Actively Recruiting
Trial of Cemiplimab, or Cemip-Chemo Followed by Biomarker-guided Treatment for Pts w/HPV H&N Ca
Led by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Updated on 2026-03-03
32
Participants Needed
1
Research Sites
311 weeks
Total Duration
On this page
Sponsors
S
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead Sponsor
R
Regeneron Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
To determine if it is feasible to use neoadjuvant immunotherapy (or immunotherapy plus chemotherapy) to reduce treatment intensity and improve long-term quality of life while maintaining very high cure rates.
CONDITIONS
Official Title
Trial of Cemiplimab, or Cemip-Chemo Followed by Biomarker-guided Treatment for Pts w/HPV H&N Ca
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed HPV-positive head and neck squamous cell carcinoma of the oropharynx or rare other subsites
- HPV16 type confirmed by appropriate testing
- At least 18 years old
- AJCC 7th edition stage III or IV without bulky nodal or bulky T4 disease, or AJCC 8th edition stage II or III, or stage I with specified nodal involvement without bulky disease
- Measurable disease by RECIST 1.1 criteria
- No prior radiation or chemotherapy for head and neck cancer
- No complete surgical resection within 8 weeks before enrollment except biopsy or excision with residual disease
- ECOG performance status 0-1 (Karnofsky ≥70%)
- Normal organ function with specified blood count and chemistry levels
- Signed informed consent
- Women of childbearing potential must have negative pregnancy test and agree to contraception during and after treatment
- Men sexually active with women of childbearing potential must agree to contraception during and after treatment
- Availability of at least 8 unstained 5 micron slides or waiver by principal investigator
You will not qualify if you...
- Presence of distant metastases (M1 disease)
- Unknown or unidentifiable primary tumor site
- Medical conditions limiting tolerance to therapy or survival including active infection, immunodeficiency, severe heart or lung disease, psychiatric illness limiting compliance
- Pregnant or nursing women
- Prior surgical therapy other than biopsy or organ-sparing procedures with residual measurable tumor required
- Receiving other investigational agents
- Peripheral neuropathy greater than grade 1
- Immunodeficiency or systemic immunosuppressive therapy within 7 days before first dose
- Active tuberculosis infection
- Hypersensitivity to cemiplimab or study drugs
- Systemic anti-cancer treatment within last 8 weeks
- Additional progressing malignancies requiring active treatment except certain skin or in situ cancers
- Active autoimmune disease requiring systemic treatment in past year
- Active non-infectious pneumonitis
- Known HIV infection
- Active Hepatitis B or C infection (unless eradicated)
- Receipt of live vaccine within 28 days before treatment start (inactivated flu vaccines allowed)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Johns Hopkins University
Baltimore, Maryland, United States, 21287
Actively Recruiting
Research Team
Z
Zubair Khan, M.D.
CONTACT
S
Sydjea Stillwell, R.N.
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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