Tadalafil + Pembrolizumab for Head and Neck Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Joseph Califano

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of California, San Diego

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial will test a combination of two drugs, pembrolizumab and tadalafil, to treat advanced head and neck cancer. The goal is to see if this combination is safe and more effective than using pembrolizumab alone. Pembrolizumab helps the immune system attack cancer by blocking a specific protein, while tadalafil helps by blocking another pathway. This approach aims to strengthen the immune system's ability to fight cancer. Pembrolizumab has been approved by the FDA for various cancers and has shown significant activity in treating advanced head and neck cancer.

Research Team

Joseph Califano

Principal Investigator

UCSD

Eligibility Criteria

Adults with recurrent or metastatic head and neck squamous cell carcinoma who have not used PD-1 or PD-L1 inhibitors in this setting, nor had certain heart conditions, autoimmune diseases, severe drug allergies, organ transplants, or are pregnant. They must have a life expectancy over 12 weeks and normal organ/marrow function.

Inclusion Criteria

You are expected to live for at least 12 more weeks.

My organs and bone marrow are functioning normally.

I am 18 or older with recurrent or metastatic squamous cell carcinoma of the head and neck.

Exclusion Criteria

My brain metastases are stable.

I am not on strong immune system suppressing drugs.

I haven't had a heart attack, heart surgery, or severe heart disease in the last 6 months.

Treatment Details

Interventions

• Pembrolizumab (Checkpoint Inhibitor)
• Tadalafil (Phosphodiesterase Inhibitor)

Trial Overview The trial is testing the safety and effectiveness of combining two drugs: pembrolizumab (an immunotherapy) and tadalafil (a medication originally for erectile dysfunction), to treat advanced head and neck cancer.

Participant Groups

Group I: Tadalafil and Pembrolizumab Experimental Treatment 2 Interventions

Tadalafil for up to 12 months and pembrolizumab for up to 24 months.

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Dr. Christopher Longhurst

University of California, San Diego

Chief Medical Officer since 2021

MD and MS in Medical Informatics from UC Davis

Patty Maysent

University of California, San Diego

Chief Executive Officer since 2016

MBA from Stanford University