NCT03482102

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of investigational drugs to learn whether the drugs work in treating a specific disease. "Investigational" means that the drugs are being studied. The FDA (the U.S. Food and Drug Administration) has not approved durvalumab for this specific disease but it has been approved for other uses. The FDA has not approved tremelimumab as a treatment for any disease. Both durvalumab and tremelimumab are antibodies (proteins that work with the immune system) that target proteins produced by the cancer cells. These cancerous proteins suppress the immune system which allows the cancer cells to grow. The study drugs may target these cancerous proteins and stop the cancer cells from suppressing the immune system. The investigators hope that the combination of these study drugs with radiation therapy will help stop the cancer cells from growing and spreading.

Conditions

• Hepatocellular Carcinoma
• Biliary Tract Cancer

Interventions

Type	Name	Description
DRUG	Tremelimumab	Tremelimumab target the cancerous proteins and stop the cancer cells from suppressing the immune system
DRUG	Durvalumab	Durvalumab target the cancerous proteins and stop the cancer cells from suppressing the immune system
RADIATION	Radiation	Radiation therapy is used to shrink cancer cells.

Timeline

• Start date: 2018-05-14
• Primary completion: 2024-10-01
• Completion: 2026-10-01
• First posted: 2018-03-29
• Last updated: 2022-09-08

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study