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OncoMatch/Clinical Trials/NCT06496178

A Phase 3 Study to Evaluate Petosemtamab Compared With Investigator's Choice Monotherapy in Previously Treated Head and Neck Squamous Cell Carcinoma Patients

Is NCT06496178 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Petosemtamab and Investigator's Choice for head and neck squamous cell carcinoma.

Phase 3RecruitingMerus B.V.NCT06496178Data as of May 2026

Treatment: Petosemtamab · Investigator's Choice · Investigator's Choice · Investigator's ChoiceThis is a phase 3 open-label, randomized, controlled, multicenter study to compare petosemtamab vs investigator's choice monotherapy in HNSCC patients for the second- and third-line treatment of incurable metastatic/recurrent disease.

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Extracted eligibility criteria

Cancer type

Head and Neck Squamous Cell Carcinoma

Biomarker criteria

Required: CDKN2A p16 status (positive or negative) by IHC

Documentation of p16 status (positive or negative) by local laboratory IHC for patients with primary oropharyngeal cancer

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 2 prior lines

Must have received: anti-PD-1 therapy

HNSCC patients progressed on or after anti-PD-1 therapy

Must have received: platinum-based chemotherapy

HNSCC patients progressed on or after...platinum-containing therapy

Cannot have received: systemic anticancer therapy

Any systemic anticancer therapy within 4 weeks of the first dose of study treatment

Lab requirements

Blood counts

adequate organ function (as per protocol)

Kidney function

adequate organ function (as per protocol)

Liver function

adequate organ function (as per protocol)

Adequate organ function (as per protocol)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Site 94 · Pearland, Texas
  • Site 160 · Mobile, Alabama
  • Site 102 · Prescott, Arizona
  • Site 125 · Scottsdale, Arizona
  • Site 82 · Duarte, California

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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