Clinical trial · Interventional
Long-Term Extension Study for Participants Previously Enrolled in an Exelixis-Sponsored Study
NCT07620574CI-TRIAL-00122567enrolling by invitationPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Differentiated Thyroid Cancer (DTC) | — | UNRESOLVED | — |
| Extra-Pancreatic NET (epNET) | — | UNRESOLVED | — |
| Hepatocellular Carcinoma (HCC) | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.85 |
| Non-Clear Cell Renal Cell Carcinoma (nccRCC) | Non-Clear Cell Renal Cell Carcinoma | ONTOLOGY_EXACT | 0.85 |
| Pancreatic Neuroendocrine Tumors (pNET) | Pancreatic Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.85 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Renal Cell Carcinoma (RCC) | Renal Cell Carcinoma | CURATED_BROADER |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abiraterone | Drug | Abiraterone | ALIAS |
| Atezolizumab | Drug | Atezolizumab | ALIAS |
| Cabozantinib | Drug | Cabozantinib | ALIAS |
| Enzalutamide | Drug | Enzalutamide | ALIAS |
| Nivolumab | Drug | Nivolumab | ALIAS |
| Prednisone | Drug | Prednisone | ALIAS |
| Zanzalintinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cabozantinib/Zanzalintinib
- description
- Depending on the study treatment received in the parent study, participants may receive cabozantinib alone or in combination with other agents; zanzalintinib alone or in combination with other agents, or comparator.
- interventionNames
- Drug: Cabozantinib
- Drug: Zanzalintinib
- Drug: Atezolizumab
- Drug: Nivolumab
- Drug: Abiraterone
- Drug: Prednisone
- Drug: Enzalutamide
Primary outcomes (1)
- measure
- Number of Participants With Treatment Emergent Adverse Events (TEAEs)
- timeFrame
- 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)
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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/Exclusion criteria may apply.
References
Publications (0)
Data not yet available
No reference posted for this study.