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CancerPhase 3NCT07620574

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

A Phase 3 study testing Cabozantinib, Zanzalintinib and Atezolizumab in people with Cancer and Renal Cell Carcinoma (RCC), run by Exelixis at 2 sites in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record

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Trial 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. Read more about this study

Who is it for?
Any age
What is being tested?
Cabozantinib, Zanzalintinib and Atezolizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5,000 participants
Where
2 sitesUnited States
Study dates
30 Jul 2026to 31 May 2030
Phase
Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

United States2 sites
  • New York Cancer and Blood Specialists

    Bay Shore, New York, 11706

  • Greater Dayton Cancer Center

    Kettering, Ohio, 45409

Other trials in United States

About this 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.

Being tested
Cabozantinib, Zanzalintinib, Atezolizumab, Nivolumab, Abiraterone
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
Medical subject headings
Neoplasms, Carcinoma, Renal Cell, Carcinoma, Hepatocellular, Colorectal Neoplasms, Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CabozantinibDrug

    Also called XL184, Cabometyx

    Administered as specified in the parent study.

  • ZanzalintinibDrug

    Also called XL092

    Administered as specified in the parent study.

  • AtezolizumabDrug

    Administered as specified in the parent study.

  • NivolumabDrug

    Administered as specified in the parent study.

  • AbirateroneDrug

    Administered as specified in the parent study.

  • PrednisoneDrug

    Administered as specified in the parent study.

  • EnzalutamideDrug

    Administered as specified in the parent study.

Study groups in NCT07620574
Study groupRoleWhat they receive
Cabozantinib/ZanzalintinibExperimentalDepending 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.
Receives: Drug: Cabozantinib; Drug: Zanzalintinib; Drug: Atezolizumab; Drug: Nivolumab; Drug: Abiraterone; Drug: Prednisone; Drug: Enzalutamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Treatment Emergent Adverse Events (TEAEs)

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2026
  2. Study start30 Jul 2026
  3. Primary completion31 May 2030 (estimated)
  4. Study completion31 May 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07620574
Sponsor's protocol ID
EXEL-LTE-1
Other IDs
2026-525795-26-00
Status last verified
Aug 2026
First submitted
27 May 2026
Last updated
18 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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