A Study Comparing Two Immunotherapy Options for Human Papillomavirus Positive HPV-Positive Head and Neck Cancer After Treatment

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Chicago
Study ID
NCT07179315
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

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 who have detectable minimal-residual disease after definitive treatment. The main question(s) it aims to answer are: * Does combining cemiplimab with fianlimab provide better results in preventing cancer recurrence than cemiplimab alone? * Is the combination treatment safe and well-tolerated by patients? Researchers will compare the group receiving cemiplimab alone to the group receiving the combination of cemiplimab and fianlimab to see if the combination leads to improved treatment outcomes, such as better disease control and longer survival. Participants will: * Receive either cemiplimab alone or a combination of cemiplimab and fianlimab. * Attend regular follow-up visits for monitoring of treatment efficacy and side effects. * Undergo assessments to measure disease progression and response to treatment.

Key Dates

First listed
Sep 17, 2025
Start date
Jun 9, 2026
Status verified
Jul 2026
Primary completion
Nov 30, 2029
Completion
Nov 30, 2029

Study Design

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

Arms

  • Experimental: two monoclonal antibodies together for 1 year
    This arm is assigned to intervention 1
  • Experimental: One monoclonal antibody alone for 1 year
    This arm is assigned to intervention 2

Primary Outcome Measure

Assess improved recurrence free survival in patients [ Time Frame: assessed up to 5 years after enrollment completed ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of ChicagoChicagoIllinois60637
Clinical Trials Intake
[email protected]
855-702-8222
Ari Rosenberg
[email protected]
Ari Rosenberg (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chicago, IL

Nationwide
Head and neck cancer trialsOncology trialsENT trials
By condition
Head and neck cancer
By specialty
OncologyENT
By research site
The University of Chicago· Chicago, IL

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