Phase I/ II Trial Combining PD-1 Inhibition and Neoadjuvant Proton or Photon Radiation Therapy in Recurrent Head and Neck Squamous Cell Carcinoma

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
University of Cincinnati
Study ID
NCT07213934
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Proton therapy — RADIATION
    Proton therapy is a type of radiation therapy that uses protons rather than x-rays. It painlessly delivers radiation to treat some types of cancer.
  • Pembrolizumab — DRUG
    PDL-1 immunotherapy drug

Study Details

The purpose of the Phase I study is to see if it is safe to use X-ray photon radiation (XRT) and proton radiation (PT) before surgery in patients with recurrent head and neck squamous cell carcinoma (rHNSCC). The purpose of the Phase II study is to see if using XRT or PT before immunotherapy (pembrolizumab) prior to surgery benefits patients with recurrent head and neck squamous cell carcinoma (rHNSCC).

Key Dates

Start date
Oct 8, 2025
Status verified
Apr 2026
Primary completion
Dec 31, 2030
Completion
Dec 31, 2031

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard Radiation Therapy
    XRT followed by PD-1 inhibition
  • Experimental: Photon Therapy
    PT followed by PD-1 inhibition

Primary Outcome Measure

Dose Limiting Toxicity (DLT) Evaluation defined as the number of subjects experiencing a major, non-grade 5 adverse event as defined by CTCAE v6 or a grade 5 adverse event as defined by CTCAE 6. [ Time Frame: From the initiation of study treatment to 28 days post resection. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Cincinnati Medical CenterCincinnatiOhio45219
UCCC CTO
[email protected]
513-584-7698
Trisha Wise-Draper, MD,PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Cincinnati, OH

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
University of Cincinnati Medical Center· Cincinnati, OH

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