Immune-checkpoint Inhibitors and Surrogate Endpoints in Cancer Trials (SURROGATE-ICI)

Sponsor
Institut Bergonié
Study ID
NCT03963518
Status
Completed

Conditions

  • Cancer Treated With Immune-checkpoint Inhibitors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

Time to next treatment or death (TNT-D) may be a patient-relevant endpoint in patients treated with immune checkpoint inhibitors. This study investigate

Key Dates

Start date
Jan 31, 2017
Status verified
Sep 2025
Primary completion
Dec 31, 2020
Completion
Dec 31, 2020

Study Design

Enrollment
631 participants (actual)

Arms

  • Arm: Control
    nivolumab monotherapy
  • Arm: Experimental
    nivolumab plus ipilimumab

Primary Outcome Measure

Correlation Between Time to Next Treatment or Death (TNT-D) and Overall Survival (OS) [ Time Frame: 4 years after the start of treatment ]