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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT03482102
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tremelimumab — DRUG
    Tremelimumab target the cancerous proteins and stop the cancer cells from suppressing the immune system
  • Durvalumab — DRUG
    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.

Study Details

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

Key Dates

Start date
May 14, 2018
Status verified
Apr 2026
Primary completion
Feb 28, 2024
Completion
Apr 30, 2026

Study Design

Enrollment
37 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Best Overall Response rate [ Time Frame: Start of cycle 3, start of cycle 5, and then the start of every subsequent cycle for the remainder of treatment. One cycle is 4 weeks. (approximately 3 years) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02214-

Find similar trials in Boston, MA

By condition
Liver cancer
By specialty
OncologyGI oncologyHepatology
By research site
Massachusetts General Hospital· Boston, MA

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