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Nivolumab / Head and Neck Cancer / Atezolizumab · Phase 2 Trial
ClinicalTrials.gov · August 18, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a planned Phase 2 feasibility trial of concurrent SBRT and checkpoint inhibitor therapy in stage IV cancers, registered but not yet recruiting and with no results reported. The registry record describes the study design and primary endpoint (6-month PFS) but provides no outcome data, safety data, or analysis results to evaluate the intervention.
Phase 2, Interventional, Single Group, Open label, Treatment purpose. Head and Neck Cancer, Non-Small Cell Lung Cancer, Cervical Cancer, Esophageal Cancer, Gastric Cancer (GC); age from 18 Years; to 99 Years. Intervention: Concurrent Immunotherapy and SBRT. n = 35. 1 site: United States.
This is a planned Phase 2 feasibility trial of concurrent SBRT and checkpoint inhibitor therapy in stage IV cancers, registered but not yet recruiting and with no results reported. The registry record describes the study design and primary endpoint (6-month PFS) but provides no outcome data, safety data, or analysis results to evaluate the intervention.
No efficacy, safety, or toxicity data are available; the study is in planning phase only. Sample size (n=35) is typical for feasibility but too small to power efficacy claims; secondary endpoints (overall survival, local recurrence-free survival, toxicity) are listed but not yet measured.
The source did not state who this applies to in practice.
This is a Phase 2, single-arm feasibility study with no results yet posted; it is designed to evaluate concurrent SBRT and immunotherapy but carries no outcome data to assess efficacy or safety.
As stated by the source record.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07770100). This is a study registration, not published results. Lead sponsor: Mark Bernard. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 35 participants (ESTIMATED). Conditions: Head and Neck Cancer, Non-Small Cell Lung Cancer, Cervical Cancer, Esophageal Cancer, Gastric Cancer (GC). Interventions: RADIATION: Stereotactic Body Radiation Therapy (SBRT); DRUG: Pembrolizumab; DRUG: Nivolumab; DRUG: Atezolizumab; DRUG: Ipilimumab. Primary outcome measures: 6-Month Progression-Free Survival (PFS) , 6 Months. Brief summary: This phase II, single arm study evaluates the feasibility and clinical outcomes of delivering stereotactic body radiation therapy (SBRT) to 6-10 metastatic lesions concurrently with standard-of-care immune checkpoint inhibitor therapy in patients with stage IV cancers, including head and neck, non-small cell lung cancers, cervical, esophageal, gastric and gastroesophageal cancers. The primary objective is to determine 6-month progression-free survival following concurrent treatment. Secondary objectives include assessment of toxicity, overall survival, local recurrence-free survival, distant metastasis progressive free survival, response rates, and continuation of systemic therapy.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.