None listed
Conditions
Interventions
Cemiplimab arm:
Drug: Cemiplimab
Investigator choice (IC) chemotherapy arm:
Drug: Investigator choice (IC) chemotherapy
Sponsors
Regeneron Pharmaceuticals, Inc.
Eligibility
Sex/Gender
Female
Inclusion criteria
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 =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
Exclusion criteria
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 (a) within fewer than 4 weeks (28 days) of the enrollment date, or (b) associated with irAEs of any grade within 90 days prior to enrollment, or (c) 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Overall Survival (OS) [Time Frame: Time from randomization to the date of death due to any cause (assessed up to 40 months)] OS 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
| Measure | Time frame |
|---|---|
| 1. Progression-free Survival (PFS) Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) [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)] 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. 2. Overall Response Rate (ORR) Assessed by Investigator Using RECIST 1.1 [Time Frame: From date of randomization up to 40 months] 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. 3. Duration of response Response (DOR) Assessed Per RECIST 1.1 [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)] 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. 4. Quality of Life (QOL) Change From Baseline in European Organiz | — |
Countries
Australia, Belgium, Brazil, Canada, Greece, Italy, Japan, Poland, Republic of Korea, Russian Federation, Spain, Taiwan, United Kingdom, United States
Contacts
Public ContactClinical Trials Administrator
Regeneron Pharmaceuticals, Inc.
Outcome results
None listed