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
Recruiting
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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

Start date
Mar 8, 2019
Status verified
Nov 2024
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

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

Arms

  • Experimental: Atezolizumab Monotherapy
    Participants will receive 840mg of atezolizumab over 15 days prior to definitive surgery.
  • Experimental: 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: 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: 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 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of San Francisco, CaliforniaSan FranciscoCalifornia94143
UCSF HDFCCC Cancer Immunotherapy Program
[email protected]
(877) 827-3222
[email protected]
Alain Algazi, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in San Francisco, CA

By condition
Head and neck cancerSkin cancer
By specialty
OncologyENTSkin cancerDermatology
By research site
University of San Francisco, California· San Francisco, CA

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