Phase 2 Trial of Maintenance Cemiplimab for Head and Neck Squamous Cell Carcinoma (HNSCC)

Sponsor
University of Miami
Study ID
NCT04831450
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

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

Interventions

  • Cemiplimab-Rwlc — DRUG
    350 mg Cemiplimab administered via intravenous infusion over 30 minutes on Day 1 of a 21-day cycle.

Study Details

The purpose of this study is to evaluate the experimental immunotherapy agent cemiplimab-rwlc when given after completion of chemotherapy and radiation treatment and determine if it will improve progression free survival and cure rates in patients with PD-L1 positive locally advanced head and neck cancer.

Key Dates

Start date
Jul 31, 2022
Status verified
Aug 2022
Primary completion
Jul 15, 2022
Completion
Jul 15, 2022

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cemiplimab After CRT in HNSCC
    Participants will receive Cemiplimab for 6 consecutive months (a total of 8 cycles) 14-42 days after completion of standard of care CRT.

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: Up to 2 years ]

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