Actively Recruiting
A Phase II Study of Pembrolizumab with Tumor DNA-Guided Chemotherapy in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Led by University of Chicago · Updated on 2026-05-12
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying people with recurrent or metastatic head and neck cancer to see if using a blood test that measures tumor DNA in the blood can help guide treatment. They want to find out if adding occasional chemotherapy to immunotherapy works better than immunotherapy alone. This study is a Phase II trial that explores a new combination of approved drugs based on tumor DNA changes. Participants receive either pembrolizumab alone or pembrolizumab combined with chemotherapy drugs carboplatin and paclitaxel. Treatments are given through an intravenous needle every 21 days for two cycles. The study uses tumor DNA levels in the blood to adapt chemotherapy use and aims to gather information about safety and effectiveness of this treatment approach. Participants will be monitored for about two years, with regular assessments to measure tumor response using standard criteria (RECIST 1.1). The study tracks side effects, survival, and response duration. Women must have pregnancy tests and use contraception during treatment. The research team will collect tissue samples and blood tests to analyze tumor DNA and monitor health throughout the study.
CONDITIONS
Brief Title
A Study of Pembrolizumab in Combination With Chemotherapy for Head and Neck Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have clinically confirmed recurrent or metastatic head and neck cancer
- No prior systemic therapy for recurrent or metastatic disease, except if completed over 3 months ago as part of multimodal treatment
- Age 18 years or older
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Measurable disease based on RECIST 1.1
- Normal organ and marrow function by lab tests
- Provided tissue for PD-L1 biomarker analysis from a biopsy
- Able and willing to sign informed consent
- Women of childbearing potential must have a negative pregnancy test within 24 hours before treatment
- Women must not be breastfeeding
- Agree to use contraception during treatment if of childbearing potential
- Men sexually active with women of childbearing potential must agree to use contraception during treatment
You will not qualify if you...
- Disease suitable for local therapy with curative intent
- Progressive disease within 3 months after curative systemic treatment for locoregional disease
- Currently receiving other investigational agents
- Non-measurable signatera ctDNA at baseline
- Radiation or non-systemic therapy within 2 weeks before enrollment without full recovery from side effects
- Active autoimmune or inflammatory disorders needing immunosuppressive therapy except low-dose prednisone
- Life expectancy less than 3 months or rapidly progressing disease
- Active second malignancy except non-melanoma skin cancer unless disease-free for 3 years
- Known brain metastases
- History of organ or tissue transplant
- Allergic reaction to pembrolizumab or related agents
- Prior anti-PD1 therapy
- Uncontrolled illnesses or psychiatric conditions limiting compliance
- History of pneumonitis requiring steroids or current pneumonitis
- Pregnant or breastfeeding
- HIV-positive on antiretroviral therapy
- Active Hepatitis B or C unless eradicated
- Active infection requiring systemic therapy
- Received live vaccine within 28 days before treatment, except COVID-19 vaccines allowed
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Two 21-day cycles
Participants receive pembrolizumab alone or pembrolizumab combined with chemotherapy drugs carboplatin and paclitaxel in 21-day cycles guided by tumor DNA levels in blood.
2 visits per cycle on day 1 (in-person), totaling 4 visits
Duration - Up to 2 years
Participants are monitored for safety and effectiveness of the treatment for up to two years after treatment ends.
Regular follow-up visits over 2 years
Trial Site Locations
Total: 1 location
1
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
Actively Recruiting
Research Team
A
Ari Rosenberg, MD
A
Ari Rosenberg, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here