A Phase II Trial of Durvalumab (MEDI4736) and Tremelimumab and Radiation Therapy in Hepatocellular Carcinoma and Biliary Tract Cancer

Who is this study for? Patients with Hepatocellular Carcinoma, Biliary Tract Cancer
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug, Radiation
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This 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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Histologically or cytologically confirmed hepatocellular carcinoma or biliary tract cancer

• Locally advanced/unresectable or metastatic disease

• Age ≥ 18 years at time of study entry

• ECOG Performance Status ≤ 1

• One previously unirradiated lesion amenable to 8 Gy x 3 radiotherapy based on dosimetric organ tolerance AND another unirradiated measurable lesion (per irRECIST) outside of the radiation field

• Immunotherapy-naïve

• Progressed on, be intolerant of, or refused sorafenib \[for HCC\], second line treatment and beyond for cholangiocarcinoma or gemcitabine-based chemotherapy for biliary tract cancer

• The benefits of sorafenib have been discussed with the patient and the patient has refused treatment with sorafenib.

• Viral status (Hepatitis B and C) must be known. All HBV-positive patients must be on antiviral medication for viral suppression.

‣ Patients with concomitant HBV infection must have a confirmed diagnosis of HBV characterized by the presence of hepatitis B core antibodies, and be sufficiently suppressed with active antiviral treatment (per local institutional practice) prior to enrollment to ensure adequate viral suppression (HBV deoxyribonucleic acid \[DNA\] \<2000 IU/mL).

⁃ Patients with concomitant HCV infection must have confirmed diagnosis of HCV characterized by the presence of detectable HCV ribonucleic acid (RNA or anti-HCV antibody upon enrollment.

• Body weight ≥ 30 kg

• Child-Pugh Score of A. A score of B7 is allowed without severe ascites or without hepatic encephalopathy.

• Adequate organ and marrow function, defined as:

‣ Hemoglobin ≥ 9 g/dL

⁃ ANC ≥ 1.5 x 10\^9/L

⁃ Platelet count ≥75×109/L

⁃ Serum bilirubin ≤2.0× the upper limit of normal (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)

• Males:

⁃ -Creatinine CL (mL/min) = Weight (kg) x (140 - Age) 72 x serum creatinine (mg/dL)

• Females:

⁃ -Creatinine CL (mL/min) = Weight (kg) x (140 - Age) x 0.85 72 x serum creatinine (mg/dL)

• Ability to understand and the willingness to sign a written informed consent document

• Female subjects must be either of non-reproductive potential (i.e., post-menopausal by history: ≥ 50 years old and no menses for ≥1 year without an alternative medical cause; OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum pregnancy test upon study entry.

• Willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations with follow up

Locations
United States
Massachusetts
Dana Farber Cancer Institute
RECRUITING
Boston
Massachusetts General Hospital
RECRUITING
Boston
Contact Information
Primary
Theodore Hong, MD
TSHONG1@mgh.harvard.edu
617-726-6050
Time Frame
Start Date: 2018-05-14
Estimated Completion Date: 2026-10
Participants
Target number of participants: 70
Treatments
Experimental: Tremelimumab + Durvalumab + Radiation
* Durvalumab via IV infusion every 28 days for up to 4 doses/cycles~* Tremelimumab via IV infusion every 28 days for up to 4 doses/cycles, and then continue durvalumab monotherapy every 4 weeks starting on Week 16 for up to 8 months.~* Radiation therapy will only be given during cycle 2
Sponsors
Leads: Massachusetts General Hospital
Collaborators: AstraZeneca

This content was sourced from clinicaltrials.gov