MedPath

Pan Tumor Rollover Study

Phase 2
Recruiting
Conditions
Cancer
Registration Number
NCT03899155
Lead Sponsor
Bristol-Myers Squibb
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
1500
Inclusion Criteria

Inclusion Criteria:<br><br> - Signed Written Informed Consent.<br><br> - Eligible to receive continued study treatment per the Parent Study, including<br> treatment beyond progression per investigator assessment in the Parent Study.<br><br> - On treatment hold in the Parent Study following long-lasting response or are<br> eligible for treatment rechallenge as defined in the Parent Study.<br><br> - WOCBP and male participants who are sexually active must agree to follow<br> instructions for method(s) of contraception as described below and included in the<br> ICF.<br><br>Exclusion Criteria:<br><br> - Participant is not eligible for study treatment per the Parent Study eligibility<br> criteria.<br><br> - Participants not receiving clinical benefit as assessed by the Investigator.<br><br> - Any clinical adverse event (AE), laboratory abnormality, or intercurrent illness<br> which, in the opinion of the Investigator, indicates that participation in the study<br> is not in the best interest of the participant.<br><br> - Other protocol-defined Inclusion/Exclusion Criteria apply

Exclusion Criteria

Not provided

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Incidence of Adverse Events (AEs);Incidence of drug related AEs;Incidence of AEs leading to Discontinuation;Incidence of Serious Adverse Events (SAEs);Incidence of Select AEs;Incidence of Immune-Mediated AEs;Incidence of Death
Secondary Outcome Measures
NameTimeMethod
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