Immune Checkpoint Inhibition (Tremelimumab and/or MEDI4736) in Combination With Radiation Therapy in Patients With Unresectable Pancreatic Cancer

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT02311361
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Cancer of Pancreas
  • Cancer of the Pancreas
  • Pancreas Cancer
  • Pancreatic Cancer
  • Pancreatic Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — BIOLOGICAL
    10 mg/kg, mg intravenous (IV), every two weeks, or 1500 mg, IV, every four weeks.
  • Tremelimumab — BIOLOGICAL
    75 mg IV, every 4 weeks for 16 weeks
  • Sterostatic body radiation therapy (SBRT) — RADIATION
    8 Gray (Gy) x 1; 5Gy x 5

Study Details

Background: \- Stereotactic body radiation therapy (SBRT) is used to treat cancer. It is a way of giving very focused beams of radiation to tumors. Researchers think that the drugs being used in this study might work better when combined with SBRT in people with pancreatic cancer. Objective: \- To study the safety and effectiveness of Durvalumab (MEDI4736) and/or tremelimumab with SBRT. Eligibility: \- People 18 and older who have pancreatic cancer that has not responded or to chemotherapy. They must be candidates for radiation but not resection. Design: * Participants will be screened with medical history and physical exam. They will have blood tests. Their tumor will be measured using computerized tomography (CT) or magnetic resonance imaging (MRI). * Participants will have their tumor biopsied with a needle. They will have also have a biopsy after cycle 1. * Participants will get 1 or 2 drugs in combination with the SBRT. * For MEDI4736, the duration of each cycle will be 28-days. Participants will get the drug through an intravenous (IV) infusion twice in each cycle (Days 1 and 15). * For tremelimumab, the duration of the first 6 cycles will each last 28 days. Then the duration of the last 3 cycles will change to 12 weeks. Participants will get the drug through an IV once in each cycle. * All participants will have SBRT. Some will get 1 dose of radiation and some will get 5. CT scans will map their tumor. * Participants will have medical history, physical exam, and blood tests in each cycle. They will have a CT scan or MRI every 8 weeks. Cycles will continue for up to 12 months. * Participants will be contacted yearly for follow-up.

Key Dates

Start date
Mar 25, 2015
Status verified
Mar 2021
Primary completion
Oct 23, 2019
Completion
Dec 31, 2020

Study Design

Enrollment
65 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Durvalumab + 8 Gray (Gy) in 1 fraction
    Cohort 1/Dose Level A1 Durvalumab + 8 Gray (Gy) in 1 fraction
  • Experimental: Durvalumab +5 Gy in 5 fractions
    Cohort 2/Dose Level A2 Durvalumab +5 Gy in 5 fractions
  • Experimental: Tremelimumab + 8 Gy in 1 fraction
    Cohort 3/Dose Level B1 (was removed with Amendment A) Tremelimumab + 8 Gy in 1 fraction
  • Experimental: Tremelimumab + 5 Gy in 5 fractions
    Cohort 4/Dose Level B2 (was removed with Amendment A) Tremelimumab + 5 Gy in 5 fractions
  • Experimental: Durvalumab +Tremelimumab + 8 Gy in 1 fraction
    Cohort C/ Dose Level C1 Durvalumab +Tremelimumab + 8 Gy in 1 fraction
  • Experimental: Durvalumab +Tremelimumab +5 Gy in 5 fractions
    Cohort C/Dose Level C2 Durvalumab +Tremelimumab +5 Gy in 5 fractions

Primary Outcome Measure

Number of Adverse Events in Each Cohort With Grade 1 Through 5 Related to Study Drug [ Time Frame: Participants were assessed from the start of study treatment at Cycle 1 then after every cycle (1 cycle = 28 days) of protocol treatment until 30 days after they were taken off treatment, approximately 4.0 months. ]

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical Center, 9000 Rockville PikeBethesdaMaryland20892-

Find similar trials in Bethesda, MD

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
National Institutes of Health Clinical Center, 9000 Rockville Pike· Bethesda, MD

Related Studies