Cancer Treatments Access Extension

Enrolling by invitation at 3 trial locations
EC
Bo
Overseen ByBackup or International
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to provide ongoing access to cancer treatments for individuals benefiting from a specific Exelixis-sponsored study. The study includes treatments such as Cabozantinib and Zanzalintinib, either alone or combined with other medications. It targets those who continue to see positive results from their current study treatment and cannot access it locally. Participants should be able to continue with the treatment plan and must not have been disqualified from their initial study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of these treatments to a wider population.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that cabozantinib is generally safe to manage. Common side effects include diarrhea and tiredness, affecting more than 25% of patients. Some patients may also experience low calcium levels, though severe cases are rare. Cabozantinib can cause heart problems, so regular check-ups are important.

Early findings suggest that zanzalintinib has a safety profile similar to other treatments targeting multiple pathways in cancer cells. Experts closely monitor its safety to protect participants. However, its safety and effectiveness are not fully confirmed yet.

Both treatments carry some risks, but researchers carefully monitor them to ensure participant safety.12345

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for cancer, which often involve chemotherapy or radiation, Cabozantinib and Zanzalintinib offer a fresh approach by targeting specific proteins that help tumors grow and spread. Cabozantinib works by inhibiting the activity of tyrosine kinases, which are enzymes involved in tumor growth and blood vessel development. Zanzalintinib, on the other hand, is designed to block the VEGFR, a receptor that plays a crucial role in the formation of blood vessels that supply the tumor. Researchers are excited about these treatments because they might not only be more effective but also potentially have fewer side effects compared to traditional cancer therapies.

What evidence suggests that this trial's treatments could be effective for cancer?

Research has shown that cabozantinib, one of the treatments in this trial, holds promise for cancer treatment. Specifically, studies found that after 12 months, 85.7% of patients treated with cabozantinib remained alive, compared to 75.6% with other treatments. More than 40% of patients experienced tumor shrinkage. Additionally, cabozantinib was associated with a 34% decrease in the rate of disease progression or death. These findings suggest that cabozantinib can be an effective option for treating cancer. Participants in this trial may receive cabozantinib alone or in combination with other agents, depending on their study treatment group.678910

Who Is on the Research Team?

MD

Medical Director

Principal Investigator

Exelixis

Are You a Good Fit for This Trial?

This trial is for people with certain cancers (like kidney, liver, prostate, thyroid, and colorectal) who were already in an Exelixis-sponsored study and are still benefiting from the treatment. Participants must be able to follow the new study rules and start treatment again within a set time.

Inclusion Criteria

Able to receive the first dose of study treatment in this extension study within the specified treatment interruption window allowed by the parent study
Able to comply with the long-term extension study protocol as determined by the investigator
Eligible to continue receiving the study treatment in the parent study (has not met parent study discontinuation/withdrawal criteria)
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Exclusion Criteria

Meet any of the study treatment discontinuation criteria specified in the parent study at the time of enrollment in this extension study
The study treatment is available and approved for my disease in my country.
I have not received any cancer treatment since my last study treatment.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Long-term Extension

Participants continue to receive study treatment if they are deriving clinical benefit and do not have access to treatment locally

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Abiraterone
  • Atezolizumab
  • Cabozantinib
  • Enzalutamide
  • Nivolumab
  • Prednisone
  • Zanzalintinib

Trial Overview

The study lets eligible participants keep getting their previous cancer treatments—such as Cabozantinib, Zanzalintinib, Abiraterone, Nivolumab, Prednisone, Enzalutamide or Atezolizumab—if they can't get them locally. It’s an extension of earlier studies.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Cabozantinib/ZanzalintinibExperimental Treatment7 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Exelixis

Lead Sponsor

Trials
126
Recruited
20,500+
Michael M. Morrissey profile image

Michael M. Morrissey

Exelixis

Chief Executive Officer since 2010

PhD in Chemistry from Harvard University, BSc in Chemistry from the University of Wisconsin

Vicki L. Goodman profile image

Vicki L. Goodman

Exelixis

Chief Medical Officer since 2022

MD

Bristol-Myers Squibb

Industry Sponsor

Trials
2,731
Recruited
4,127,000+
Headquarters
New York City, USA
Known For
Oncology & Cardiovascular
Top Products
Eliquis, Opdivo, Revlimid, Orencia
Christopher Boerner profile image

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt profile image

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Citations

Real-World Results of Cabozantinib Given as Alternative ...

(85.7% vs. 75.6% survival rate after 12 months) and objective response rate. More than 40% of all patients had a response in terms of tumor shrinkage (PR+CR) ...

Exelixis Announces Phase 1 Trial Results for Cabozantinib in ...

The objective response rate was 43 percent … the five-year survival rate is only 12 percent, with no identified cure for the disease.4

Cabozantinib Efficacious After Treatment with First-Line ...

On average, patients received cabozantinib for 4.7 months. The objective response rate was 27.2% (all partial responses). An additional 22.7% of patients ...

Real-world outcomes of nivolumab and cabozantinib in ... - PMC

The final results of the meteor trial demonstrated, for the cabozantinib and everolimus groups, an overall survival (os) of 21.4 months and 16.5 ...

4197474 This label may not be the latest approved by FDA ...

The most commonly reported (≥ 25%) adverse reactions are: diarrhea, fatigue or altered mental function. CABOMETYX can cause fetal harm when administered to a ...

This label may not be the latest approved by FDA. For current ...

CABOMETYX can cause hypocalcemia. hypocalcemia occurred in 13% of patients treated with CABOMETYX, including Grade 3 in 2% and Grade 4 in 1% of patients.

Cabozantinib (oral route) - Side effects & dosage

Safety and efficacy have not been established. This medicine may cause heart failure, which may lead to death. Check with your doctor right ...

View of Cabozantinib (Cabometyx)

The safety profile in the population assessed was considered manageable and consistent with the known safety profile of cabozantinib. Introduction. Disease ...

Label: Cabometyx — Cabozantinib Tablet - DailyMed - NIH

Based on data from animal studies and its mechanism of action, CABOMETYX can cause fetal harm when administered to a pregnant woman. Cabozantinib administration ...