Immune-checkpoint Inhibitors and Surrogate Endpoints in Cancer Trials (SURROGATE-ICI)
Sponsor
Institut Bergonié (Other)
Overall Status
Completed
CT.gov ID
NCT03963518
Collaborator
Institut National de la Santé Et de la Recherche Médicale, France (Other)
300
1
46
6.5
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
300 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Immune-checkpoint Inhibitors and Surrogate Endpoints in Cancer Trials
Actual Study Start Date
:
Jan 1, 2017
Actual Primary Completion Date
:
Nov 1, 2020
Actual Study Completion Date
:
Nov 1, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Control chemotherapy |
|
| Experimental immune-checkpoint inhibitor |
Drug: Immune checkpoint inhibitor
Immune checkpoint inhibitor
|
Outcome Measures
Primary Outcome Measures
- overall survival [2 years]
time from randomization to death
Secondary Outcome Measures
- Progression-free survival (PFS) [2 years]
Time from randomization to progression or death
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
-
Patients included in phase III randomized clinical trials (RCT)
-
Metastatic melanoma
Exclusion Criteria:
- N/A
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Institut Bergonié, Comprehensive Cancer Center | Bordeaux | France |
Sponsors and Collaborators
- Institut Bergonié
- Institut National de la Santé Et de la Recherche Médicale, France
Investigators
- Principal Investigator: Carine A Bellera, PhD, Institut Bergonié
Study Documents (Full-Text)
None provided.More Information
Publications
Responsible Party:
Institut Bergonié
ClinicalTrials.gov Identifier:
NCT03963518
Other Study ID Numbers:
- IB2017-SURROGATE-ICI
First Posted:
May 24, 2019
Last Update Posted:
Dec 20, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Institut Bergonié
Additional relevant MeSH terms: