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OncoMatch/Clinical Trials/NCT03482102

Durvalumab (MEDI4736) and Tremelimumab and Radiation Therapy in Hepatocellular Carcinoma and Biliary Tract Cancer

Is NCT03482102 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Tremelimumab and Durvalumab for hepatocellular carcinoma.

Phase 2RecruitingMassachusetts General HospitalNCT03482102Data as of May 2026

Treatment: Tremelimumab · DurvalumabThis research study is studying a combination of drugs as a possible treatment for Hepatocellular Carcinoma or Biliary Tract Cancer. The interventions involved in this study are: * Durvalumab * Tremelimumab * Radiation Therapy

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Extracted eligibility criteria

Cancer type

Hepatocellular Carcinoma

Cholangiocarcinoma

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 1 prior line

Must have received: gemcitabine-based chemotherapy

second line treatment and beyond for cholangiocarcinoma or gemcitabine-based chemotherapy for biliary tract cancer

Cannot have received: immunotherapy (anti-CTLA4, tremelimumab, anti-PD-1, anti-PD-L1, durvalumab)

Prior immunotherapy including but not limited to anti-CTLA4, including tremelimumab anti-PD-1, and anti-PD-L1, including durvalumab

Cannot have received: radiation therapy

Exception: prior irradiation to the planned radiation target lesion

Prior irradiation to the planned radiation target lesion

Lab requirements

Blood counts

Hemoglobin ≥ 9 g/dL; ANC ≥ 1.5 x 10^9/L; Platelet count ≥75×10^9/L; INR < 2.0

Kidney function

Calculated creatinine clearance > 40 mL/min as determined by Cockcroft-Gault (using actual body weight)

Liver function

Serum bilirubin ≤2.0× ULN; ALT and AST ≤ 3 x institutional ULN; Albumin > 2.8 g/dL; Child-Pugh Score of A. A score of B7 is allowed without severe ascites or without hepatic encephalopathy.

Cardiac function

Mean QTc < 470 ms using Fredericia's Correction

Adequate organ and marrow function, defined as: Hemoglobin ≥ 9 g/dL; ANC ≥ 1.5 x 10^9/L; Platelet count ≥75×10^9/L; Serum bilirubin ≤2.0× ULN; ALT and AST ≤ 3 x institutional ULN; Albumin > 2.8 g/dL; INR < 2.0; Calculated creatinine clearance > 40 mL/min as determined by Cockcroft-Gault (using actual body weight); Mean QTc < 470 ms using Fredericia's Correction

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

US trial sites

  • Massachusetts General Hospital · Boston, Massachusetts
  • Dana Farber Cancer Institute · Boston, Massachusetts

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