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Checkpoint Inhibitor

Tadalafil + Pembrolizumab for Head and Neck Cancer

Phase 2
Recruiting
Led By Joseph Califano
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have normal organ and marrow function
Patients (at least 18 years of age) must have recurrent or metastatic squamous cell carcinoma of the head and neck
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial will test a new combination therapy for advanced head and neck cancer. The goal is to see if it is safe and effective.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects include immune-related reactions like inflammation in various organs, fatigue, skin rash; as well as headaches, indigestion from tadalafil. Serious cardiac events could occur due to pre-existing conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My organs and bone marrow are functioning normally.
Select...
I am 18 or older with recurrent or metastatic squamous cell carcinoma of the head and neck.
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My cancer can be measured by tests.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Survival (OS)
Rate of Dose Limiting Toxicity (DLT)
Secondary outcome measures
Adverse event rates
Progression free survival
Response measured by RECIST 1.1

Side effects data

From 2017 Phase 4 trial • 635 Patients • NCT02224846
9%
Viral upper respiratory tract infection
3%
Periodontitis
3%
Prostatitis
2%
Alanine aminotransferase increased
2%
Upper respiratory tract infection
2%
Abdominal pain upper
2%
Chronic gastritis
2%
Blood uric acid increased
2%
Insomnia
1%
Pharyngitis
1%
Gout
1%
Sleep disorder
1%
Rhinitis allergic
1%
Rhinitis
1%
Eczema
1%
Influenza
1%
Back pain
1%
Diabetes mellitus
1%
Enteritis
1%
Gastritis
1%
Urinary tract infection
1%
Dizziness
1%
Epistaxis
1%
Renal cyst
1%
Gastric polyps
1%
Gastrooesophageal reflux disease
1%
Nephrolithiasis
1%
Hypertension
1%
Pyrexia
1%
Large intestine polyp
1%
Abdominal distension
1%
Abdominal pain
1%
Dental caries
1%
Diarrhoea
1%
Gamma-glutamyltransferase increased
1%
Headache
1%
Cough
100%
80%
60%
40%
20%
0%
Study treatment Arm
2.5 mg/5 mg Tadalafil
5 mg Tadalafil

Trial Design

1Treatment groups
Experimental Treatment
Group I: Tadalafil and PembrolizumabExperimental Treatment2 Interventions
Tadalafil for up to 12 months and pembrolizumab for up to 24 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Tadalafil
FDA approved

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,117 Previous Clinical Trials
1,520,282 Total Patients Enrolled
Joseph Califano4.711 ReviewsPrincipal Investigator - UCSD
University of California, San Diego
5Patient Review
He is an excellent doctor and surgeon. I am an anaplastic thyroid cancer patient and he saved my life.

Media Library

Pembrolizumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03993353 — Phase 2
Head and Neck Cancers Research Study Groups: Tadalafil and Pembrolizumab
Head and Neck Cancers Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT03993353 — Phase 2
Pembrolizumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03993353 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~2 spots leftby Mar 2026