Preoperative Immunotherapy in Patients With Squamous Cell Carcinoma of the Head and Neck

Part of paid clinical trials in San Francisco, California.

Sponsor
Alain Algazi
Study ID
NCT03708224
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Atezolizumab — BIOLOGICAL
    Given intravenously (IV)
  • Tocilizumab — BIOLOGICAL
    Given IV
  • Tiragolumab — BIOLOGICAL
    Given IV

Study Details

To determine the effect of neoadjuvant atezolizumab alone or in combination with other immune modulating agents on T-cell infiltration in advanced SCCHN. To determine the impact of neo-adjuvant immunotherapy on surgical outcomes.

Key Dates

First listed
Oct 17, 2018
Start date
Mar 8, 2019
Status verified
Aug 2026
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

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

Arms

  • Experimental: Arm A: Atezolizumab Monotherapy
    Participants will receive 840mg of atezolizumab between 15 - 42 days prior to definitive surgery. In addition to neoadjuvant atezolizumab, the first 9 participants in Arm A (atezolizumab monotherapy) will also receive atezolizumab administered at a fixed dose of 1200 mg IV every 3 weeks following surgery.
  • Experimental: Arm A (Adjuvant): Atezolizumab (Adjuvant)
    Participants will receive 840mg of atezolizumab over 15 days prior to definitive surgery. The first 9 participants in Arm A (atezolizumab monotherapy) will also receive adjuvant atezolizumab 16 weeks after standard of care surgery and radiation, or chemoradiation therapy, at a fixed dose of 1200 mg IV every 3 weeks for an additional 12 cycles.
  • Experimental: Arm B: Atezolizumab + Tiragolumab
    Participants will receive 840 mg of atezolizumab IV and 600 mg of Tiragolumab during the 15-day neoadjuvant period prior to definitive surgery.
  • Experimental: Arm C: Atezolizumab + Tocilizumab
    Participants will receive 840 mg of atezolizumab IV and 6 mg/kg of Tocilizumab during the 15-day neoadjuvant period prior to definitive surgery.

Primary Outcome Measure

Proportion of subjects with a >= 40% increase in the cluster of differentiation 3 (CD3) counts [ Time Frame: Up to 12 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of San Francisco, CaliforniaSan FranciscoCalifornia94143-

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University of San Francisco, California· San Francisco, CA

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