RecruitingPhase 2NCT03482102

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

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


Sponsor

Massachusetts General Hospital

Enrollment

70 participants

Start Date

May 14, 2018

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing the combination of two immunotherapy drugs — durvalumab and tremelimumab — together with a short course of radiation therapy in patients with advanced biliary tract cancer (cancer of the bile ducts or gallbladder) that cannot be surgically removed and has already been treated with prior chemotherapy. **You may be eligible if...** - You are 18 or older - You have confirmed biliary tract cancer (bile duct or gallbladder cancer) that has spread or cannot be removed by surgery - Your cancer has progressed after prior chemotherapy (second line or beyond) - You have not previously received immunotherapy (no prior anti-PD-1, anti-PD-L1, or anti-CTLA4 drugs) - One of your tumors is suitable for local radiation and another separate, measurable tumor exists outside the radiation field - Your liver, kidney, and blood counts are within acceptable ranges - If you have hepatitis B: you are on antiviral medication with good viral control - You are willing to use effective contraception **You may NOT be eligible if...** - You have previously received immunotherapy - You have active autoimmune disease, inflammatory bowel disease, or required immunosuppressant medications recently - You are pregnant or breastfeeding - Your cancer has spread to the brain or spinal cord (unless stable) - You have HIV or active hepatitis - You have had a major surgery within 28 days Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTremelimumab

Tremelimumab target the cancerous proteins and stop the cancer cells from suppressing the immune system

DRUGDurvalumab

Durvalumab target the cancerous proteins and stop the cancer cells from suppressing the immune system

RADIATIONRadiation

Radiation therapy is used to shrink cancer cells.


Locations(2)

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

View Full Details on ClinicalTrials.gov

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NCT03482102


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