Study of Immune Checkpoint Inhibition With Radiation Therapy in Unresectable, Non-metastatic Pancreatic Cancer

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
NYU Langone Health
Study ID
NCT02868632
Phase
PHASE1
Status
Withdrawn

Conditions

Eligibility Criteria

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

Interventions

  • MEDI4736 — DRUG
    anti-PD-L1 human monoclonal antibody
  • Tremelimumab — DRUG
    anti-CTLA4 human monoclonal antibody
  • Stereotactic Body Radiation Therapy (SBRT) — RADIATION
    Stereotactic body radiation therapy (SBRT) will be administered at the standard dose of 6 Gy daily for 5 days.

Study Details

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.

Key Dates

Start date
Aug 7, 2016
Status verified
Apr 2019
Primary completion
Mar 4, 2019
Completion
Mar 4, 2019

Study Design

Enrollment
0 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A: MEDI4736 + SBRT
    MEDI4736 10 mg/kg IV every 2 weeks plus Stereotactic Body Radiation (SBRT) 6 Gy x 5 Days, 10 Subjects
  • Experimental: Cohort B:Tremelimumab + SBRT
    Tremelimumab 10 mg/kg IV every 4 weeks plus Stereotactic Body Radiation (SBRT) 6 Gy x 5 Days, 10 Subjects
  • Experimental: Cohort C: MEDI4736 + Tremelimumab + SBRT
    MEDI4736 + Tremelimumab (recommended phase 2 IV dose for combination) plus Stereotactic Body Radiation (SBRT) 6 Gy x 5 Days, 16 Subjects

Primary Outcome Measure

Overall Survival [ Time Frame: 24 Months ]

Locations (3)

FacilityCityStateZIPSite coordinators
Georgetown University Medical CenterWashington D.C.District of Columbia20007-
New York University School of MedicineNew YorkNew York10016-
Montefiore Medical CenterThe BronxNew York10461-

Find similar trials in Washington D.C., DC

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
Georgetown University Medical Center· Washington D.C., DCNew York University School of Medicine· New York, NYMontefiore Medical Center· The Bronx, NY

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