Trial Outcomes & Findings for Study of Cemiplimab in Adults With Cervical Cancer (NCT NCT03257267)

Last Updated: 2025-04-08

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

608 participants

Primary outcome timeframe

From first dose up to 90 following last dose (~42 months)

Results posted on

2025-04-08

Participant Flow

752 participants were screened, 144 participants failed screening, 608 participants randomized to receive cemiplimab or investigator choice of chemotherapy. Control treatment determined before randomization by investigator from options per protocol.

Participant milestones

Participant milestones
Measure	Cemiplimab 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.	Investigator Choice (IC) Chemotherapy 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 Study STARTED	304	304
Overall Study Full Analysis Set (FAS)	304	304
Overall Study Safety Analysis Set (SAF)	300	290
Overall Study Completed Treatment	38	0
Overall Study COMPLETED	35	0
Overall Study NOT COMPLETED	269	304

Reasons for withdrawal

Reasons for withdrawal
Measure	Cemiplimab 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.	Investigator Choice (IC) Chemotherapy 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 Study Adverse Event	17	7
Overall Study Death	96	98
Overall Study Lost to Follow-up	2	2
Overall Study Non-compliance with Study Drug	0	2
Overall Study Participant Decision	35	43
Overall Study Sponsor Decision	1	0
Overall Study Physician Decision	1	3
Overall Study Disease Progression	109	121
Overall Study Withdrawal by Subject	8	26
Overall Study Other	0	2

Baseline Characteristics

Study of Cemiplimab in Adults With Cervical Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cemiplimab n=304 Participants 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.	Investigator Choice (IC) Chemotherapy n=304 Participants 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 n=608 Participants Total of all reporting groups
Age, Continuous	51.1 Years STANDARD_DEVIATION 11.59 • n=93 Participants	51.2 Years STANDARD_DEVIATION 11.77 • n=4 Participants	51.1 Years STANDARD_DEVIATION 11.67 • n=27 Participants
Sex: Female, Male Female	304 Participants n=93 Participants	304 Participants n=4 Participants	608 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	47 Participants n=93 Participants	44 Participants n=4 Participants	91 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	251 Participants n=93 Participants	250 Participants n=4 Participants	501 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	6 Participants n=93 Participants	10 Participants n=4 Participants	16 Participants n=27 Participants
Race/Ethnicity, Customized White	193 Participants n=93 Participants	192 Participants n=4 Participants	385 Participants n=27 Participants
Race/Ethnicity, Customized Black or African American	9 Participants n=93 Participants	12 Participants n=4 Participants	21 Participants n=27 Participants
Race/Ethnicity, Customized Asian	88 Participants n=93 Participants	88 Participants n=4 Participants	176 Participants n=27 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	2 Participants n=93 Participants	1 Participants n=4 Participants	3 Participants n=27 Participants
Race/Ethnicity, Customized Other	8 Participants n=93 Participants	4 Participants n=4 Participants	12 Participants n=27 Participants
Race/Ethnicity, Customized Unknown	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Race/Ethnicity, Customized Not Reported	3 Participants n=93 Participants	6 Participants n=4 Participants	9 Participants n=27 Participants

PRIMARY outcome

Timeframe: From first dose up to 90 following last dose (~42 months)

Population: The full analysis set (FAS) included all randomized participants.

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.

Outcome measures

Outcome measures
Measure	Cemiplimab n=304 Participants 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.	Investigator Choice (IC) Chemotherapy n=304 Participants 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 Survival (OS)	11.7 Months Interval 9.6 to 13.4	8.5 Months Interval 7.5 to 9.6

PRIMARY outcome

Timeframe: From first dose up to 90 following last dose (~42 months)

Population: All randomized participants who presented SCC (Squamous cell carcinoma) histology. Here 'n' = the number of evaluable participants

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.

Outcome measures

Outcome measures
Measure	Cemiplimab n=239 Participants 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.	Investigator Choice (IC) Chemotherapy n=238 Participants 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 Survival (OS) in the SCC Population	10.9 Months Interval 8.9 to 12.9	8.8 Months Interval 7.6 to 9.8

SECONDARY outcome

Timeframe: Time from randomization to the date of the first documented tumor progression or death due to any cause (assessed up to 40 months)

Population: The FAS included all randomized participants.

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 did not have a documented tumor progression or death were censored on the date of their last evaluable tumor assessment.

Outcome measures

Outcome measures
Measure	Cemiplimab n=304 Participants 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.	Investigator Choice (IC) Chemotherapy n=304 Participants 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.
Progression-free Survival (PFS) Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST 1.1)	2.8 Months Interval 2.6 to 3.9	2.9 Months Interval 2.7 to 3.5

SECONDARY outcome

Timeframe: From date of randomization up to 40 months

Population: The FAS included all randomized participants.

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.

Outcome measures

Outcome measures
Measure	Cemiplimab n=304 Participants 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.	Investigator Choice (IC) Chemotherapy n=304 Participants 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.
Objective Response Rate (ORR) Assessed by Investigator Using RECIST 1.1	52 Participants	19 Participants

SECONDARY outcome

Timeframe: 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)

Population: The FAS included all randomized participants with confirmed CR or PR. Here 'n' = number of evaluable participants at a specified timeframe.

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 progressed while being followed was censored at the last valid tumor measurement. DOR was determined by Kaplan-Meier estimate.

Outcome measures

Outcome measures
Measure	Cemiplimab n=52 Participants 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.	Investigator Choice (IC) Chemotherapy n=19 Participants 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.
Duration of Response (DOR) Assessed Per RECIST 1.1	18.7 Months Interval 16.4 to Insufficient number of participants with events	7.2 Months Interval 5.1 to 9.9

SECONDARY outcome

Timeframe: From Cycle 1 Day 1 up to 40 months (Each cycle = 42 days)

Population: The FAS included all randomized participants.

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.

Outcome measures

Outcome measures
Measure	Cemiplimab n=304 Participants 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.	Investigator Choice (IC) Chemotherapy n=304 Participants 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.
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 Overall: Change from Baseline of EORTC QLQ-C30 GHS/QoL	0.46 Score on a Scale Interval -2.715 to 3.642	-8.54 Score on a Scale Interval -13.004 to -4.084
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 Overall: Changes from Baseline of EORTC QLQ-C30 Physical Functioning	-0.27 Score on a Scale Interval -3.014 to 2.473	-8.86 Score on a Scale Interval -12.517 to -5.196

SECONDARY outcome

Timeframe: From first dose up to 90 following last dose (~36 months)

Population: The safety analysis set (SAF) included all randomized participants who received any study drug. Here 'n' = number of evaluable participants at a specified timeframe.

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 Treatment-emergent adverse event (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.

Outcome measures

Outcome measures
Measure	Cemiplimab n=300 Participants 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.	Investigator Choice (IC) Chemotherapy n=290 Participants 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.
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Death Participants with any TEAE	269 Participants	266 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Death Participants with any Serious TEAE	96 Participants	78 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Death Participants with any TEAE leading to Death	5 Participants	2 Participants

SECONDARY outcome

Timeframe: From first dose up to 90 following last dose (~36 months)

Population: The SAF included all randomized participants who received any study drug. Here 'n' = number of evaluable participants at a specified timeframe.

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.

Outcome measures

Outcome measures
Measure	Cemiplimab n=300 Participants 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.	Investigator Choice (IC) Chemotherapy n=290 Participants 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.
Number of Participants With New or Worsened Laboratory Results by National Cancer Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE) Grade Hematology (Grades 3/4)	84 Participants	137 Participants
Number of Participants With New or Worsened Laboratory Results by National Cancer Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE) Grade Electrolytes (Grades 3/4)	47 Participants	32 Participants
Number of Participants With New or Worsened Laboratory Results by National Cancer Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE) Grade Chemistry (Other) (Grades 3/4)	12 Participants	10 Participants
Number of Participants With New or Worsened Laboratory Results by National Cancer Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE) Grade Liver Function (Grades 3/4)	28 Participants	23 Participants

Adverse Events

Cemiplimab

Serious events: 100 serious events

Other events: 239 other events

Deaths: 234 deaths

Chemotherapy*

Serious events: 84 serious events

Other events: 253 other events

Deaths: 249 deaths

Chemotherapy to Cemiplimab*

Serious events: 1 serious events

Other events: 4 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Additional Information

Clinical Trials Administrator

Regeneron Pharmaceuticals, Inc

Phone: 844-734-6643

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER

Measure	Cemiplimab n=300 participants at risk 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.	Chemotherapy* n=290 participants at risk 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.	Chemotherapy to Cemiplimab* n=8 participants at risk Treatment until disease progression, unacceptable toxicity, or voluntary withdrawal from the study, or until 96 weeks (16 cycles, each 6 weeks). 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.
Gastrointestinal disorders Nausea	21.0% 63/300 • Number of events 74 • From first dose up to 90 following last dose (~42 months)	34.5% 100/290 • Number of events 175 • From first dose up to 90 following last dose (~42 months)	0.00% 0/8 • From first dose up to 90 following last dose (~42 months)
Gastrointestinal disorders Vomiting	16.3% 49/300 • Number of events 65 • From first dose up to 90 following last dose (~42 months)	22.8% 66/290 • Number of events 101 • From first dose up to 90 following last dose (~42 months)	0.00% 0/8 • From first dose up to 90 following last dose (~42 months)
Gastrointestinal disorders Constipation	15.3% 46/300 • Number of events 50 • From first dose up to 90 following last dose (~42 months)	20.0% 58/290 • Number of events 64 • From first dose up to 90 following last dose (~42 months)	12.5% 1/8 • Number of events 1 • From first dose up to 90 following last dose (~42 months)
Gastrointestinal disorders Diarrhoea	11.7% 35/300 • Number of events 61 • From first dose up to 90 following last dose (~42 months)	14.1% 41/290 • Number of events 60 • From first dose up to 90 following last dose (~42 months)	12.5% 1/8 • Number of events 1 • From first dose up to 90 following last dose (~42 months)
Gastrointestinal disorders Abdominal pain	9.3% 28/300 • Number of events 31 • From first dose up to 90 following last dose (~42 months)	11.7% 34/290 • Number of events 52 • From first dose up to 90 following last dose (~42 months)	0.00% 0/8 • From first dose up to 90 following last dose (~42 months)
Gastrointestinal disorders Stomatitis	4.0% 12/300 • Number of events 12 • From first dose up to 90 following last dose (~42 months)	7.6% 22/290 • Number of events 24 • From first dose up to 90 following last dose (~42 months)	0.00% 0/8 • From first dose up to 90 following last dose (~42 months)
Blood and lymphatic system disorders Anaemia	26.3% 79/300 • Number of events 99 • From first dose up to 90 following last dose (~42 months)	44.1% 128/290 • Number of events 161 • From first dose up to 90 following last dose (~42 months)	0.00% 0/8 • From first dose up to 90 following last dose (~42 months)
Blood and lymphatic system disorders Neutropenia	3.0% 9/300 • Number of events 11 • From first dose up to 90 following last dose (~42 months)	15.5% 45/290 • Number of events 75 • From first dose up to 90 following last dose (~42 months)	0.00% 0/8 • From first dose up to 90 following last dose (~42 months)
Blood and lymphatic system disorders Thrombocytopenia	0.67% 2/300 • Number of events 2 • From first dose up to 90 following last dose (~42 months)	5.2% 15/290 • Number of events 17 • From first dose up to 90 following last dose (~42 months)	0.00% 0/8 • From first dose up to 90 following last dose (~42 months)
General disorders Pyrexia	12.0% 36/300 • Number of events 54 • From first dose up to 90 following last dose (~42 months)	21.4% 62/290 • Number of events 117 • From first dose up to 90 following last dose (~42 months)	25.0% 2/8 • Number of events 2 • From first dose up to 90 following last dose (~42 months)
General disorders Asthenia	11.7% 35/300 • Number of events 37 • From first dose up to 90 following last dose (~42 months)	15.5% 45/290 • Number of events 63 • From first dose up to 90 following last dose (~42 months)	0.00% 0/8 • From first dose up to 90 following last dose (~42 months)
General disorders Fatigue	17.3% 52/300 • Number of events 54 • From first dose up to 90 following last dose (~42 months)	15.5% 45/290 • Number of events 81 • From first dose up to 90 following last dose (~42 months)	0.00% 0/8 • From first dose up to 90 following last dose (~42 months)
General disorders Oedema peripheral	7.3% 22/300 • Number of events 22 • From first dose up to 90 following last dose (~42 months)	5.5% 16/290 • Number of events 16 • From first dose up to 90 following last dose (~42 months)	0.00% 0/8 • From first dose up to 90 following last dose (~42 months)
Investigations Neutrophil count decreased	1.0% 3/300 • Number of events 7 • From first dose up to 90 following last dose (~42 months)	9.0% 26/290 • Number of events 64 • From first dose up to 90 following last dose (~42 months)	0.00% 0/8 • From first dose up to 90 following last dose (~42 months)
Investigations Alanine aminotransferase increased	4.7% 14/300 • Number of events 14 • From first dose up to 90 following last dose (~42 months)	6.9% 20/290 • Number of events 26 • From first dose up to 90 following last dose (~42 months)	0.00% 0/8 • From first dose up to 90 following last dose (~42 months)
Investigations Aspartate aminotransferase increased	4.7% 14/300 • Number of events 19 • From first dose up to 90 following last dose (~42 months)	6.6% 19/290 • Number of events 25 • From first dose up to 90 following last dose (~42 months)	0.00% 0/8 • From first dose up to 90 following last dose (~42 months)
Investigations Blood creatinine increased	6.3% 19/300 • Number of events 26 • From first dose up to 90 following last dose (~42 months)	5.5% 16/290 • Number of events 16 • From first dose up to 90 following last dose (~42 months)	0.00% 0/8 • From first dose up to 90 following last dose (~42 months)
Investigations White blood cell count decreased	0.67% 2/300 • Number of events 3 • From first dose up to 90 following last dose (~42 months)	5.9% 17/290 • Number of events 35 • From first dose up to 90 following last dose (~42 months)	0.00% 0/8 • From first dose up to 90 following last dose (~42 months)
Metabolism and nutrition disorders Decreased appetite	15.3% 46/300 • Number of events 49 • From first dose up to 90 following last dose (~42 months)	15.9% 46/290 • Number of events 55 • From first dose up to 90 following last dose (~42 months)	0.00% 0/8 • From first dose up to 90 following last dose (~42 months)
Metabolism and nutrition disorders Hypoalbuminaemia	7.7% 23/300 • Number of events 26 • From first dose up to 90 following last dose (~42 months)	6.6% 19/290 • Number of events 19 • From first dose up to 90 following last dose (~42 months)	0.00% 0/8 • From first dose up to 90 following last dose (~42 months)
Metabolism and nutrition disorders Hypokalaemia	7.3% 22/300 • Number of events 23 • From first dose up to 90 following last dose (~42 months)	5.9% 17/290 • Number of events 20 • From first dose up to 90 following last dose (~42 months)	0.00% 0/8 • From first dose up to 90 following last dose (~42 months)
Metabolism and nutrition disorders Hyperglycaemia	1.3% 4/300 • Number of events 4 • From first dose up to 90 following last dose (~42 months)	5.5% 16/290 • Number of events 21 • From first dose up to 90 following last dose (~42 months)	0.00% 0/8 • From first dose up to 90 following last dose (~42 months)
Infections and infestations Urinary tract infection	9.0% 27/300 • Number of events 36 • From first dose up to 90 following last dose (~42 months)	6.2% 18/290 • Number of events 25 • From first dose up to 90 following last dose (~42 months)	0.00% 0/8 • From first dose up to 90 following last dose (~42 months)
Musculoskeletal and connective tissue disorders Back pain	11.0% 33/300 • Number of events 37 • From first dose up to 90 following last dose (~42 months)	9.7% 28/290 • Number of events 29 • From first dose up to 90 following last dose (~42 months)	0.00% 0/8 • From first dose up to 90 following last dose (~42 months)
Musculoskeletal and connective tissue disorders Arthralgia	11.0% 33/300 • Number of events 38 • From first dose up to 90 following last dose (~42 months)	2.8% 8/290 • Number of events 11 • From first dose up to 90 following last dose (~42 months)	0.00% 0/8 • From first dose up to 90 following last dose (~42 months)
Musculoskeletal and connective tissue disorders Pain in extremity	6.0% 18/300 • Number of events 20 • From first dose up to 90 following last dose (~42 months)	2.8% 8/290 • Number of events 9 • From first dose up to 90 following last dose (~42 months)	0.00% 0/8 • From first dose up to 90 following last dose (~42 months)
Skin and subcutaneous tissue disorders Rash	6.3% 19/300 • Number of events 29 • From first dose up to 90 following last dose (~42 months)	6.6% 19/290 • Number of events 22 • From first dose up to 90 following last dose (~42 months)	0.00% 0/8 • From first dose up to 90 following last dose (~42 months)
Skin and subcutaneous tissue disorders Pruritus	6.0% 18/300 • Number of events 19 • From first dose up to 90 following last dose (~42 months)	5.2% 15/290 • Number of events 15 • From first dose up to 90 following last dose (~42 months)	0.00% 0/8 • From first dose up to 90 following last dose (~42 months)
Nervous system disorders Headache	7.3% 22/300 • Number of events 43 • From first dose up to 90 following last dose (~42 months)	6.2% 18/290 • Number of events 19 • From first dose up to 90 following last dose (~42 months)	0.00% 0/8 • From first dose up to 90 following last dose (~42 months)
Respiratory, thoracic and mediastinal disorders Cough	6.7% 20/300 • Number of events 25 • From first dose up to 90 following last dose (~42 months)	7.2% 21/290 • Number of events 28 • From first dose up to 90 following last dose (~42 months)	0.00% 0/8 • From first dose up to 90 following last dose (~42 months)
Respiratory, thoracic and mediastinal disorders Dyspnoea	9.0% 27/300 • Number of events 28 • From first dose up to 90 following last dose (~42 months)	6.2% 18/290 • Number of events 22 • From first dose up to 90 following last dose (~42 months)	0.00% 0/8 • From first dose up to 90 following last dose (~42 months)
Psychiatric disorders Insomnia	6.7% 20/300 • Number of events 21 • From first dose up to 90 following last dose (~42 months)	5.9% 17/290 • Number of events 18 • From first dose up to 90 following last dose (~42 months)	0.00% 0/8 • From first dose up to 90 following last dose (~42 months)
Reproductive system and breast disorders Pelvic pain	4.3% 13/300 • Number of events 14 • From first dose up to 90 following last dose (~42 months)	5.5% 16/290 • Number of events 16 • From first dose up to 90 following last dose (~42 months)	0.00% 0/8 • From first dose up to 90 following last dose (~42 months)
Reproductive system and breast disorders Vaginal haemorrhage	5.0% 15/300 • Number of events 16 • From first dose up to 90 following last dose (~42 months)	2.1% 6/290 • Number of events 9 • From first dose up to 90 following last dose (~42 months)	0.00% 0/8 • From first dose up to 90 following last dose (~42 months)
Endocrine disorders Hypothyroidism	5.7% 17/300 • Number of events 17 • From first dose up to 90 following last dose (~42 months)	0.00% 0/290 • From first dose up to 90 following last dose (~42 months)	0.00% 0/8 • From first dose up to 90 following last dose (~42 months)
Infections and infestations Subcutaneous abscess	0.00% 0/300 • From first dose up to 90 following last dose (~42 months)	0.00% 0/290 • From first dose up to 90 following last dose (~42 months)	12.5% 1/8 • Number of events 1 • From first dose up to 90 following last dose (~42 months)
Injury, poisoning and procedural complications Infusion related reaction	2.7% 8/300 • Number of events 8 • From first dose up to 90 following last dose (~42 months)	4.5% 13/290 • Number of events 38 • From first dose up to 90 following last dose (~42 months)	12.5% 1/8 • Number of events 1 • From first dose up to 90 following last dose (~42 months)
Endocrine disorders Hyperthyroidism	3.0% 9/300 • Number of events 9 • From first dose up to 90 following last dose (~42 months)	0.00% 0/290 • From first dose up to 90 following last dose (~42 months)	12.5% 1/8 • Number of events 1 • From first dose up to 90 following last dose (~42 months)