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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cancer; Colorectal Cancer; Hepatocellular Carcinoma (HCC); Prostate Cancer; Renal Cell Carcinoma (RCC); Differentiated Thyroid Cancer (DTC); Pancreatic Neuroendocrine Tumors (pNET); Non-Clear Cell Renal Cell Carcinoma (nccRCC); Extra-Pancreatic NET (epNET)
• Intervention / Treatment: Drug: Cabozantinib; Drug: Zanzalintinib; Drug: Atezolizumab; Drug: Nivolumab; Drug: Abiraterone; Drug: Prednisone; Drug: Enzalutamide

• Study Type: Interventional
• Enrollment (Estimated): 5000
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Exelixis Clinical Trials; Phone Number: 1-888-EXELIXIS (888-393-5494); Email: druginfo@exelixis.com
• Study Contact Backup: Name: Backup or International; Phone Number: 650-837-7400

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Cabozantinib/Zanzalintinib; 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; Administered as specified in the parent study.; Other Names: Cabometyx; XL184; Drug: Zanzalintinib; Administered as specified in the parent study.; Other Names: XL092; Drug: Atezolizumab; Administered as specified in the parent study.; Drug: Nivolumab; Administered as specified in the parent study.; Drug: Abiraterone; Administered as specified in the parent study.; Drug: Prednisone; Administered as specified in the parent study.; Drug: Enzalutamide; Administered as specified in the parent study.

What is the study measuring?

Primary Outcome Measures

Outcome 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)

Collaborators and Investigators

• Sponsor: Exelixis
• Investigators: Study Director: Medical Director, Exelixis

Study record dates

Study Major Dates

• Study Start (Estimated): May 31, 2026
• Primary Completion (Estimated): May 31, 2030
• Study Completion (Estimated): May 31, 2030

Study Registration Dates

• First Submitted: May 27, 2026
• First Submitted That Met QC Criteria: May 27, 2026
• First Posted (Actual): June 2, 2026

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Renal Cell Carcinoma (RCC); Colorectal Cancer; Hepatocellular Carcinoma (HCC); Differentiated Thyroid Cancer (DTC); Pancreatic Neuroendocrine Tumors (pNET); Extra-Pancreatic NET (epNET); Non-Clear Cell Renal Cell Carcinoma (nccRCC)
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Intestinal Diseases; Neoplasms by Histologic Type; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Liver Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Liver Neoplasms; Colonic Diseases; Urologic Neoplasms; Carcinoma; Kidney Neoplasms; Neoplasms; Prostatic Neoplasms; Carcinoma, Hepatocellular; Colorectal Neoplasms; Carcinoma, Renal Cell; Amino Acids, Peptides, and Proteins; Proteins; Polycyclic Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Pregnadienediols; Nivolumab; Prednisone; abiraterone; enzalutamide; atezolizumab; cabozantinib
• Other Study ID Numbers: EXEL-LTE-1; 2026-525795-26-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No