/5 (40.00%)  59
Fever † 1  0/4 (0.00%)  0 1/5 (20.00%)  1
Gait disturbance † 1  0/4 (0.00%)  0 1/5 (20.00%)  35
Gen disord and admin site conds-Oth spec † 1  0/4 (0.00%)  0 1/5 (20.00%)  14
Generalized edema † 1  0/4 (0.00%)  0 1/5 (20.00%)  1
Pain † 1  0/4 (0.00%)  0 3/5 (60.00%)  5
Infections and infestations     
Papulopustular rash † 1  0/4 (0.00%)  0 1/5 (20.00%)  4
Wound infection † 1  0/4 (0.00%)  0 1/5 (20.00%)  2
Injury, poisoning and procedural complications     
Fall † 1  0/4 (0.00%)  0 1/5 (20.00%)  2
Investigations     
Aspartate aminotransferase increased † 1  1/4 (25.00%)  9 2/5 (40.00%)  2
Creatinine increased † 1  2/4 (50.00%)  2 0/5 (0.00%)  0
Lymphocyte count decreased † 1  1/4 (25.00%)  3 0/5 (0.00%)  0
Weight loss † 1  1/4 (25.00%)  1 0/5 (0.00%)  0
Metabolism and nutrition disorders     
Anorexia † 1  2/4 (50.00%)  2 2/5 (40.00%)  2
Dehydration † 1  1/4 (25.00%)  1 0/5 (0.00%)  0
Hyperglycemia † 1  1/4 (25.00%)  21 1/5 (20.00%)  4
Hypoalbuminemia † 1  1/4 (25.00%)  2 1/5 (20.00%)  1
Hypokalemia † 1  1/4 (25.00%)  5 2/5 (40.00%)  3
Hyponatremia † 1  1/4 (25.00%)  6 1/5 (20.00%)  4
Musculoskeletal and connective tissue disorders     
Arthralgia † 1  0/4 (0.00%)  0 1/5 (20.00%)  35
Arthritis † 1  0/4 (0.00%)  0 1/5 (20.00%)  35
Back pain † 1  1/4 (25.00%)  1 1/5 (20.00%)  2
Generalized muscle weakness † 1  1/4 (25.00%)  1 1/5 (20.00%)  1
Muscle weakness lower limb † 1  0/4 (0.00%)  0 2/5 (40.00%)  11
Musculoskeletal, conn tissue - Oth spec † 1  0/4 (0.00%)  0 1/5 (20.00%)  19
Myalgia † 1  0/4 (0.00%)  0 1/5 (20.00%)  2
Pain in extremity † 1  0/4 (0.00%)  0 1/5 (20.00%)  5
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Tumor hemorrhage † 1  0/4 (0.00%)  0 1/5 (20.00%)  1
Nervous system disorders     
Dysgeusia † 1  1/4 (25.00%)  1 0/5 (0.00%)  0
Extrapyramidal disorder † 1  0/4 (0.00%)  0 1/5 (20.00%)  1
Peripheral sensory neuropathy † 1  2/4 (50.00%)  3 2/5 (40.00%)  37
Psychiatric disorders     
Insomnia † 1  2/4 (50.00%)  2 1/5 (20.00%)  14
Renal and urinary disorders     
Urinary frequency † 1  0/4 (0.00%)  0 1/5 (20.00%)  12
Urinary urgency † 1  0/4 (0.00%)  0 1/5 (20.00%)  12
Respiratory, thoracic and mediastinal disorders     
Cough † 1  0/4 (0.00%)  0 1/5 (20.00%)  8
Hoarseness † 1  0/4 (0.00%)  0 1/5 (20.00%)  14
Postnasal drip † 1  0/4 (0.00%)  0 1/5 (20.00%)  3
Sneezing † 1  0/4 (0.00%)  0 1/5 (20.00%)  3
Skin and subcutaneous tissue disorders     
Dry skin † 1  1/4 (25.00%)  2 0/5 (0.00%)  0
Pruritus † 1  0/4 (0.00%)  0 3/5 (60.00%)  22
Rash maculo-papular † 1  0/4 (0.00%)  0 2/5 (40.00%)  5
Skin and subcut tissue disord - Oth spec † 1  1/4 (25.00%)  1 1/5 (20.00%)  3
Vascular disorders     
Hypertension † 1  1/4 (25.00%)  1 1/5 (20.00%)  30
Hypotension † 1  0/4 (0.00%)  0 1/5 (20.00%)  2
Lymphedema † 1  0/4 (0.00%)  0 1/5 (20.00%)  2
1
Term from vocabulary, MEDRA 5
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Jason Luke
Organization: University of Pittsburgh Medical Center
Phone: 412-647-2811
EMail: lukejj@upmc.edu
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT03304639    
Other Study ID Numbers: NCI-2017-01817
NCI-2017-01817 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
A091605 ( Other Identifier: Alliance for Clinical Trials in Oncology )
A091605 ( Other Identifier: CTEP )
U10CA180821 ( U.S. NIH Grant/Contract )
First Submitted: October 5, 2017
First Posted: October 9, 2017
Results First Submitted: June 28, 2023
Results First Posted: February 8, 2024
Last Update Posted: March 25, 2024