Study of Nivolumab, Cabiralizumab, and Stereotactic Body Radiotherapy (SBRT) for Locally Advanced Unresectable Pancreatic Cancer

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT03599362
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab + Cabiralizumab — DRUG
    Will be administered on Day 1 and Day 14; Subjects will continue treatment every 2 weeks with subsequent imaging every 8 weeks.
  • Stereotactic Body Radiotherapy (SBRT) — RADIATION
    Patients will be simulated supine with the addition of a 4D C T if appropriate. A stereotactic immobilization device with abdominal compression will be used.

Study Details

A multi-institutional, single arm phase II study of nivolumab, cabiralizumab and stereotactic body radiotherapy (SBRT) in patients with LAUPC. The purpose of this study is to determine the safety and tolerability of combined cabiralizumab, nivolumab and radiotherapy in the treatment of locally advanced pancreatic cancer. Investigators will also estimate the surgical resection rate following treatment with combined cabiralizumab, nivolumab and radiotherapy in subjects with locally advanced unresectable pancreatic cancer.

Key Dates

Start date
Jul 31, 2018
Status verified
Sep 2021
Primary completion
Jun 15, 2020
Completion
Jun 15, 2020

Study Design

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

Arms

  • Experimental: Multi Agent Chemotherapy Cancer Patients
    Subjects will be enrolled into this study following completion of 2-6 months of multi agent chemotherapy with documentation of stable or responsive disease.

Primary Outcome Measure

Number of Participants With Incidence of Unacceptable Toxicity [ Time Frame: 24 Months ]

Locations (2)

FacilityCityStateZIPSite coordinators
New York University School of MedicineNew YorkNew York10016-
University of WashingtonSeattleWashington98109-

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