Pembrolizumab + Cabozantinib for Head and Neck Cancer

Recruiting at1 trial location

Overseen by Nabil F. Saba, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Emory University

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well pembrolizumab and cabozantinib in treating patients with head and neck squamous cell cancer that has come back or spread to other places in the body and cannot be removed by surgery. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Cabozantinib may stop the growth of tumor cells by blocking some of the pathways needed for cell growth. Giving pembrolizumab and cabozantinib may improve the chances of tumor response in patients with head and neck squamous cell cancer.

Research Team

Nabil F. Saba, MD

Principal Investigator

Emory University

Eligibility Criteria

This trial is for adults with head and neck squamous cell cancer that's returned or spread and can't be surgically removed. They should have had some previous treatment, be in fairly good health (ECOG 0 or 1), not pregnant, willing to use contraception, and without certain medical conditions like major blood vessel invasion by the tumor or recent significant bleeding.

Inclusion Criteria

Serum phosphorus, calcium, magnesium and potassium ≥ LLN within 7 days before the first dose of cabozantinib

I understand the study requirements and have signed the consent form.

Disease progression must be documented following prior therapy

Exclusion Criteria

I haven't had radiation for bone metastasis in the last 2 weeks or any other radiation in the last 4 weeks.

I haven't had significant GI bleeding or coughed up blood recently.

I haven't had chemotherapy or biological treatment in the last 4 weeks.

Treatment Details

Interventions

• Cabozantinib (Tyrosine Kinase Inhibitor)
• Pembrolizumab (Checkpoint Inhibitor)

Trial Overview The study tests pembrolizumab (a monoclonal antibody) combined with cabozantinib (which blocks pathways for cell growth) on patients with advanced head and neck cancer. The goal is to see if this combination improves tumor response compared to what's currently available.

Participant Groups

Group I: Treatment (pembrolizumab, cabozantinib) Experimental Treatment 2 Interventions

Patients receive pembrolizumab IV over 30 minutes on day 1 and cabozantinib PO QD on days 1-21. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Cabozantinib is already approved in Canada, Japan for the following indications:

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?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Dr. R. Donald Harvey

Emory University

Chief Medical Officer

MD from Emory University School of Medicine

Dr. George Painter

Emory University

Chief Executive Officer since 2013

PhD in Synthetic Organic Chemistry from Emory University

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

Exelixis

Industry Sponsor

Trials

126

Recruited

20,500+

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

Exelixis

Chief Medical Officer since 2022

MD

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Dr. Jeanne Marrazzo

National Institutes of Health (NIH)

Chief Medical Officer

MD from University of California, Los Angeles

Dr. Jay Bhattacharya

National Institutes of Health (NIH)

Chief Executive Officer

MD, PhD from Stanford University