The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of Cemiplimab in Adults With Cervical 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: NCT03257267
Recruitment Status : Completed
First Posted : August 22, 2017
Results First Posted : April 6, 2022
Last Update Posted : July 11, 2023
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Squamous Cell Carcinoma (SCC)
Recurrent or Metastatic, Platinum-refractory Cervical Cancer
Interventions Drug: Cemiplimab
Drug: Investigator Choice (IC) Chemotherapy
Enrollment 608
Recruitment Details  
Pre-assignment Details Eligible participants were randomized in a 1:1 ratio to receive cemiplimab or investigator choice of chemotherapy (control treatment determined before randomization by investigator from options per protocol). Randomization was stratified according to histologic type (squamous-cell carcinoma or adenocarcinoma [including adenosquamous carcinoma]), region (N. America/Asia/rest of world), previous bevacizumab exposure (y/n), & Eastern Cooperative Oncology Group (ECOG) performance-status score (0/1).
Arm/Group Title Cemiplimab Investigator Choice (IC) Chemotherapy
Hide Arm/Group Description Participants received a fixed dose of 350 milligrams (mg) of cemiplimab intravenous (IV) infusion on Day 1 of every 3 weeks (Q3W) for up to 96 weeks (up to 16 cycles of 6 weeks each) or until progression of disease or unacceptable toxicity, voluntary withdrawal from the study. Participants received IC of chemotherapy (options listed by class): (1) Antifolate: pemetrexed 500 mg per meter square (mg/m^2) on Day 1; (2) Topoisomerase 1 inhibitor: topotecan 1 mg/m^2 daily for 5 days, starting on Day 1 or irinotecan 100 mg/m^2 weekly (Days 1, 8, 15 and 22), followed by 10 to 14 days rest, for a 42-day (6-week) cycle; (3) Nucleoside analogue: gemcitabine 1000 mg/m^2 on Days 1 and 8; (4) Vinca alkaloid: vinorelbine 30 mg/m^2 IV infusion based on body surface area for Q3W up to 96 weeks (up to 16 cycles of 6 weeks each) or until progression of disease or unacceptable toxicity, voluntary withdrawal from the study.
Period Title: Overall Study
Started 304 304
Full Analysis Set (FAS) [1] 304 304
Safety Analysis Set (SAF) [2] 300 290
Completed Treatment 13 0
Completed [3] 7 0
Not Completed 297 304
Reason Not Completed
Adverse Event             9             7
Death             92             95
Lost to Follow-up             2             2
Non-compliance with Study Drug             0             1
Participant Decision             34             42
Physician Decision             1             3
Disease Progression             98             117
Withdrawal of Consent             8             26
Study Ongoing             53             11
[1]
The FAS included all randomized participants.
[2]
The SAF included all randomized participants who received any study drug.
[3]
Completed Study
Arm/Group Title Cemiplimab Investigator Choice (IC) Chemotherapy Total
Hide Arm/Group Description Participants received a fixed dose of 350 milligrams (mg) of cemiplimab intravenous (IV) infusion on Day 1 of every 3 weeks (Q3W) for up to 96 weeks (up to 16 cycles of 6 weeks each) or until progression of disease or unacceptable toxicity, voluntary withdrawal from the study. Participants received IC of chemotherapy (options listed by class): (1) Antifolate: pemetrexed 500 mg per meter square (mg/m^2) on Day 1; (2) Topoisomerase 1 inhibitor: topotecan 1 mg/m^2 daily for 5 days, starting on Day 1 or irinotecan 100 mg/m^2 weekly (Days 1, 8, 15 and 22), followed by 10 to 14 days rest, for a 42-day (6-week) cycle; (3) Nucleoside analogue: gemcitabine 1000 mg/m^2 on Days 1 and 8; (4) Vinca alkaloid: vinorelbine 30 mg/m^2 IV infusion based on body surface area for Q3W up to 96 weeks (up to 16 cycles of 6 weeks each) or until progression of disease or unacceptable toxicity, voluntary withdrawal from the study. Total of all reporting groups
Overall Number of Baseline Participants 304 304 608
Hide Baseline Analysis Population Description
The FAS included all randomized participants.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 304 participants 304 participants 608 participants
51.0
(22 to 81)
50.0
(24 to 87)
51.0
(22 to 87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 304 participants 304 participants 608 participants
Female
304
 100.0%
304
 100.0%
608
 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 304 participants 304 participants 608 participants
Hispanic or Latino
47
  15.5%
44
  14.5%
91
  15.0%
Not Hispanic or Latino
251
  82.6%
250
  82.2%
501
  82.4%
Unknown or Not Reported
6
   2.0%
10
   3.3%
16
   2.6%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 304 participants 304 participants 608 participants
White 193 192 385
Black or African American 9 12 21
Asian 88 88 176
American Indian or Alaska Native 2 1 3
Other 8 4 12
Unknown 1 1 2
Not Reported 3 6 9
1.Primary Outcome
Title Overall Survival (OS)
Hide Description Overall survival was defined as the time from randomization to the date of death due to any cause. A participant who had not died was censored at the last known date of contact.
Time Frame Time from randomization to the date of death due to any cause (assessed up to 40 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) included all randomized participants.
Arm/Group Title Cemiplimab Investigator Choice (IC) Chemotherapy
Hide Arm/Group Description:
Participants received a fixed dose of 350 milligrams (mg) of cemiplimab intravenous (IV) infusion on Day 1 of every 3 weeks (Q3W) for up to 96 weeks (up to 16 cycles of 6 weeks each) or until progression of disease or unacceptable toxicity, voluntary withdrawal from the study.
Participants received IC of chemotherapy (options listed by class): (1) Antifolate: pemetrexed 500 mg per meter square (mg/m^2) on Day 1; (2) Topoisomerase 1 inhibitor: topotecan 1 mg/m^2 daily for 5 days, starting on Day 1 or irinotecan 100 mg/m^2 weekly (Days 1, 8, 15 and 22), followed by 10 to 14 days rest, for a 42-day (6-week) cycle; (3) Nucleoside analogue: gemcitabine 1000 mg/m^2 on Days 1 and 8; (4) Vinca alkaloid: vinorelbine 30 mg/m^2 IV infusion based on body surface area for Q3W up to 96 weeks (up to 16 cycles of 6 weeks each) or until progression of disease or unacceptable toxicity, voluntary withdrawal from the study.
Overall Number of Participants Analyzed 304 304
Median (95% Confidence Interval)
Unit of Measure: Months
12.0
(10.3 to 13.5)
8.5
(7.5 to 9.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cemiplimab, Investigator Choice (IC) Chemotherapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00011
Comments One-sided p-value
Method Stratified Log-rank Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.685
Confidence Interval (2-Sided) 95%
0.560 to 0.838
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Progression-free Survival (PFS) Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Hide Description PFS was defined as the time from randomization to the date of the first documented tumor progression (radiographic) or death due to any cause. Participants who do not have a documented tumor progression or death were censored on the date of their last evaluable tumor assessment.
Time Frame Time from randomization to the date of the first documented tumor progression or death due to any cause (assessed up to 40 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomized participants.
Arm/Group Title Cemiplimab Investigator Choice (IC) Chemotherapy
Hide Arm/Group Description:
Participants received a fixed dose of 350 milligrams (mg) of cemiplimab intravenous (IV) infusion on Day 1 of every 3 weeks (Q3W) for up to 96 weeks (up to 16 cycles of 6 weeks each) or until progression of disease or unacceptable toxicity, voluntary withdrawal from the study.
Participants received IC of chemotherapy (options listed by class): (1) Antifolate: pemetrexed 500 mg per meter square (mg/m^2) on Day 1; (2) Topoisomerase 1 inhibitor: topotecan 1 mg/m^2 daily for 5 days, starting on Day 1 or irinotecan 100 mg/m^2 weekly (Days 1, 8, 15 and 22), followed by 10 to 14 days rest, for a 42-day (6-week) cycle; (3) Nucleoside analogue: gemcitabine 1000 mg/m^2 on Days 1 and 8; (4) Vinca alkaloid: vinorelbine 30 mg/m^2 IV infusion based on body surface area for Q3W up to 96 weeks (up to 16 cycles of 6 weeks each) or until progression of disease or unacceptable toxicity, voluntary withdrawal from the study.
Overall Number of Participants Analyzed 304 304
Median (95% Confidence Interval)
Unit of Measure: Months
2.8
(2.6 to 3.9)
2.9
(2.7 to 3.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cemiplimab, Investigator Choice (IC) Chemotherapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00048
Comments [Not Specified]
Method Stratified Log-rank Test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.745
Confidence Interval (2-Sided) 95%
0.625 to 0.890
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Objective Response Rate (ORR) Assessed by Investigator Using RECIST 1.1
Hide Description ORR was defined as the number of participants who achieved complete response (CR) or partial response (PR) as per RECIST 1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeters (mm) (<1 centimeter [cm]). PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Time Frame From date of randomization up to 40 months
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomized participants.
Arm/Group Title Cemiplimab Investigator Choice (IC) Chemotherapy
Hide Arm/Group Description:
Participants received a fixed dose of 350 milligrams (mg) of cemiplimab intravenous (IV) infusion on Day 1 of every 3 weeks (Q3W) for up to 96 weeks (up to 16 cycles of 6 weeks each) or until progression of disease or unacceptable toxicity, voluntary withdrawal from the study.
Participants received IC of chemotherapy (options listed by class): (1) Antifolate: pemetrexed 500 mg per meter square (mg/m^2) on Day 1; (2) Topoisomerase 1 inhibitor: topotecan 1 mg/m^2 daily for 5 days, starting on Day 1 or irinotecan 100 mg/m^2 weekly (Days 1, 8, 15 and 22), followed by 10 to 14 days rest, for a 42-day (6-week) cycle; (3) Nucleoside analogue: gemcitabine 1000 mg/m^2 on Days 1 and 8; (4) Vinca alkaloid: vinorelbine 30 mg/m^2 IV infusion based on body surface area for Q3W up to 96 weeks (up to 16 cycles of 6 weeks each) or until progression of disease or unacceptable toxicity, voluntary withdrawal from the study.
Overall Number of Participants Analyzed 304 304
Measure Type: Count of Participants
Unit of Measure: Participants
50
  16.4%
19
   6.3%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cemiplimab, Investigator Choice (IC) Chemotherapy
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.00004
Comments [Not Specified]
Method Stratified Cochran-Mantel-Haenszel test
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.984
Confidence Interval (2-Sided) 95%
1.707 to 5.215
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Duration of Response (DOR) Assessed Per RECIST 1.1
Hide Description DOR was defined as the time from the date of first response (CR or PR) to the date of the first documented progressive disease (per RECIST 1.1) or death due to any cause. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm (<1 cm). PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Participants who never progress while being followed was censored at the last valid tumor measurement. DOR was determined by Kaplan-Meier estimate.
Time Frame Time from the date of first response to the date of the first documented progressive disease or death due to any cause (up to 40 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomized participants with confirmed CR or PR
Arm/Group Title Cemiplimab Investigator Choice (IC) Chemotherapy
Hide Arm/Group Description:
Participants received a fixed dose of 350 milligrams (mg) of cemiplimab intravenous (IV) infusion on Day 1 of every 3 weeks (Q3W) for up to 96 weeks (up to 16 cycles of 6 weeks each) or until progression of disease or unacceptable toxicity, voluntary withdrawal from the study.
Participants received IC of chemotherapy (options listed by class): (1) Antifolate: pemetrexed 500 mg per meter square (mg/m^2) on Day 1; (2) Topoisomerase 1 inhibitor: topotecan 1 mg/m^2 daily for 5 days, starting on Day 1 or irinotecan 100 mg/m^2 weekly (Days 1, 8, 15 and 22), followed by 10 to 14 days rest, for a 42-day (6-week) cycle; (3) Nucleoside analogue: gemcitabine 1000 mg/m^2 on Days 1 and 8; (4) Vinca alkaloid: vinorelbine 30 mg/m^2 IV infusion based on body surface area for Q3W up to 96 weeks (up to 16 cycles of 6 weeks each) or until progression of disease or unacceptable toxicity, voluntary withdrawal from the study.
Overall Number of Participants Analyzed 50 19
Median (95% Confidence Interval)
Unit of Measure: Months
16.4 [1] 
(12.4 to NA)
6.9
(5.1 to 7.7)
[1]
Data could not be estimated due to higher number (> 50%) of censored participants.
5.Secondary Outcome
Title Quality of Life (QoL): Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) of Global Health Status /Quality of Life (GHS/QoL) and Physical Functioning Scales
Hide Description EORTC QLQ-C30 is a 30-question tool used to assess the overall QoL in cancer participants. It consisted of 15 domains: 1 GHS/QoL scale, 5 functional scales (Physical, role, cognitive, emotional, social), and 9 symptom scales/items (Fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact). Most items are scored 1 ("not at all") to 4 ("very much") except for the items contributing to the GHS/QoL, which are scored 1 ("very poor") to 7 ("excellent"). A linear transformation was applied to the raw scores so that all transformed scores lie between 0 to 100. For the GHS/QoL and 5 functional scales a high score indicates better global health status/functioning and a negative change from baseline indicated less improvement. For the symptom scales, a high score indicates a higher level of symptoms, and a negative change from baseline indicated an improvement in symptoms.
Time Frame From Cycle 1 Day 1 up to 40 months (Each cycle = 42 days)
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomized participants.
Arm/Group Title Cemiplimab Investigator Choice (IC) Chemotherapy
Hide Arm/Group Description:
Participants received a fixed dose of 350 milligrams (mg) of cemiplimab intravenous (IV) infusion on Day 1 of every 3 weeks (Q3W) for up to 96 weeks (up to 16 cycles of 6 weeks each) or until progression of disease or unacceptable toxicity, voluntary withdrawal from the study.
Participants received IC of chemotherapy (options listed by class): (1) Antifolate: pemetrexed 500 mg per meter square (mg/m^2) on Day 1; (2) Topoisomerase 1 inhibitor: topotecan 1 mg/m^2 daily for 5 days, starting on Day 1 or irinotecan 100 mg/m^2 weekly (Days 1, 8, 15 and 22), followed by 10 to 14 days rest, for a 42-day (6-week) cycle; (3) Nucleoside analogue: gemcitabine 1000 mg/m^2 on Days 1 and 8; (4) Vinca alkaloid: vinorelbine 30 mg/m^2 IV infusion based on body surface area for Q3W up to 96 weeks (up to 16 cycles of 6 weeks each) or until progression of disease or unacceptable toxicity, voluntary withdrawal from the study.
Overall Number of Participants Analyzed 304 304
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Score on a Scale
Overall: Change from Baseline of EORTC QLQ-C30 GHS/QoL
1.01
(-2.033 to 4.047)
-6.81
(-10.977 to -2.637)
Overall: Changes from Baseline of EORTC QLQ-C30 Physical Functioning
-0.45
(-3.197 to 2.298)
-8.70
(-12.300 to -5.110)
6.Secondary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Death
Hide Description An adverse event (AE) was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. A TEAE was defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the on-treatment period. A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life- threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious TEAEs. Number of participants with TEAEs, serious TEAEs, and TEAEs leading to death were reported.
Time Frame From date of randomization up to 40 months
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set (SAF) included all randomized participants who received any study drug.
Arm/Group Title Cemiplimab Investigator Choice (IC) Chemotherapy
Hide Arm/Group Description:
Participants received a fixed dose of 350 milligrams (mg) of cemiplimab intravenous (IV) infusion on Day 1 of every 3 weeks (Q3W) for up to 96 weeks (up to 16 cycles of 6 weeks each) or until progression of disease or unacceptable toxicity, voluntary withdrawal from the study.
Participants received IC of chemotherapy (options listed by class): (1) Antifolate: pemetrexed 500 mg per meter square (mg/m^2) on Day 1; (2) Topoisomerase 1 inhibitor: topotecan 1 mg/m^2 daily for 5 days, starting on Day 1 or irinotecan 100 mg/m^2 weekly (Days 1, 8, 15 and 22), followed by 10 to 14 days rest, for a 42-day (6-week) cycle; (3) Nucleoside analogue: gemcitabine 1000 mg/m^2 on Days 1 and 8; (4) Vinca alkaloid: vinorelbine 30 mg/m^2 IV infusion based on body surface area for Q3W up to 96 weeks (up to 16 cycles of 6 weeks each) or until progression of disease or unacceptable toxicity, voluntary withdrawal from the study.
Overall Number of Participants Analyzed 300 290
Measure Type: Count of Participants
Unit of Measure: Participants
Participants with any TEAE
265
  88.3%
265
  91.4%
Participants with any Serious TEAE
89
  29.7%
78
  26.9%
Participants with any TEAE leading to Death
5
   1.7%
2
   0.7%
7.Secondary Outcome
Title Number of Participants With New or Worsened Laboratory Results by National Cancer Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE) Grade
Hide Description Laboratory parameters included hematology, electrolytes, chemistry (other), and liver function. Clinically significant abnormalities were determined by the investigator based on NCI-CTCAE Grade where Grade 1 = Mild, Grade 2 = moderate, Grade 3 = severe; Grade 4 = life threatening or disabling; Grade 5 = death. Participants with at least 1 lab abnormality Graded 3/4 in hematology, electrolytes, chemistry (other), or liver function reported.
Time Frame From date of randomization up to 40 months
Hide Outcome Measure Data
Hide Analysis Population Description
The SAF included all randomized participants who received any study drug.
Arm/Group Title Cemiplimab Investigator Choice (IC) Chemotherapy
Hide Arm/Group Description:
Participants received a fixed dose of 350 milligrams (mg) of cemiplimab intravenous (IV) infusion on Day 1 of every 3 weeks (Q3W) for up to 96 weeks (up to 16 cycles of 6 weeks each) or until progression of disease or unacceptable toxicity, voluntary withdrawal from the study.
Participants received IC of chemotherapy (options listed by class): (1) Antifolate: pemetrexed 500 mg per meter square (mg/m^2) on Day 1; (2) Topoisomerase 1 inhibitor: topotecan 1 mg/m^2 daily for 5 days, starting on Day 1 or irinotecan 100 mg/m^2 weekly (Days 1, 8, 15 and 22), followed by 10 to 14 days rest, for a 42-day (6-week) cycle; (3) Nucleoside analogue: gemcitabine 1000 mg/m^2 on Days 1 and 8; (4) Vinca alkaloid: vinorelbine 30 mg/m^2 IV infusion based on body surface area for Q3W up to 96 weeks (up to 16 cycles of 6 weeks each) or until progression of disease or unacceptable toxicity, voluntary withdrawal from the study.
Overall Number of Participants Analyzed 300 290
Measure Type: Count of Participants
Unit of Measure: Participants
Hematology (Grades 3/4) Number Analyzed 293 participants 278 participants
83
  28.3%
137
  49.3%
Electrolytes (Grades 3/4) Number Analyzed 294 participants 271 participants
42
  14.3%
32
  11.8%
Chemistry (Other) (Grades 3/4) Number Analyzed 294 participants 272 participants
12
   4.1%
10
   3.7%
Liver Function (Grades 3/4) Number Analyzed 294 participants 271 participants
27
   9.2%
24
   8.9%
Time Frame Up to 40 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cemiplimab Investigator Choice (IC) Chemotherapy
Hide Arm/Group Description Participants received a fixed dose of 350 milligrams (mg) of cemiplimab intravenous (IV) infusion on Day 1 of every 3 weeks (Q3W) for up to 96 weeks (up to 16 cycles of 6 weeks each) or until progression of disease or unacceptable toxicity, voluntary withdrawal from the study. Participants received IC of chemotherapy (options listed by class): (1) Antifolate: pemetrexed 500 mg per meter square (mg/m^2) on Day 1; (2) Topoisomerase 1 inhibitor: topotecan 1 mg/m^2 daily for 5 days, starting on Day 1 or irinotecan 100 mg/m^2 weekly (Days 1, 8, 15 and 22), followed by 10 to 14 days rest, for a 42-day (6-week) cycle; (3) Nucleoside analogue: gemcitabine 1000 mg/m^2 on Days 1 and 8; (4) Vinca alkaloid: vinorelbine 30 mg/m^2 IV infusion based on body surface area for Q3W up to 96 weeks (up to 16 cycles of 6 weeks each) or until progression of disease or unacceptable toxicity, voluntary withdrawal from the study.
All-Cause Mortality
Cemiplimab Investigator Choice (IC) Chemotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   181/300 (60.33%)      206/290 (71.03%)    
Hide Serious Adverse Events
Cemiplimab Investigator Choice (IC) Chemotherapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   91/300 (30.33%)      81/290 (27.93%)    
Blood and lymphatic system disorders     
Anaemia † 1  2/300 (0.67%)  2 14/290 (4.83%)  18
Febrile neutropenia † 1  3/300 (1.00%)  3 6/290 (2.07%)  6
Pancytopenia † 1  0/300 (0.00%)  0 3/290 (1.03%)  4
Thrombocytopenia † 1  0/300 (0.00%)  0 3/290 (1.03%)  3
Neutropenia † 1  0/300 (0.00%)  0 1/290 (0.34%)  1
Cardiac disorders     
Cardiac failure † 1  0/300 (0.00%)  0 1/290 (0.34%)  1
Autoimmune pericarditis † 1  1/300 (0.33%)  1 0/290 (0.00%)  0
Pericardial effusion † 1  1/300 (0.33%)  1 0/290 (0.00%)  0
Endocrine disorders     
Hypothyroidism † 1  1/300 (0.33%)  1 0/290 (0.00%)  0
Eye disorders     
Cataract † 1  1/300 (0.33%)  1 0/290 (0.00%)  0
Gastrointestinal disorders     
Diarrhoea † 1  2/300 (0.67%)  3 3/290 (1.03%)  3
Vomiting † 1  1/300 (0.33%)  1 3/290 (1.03%)  3
Ileus † 1  0/300 (0.00%)  0 2/290 (0.69%)  2
Rectal haemorrhage † 1  0/300 (0.00%)  0 2/290 (0.69%)  2
Abdominal pain † 1  2/300 (0.67%)  2 1/290 (0.34%)  1
Diverticular perforation † 1  0/300 (0.00%)  0 1/290 (0.34%)  1
Haematochezia † 1  0/300 (0.00%)  0 1/290 (0.34%)  1
Intestinal obstruction † 1  1/300 (0.33%)  1 1/290 (0.34%)  1
Stomatitis † 1  0/300 (0.00%)  0 1/290 (0.34%)  1
Upper gastrointestinal haemorrhage † 1  0/300 (0.00%)  0 1/290 (0.34%)  1
Colitis † 1  1/300 (0.33%)  1 0/290 (0.00%)  0
Colonic fistula † 1  1/300 (0.33%)  1 0/290 (0.00%)  0
Duodenal ulcer † 1  2/300 (0.67%)  2 0/290 (0.00%)  0
Gastritis † 1  1/300 (0.33%)  1 0/290 (0.00%)  0
Nausea † 1  1/300 (0.33%)  1 0/290 (0.00%)  0
Oral papule † 1  1/300 (0.33%)  1 0/290 (0.00%)  0
Rectal perforation † 1  1/300 (0.33%)  1 0/290 (0.00%)  0
General disorders     
Pyrexia † 1  4/300 (1.33%)  4 5/290 (1.72%)  6
Catheter site thrombosis † 1  0/300 (0.00%)  0 1/290 (0.34%)  1
Multiple organ dysfunction syndrome † 1  0/300 (0.00%)  0 1/290 (0.34%)  1
Pain † 1  0/300 (0.00%)  0 1/290 (0.34%)  1
Performance status decreased † 1  0/300 (0.00%)  0 1/290 (0.34%)  1
Asthenia † 1  1/300 (0.33%)  1 0/290 (0.00%)  0
Death † 1  1/300 (0.33%)  1 0/290 (0.00%)  0
Hyperpyrexia † 1  2/300 (0.67%)  2 0/290 (0.00%)  0
Influenza like illness † 1  1/300 (0.33%)  1 0/290 (0.00%)  0
Soft tissue inflammation † 1  1/300 (0.33%)  1 0/290 (0.00%)  0
Sudden death † 1  1/300 (0.33%)  1 0/290 (0.00%)  0
Vascular stent thrombosis † 1  1/300 (0.33%)  1 0/290 (0.00%)  0
Hepatobiliary disorders     
Autoimmune hepatitis † 1  4/300 (1.33%)  4 0/290 (0.00%)  0
Cholecystitis acute † 1  1/300 (0.33%)  1 0/290 (0.00%)  0
Hepatic function abnormal † 1  1/300 (0.33%)  1 0/290 (0.00%)  0
Immune-mediated hepatitis † 1  3/300 (1.00%)  3 0/290 (0.00%)  0
Immune system disorders     
Hypersensitivity † 1  0/300 (0.00%)  0 1/290 (0.34%)  1
Contrast media allergy † 1  1/300 (0.33%)  1 0/290 (0.00%)  0
Infections and infestations     
Urinary tract infection † 1  12/300 (4.00%)  16 10/290 (3.45%)  12
Pneumonia † 1  4/300 (1.33%)  4 3/290 (1.03%)  4
Pyelonephritis † 1  3/300 (1.00%)  3 3/290 (1.03%)  3
Cellulitis † 1  1/300 (0.33%)  4 2/290 (0.69%)  2
Pyelonephritis acute † 1  2/300 (0.67%)  2 2/290 (0.69%)  2
Catheter site infection † 1  1/300 (0.33%)  1 1/290 (0.34%)  1
Gastroenteritis † 1  0/300 (0.00%)  0 1/290 (0.34%)  1
Gastroenteritis viral † 1  0/300 (0.00%)  0 1/290 (0.34%)  1
Infected lymphocele † 1  0/300 (0.00%)  0 1/290 (0.34%)  1
Infection † 1  0/300 (0.00%)  0 1/290 (0.34%)  1
Neutropenic sepsis † 1  0/300 (0.00%)  0 1/290 (0.34%)  1
Pelvic abscess † 1  1/300 (0.33%)  1 1/290 (0.34%)  1
Peritonitis † 1  1/300 (0.33%)  1 1/290 (0.34%)  1
Respiratory tract infection † 1  0/300 (0.00%)  0 1/290 (0.34%)  1
Skin infection † 1  1/300 (0.33%)  1 1/290 (0.34%)  1
Staphylococcal bacteraemia † 1  0/300 (0.00%)  0 1/290 (0.34%)  1
Staphylococcal infection † 1  0/300 (0.00%)  0 1/290 (0.34%)  1
Streptococcal sepsis † 1  0/300 (0.00%)  0 1/290 (0.34%)  1
Toxic shock syndrome streptococcal † 1  0/300 (0.00%)  0 1/290 (0.34%)  1
Urosepsis † 1  0/300 (0.00%)  0 1/290 (0.34%)  1
COVID-19 pneumonia † 1  1/300 (0.33%)  1 0/290 (0.00%)  0
Clostridium difficile infection † 1  1/300 (0.33%)  1 0/290 (0.00%)  0
Device related infection † 1  1/300 (0.33%)  1 0/290 (0.00%)  0
Empyema † 1  1/300 (0.33%)  1 0/290 (0.00%)  0
Kidney infection † 1  2/300 (0.67%)  3 0/290 (0.00%)  0
Ophthalmic herpes zoster † 1  1/300 (0.33%)  1 0/290 (0.00%)  0
Pyomyositis † 1  1/300 (0.33%)  1 0/290 (0.00%)  0
Sepsis † 1  2/300 (0.67%)  2 0/290 (0.00%)  0
Staphylococcal sepsis † 1  1/300 (0.33%)  1 0/290 (0.00%)  0
Stoma site infection † 1  1/300 (0.33%)  1 0/290 (0.00%)  0
Urinary tract infection bacterial † 1  1/300 (0.33%)  1 0/290 (0.00%)  0
Viral rash † 1  1/300 (0.33%)  1 0/290 (0.00%)  0
Viral upper respiratory tract infection † 1  1/300 (0.33%)  1 0/290 (0.00%)  0
Injury, poisoning and procedural complications     
Transfusion reaction † 1  0/300 (0.00%)  0 2/290 (0.69%)  2
Overdose † 1  0/300 (0.00%)  0 1/290 (0.34%)  1
Cystitis radiation † 1  1/300 (0.33%)  1 0/290 (0.00%)  0
Device use error † 1  1/300 (0.33%)  1 0/290 (0.00%)  0
Spinal compression fracture † 1  1/300 (0.33%)  1 0/290 (0.00%)  0
Investigations     
Blood creatinine increased † 1  3/300 (1.00%)  3 1/290 (0.34%)  1
Lymphocyte count decreased † 1  0/300 (0.00%)  0 1/290 (0.34%)  1
Neutrophil count decreased † 1  0/300 (0.00%)  0 1/290 (0.34%)  1
Blood creatine phosphokinase MB increased † 1  1/300 (0.33%)  1 0/290 (0.00%)  0
Platelet count decreased † 1  1/300 (0.33%)  1 0/290 (0.00%)  0
Metabolism and nutrition disorders     
Hyperglycaemia † 1  0/300 (0.00%)  0 1/290 (0.34%)  1
Hypocalcaemia † 1  0/300 (0.00%)  0 1/290 (0.34%)  1
Hypokalaemia † 1  0/300 (0.00%)  0 1/290 (0.34%)  1
Hypomagnesaemia † 1  0/300 (0.00%)  0 1/290 (0.34%)  1
Hyponatraemia † 1  0/300 (0.00%)  0 1/290 (0.34%)  1
Decreased appetite † 1  1/300 (0.33%)  1 0/290 (0.00%)  0
Electrolyte imbalance † 1  1/300 (0.33%)  1 0/290 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Flank pain † 1  0/300 (0.00%)  0 1/290 (0.34%)  1
Muscular weakness † 1  1/300 (0.33%)  1 1/290 (0.34%)  1
Pathological fracture † 1  1/300 (0.33%)  1 1/290 (0.34%)  1
Arthritis † 1  1/300 (0.33%)  1 0/290 (0.00%)  0
Back pain † 1  1/300 (0.33%)  1 0/290 (0.00%)  0
Groin pain † 1  1/300 (0.33%)  1 0/290 (0.00%)  0
Spondylolisthesis † 1  1/300 (0.33%)  1 0/290 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Tumour associated fever † 1  1/300 (0.33%)  1 0/290 (0.00%)  0
Nervous system disorders     
Seizure † 1  0/300 (0.00%)  0 2/290 (0.69%)  2
Transient ischaemic attack † 1  0/300 (0.00%)  0 1/290 (0.34%)  1
Cerebrovascular accident † 1  1/300 (0.33%)  2 0/290 (0.00%)  0
Ischaemic stroke † 1  1/300 (0.33%)  1 0/290 (0.00%)  0
Product Issues     
Device occlusion † 1  1/300 (0.33%)  1 1/290 (0.34%)  1
Psychiatric disorders     
Anxiety † 1  1/300 (0.33%)  1 0/290 (0.00%)  0
Personality change † 1  1/300 (0.33%)  1 0/290 (0.00%)  0
Renal and urinary disorders     
Acute kidney injury † 1  5/300 (1.67%)  5 3/290 (1.03%)  3
Renal failure † 1  1/300 (0.33%)  1 2/290 (0.69%)  2
Chronic kidney disease † 1  0/300 (0.00%)  0 1/290 (0.34%)  1
Cystitis haemorrhagic † 1  1/300 (0.33%)  1 1/290 (0.34%)  1
Haematuria † 1  3/300 (1.00%)  4 1/290 (0.34%)  1
Renal colic † 1  0/300 (0.00%)  0 1/290 (0.34%)  1
Renal impairment † 1  0/300 (0.00%)  0 1/290 (0.34%)  1
Hydronephrosis † 1  3/300 (1.00%)  3 0/290 (0.00%)  0
Ureteric obstruction † 1  1/300 (0.33%)  1 0/290 (0.00%)  0
Urinary tract obstruction † 1  1/300 (0.33%)  1 0/290 (0.00%)  0
Reproductive system and breast disorders     
Female genital tract fistula † 1  1/300 (0.33%)  1 1/290 (0.34%)  1
Pelvic pain † 1  1/300 (0.33%)  1 1/290 (0.34%)  1
Vaginal haemorrhage † 1  1/300 (0.33%)  1 1/290 (0.34%)  1
Uterine haemorrhage † 1  1/300 (0.33%)  1 0/290 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism † 1  1/300 (0.33%)  1 2/290 (0.69%)  2
Cough † 1  0/300 (0.00%)  0 1/290 (0.34%)  1
Dyspnoea † 1  1/300 (0.33%)  1 1/290 (0.34%)  1
Pneumonitis † 1  3/300 (1.00%)  3 1/290 (0.34%)  1
Atelectasis † 1  1/300 (0.33%)  1 0/290 (0.00%)  0
Haemoptysis † 1  1/300 (0.33%)  1 0/290 (0.00%)  0
Pneumothorax † 1  1/300 (0.33%)  1 0/290 (0.00%)  0
Respiratory failure † 1  1/300 (0.33%)  1 0/290 (0.00%)  0
Skin and subcutaneous tissue disorders     
Drug eruption † 1  0/300 (0.00%)  0 1/290 (0.34%)  1
Rash † 1  1/300 (0.33%)  1 1/290 (0.34%)  1
Vascular disorders     
Arterial haemorrhage † 1  0/300 (0.00%)  0 1/290 (0.34%)  1
Deep vein thrombosis † 1  1/300 (0.33%)  1 1/290 (0.34%)  1
Hypotension † 1  0/300 (0.00%)  0 1/290 (0.34%)  1
Hypovolaemic shock † 1  0/300 (0.00%)  0 1/290 (0.34%)  1
Embolism arterial † 1  1/300 (0.33%)  1 0/290 (0.00%)  0
Subclavian vein thrombosis † 1  1/300 (0.33%)  1 0/290 (0.00%)  0
1
Term from vocabulary, MedDRA (23.1)
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cemiplimab Investigator Choice (IC) Chemotherapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   263/300 (87.67%)      264/290 (91.03%)    
Blood and lymphatic system disorders     
Anaemia † 1  75/300 (25.00%)  94 127/290 (43.79%)  159
Neutropenia † 1  9/300 (3.00%)  10 44/290 (15.17%)  74
Thrombocytopenia † 1  2/300 (0.67%)  2 15/290 (5.17%)  17
Endocrine disorders     
Hypothyroidism † 1  17/300 (5.67%)  17 0/290 (0.00%)  0
Gastrointestinal disorders     
Nausea † 1  59/300 (19.67%)  67 97/290 (33.45%)  172
Vomiting † 1  47/300 (15.67%)  61 66/290 (22.76%)  101
Constipation † 1  46/300 (15.33%)  50 59/290 (20.34%)  64
Diarrhoea † 1  32/300 (10.67%)  55 41/290 (14.14%)  60
Abdominal pain † 1  27/300 (9.00%)  28 34/290 (11.72%)  51
Stomatitis † 1  12/300 (4.00%)  12 22/290 (7.59%)  24
General disorders     
Pyrexia † 1  32/300 (10.67%)  48 61/290 (21.03%)  115
Asthenia † 1  33/300 (11.00%)  35 45/290 (15.52%)  63
Fatigue † 1  51/300 (17.00%)  53 45/290 (15.52%)  81
Oedema peripheral † 1  20/300 (6.67%)  20 16/290 (5.52%)  16
Infections and infestations     
Urinary tract infection † 1  27/300 (9.00%)  30 18/290 (6.21%)  22
Investigations     
Neutrophil count decreased † 1  3/300 (1.00%)  7 26/290 (8.97%)  64
Alanine aminotransferase increased † 1  13/300 (4.33%)  14 20/290 (6.90%)  26
Aspartate aminotransferase increased † 1  13/300 (4.33%)  18 19/290 (6.55%)  24
Blood creatinine increased † 1  17/300 (5.67%)  23 16/290 (5.52%)  16
White blood cell count decreased † 1  2/300 (0.67%)  3 16/290 (5.52%)  34
Metabolism and nutrition disorders     
Decreased appetite † 1  45/300 (15.00%)  48 46/290 (15.86%)  55
Hypoalbuminaemia † 1  21/300 (7.00%)  24 18/290 (6.21%)  18
Hypokalaemia † 1  19/300 (6.33%)  19 17/290 (5.86%)  19
Hyperglycaemia † 1  4/300 (1.33%)  4 16/290 (5.52%)  21
Musculoskeletal and connective tissue disorders     
Back pain † 1  34/300 (11.33%)  37 25/290 (8.62%)  26
Arthralgia † 1  31/300 (10.33%)  34 8/290 (2.76%)  11
Pain in extremity † 1  18/300 (6.00%)  19 8/290 (2.76%)  9
Nervous system disorders     
Headache † 1  22/300 (7.33%)  39 17/290 (5.86%)  18
Psychiatric disorders     
Insomnia † 1  19/300 (6.33%)  20 16/290 (5.52%)  17
Reproductive system and breast disorders     
Pelvic pain † 1  13/300 (4.33%)  14 15/290 (5.17%)  15
Vaginal haemorrhage † 1  15/300 (5.00%)  16 6/290 (2.07%)  9
Respiratory, thoracic and mediastinal disorders     
Cough † 1  20/300 (6.67%)  24 21/290 (7.24%)  28
Dyspnoea † 1  26/300 (8.67%)  27 17/290 (5.86%)  21
Skin and subcutaneous tissue disorders     
Rash † 1  18/300 (6.00%)  28 19/290 (6.55%)  22
Pruritus † 1  16/300 (5.33%)  17 15/290 (5.17%)  15
1
Term from vocabulary, MedDRA (23.1)
†
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.
The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Trials Administrator
Organization: Regeneron Pharmaceuticals, Inc
Phone: 844-734-6643
EMail: clinicaltrials@regeneron.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03257267    
Other Study ID Numbers: R2810-ONC-1676
2017-000350-19 ( EudraCT Number )
First Submitted: July 26, 2017
First Posted: August 22, 2017
Results First Submitted: March 11, 2022
Results First Posted: April 6, 2022
Last Update Posted: July 11, 2023