Cancer
Conditions
Keywords
Rollover, pan-tumor
Brief summary
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
DRUGNivolumab
Specified dose on specified days
DRUGIpilimumab
Specified dose on specified days
DRUGCabozantinib
Specified dose on specified days
DRUGTrametinib
Specified dose on specified days
DRUGRelatlimab
Specified dose on specified days
Specified dose on specified days
DRUGCapecitabine
Specified dose on specified days
DRUGBevacizumab
Specified dose on specified days
DRUGTemozolomide
Specified dose on specified days
DRUGRucaparib
Specified dose on specified days
DRUGDaratumumab
Specified dose on specified days
DRUGRegorafinib
Specified dose on specified days
DRUGLeucovorin
Specified dose on specified days
DRUGFluorouracil
Specified dose on specified days
DRUGOxaliplatin
Specified dose on specified days
DRUGEnzalutamide
Specified dose on specified days
DRUGSunitinib
Specified dose on specified days
DRUGPemetrexed
Specified dose on specified days
DRUGPembrolizumab
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Exelixis
Novartis
Clovis Oncology, Inc.
Janssen Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Adverse Events (AEs) | From Day 1 up to 135 Days after discontinuation of treatment |
| Incidence of drug related AEs | From Day 1 up to 135 Days after discontinuation of treatment |
| Incidence of AEs leading to Discontinuation | From Day 1 up to 135 Days after discontinuation of treatment |
| Incidence of Serious Adverse Events (SAEs) | From signature of Informed Consent up to 135 Days after discontinuation of treatment |
| Incidence of Select AEs | From Day 1 up to 135 Days after discontinuation of treatment |
| Incidence of Immune-Mediated AEs | From Day 1 up to 135 Days after discontinuation of treatment |
| Incidence of Death | From signature of Informed Consent up to 135 Days after discontinuation of treatment |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czechia, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Mexico, Netherlands, New Zealand, Norway, Peru, Poland, Portugal, Puerto Rico, Romania, Russia, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom, United States
Contacts
CONTACTBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACTFirst line of the email MUST contain NCT # and Site #.
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed