A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Standard of Care in Subjects With Previously Treated Metastatic PD-L1 Positive Colorectal Cancer (MK-4280A-007)

Official Title

A Phase 3 Study of MK-4280A (Coformulated Favezelimab [MK-4280] Plus Pembrolizumab [MK-3475]) Versus Standard of Care in Previously Treated Metastatic PD-L1 Positive Colorectal Cancer

Summary:

The purpose of this study is to assess the safety and efficacy of coformulated favezelimab/pembrolizumab (MK-4280A) in participants with metastatic colorectal cancer. The study will also compare MK-4280A with the standard of care treatment of regorafenib and TAS-102 (trifluridine and tipiracil). The primary study hypothesis is that coformulated favezelimab/pembrolizumab (MK-4280A) is superior to standard of care with respect to overall survival.

Trial Description

Primary Outcome:

  • Overall Survival (OS)
Secondary Outcome:
  • Progression-Free Survival (PFS) according per Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR)
  • Objective Response Rate (ORR) per RECIST 1.1 as Assessed by BICR
  • Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR
  • Number of Participants Who Experience at least One Adverse Event (AE)
  • Number of Participants Who Discontinue Study Treatment Due to an AE
  • Change from Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score
  • Change from Baseline in EORTC QLQ-C30 Physical Functioning (Items 1-5) Score
  • Change from Baseline in EORTC QLQ-C30 Appetite Loss (Item 13) Score
  • Change from Baseline in EORTC Quality of Life Questionnaire-Colorectal Cancer-Specific 29 Items (QLQ-CR29) Bloating (Item 37) Score
  • Time to Deterioration (TTD) in EORTC QLQ-C30 GHS (Item 29) and QoL (Item 30) Combined Score
  • TTD in EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score
  • TTD in in EORTC QLQ-C30 Appetite Loss (Item 13) Score
  • TTD in EORTC Quality of Life Questionnaire-Colorectal Cancer-Specific 29 Items (QLQ-CR29) Bloating (Item 37) Score

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

Bookmark & Share