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

Cancer Treated With Immune-checkpoint Inhibitors Clinical Trial

— SURROGATE-ICI  

Official title:

Immune-checkpoint Inhibitors and Surrogate Endpoints in Cancer Trials

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03963518
• Other study ID #: IB2017-SURROGATE-ICI
• Status: Completed
• Start date: January 2017
• Est. completion date: November 2020

Study information

• Verified date: December 2021
• Source: Institut Bergonié
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objective of this research work is two-fold: (i) to conduct a systematic literature review to identify surrogate endpoints in this specific drug class (review registered in the PROSPERO database) and (ii) to assess the surrogate properties of candidate surrogate endpoints in the specific context of melanoma cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: November 2020
• Est. primary completion date: November 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients included in phase III randomized clinical trials (RCT)

• Metastatic melanoma

Exclusion Criteria:

• N/A

Related Conditions & MeSH terms

• Cancer Treated With Immune-checkpoint Inhibitors

Intervention

Drug:
• Immune checkpoint inhibitor
Immune checkpoint inhibitor

Locations

Country	Name	City	State
France	Institut Bergonié, Comprehensive Cancer Center	Bordeaux

Sponsors (2)

Lead Sponsor	Collaborator
Institut Bergonié	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival	time from randomization to death	2 years
Secondary	Progression-free survival (PFS)	Time from randomization to progression or death	2 years