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

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 Tumours (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 Description

Primary Outcome:

  • Overall survival (OS)
Secondary Outcome:
  • Progression-free survival (PFS)
  • Objective Response Rate (ORR)
  • Duration of response (DOR)
  • Quality of life (QOL)
  • Incidence of Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability]

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society