Study Evaluating NEOadjuvant Immunotherapy in Resectable PANCreatic Ductal Adenocarcinoma

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

Sponsor
Gulam Manji
Study ID
NCT03979066
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Atezolizumab — DRUG
    840mg IV every 2 weeks for 2 doses prior to surgery and 4 doses after surgery.
  • PEGPH20 — DRUG
    PEGPH20 3ug/kg IV twice weekly for 3 weeks prior to surgery and once weekly for 3 weeks (of 28 day cycle) for two cycles after surgery.

Study Details

The purpose of this study is to determine if study treatment with atezolizumab and PEGPH20 given before and after surgery, followed by chemotherapy is safe and if it can further increase the immune response against the tumor rather than increase the chance of cure.

Key Dates

Start date
Nov 1, 2019
Status verified
Dec 2020
Primary completion
Nov 3, 2019
Completion
Nov 3, 2019

Study Design

Enrollment
1 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Atezolizumab
    Atezolizumab 840mg IV every 2 weeks for 2 doses prior to surgery and 4 doses after surgery.
  • Experimental: Atezolizumab in combination with PEGPH20
    Atezolizumab 840mg IV every 2 weeks for 2 doses prior to surgery and 4 doses after surgery in combination with PEGPH20 3ug/kg IV twice weekly for 3 weeks prior to surgery and once weekly for 3 weeks (of 28 day cycle) for two cycles after surgery.

Primary Outcome Measure

Change in the Number of CD8+ T Cells Within the Tumor [ Time Frame: At time of surgery (approximately 3 weeks) ]

Locations (1)

FacilityCityStateZIP
Columbia UniversityNew YorkNew York10032

Find similar trials in New York, NY

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
Columbia University· New York, NY

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