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OncoMatch/Clinical Trials/NCT04080804

Study of Safety and Tolerability of Nivolumab Treatment Alone or in Combination With Relatlimab or Ipilimumab in Head and Neck Cancer

Is NCT04080804 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Nivolumab and Relatlimab for head and neck squamous cell carcinoma (hnscc).

Phase 2RecruitingDan ZandbergNCT04080804Data as of May 2026

Treatment: Nivolumab · Relatlimab · IpilimumabThe aim of this study is to potentiate adaptive immunity to enhance the anti-tumor activity of anti-PD1 antibody by the addition of anti-CTLA4 antibody or anti-LAG3 antibody (relatlimab) given in subjects with resectable locally advanced HNSCC prior to surgical resection.

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Extracted eligibility criteria

Cancer type

Head and Neck Squamous Cell Carcinoma

Biomarker criteria

Required: PD-L1 (CD274) any tested (testing required; no eligibility threshold specified)

Required: LAG3 any tested (testing required; no eligibility threshold specified)

Disease stage

Required: Stage III, IVA

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: radiation therapy

Prior radiation ... [excluded]

Cannot have received: chemotherapy

Prior ... chemotherapy ... [excluded]

Cannot have received: oncology vaccine

Prior ... oncology vaccine ... [excluded]

Cannot have received: immunotherapy

Prior ... immunotherapy [excluded]

Cannot have received: LAG-3 targeted agent

Prior treatment with LAG-3 targeted agents

Lab requirements

Cardiac function

LVEF ≥50% by TTE or MUGA within 28 days prior to first study drug administration; Troponin T or I ≤ 2 × institutional ULN (with retesting/monitoring as described)

LVEF assessment with documented LVEF ≥50% by either TTE or MUGA ... Troponin T (TnT) or I (TnI) > 2 × institutional ULN [excluded].

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

US trial sites

  • UPMC Hillman Cancer Center · Pittsburgh, Pennsylvania

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

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