NCT03708224 Preoperative Immunotherapy in Patients With Squamous Cell Carcinoma of the Head and Neck
| NCT ID | NCT03708224 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Alain Algazi |
| Condition | Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 55 participants |
| Start Date | 2019-03-08 |
| Primary Completion | 2028-06-30 |
Trial Parameters
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Patients must have clinically suspected SCCHN that is amenable to surgical resection with therapeutic intent 2. Be willing and able to provide written informed consent/assent for the trial 3. Be \>=18 years of age on day of signing informed consent. 4. Agree to research analysis of an existing pre-treatment biopsy available that was obtained within 90 days prior to the day of consent or agree to a new biopsy for research (or clinical diagnosis) within the screening window. Needle biopsies must be at least 20 Gauge in diameter 5. Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale 6. Demonstrate adequate organ function as defined below. All screening labs should be performed within 14 days of treatment initiation * Absolute neutrophil count (ANC) \>=1,500 /microliter (mcL) * Platelets \>=100,000 / mcL * Hemoglobin \>= 9 g/dL * Lymphocyte count \>= 500/mcL * White blood count \>=3,000/mcL or \<=14,000/mcL * Serum c
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