Description:
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)
Title
- Brief Title: Study of Cemiplimab in Adults With Cervical Cancer
- Official Title: An Open-Label, Randomized, Phase 3 Clinical Trial of REGN2810 Versus Investigator's Choice of Chemotherapy in Recurrent or Metastatic Cervical Carcinoma
Clinical Trial IDs
- ORG STUDY ID:
R2810-ONC-1676
- SECONDARY ID:
2017-000350-19
- NCT ID:
NCT03257267
Conditions
- Squamous Cell Carcinoma (SCC)
- Recurrent or Metastatic, Platinum-refractory Cervical Cancer
Interventions
Drug | Synonyms | Arms |
---|
Cemiplimab | REGN2810, Libtayo | Experimental Therapy |
Investigator Choice (IC) Chemotherapy | | Control Therapy |
Purpose
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)
Trial Arms
Name | Type | Description | Interventions |
---|
Experimental Therapy | Experimental | Cemiplimab | |
Control Therapy | Active Comparator | Investigator choice (IC) chemotherapy | - Investigator Choice (IC) Chemotherapy
|
Eligibility Criteria
The criteria listed below are not intended to contain all considerations relevant to a
patient's potential participation in this clinical trial.
Key Inclusion Criteria:
1. 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
2. Tumor progression or recurrence after treatment with platinum therapy (must have been
used to treat metastatic, persistent, or recurrent cervical cancer)
3. Patient must have measurable disease as defined by RECIST 1.1.
4. Eastern Cooperative Oncology Group (ECOG) performance status ≤1
5. ≥18 years old
6. Adequate organ or bone marrow function
7. Received prior bevacizumab therapy or had clinically documented reason why not
administered
8. Received prior paclitaxel therapy or had clinically documented reason why not
administered
Key Exclusion Criteria:
1. Ongoing or recent (within 5 years) evidence of significant autoimmune disease that
required treatment with systemic immunosuppressive treatments
2. Prior treatment with an agent that blocks the PD-1/PD-L1 pathway
3. Prior treatment with other systemic immune-modulating agents that was
1. within fewer than 4 weeks (28 days) of the enrollment date, or
2. associated with irAEs of any grade within 90 days prior to enrollment, or
3. associated with toxicity that resulted in discontinuation of the immune
modulating agent
4. Active or untreated brain metastases
5. Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within
4 weeks prior to the first dose of study drug cemiplimab or IC chemo)
6. Active infection requiring therapy
7. History of pneumonitis within the last 5 years
8. History of documented allergic reactions or acute hypersensitivity reaction attributed
to antibody treatments
9. Concurrent malignancy other than cervical cancer and/or history of malignancy other
than cervical cancer within 3 years of date of first planned dose of study drug
cemiplimab or IC chemo), except for tumors with negligible risk of metastasis or
death, such as adequately treated cutaneous squamous cell carcinoma or basal cell
carcinoma of the skin or ductal carcinoma in situ of the breast. Patients with
hematologic malignancies (eg, chronic lymphocytic leukemia) are excluded.
Note: Other protocol defined Inclusion/Exclusion apply
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Female |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Overall survival (OS) |
Time Frame: | Time from randomization up to approximately 44 months |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Progression-free survival (PFS) |
Time Frame: | Will be analyzed at time of primary outcome measure; approximately 44 months |
Safety Issue: | |
Description: | |
Measure: | Objective Response Rate (ORR) |
Time Frame: | Will be analyzed at time of primary outcome measure; approximately 44 months |
Safety Issue: | |
Description: | |
Measure: | Duration of response (DOR) |
Time Frame: | Will be analyzed at time of primary outcome measure; approximately 44 months |
Safety Issue: | |
Description: | |
Measure: | Quality of life (QOL) |
Time Frame: | Will be analyzed at time of primary outcome measure; approximately 44 months |
Safety Issue: | |
Description: | Quality of life will be measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) |
Measure: | Incidence of Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability] |
Time Frame: | Will be analyzed at time of primary outcome measure; approximately 44 months |
Safety Issue: | |
Description: | TEAEs include adverse events (AEs), serious adverse events (SAEs), deaths, and laboratory abnormalities. |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Regeneron Pharmaceuticals |
Last Updated
July 15, 2020