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NCT02868632 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL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

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02868632 on ClinicalTrials.gov