Study of Immune Checkpoint Inhibition With Radiation Therapy in Unresectable, Non-metastatic Pancreatic Cancer
NCT02868632 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL
Last updated 2019-04-05
Summary
This is an open-label, three-cohort, phase Ib study to determine the safety, recommended phase 2 dose (RP2D), and efficacy of Stereotactic Body Radiation Therapy (SBRT) in combination with either (A) MEDI4736 alone, (B) tremelimumab alone, or (C) the combination of MEDI4736 and tremelimumab for patients with unresectable locally advanced adenocarcinoma of pancreas.
Conditions
Interventions
- DRUG
-
MEDI4736
anti-PD-L1 human monoclonal antibody
- DRUG
-
Tremelimumab
anti-CTLA4 human monoclonal antibody
- RADIATION
-
Stereotactic Body Radiation Therapy (SBRT)
Stereotactic body radiation therapy (SBRT) will be administered at the standard dose of 6 Gy daily for 5 days.
Sponsors & Collaborators
- collaborator INDUSTRY
- lead OTHER
Principal Investigators
-
Jennifer Wu, MD · NYU Langone Medical Center
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-08-07
- Primary Completion
- 2019-03-04
- Completion
- 2019-03-04
- FDA Drug
- Yes
Countries
- United States
Study Locations
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