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

Institut Bergonié

Status: Completed

Conditions: Cancer Treated With Immune-checkpoint Inhibitors

Treatments: Drug: nivolumab plus ipilimumab; Drug: nivolumab monotherapy

Study type: Observational

Funder types: Other

Identifiers

NCT03963518

IB2017-SURROGATE-ICI

Details and patient eligibility

About

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

Enrollment: 631 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

previously untreated advanced melanoma patients.

Trial design

631 participants in 2 patient groups

Control

Description:

nivolumab monotherapy

Treatment:

Drug: nivolumab monotherapy

Experimental

Description:

nivolumab plus ipilimumab

Treatment:

Drug: nivolumab plus ipilimumab