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OncoMatch/Clinical Trials/NCT06064097

A Study Using Nivolumab, in Combination With Chemotherapy Drugs to Treat Nasopharyngeal Carcinoma (NPC)

Is NCT06064097 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Nivolumab and Cisplatin for stage ii nasopharyngeal carcinoma ajcc v8.

Phase 2RecruitingNational Cancer Institute (NCI)NCT06064097Data as of May 2026

Treatment: Cisplatin · Gemcitabine · NivolumabThis phase II trial tests effects of nivolumab in combination with chemotherapy drugs prior to radiation therapy patients with nasopharyngeal carcinoma (NPC). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Researchers want to find out what effects, good and/or bad, adding nivolumab to chemotherapy has on patients with newly diagnosed NPC. In addition, they want to find out if children with NPC may be treated with less radiation therapy and whether this decreases the side effects of therapy.

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Extracted eligibility criteria

Cancer type

Head and Neck Squamous Cell Carcinoma

Disease stage

Required: Stage II, III, IV

Prior therapy

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

Cannot have received: radiotherapy

Patients who received prior radiotherapy to the head or neck

Cannot have received: chemotherapy or radiation

Exception: for the treatment of any cancer in the last 3 years. These patients must also be in remission

Patients who received prior chemotherapy or radiation for the treatment of any cancer in the last 3 years. These patients must also be in remission

Lab requirements

Blood counts

ANC ≥ 1000/uL; Platelet count ≥ 100,000/uL (transfusion independent)

Kidney function

Creatinine clearance or GFR ≥ 60 mL/min/1.73 m^2; serum creatinine based on age/sex

Liver function

Total bilirubin ≤ 1.5 x ULN for age; SGPT (ALT) ≤ 135 U/L (ULN set to 45 U/L)

Cardiac function

Shortening fraction of ≥ 27% by echocardiogram, or ejection fraction of ≥ 50% by radionuclide angiogram; no evidence of dyspnea at rest, no exercise intolerance, and pulse oximetry > 94% if indicated

Peripheral absolute neutrophil count (ANC) ≥ 1000/uL; Platelet count ≥ 100,000/uL (transfusion independent); Creatinine clearance or GFR ≥ 60 mL/min/1.73 m^2; serum creatinine based on age/sex; Total bilirubin ≤ 1.5 x ULN for age; SGPT (ALT) ≤ 135 U/L (ULN set to 45 U/L); Shortening fraction of ≥ 27% by echocardiogram, or ejection fraction of ≥ 50% by radionuclide angiogram; no evidence of dyspnea at rest, no exercise intolerance, and pulse oximetry > 94% if indicated

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

US trial sites

  • Children's Hospital of Alabama · Birmingham, Alabama
  • Phoenix Childrens Hospital · Phoenix, Arizona
  • Arkansas Children's Hospital · Little Rock, Arkansas
  • Kaiser Permanente Downey Medical Center · Downey, California
  • Loma Linda University Medical Center · Loma Linda, California

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

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