Study of REGN2810 in Adults With Cervical Cancer

Official Title

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

Summary:

The primary objective is to compare overall survival (OS) for patients with recurrent or metastatic platinum-refractory cervical cancer treated with either REGN2810 or investigator's choice (IC) chemotherapy. The secondary objectives are: - To compare progression-free survival (PFS) of REGN2810 versus IC chemotherapy - To compare overall response rate (ORR) (partial response [PR] + complete response [CR]) of REGN2810 versus IC chemotherapy per Response Evaluation Criteria in Solid Tumours 1.1 - To compare the duration of response (DOR) of REGN2810 versus IC chemotherapy - To compare the safety profiles of REGN2810 versus IC chemotherapy by describing adverse events (AE) - To compare quality of life (QOL) for patients treated with REGN2810 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

Interested in this trial?

Print this page and take it to your doctor to discuss your eligibilty and treatment options. Only your doctor can refer you to a clinical trial.

Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society