An Open-Label, Randomized, Phase 3 Clinical Trial of REGN2810 Versus Investigator's Choice of Chemotherapy in Recurrent or Metastatic Cervical Carcinoma

Regeneron Pharmaceuticals104 sites in 7 countries608 target enrollmentSeptember 5, 2017

ConditionsSquamous Cell Carcinoma (SCC)Recurrent or Metastatic, Platinum-refractory Cervical Cancer

InterventionsCemiplimab Investigator Choice (IC) Chemotherapy

DrugsCemiplimab Investigator Choice (IC) Chemotherapy

Overview

Phase: Phase 3
Intervention: Cemiplimab
Conditions: Squamous Cell Carcinoma (SCC)
Sponsor: Regeneron Pharmaceuticals
Enrollment: 608
Locations: 104
Primary Endpoint: Overall Survival (OS)
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective is to compare overall survival (OS) for patients with recurrent or metastatic cervical cancer who have histology of squamous cell carcinoma (SCC) and who have any eligible histology treated with either cemiplimab or investigator's choice (IC) chemotherapy.

The secondary objectives performed among SCC patients and among all eligible histologies (SCC and adenocarcinoma/adenosquamous carcinoma (AC) are:

To compare progression-free survival (PFS) of cemiplimab versus IC chemotherapy
To compare objective response rate (ORR) (partial response [PR] + complete response [CR]) of cemiplimab versus IC chemotherapy per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
To compare the duration of response (DOR) of cemiplimab versus IC chemotherapy
To compare the safety profiles of cemiplimab versus IC chemotherapy by describing adverse events (AE)
To compare quality of life (QOL) for patients treated with cemiplimab versus IC chemotherapy using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)

Registry

clinicaltrials.gov

Start Date

September 5, 2017

End Date

April 20, 2023

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Regeneron Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Recurrent, persistent, and/or metastatic cervical cancer with squamous cell histology, for which there is not a curative-intent option (surgery or radiation therapy with or without chemotherapy).
•Acceptable histologies (squamous carcinoma, adenocarcinoma, and adenosquamous carcinoma) as defined in the protocol
•Tumor progression or recurrence after treatment with platinum therapy (must have been used to treat metastatic, persistent, or recurrent cervical cancer)
•Patient must have measurable disease as defined by RECIST 1.
•Eastern Cooperative Oncology Group (ECOG) performance status ≤1
•≥18 years old
•Adequate organ or bone marrow function
•Received prior bevacizumab therapy or had clinically documented reason why not administered
•Received prior paclitaxel therapy or had clinically documented reason why not administered

Exclusion Criteria

•Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments
•Prior treatment with an agent that blocks the PD-1/PD-L1 pathway
•Prior treatment with other systemic immune-modulating agents that was
•within fewer than 4 weeks (28 days) of the enrollment date, or
•associated with irAEs of any grade within 90 days prior to enrollment, or
•associated with toxicity that resulted in discontinuation of the immune modulating agent
•Active or untreated brain metastases
•Immunosuppressive corticosteroid doses (\>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of study drug cemiplimab or IC chemo)
•Active infection requiring therapy
•History of pneumonitis within the last 5 years

Arms & Interventions

Experimental Therapy

Cemiplimab

Intervention: Cemiplimab

Control Therapy

Investigator choice (IC) chemotherapy

Intervention: Investigator Choice (IC) Chemotherapy

Outcomes

Primary Outcomes

Overall Survival (OS)

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

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.

Overall Survival (OS) in the SCC Population

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

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.

Secondary Outcomes

Progression-free Survival (PFS) Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST 1.1)(Time from randomization to the date of the first documented tumor progression or death due to any cause (assessed up to 40 months))
Objective Response Rate (ORR) Assessed by Investigator Using RECIST 1.1(From date of randomization up to 40 months)
Duration of Response (DOR) Assessed Per RECIST 1.1(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))
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(From Cycle 1 Day 1 up to 40 months (Each cycle = 42 days))
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Leading to Death(From first dose up to 90 following last dose (~36 months))
Number of Participants With New or Worsened Laboratory Results by National Cancer Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE) Grade(From first dose up to 90 following last dose (~36 months))