Study of REGN2810 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 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 Tumours (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)

Trial Description

Primary Outcome:

  • Overall survival (OS)
Secondary Outcome:
  • Progression-free survival (PFS)
  • Overall 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