Cancer, Colorectal Cancer, Differentiated Thyroid Cancer (DTC), Extra-Pancreatic NET (epNET), Hepatocellular Carcinoma (HCC), Non-Clear Cell Renal Cell Carcinoma (nccRCC), Pancreatic Neuroendocrine Tumors (pNET), Prostate Cancer, Renal Cell Carcinoma (RCC)
Conditions
Keywords
Renal Cell Carcinoma (RCC), Pancreatic Neuroendocrine Tumors (pNET), Extra-Pancreatic NET (epNET), Hepatocellular Carcinoma (HCC), Differentiated Thyroid Cancer (DTC), Non-Clear Cell Renal Cell Carcinoma (nccRCC), Colorectal Cancer
Brief summary
The primary objective of this long-term extension study is to allow continued access to study treatment for eligible participants who are deriving clinical benefit in an Exelixis-sponsored study who do not have access to treatment locally.
Interventions
DRUGCabozantinib
Administered as specified in the parent study.
DRUGZanzalintinib
Administered as specified in the parent study.
DRUGAtezolizumab
Administered as specified in the parent study.
DRUGNivolumab
Administered as specified in the parent study.
DRUGAbiraterone
Administered as specified in the parent study.
DRUGPrednisone
Administered as specified in the parent study.
DRUGEnzalutamide
Administered as specified in the parent study.
Sponsors
Exelixis
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Eligible to continue receiving the study treatment in the parent study (that is, has not met parent study discontinuation/withdrawal criteria). * Continuing to derive clinical benefit from the study treatment at the time of transition from the parent study as assessed by the investigator. * Able to comply with the long-term extension study protocol as determined by the investigator. * Able to receive the first dose of study treatment in this extension study within the specified treatment interruption window allowed by the parent study. Key
Exclusion criteria
* Meet any of the study treatment discontinuation criteria specified in the parent study at the time of enrollment in this extension study. * Study treatment is commercially marketed in the participant's country for the participant-specific disease and is accessible to the participant. * Treatment with any anticancer treatment (other than treatment permitted in the parent study) during the time between last treatment in the parent study and the first dose of study treatment in this long-term extension study. * Permanent discontinuation of all study treatment(s) for any reason during the parent study or during the time between last treatment in the parent study and the first dose of study treatment in this long-term extension study (if applicable). * Concurrent participation in any therapeutic clinical trial (other than the parent study). NOTE: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Up to 4 years (until the event resolves, returns to baseline, stabilizes, a new anticancer therapy is initiated, or the participant is lost to follow-up or withdraws consent, whichever occurs first) |
Countries
United States
Contacts
STUDY_DIRECTORMedical Director
Exelixis
Outcome results
None listed