Recruiting NCT03899155

Pan Tumor Rollover Study

Phase II Interventional Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Nivolumab, Ipilimumab, Cabozantinib, Trametinib.
Who it may be relevant to: Registry conditions: Cancer. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Australia, Austria, Belgium +33
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Pan-Tumor Study for Long-term Treatment of Cancer Patients Who Have Participated in BMS Sponsored Trials Investigating Nivolumab and Other Cancer Therapies

Overview

Main Objective of this study is to examine long-term safety of nivolumab monotherapy including combinations and other cancer therapies in various tumor types.

Interventions

Drug Nivolumab
Specified dose on specified days
Drug Ipilimumab
Specified dose on specified days
Drug Cabozantinib
Specified dose on specified days
Drug Trametinib
Specified dose on specified days
Drug Relatlimab
Specified dose on specified days
Drug Nivolumab + Relatlimab
Specified dose on specified days
Drug Capecitabine
Specified dose on specified days
Drug Bevacizumab
Specified dose on specified days
Drug Temozolomide
Specified dose on specified days
Drug Rucaparib
Specified dose on specified days

Primary outcome measures

Incidence of Adverse Events (AEs) [Time frame: From Day 1 up to 135 Days after discontinuation of treatment]
Incidence of drug related AEs [Time frame: From Day 1 up to 135 Days after discontinuation of treatment]
Incidence of AEs leading to Discontinuation [Time frame: From Day 1 up to 135 Days after discontinuation of treatment]
Incidence of Serious Adverse Events (SAEs) [Time frame: From signature of Informed Consent up to 135 Days after discontinuation of treatment]
Incidence of Select AEs [Time frame: From Day 1 up to 135 Days after discontinuation of treatment]
Incidence of Immune-Mediated AEs [Time frame: From Day 1 up to 135 Days after discontinuation of treatment]
Incidence of Death [Time frame: From signature of Informed Consent up to 135 Days after discontinuation of treatment]

Eligibility criteria

Inclusion criteria

Signed Written Informed Consent.
Eligible to receive continued study treatment per the Parent Study, including treatment beyond progression per investigator assessment in the Parent Study.
On treatment hold in the Parent Study following long-lasting response or are eligible for treatment rechallenge as defined in the Parent Study.
WOCBP and male participants who are sexually active must agree to follow instructions for method(s) of contraception as described below and included in the ICF.

Exclusion criteria

Participant is not eligible for study treatment per the Parent Study eligibility criteria.
Participants not receiving clinical benefit as assessed by the Investigator.
Any clinical adverse event (AE), laboratory abnormality, or intercurrent illness which, in the opinion of the Investigator, indicates that participation in the study is not in the best interest of the participant.
Other protocol-defined Inclusion/Exclusion Criteria apply

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Non-randomized
Model: Parallel assignment
Masking: Open label
Primary purpose: Treatment