Pembrolizumab + Cabozantinib for Kidney Cancer

Recruiting at 4 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of Colorado, Denver

Must not be taking: Immunosuppressants, Steroids

Disqualifiers: Immunodeficiency, Active TB, CNS metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 2

45 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a combination of two drugs, pembrolizumab and cabozantinib, in patients with advanced kidney cancer. Pembrolizumab boosts the immune system to fight cancer, and cabozantinib stops cancer cells from growing. The goal is to find the best dose and see how well the combination works. Cabozantinib was approved for the treatment of advanced kidney cancer after other treatments.

Research Team

Elaine T. Lam, MD

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

Adults with advanced kidney cancer who can provide a tumor sample and have good performance status. They must not be pregnant, agree to use contraception, and have no recent treatments or significant health issues that could interfere with the trial. Prior immune therapy is allowed if there were no severe side effects.

Inclusion Criteria

My kidney cancer diagnosis was confirmed through lab tests.

My cancer has spread or come back and is advanced.

Be willing and able to provide written informed consent/assent for the trial

Exclusion Criteria

You have a current, active Hepatitis B or Hepatitis C infection.

I have not received a live vaccine in the last 30 days.

I have not been in a clinical trial for a new treatment or device within the last 4 weeks.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase I Treatment

Sequential dose escalation of cabozantinib with standard dose pembrolizumab to determine the recommended phase 2 dose (RP2D).

21 days per cycle, until disease progression or unacceptable toxicity

1 visit per cycle (in-person)

Phase II Treatment

Participants receive cabozantinib at the RP2D in combination with pembrolizumab for up to 35 cycles.

21 days per cycle, up to 35 cycles

1 visit per cycle (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 5 years

Open-label extension (optional)

Participants who stop pembrolizumab after 35 cycles with stable disease or better may be eligible for up to an additional 17 cycles of pembrolizumab treatment.

Approximately 1 year

Treatment Details

Interventions

• Cabozantinib
• Pembrolizumab

Trial Overview The study tests Pembrolizumab combined with Cabozantinib in patients with metastatic renal cell carcinoma. Phase I finds the safest dose of Cabozantinib alongside standard Pembrolizumab, then Phase II expands this combination treatment to more patients.

Participant Groups

Group I: Phase 2: Pembrolizumab 200 mg plus Cabozantinib at the RP2D Experimental Treatment 2 Interventions

Pembrolizumab 200 mg intravenous (IV) infusion on day 1 of each 21-day cycle in combination with cabozantinib at the RP2D orally once daily for up to 35 cycles, until disease progression, unacceptable toxicity, or consent withdrawal. All participants who stop pembrolizumab after 35 cycles with SD or better may be eligible for up to an additional 17 cycles (approximately 1 year) of pembrolizumab treatment if they progress after stopping pembrolizumab from the initial treatment phase.

Group II: Phase 1: Pembrolizumab 200 mg plus Cabozantinib 60mg Experimental Treatment 2 Interventions

Pembrolizumab 200 mg intravenous (IV) infusion on day 1 of each 21-day cycle in combination with cabozantinib 60 mg orally once daily until disease progression, unacceptable toxicity, or consent withdrawal.

Group III: Phase 1: Pembrolizumab 200 mg plus Cabozantinib 40mg Experimental Treatment 2 Interventions

Pembrolizumab 200 mg intravenous (IV) infusion on day 1 of each 21-day cycle in combination with cabozantinib 40 mg orally once daily until disease progression, unacceptable toxicity, or consent withdrawal.

Cabozantinib is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Cabometyx for:

• Renal cell carcinoma
• Hepatocellular carcinoma

Approved in United States as Cabometyx for:

• Renal cell carcinoma
• Hepatocellular carcinoma

Approved in Canada as Cabometyx for:

• Renal cell carcinoma
• Hepatocellular carcinoma

Approved in Japan as Cabometyx for:

• Renal cell carcinoma

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University