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OncoMatch/Clinical Trials/NCT05904080

Testing Nivolumab and Ipilimumab Immunotherapy With or Without the Targeted Drug Cabozantinib in Recurrent, Metastatic, or Incurable Nasopharyngeal Cancer

Is NCT05904080 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Ipilimumab and Nivolumab for metastatic nasopharyngeal carcinoma.

Phase 2RecruitingNational Cancer Institute (NCI)NCT05904080Data as of May 2026

Treatment: Cabozantinib S-malate · Ipilimumab · NivolumabThis phase II trial tests how well nivolumab and ipilimumab immunotherapy with or without cabozantinib works in treating patients with nasopharyngeal cancer that has come back (after a period of improvement) (recurrent), has spread from where it first started (primary site) to other places in the body (metastatic), or for which no treatment is currently available (incurable). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells. Giving immunotherapy with nivolumab and ipilimumab and targeted therapy with cabozantinib may help shrink and stabilize nasopharyngeal cancer.

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Extracted eligibility criteria

Cancer type

Head and Neck Squamous Cell Carcinoma

Disease stage

Required: Stage IV

Metastatic disease required

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Max 2 prior lines

Must have received: platinum-based chemotherapy (platinum-gemcitabine) — recurrent/metastatic

disease treated with platinum-gemcitabine

Must have received: anti-PD-1/PD-L1 therapy — recurrent/metastatic

prior PD-1/L1 blockade (as first or second-line therapy) where immunotherapy was part of the most recent prior line of therapy

Cannot have received: VEGFR inhibitor

No prior VEGFR targeted therapy permitted

Lab requirements

Blood counts

ANC >= 1,000/mm^3; Hemoglobin >= 9 g/dL; Platelet count >= 100,000/mm^3

Kidney function

Creatinine or creatinine clearance <= 1.5 mg/dL or >= 30 mL/min (MDRD)

Liver function

Total bilirubin <= 1.5 x institutional upper limit of normal (ULN); except subjects with Gilbert syndrome who can have a total bilirubin < 3 mg/dL; AST/ALT <= 3 x ULN (up to <= 5 x ULN with liver metastases)

ANC >= 1,000/mm^3; Hemoglobin >= 9 g/dL; Platelet count >= 100,000/mm^3; Creatinine or creatinine clearance <= 1.5 mg/dL or >= 30 MDRD; Total bilirubin <= 1.5 x institutional ULN; except subjects with Gilbert syndrome who can have a total bilirubin < 3 mg/dL; AST/ALT <= 3 x ULN (up to <= 5 x ULN with liver metastases)

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

US trial sites

  • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care · Irvine, California
  • Keck Medicine of USC Koreatown · Los Angeles, California
  • Los Angeles General Medical Center · Los Angeles, California
  • USC / Norris Comprehensive Cancer Center · Los Angeles, California
  • USC Norris Oncology/Hematology-Newport Beach · Newport Beach, California

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

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