Summary

for females ages 18 years and up (full criteria)
at Orange, California and other locations
study started
estimated completion

Description

Summary

The primary objective is to compare overall survival (OS) for patients with recurrent or metastatic cervical cancer treated with either REGN2810 (cemiplimab) or investigator's choice (IC) chemotherapy. The secondary objectives are: - To compare progression-free survival (PFS) of REGN2810 (cemiplimab) versus IC chemotherapy - To compare overall response rate (ORR) (partial response [PR] + complete response [CR]) of REGN2810 (cemiplimab) versus IC chemotherapy per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 - To compare the duration of response (DOR) of REGN2810 (cemiplimab) versus IC chemotherapy - To compare the safety profiles of REGN2810 (cemiplimab) versus IC chemotherapy by describing adverse events (AE) - To compare quality of life (QOL) for patients treated with REGN2810 (cemiplimab) versus IC chemotherapy using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)

Official Title

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

Keywords

Recurrent or Metastatic, Platinum-refractory Cervical Cancer Uterine Cervical Neoplasms Cemiplimab REGN2810 Investigator Choice (IC) Chemotherapy

Eligibility

For females ages 18 years and up

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, for which there is not a curative-intent option (surgery or radiation therapy with or without chemotherapy).

Acceptable histologies are squamous carcinoma, adenocarcinoma, and adenosquamous carcinoma. Sarcomas and neuro-endocrine carcinomas are not eligible histologies.

  1. Tumor progression or recurrence after treatment with platinum therapy (must have been used to treat metastatic, persistent, or recurrent cervical cancer)
  2. Patient must have measurable disease as defined by RECIST 1.1.
  3. Eastern Cooperative Oncology Group (ECOG) performance status ≤1
  4. ≥18 years old
  5. Adequate organ or bone marrow function
  6. Received prior bevacizumab therapy or had clinically documented reason why not administered
  7. 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 (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 (REGN2810 [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 (REGN2810 [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

Locations

  • University of California Irvine accepting new patients
    Orange California 92868 United States
  • Gynecologic Oncology Associates completed
    Newport Beach California 92663 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Regeneron Pharmaceuticals
ID
NCT03257267
Phase
Phase 3
Study Type
Interventional
Last Updated