A Study of Pembrolizumab in Combination With Chemotherapy for Head and Neck Cancer

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Chicago
Study ID
NCT05420948
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Pembrolizumab — DRUG
    A drug that binds to a protein called programmed cell death 1 (PD-1) to help immune cells kill cancer cells better. Pembrolizumab is used to treat many different types of cancer.
  • Carboplatin — DRUG
    A chemotherapy drug used to treat cancer.
  • Paclitaxel — DRUG
    A chemotherapy drug used to treat cancer.

Study Details

By doing this study, the research team would like to learn if using a blood test that measures the amount of tumor DNA in blood can help guide how to use chemotherapy combined with immunotherapy for individuals with head and neck cancer. Using this blood test, the research team hopes to learn if intermittent (occasional) chemotherapy added to immunotherapy will work better than immunotherapy alone. Participation in this research will last about two years.

Key Dates

Start date
Oct 17, 2022
Status verified
May 2026
Primary completion
Dec 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1: Participants Who Receive Pembrolizumab (Alone)
    Participants in this group will receive pembrolizumab 200 mg through an intravenous (IV) needle inserted into the arm. Medications will be given on day 1 of each 21-day cycle for two cycles..
  • Experimental: Group 2: Participants Who Receive Pembrolizumab + Chemotherapy with Carboplatin and Paclitaxel
    Participants in this group will receive 200 mg of pembrolizumab through an intravenous (IV) needle inserted into the arm plus chemotherapy with carboplatin (AUC 6) on day 1 and paclitaxel (200 mg) on day 1 of each 21-day cycle for two cycles.

Primary Outcome Measure

Objective Response Rate of Participants as Assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). [ Time Frame: 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Chicago Comprehensive Cancer CenterChicagoIllinois60637
Cancer Clinical Trials Intake
[email protected]
855-702-8222
Ari Rosenberg (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chicago, IL

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
University of Chicago Comprehensive Cancer Center· Chicago, IL

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