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Clinical Trials/NCT03963518
NCT03963518CompletedNot Applicable

Immune-checkpoint Inhibitors and Surrogate Endpoints in Cancer Trials

Institut Bergonié1 site in 1 country631 target enrollmentStarted: January 1, 2017Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
631
Locations
1
Primary Endpoint
Correlation Between Time to Next Treatment or Death (TNT-D) and Overall Survival (OS)

Study Overview

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

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Control

nivolumab monotherapy

Intervention: nivolumab monotherapy (Drug)

Experimental

nivolumab plus ipilimumab

Intervention: nivolumab plus ipilimumab (Drug)

Outcomes

Primary Outcomes

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

Time Frame: 4 years after the start of treatment

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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