Actively Recruiting
A Study of Pembrolizumab in Combination With Chemotherapy for Head and Neck Cancer
Led by University of Chicago · Updated on 2026-05-12
30
Participants Needed
1
Research Sites
215 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
By doing this study, the research team would like to learn if using a blood test that measures the amount of tumor DNA in blood can help guide how to use chemotherapy combined with immunotherapy for individuals with head and neck cancer. Using this blood test, the research team hopes to learn if intermittent (occasional) chemotherapy added to immunotherapy will work better than immunotherapy alone. Participation in this research will last about two years.
CONDITIONS
Official 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 in the recurrent or metastatic setting; systemic therapy completed over 3 months ago for locally advanced disease is allowed
- Age 18 years or older
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Measurable disease per RECIST 1.1 criteria
- Normal organ and marrow function based on lab tests
- Provided tissue for PD-L1 biomarker analysis from core or excisional biopsy
- Signed informed consent and able to understand study requirements
- Negative pregnancy test within 24 hours before starting study drug for women of childbearing potential
- Women not breastfeeding
- Women and men of childbearing potential 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 locoregionally advanced cancer
- Receiving other investigational agents
- Unmeasurable tumor DNA at baseline
- Radiation or other non-systemic therapy within 2 weeks before enrollment without recovery
- Active autoimmune or inflammatory disorders needing immunosuppressive therapy (except low-dose prednisone 10 mg)
- 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
- Prior allogeneic tissue or organ transplant
- Allergic reactions to pembrolizumab or similar agents
- Prior anti-PD1 therapy
- Uncontrolled illness or infection
- History of pneumonitis requiring steroids or current pneumonitis
- Pregnant or breastfeeding women
- HIV-positive on combination antiretroviral therapy
- Active Hepatitis B or C (unless eradicated)
- History of active infection requiring systemic therapy
- Received live vaccine within 28 days prior to study (COVID-19 vaccines allowed except live vaccines)
AI-Screening
AI-Powered Screening
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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
CONTACT
A
Ari Rosenberg, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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