Efficacy and Safety Study of First-line Treatment With Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Women With Persistent, Recurrent, or Metastatic Cervical Cancer (MK-3475-826/KEYNOTE-826)

Official Title

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Chemotherapy Plus Placebo for the First-Line Treatment of Persistent, Recurrent, or Metastatic Cervical Cancer (KEYNOTE-826)

Summary:

The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) plus one of four platinum-based chemotherapy regimens compared to the efficacy and safety of placebo plus one of four platinum-based chemotherapy regimens in the treatment of adult women with persistent, recurrent, or metastatic cervical cancer. Possible chemotherapy regimens include: paclitaxel plus cisplatin with or without bevacizumab and paclitaxel plus carboplatin with or without bevacizumab. The primary study hypotheses are that the combination of pembrolizumab plus chemotherapy is superior to placebo plus chemotherapy with respect to: 1) Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumours (RECIST 1.1) as assessed by blinded independent central review (BICR), or, 2) Overall Survival (OS).

Trial Description

Primary Outcome:

  • Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
  • Overall Survival (OS)
Secondary Outcome:
  • Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BICR
  • Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR
  • Month 12 PFS Rate Per RECIST 1.1 as Assessed by BICR
  • Number of Participants Who Experience an Adverse Event (AE)
  • Number of Participants Who Experience a Serious AE (SAE)
  • Number of Participants Who Experience an Immune-related AE (irAE)
  • Number of Participants Who Discontinue Study Treatment Due to an AE
  • Number of Participants with a 10-point Change from Baseline in Quality of Life (QoL) Based on the European Organisation for the Research & Treatment of Cancer (EORTC) QoL Questionnaire-30 (QLQ-C30) Global Score

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