Actively Recruiting
A Phase II Trial of Cemiplimab or Cemiplimab-Chemotherapy Followed by Biomarker-Guided De-escalated Curative Treatment for Advanced HPV-Related Head and Neck Cancer (The MINIMA Study)
Led by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Updated on 2026-03-03
32
Participants Needed
1
Research Sites
22 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
Researchers are investigating whether using neoadjuvant immunotherapy, with or without chemotherapy, can reduce the intensity of treatment for patients with advanced HPV-related head and neck squamous cell carcinoma while maintaining high cure rates and improving long-term quality of life. This Phase II trial focuses on patients with confirmed HPV16-positive tumors and aims to evaluate treatment feasibility and quality of life outcomes. Participants will receive three cycles of Cemiplimab through intravenous infusion over nine weeks before their main curative treatment. Some may also receive chemotherapy drugs Carboplatin and Paclitaxel depending on individual benefit. After this initial phase, a multidisciplinary team will decide whether patients undergo de-escalated treatment, such as Transoral Robotic Surgery (TORS) or low-dose radiation therapy (42 Gy), or non-minimally de-escalated treatment including surgery followed by post-operative radiation or chemoradiation therapy. Following curative treatment, patients will receive adjuvant Cemiplimab for four months, administered as five doses every 21 days. During the study, participants will be closely monitored weekly by a multidisciplinary team and assessed at weeks 9 or 10 to guide treatment decisions. Researchers will measure progression-free survival and changes in swallowing function and quality of life through specific questionnaires over two years. Safety will be tracked by recording any significant toxicities or immune-related adverse events. This study will last up to two years and includes detailed follow-up to evaluate the effectiveness and impact of the treatment approach on patient well-being.
CONDITIONS
Brief 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 other eligible subsites
- HPV16-positive disease confirmed by p16 IHC and validated by nucleic acid-based testing
- Availability of at least 8 unstained 5 micron slides or ability to undergo biopsy if needed
- Age 18 years or older
- AJCC 7th or 8th edition stage III or IV without bulky nodal or bulky T4 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
- ECOG performance status 0-1 (Karnofsky ≥70%)
- Normal organ function as defined by specified blood counts and chemistry
- Signed informed consent
- Women of childbearing potential must have negative pregnancy test and agree to contraception
- Men sexually active with women of childbearing potential must agree to contraception
- Azoospermic males and non-heterosexually active women exempt from contraceptive requirements but must undergo pregnancy testing
You will not qualify if you...
- Distant metastases (M1 disease)
- Unknown primary tumor site not identified by exam, imaging, or biopsy
- Intercurrent illnesses impairing tolerance or survival, including active infection, immunodeficiency, heart or lung conditions, or 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 steroid or immunosuppressive therapy within 7 days prior to treatment
- Active tuberculosis
- Hypersensitivity to cemiplimab or study drugs
- Systemic anti-cancer treatment within last 8 weeks
- Additional progressing malignancy requiring treatment (with some exceptions)
- Active autoimmune disease requiring systemic treatment in past year
- Active non-infectious pneumonitis
- History of HIV infection
- Active Hepatitis B or C (unless eradicated)
- Live vaccine within 28 days prior to study therapy (except inactivated influenza vaccines)
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 visit (in-person)
Duration - 9 weeks
Participants receive 3 cycles (9 weeks) of Cemiplimab with or without Carboplatin and Paclitaxel depending on measurable benefit.
Weekly visits for assessments and treatment infusions
Duration - Varies by treatment type
Participants undergo either de-escalated curative treatment (Transoral Robotic Surgery or Low Dose Radiation Therapy) or non-minimally de-escalated treatment (Surgery plus Post-Operative Radiation Therapy or Chemoradiation Therapy) based on biomarker-guided decisions.
1 to 2 treatment visits depending on assigned therapy
Duration - 4 months
Participants receive adjuvant Cemiplimab for 4 months with doses every 21 days after curative treatment.
5 visits (in-person) every 3 weeks for adjuvant therapy
Trial Site Locations
Total: 1 location
1
Johns Hopkins University
Baltimore, Maryland, United States, 21287
Actively Recruiting
Research Team
Z
Zubair Khan, M.D.
S
Sydjea Stillwell, R.N.
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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