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

NCT03963518 | Completed Results

• 1 other identifier: IB2017-SURROGATE-ICI
• Study Type: observational
• Target: 631
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cancer Treated With Immune-checkpoint Inhibitors

Keywords

cancer; trial; immune-checkpoint inhibitors; meta-analysis

Outcome Measures

Primary Outcomes (1)

• Correlation Between Time to Next Treatment or Death (TNT-D) and Overall Survival (OS)

  Correlation between Time to next treatment or death (TNT-D) and overall survival (OS) in previously untreated advanced melanoma patients.

  4 years after the start of treatment

Study Arms (2)

Control

nivolumab monotherapy

Drug: nivolumab monotherapy

Experimental

nivolumab plus ipilimumab

Drug: nivolumab plus ipilimumab

Interventions

nivolumab monotherapy DRUG

nivolumab monotherapy

Control

nivolumab plus ipilimumab DRUG

nivolumab plus ipilimumab

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

previously untreated advanced melanoma patients included in a recently published clinical trial

previously untreated advanced melanoma patients.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Institut Bergonié: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

Institut Bergonié, Comprehensive Cancer Center

Bordeaux, France

Location

Related Publications (2)

• Branchoux S, Bellera C, Italiano A, Rustand D, Gaudin AF, Rondeau V. Immune-checkpoint inhibitors and candidate surrogate endpoints for overall survival across tumour types: A systematic literature review. Crit Rev Oncol Hematol. 2019 May;137:35-42. doi: 10.1016/j.critrevonc.2019.02.013. Epub 2019 Mar 1.

  PMID: 31014514 BACKGROUND

• Branchoux S, Sofeu CL, Gaudin AF, Kurt M, Moshyk A, Italiano A, Bellera C, Rondeau V. Time to next treatment or death as a candidate surrogate endpoint for overall survival in advanced melanoma patients treated with immune checkpoint inhibitors: an insight from the phase III CheckMate 067 trial. ESMO Open. 2022 Feb;7(1):100340. doi: 10.1016/j.esmoop.2021.100340. Epub 2021 Dec 17.

  PMID: 34929616 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Interventions

Nivolumab; Ipilimumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Carine Bellera
• Organization: Institut Bergonié, Comprehensive Cancer Center, Bordeaux, FR

c.bellera@bordeaux.unicancer.fr

+33556333333

Study Officials

• Carine A Bellera, PhD

  Institut Bergonié

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2019
• First Posted: May 24, 2019
• Study Start: January 1, 2017
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: October 6, 2025
• Results First Posted: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)