Long-Term Extension Study for Participants Previously Enrolled in an Exelixis-Sponsored Study

NCT07620574 | Not Yet Recruiting Phase 3 FDA Drug

• 2 other identifiers: EXEL-LTE-12026-525795-26-00
• Study Type: interventional
• Target: 5,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cancer; 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; Prostate Cancer

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

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

Cabozantinib/Zanzalintinib

EXPERIMENTAL

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.

Drug: Cabozantinib; Drug: Zanzalintinib; Drug: Atezolizumab; Drug: Nivolumab; Drug: Abiraterone; Drug: Prednisone; Drug: Enzalutamide

Interventions

Cabozantinib DRUG

Administered as specified in the parent study.

Also known as: XL184, Cabometyx

Cabozantinib/Zanzalintinib

Zanzalintinib DRUG

Administered as specified in the parent study.

Also known as: XL092

Cabozantinib/Zanzalintinib

Atezolizumab DRUG

Administered as specified in the parent study.

Cabozantinib/Zanzalintinib

Nivolumab DRUG

Administered as specified in the parent study.

Cabozantinib/Zanzalintinib

Abiraterone DRUG

Administered as specified in the parent study.

Cabozantinib/Zanzalintinib

Prednisone DRUG

Administered as specified in the parent study.

Cabozantinib/Zanzalintinib

Enzalutamide DRUG

Administered as specified in the parent study.

Cabozantinib/Zanzalintinib

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Exelixis: lead

MeSH Terms

Conditions

Neoplasms; Carcinoma, Renal Cell; Carcinoma, Hepatocellular; Colorectal Neoplasms; Prostatic Neoplasms

Interventions

cabozantinib; atezolizumab; Nivolumab; abiraterone; Prednisone; enzalutamide

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Liver Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Genital Neoplasms, Male; Genital Diseases, Male; Genital Diseases; Prostatic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Medical Director

  Exelixis

  STUDY DIRECTOR

Central Study Contacts

Exelixis Clinical Trials

CONTACT

1-888-EXELIXIS (888-393-5494); druginfo@exelixis.com

Backup or International

CONTACT

650-837-7400

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: June 2, 2026
• Study Start: May 31, 2026
• Primary Completion (Estimated): May 31, 2030
• Study Completion (Estimated): May 31, 2030
• Last Updated: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share