A Trial of Locoregionally Advanced Squamous Cell Carcinoma of The Head and Neck

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Chicago
Study ID
NCT07346196
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • Cemiplimab — DRUG
    350 mg via IV
  • Fianlimab — DRUG
    1600 mg via IV
  • Carboplatin — DRUG
    Target AUC 5 via IV
  • Paclitaxel — DRUG
    100 mg/m2 via IV
  • Radiation — RADIATION
    Radiotherapy will be delivered to a total dose of 70 Gy.

Study Details

The goal of this clinical trial is to learn if the combination of cemiplimab and fianlimab can improve outcomes compared to cemiplimab alone in adults with Human Papillomavirus Positive HPV-positive head and neck cancer.

Key Dates

Start date
Feb 7, 2027
Status verified
Jan 2026
Primary completion
Aug 22, 2031
Completion
Aug 22, 2031

Study Design

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

Arms

  • Experimental: Cemiplimab + chemo
    Participants assigned to this arm will receive Cemiplimab in combination with chemotherapy (paclitaxel and carboplatin) for 3 cycles (9 weeks). This will be followed by Chemoradiation with Cisplatin and Radiotherapy for 7 weeks. Cemiplimab will then be given for an additional 6 months.
  • Experimental: Cemiplimab + chemo + fianlimab
    Participants assigned to this arm will receive Cemiplimab and Fianlimab in combination with chemotherapy (paclitaxel and carboplatin) for 3 cycles (9 weeks). This will be followed by Chemoradiation with Cisplatin and Radiotherapy for 7 weeks. Cemiplimab will then be given for an additional 6 months.

Primary Outcome Measure

Overall Response Rate [ Time Frame: 9 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Chicago Medicine Comprehensive Cancer CenterChicagoIllinois60637-

Find similar trials in Chicago, IL

By condition
Skin cancer
By specialty
OncologySkin cancerDermatology
By research site
The University of Chicago Medicine Comprehensive Cancer Center· Chicago, IL

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