R2810-ONC-1676

Regeneron Pharmaceuticals, Inc

777 Old Saw Mill River Road, Tarrytown, United States, 10591

Clinical Trials Administrator, Regeneron Pharmaceuticals, Inc., 001 844-734-6643, clinicaltrials@regeneron.com

Clinical Trials Administrator, Regeneron Pharmaceuticals, Inc, 001 844-734-6643, clinicaltrials@regeneron.com

No

No

No

Final

20 Apr 2023

No

Yes

20 Apr 2023

No

To compare overall survival (OS) for participants with recurrent or metastatic cervical cancer who have histology of squamous cell carcinoma (SCC) and who had any eligible histology, treated with either cemiplimab or investigator’s choice (IC) chemotherapy.

It is the responsibility of both the sponsor and the investigator(s) to ensure that this clinical study will be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with the ICH guidelines for GCP and applicable regulatory requirements

05 Sep 2017

No

Yes

Australia: 30

Belgium: 15

Brazil: 89

Canada: 42

Greece: 9

Italy: 35

Japan: 56

Korea, Republic of: 76

Poland: 45

Russian Federation: 85

Spain: 66

Taiwan: 34

United Kingdom: 2

United States: 24

608

170

0

0

0

0

0

0

533

73

2

Overall Study (overall period)

Randomised - controlled

Yes

LIBTAYO

REGN2810

cemiplimab

Concentrate for solution for infusion

Intravenous use

Fixed Dose of 350 mg at a frequency of Day 1, every three weeks

Antifolate: Pemetrexed

Concentrate for solution for infusion

Intravenous use

500 mg/m^2, , body surface area Day 1 every 3 weeks for up to 96 weeks

Topoisomerase 1 inhibitor: toptecan

Powder for concentrate for solution for infusion, Concentrate for solution for infusion

Intravenous use

1 mg/m^2 body surface area daily for 5 days, starting on Day 1 for three weeks (up to 96 weeks)

Vinca alkaloid: Vinorelbine

Concentrate for solution for infusion

Intravenous use

30 mg/m^2 for a frequency of Days 1 and 8 for every three weeks, for up to 96 weeks

Nucleoside analogue: gemcitabine

Concentrate for solution for infusion

Intravenous use

Dose: 1000 mg/m2 body surface area at a frequency of Days 1 and 8 every 3 weeks for up to 96 weeks

Topoisomerase 1 inhibitor: irinotecan

Concentrate for solution for infusion

Intravenous use

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 for up to 96 weeks

Cemiplimab

Investigator Choice (IC) Chemotherapy

Cemiplimab

Investigator Choice (IC) Chemotherapy

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.

Primary

Time from randomization to the date of death due to any cause (assessed up to 40 months)

Cemiplimab v Investigator Choice (IC) Chemotherapy

608

Pre-specified

0.665

2-sided

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

Primary

Time from randomization to the date of death due to any cause (assessed up to 40 months)

Cemiplimab v Investigator Choice (IC) Chemotherapy

477

Pre-specified

2-sided

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.

Secondary

From date of randomization up to 40 months

Cemiplimab v Investigator Choice (IC) Chemotherapy

608

Pre-specified

3.136

2-sided

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.

Secondary

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

Cemiplimab v Investigator Choice (IC) Chemotherapy

608

Pre-specified

0.741

2-sided

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. Here ‘n’ = the number of evaluable subjects at the specific point in time. Here ‘n’ = the number of evaluable participants

Secondary

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)

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. Here ‘n’ = the number of evaluable participants

Secondary

From date of randomization up to 40 months

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.

Secondary

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

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. Here ‘n’ = the number of evaluable participants

Secondary

From date of randomization up to 40 months

From first dose up to 40 months

25.1

Chemotherapy*

Cemiplimab

Chemotherapy to Cemiplimab*