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.
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
- Conditions the study is for
- Cancer, Renal Cell Carcinoma (RCC), Pancreatic Neuroendocrine Tumors (pNET)
- 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
- Are there results?
- Not yet: the study is under way
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
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.
- Conditions
- Cancer, Renal Cell Carcinoma (RCC), Pancreatic Neuroendocrine Tumors (pNET), Extra-Pancreatic NET (epNET), Hepatocellular Carcinoma (HCC), Differentiated Thyroid Cancer (DTC)
- 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 group | Role | What they receive |
|---|---|---|
| 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. 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.
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.
- First posted2 Jun 2026
- Study start30 Jul 2026
- Primary completion31 May 2030 (estimated)
- Study completion31 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by ExelixisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Exelixis
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Exelixis
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Extension Study for Participants Previously Enrolled in an Exelixis-Sponsored Study
- ClinicalTrials.gov ID
- NCT07620574
- Acronym / sponsor ID
- EXEL-LTE-1
- Conditions
- Cancer, Renal Cell Carcinoma (RCC), Pancreatic Neuroendocrine Tumors (pNET), Extra-Pancreatic NET (epNET), Hepatocellular Carcinoma (HCC), Differentiated Thyroid Cancer (DTC)
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- ExelixisIndustry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Study start
- 30 Jul 2026 (actual)
- Primary completion
- 31 May 2030 (estimated)
- Study completion
- 31 May 2030 (estimated)
- First posted
- 2 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cabozantinib/Zanzalintinib | Experimental | Drug: Cabozantinib, Drug: Zanzalintinib, Drug: Atezolizumab, Drug: Nivolumab, Drug: Abiraterone, Drug: Prednisone, Drug: EnzalutamideDepending 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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 (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CabozantinibAlso: XL184, CabometyxAdministered as specified in the parent study. | Drug | Cabozantinib/Zanzalintinib |
| ZanzalintinibAlso: XL092Administered as specified in the parent study. | Drug | Cabozantinib/Zanzalintinib |
| AtezolizumabAdministered as specified in the parent study. | Drug | Cabozantinib/Zanzalintinib |
| NivolumabAdministered as specified in the parent study. | Drug | Cabozantinib/Zanzalintinib |
| AbirateroneAdministered as specified in the parent study. | Drug | Cabozantinib/Zanzalintinib |
| PrednisoneAdministered as specified in the parent study. | Drug | Cabozantinib/Zanzalintinib |
| EnzalutamideAdministered as specified in the parent study. | Drug | Cabozantinib/Zanzalintinib |
Primary outcome
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Medical Director study director
Exelixis
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.