Cemiplimab and Cetuximab Prior Salvage Surgery in Patients With Recurrent Oral Cavity and HPV-negative Oropharyngeal Squamous Cell Carcinoma

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT06448026
Phase
PHASE2
Status
Recruiting
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Conditions

  • Locally Recurrent Oral Cavity Squamous Cell Carcinoma

Eligibility Criteria

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

Interventions

  • Cemiplimab — DRUG
    Given by IV
  • Cetuximab — DRUG
    Given by IV

Study Details

To learn if giving cemiplimab and cetuximab before salvage surgery can help to control recurrent oral cavity squamous cell carcinoma.

Key Dates

First listed
Jun 7, 2024
Start date
Nov 21, 2024
Status verified
Jun 2026
Primary completion
May 15, 2027
Completion
May 15, 2027

Study Design

Enrollment
17 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cemiplimab + Cetuximab
    Participants will receive cemiplimab and cetuximab together for 6 weeks, and then you will have salvage surgery. Based on how the tumor responds to the study therapy, you may also receive cemiplimab alone for up to 1 year after surgery.

Primary Outcome Measure

Safety and adverse events (AEs) [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030
Luana Guimaraes De Sousa, MD
[email protected]
Luana Guimaraes De Sousa, MD (PRINCIPAL_INVESTIGATOR)

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By research site
MD Anderson Cancer Center· Houston, TX

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