Response-Adaptive Treatment in Untreated Locoregional HPV-Negative Head and Neck Cancer

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Chicago
Study ID
NCT07065630
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Volrustomig — DRUG
    500mg or 750mg (cycles 1-2) and 250mg thereafter IV day 1.
  • Carboplatin — DRUG
    100mg/m2 IV day 1 and day 8.
  • Paclitaxel — DRUG
    AUC 5 IV day 1

Study Details

The purpose of this study is to assess the objective response rate following neoadjuvant therapy with volrustomig, paclitaxel, and carboplatin in previously untreated human papillomavirus (HPV)-negative locally advanced head and neck squamous cell carcinoma .

Key Dates

Start date
Oct 7, 2025
Status verified
Mar 2026
Primary completion
Aug 13, 2029
Completion
Aug 13, 2029

Study Design

Enrollment
38 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Volrustomig
    Dose Level 0: 500 mg IV on day 1 of 21-day cycle Dose Level 1: 750 mg IV on day 1 of 21-day cycle After the completion of radiation, patients will be initiated on maintenance volrustomig. Volrustomig will be administered at 250mg on day 1 of a 21-day cycle for 12 cycles (36 weeks/9 months)
  • Experimental: Carboplatin (AUC)
    Dose Level 0: AUC 5 IV on day 1 of 21-day cycle Dose Level 1: AUC 5 IV on day 1 of 21-day cycle
  • Experimental: Paclitaxel (mg/m2)
    Dose Level 0: 100 mg/m2 IV on Day 1 and Day 8 of 21-day cycle Dose Level 1: 100 mg/m2 IV on Day 1 and Day 8 of 21-day cycle

Primary Outcome Measure

Response rate [ Time Frame: 24 months ]

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

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

Related Studies