A Study Evaluating Efficacy and Safety of Multiple Treatment Combinations in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck (Morpheus-Head and Neck Cancer)

Part of paid clinical trials in Duarte, California.

Sponsor
Hoffmann-La Roche
Study ID
NCT05459129
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Squamous Cell Carcinoma of the Head and Neck

Eligibility Criteria

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

Interventions

  • Atezolizumab — DRUG
    Atezolizumab will be administered intravenously at a fixed dose of 1200 mg on Day 1 of each 21-day cycle.
  • Tiragolumab — DRUG
    Tiragolumab will be administered intravenously at a fixed dose of 600 mg on Day 1 of each 21-day cycle.
  • Carboplatin — DRUG
    Carboplatin will be administered intravenously at a dose of area under the concentration-time curve (AUC) 5 mg/mL/min on Day 1 of each 21 day cycle.
  • Paclitaxel — DRUG
    Paclitaxel will be administered intravenously at a dose of 175 mg/m2 on Day 1 of each 21 day cycle.

Study Details

This is a Phase Ib/II, open-label, multicenter, randomized, umbrella study in participants with locally advanced squamous cell carcinoma of the head and neck (SCCHN). The study will enroll treatment-naive participants with resectable Stage III-IVA human papillomavirus (HPV)-negative, programmed death-ligand 1 (PD-L1)-positive SCCHN with measurable disease, as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) who have not received systemic treatment for their disease.

Key Dates

Start date
Apr 12, 2023
Status verified
Aug 2025
Primary completion
Aug 15, 2024
Completion
Aug 15, 2024

Study Design

Enrollment
12 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Atezo + Tira
    Participants in the atezolizumab plus tiragolumab arm will receive treatment for two cycles (6 weeks) until surgery or until unacceptable toxicity or loss of clinical benefit, whichever occurs first.
  • Experimental: Atezo + Tira + CP
    Participants in the atezolizumab plus tiragolumab plus carboplatin plus paclitaxel arm arm will receive treatment for two cycles (6 weeks) until surgery or until unacceptable toxicity or loss of clinical benefit, whichever occurs first.

Primary Outcome Measure

Percentage of Participants With Pathologic Complete Response (pCR) as Determined by Local Pathologic Review [ Time Frame: At the time of surgery (Week 7 ± 1 week) ]

Locations (3)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010-
Thomas Jefferson University HospitalPhiladelphiaPennsylvania19107-
University of Pittsburgh Medical CenterPittsburghPennsylvania15213-

Related coverage on Hipa.ai

Find similar trials in Duarte, CA

By research site
City of Hope· Duarte, CAThomas Jefferson University Hospital· Philadelphia, PAUniversity of Pittsburgh Medical Center· Pittsburgh, PA

Related Studies