Study of Pembrolizumab With REOLYSIN® and Chemotherapy in Patients With Advanced Pancreatic Adenocarcinoma

Part of paid clinical trials in San Antonio, Texas.

Sponsor
Oncolytics Biotech
Study ID
NCT02620423
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • REOLYSIN® — BIOLOGICAL
    4.5x10E10 TCID50 1 hour intravenous infusion, administered on Day 1 and 2 of a 21-day cycle
  • Chemotherapy — DRUG
    Patients may be treated with one of three chemotherapy backbone regimens. The decision on the chemotherapy backbone is based on physician preference.This includes either: a) Gemcitabine or b) Irinotecan or c)Leucovorin followed by 5-fluorouracil
  • Gemcitabine — DRUG
    1000 mg/m2 intravenous infusion over 30 minutes on Day 1 of a 21-day cycle or
  • Irinotecan — DRUG
    125 mg/m2 intravenous infusion over 90 minutes on Day 1 of a 21-day cyle or
  • Leucovorin — DRUG
    Leucovorin (LV) followed by 5-fluorouracil (5FU). LV 200 mg/m2 intravenous infusion over 2 hours on Day 1, 5FU 200 mg/m2 intravenous infusion bolus over 5-10 minutes on Day 1, followed by 5FU 1200 mg/m2 continuous intravenous infusion over 22 hours on Day 1 of a 21-day cycle
  • 5-fluorouracil — DRUG
    Leucovorin (LV) followed by 5-fluorouracil (5FU). LV 200 mg/m2 intravenous infusion over 2 hours on Day 1, 5FU 200 mg/m2 intravenous infusion bolus over 5-10 minutes on Day 1, followed by 5FU 1200 mg/m2 continuous intravenous infusion over 22 hours on Day 1 of a 21-day cycle
  • Pembrolizumab — DRUG
    Pembrolizumab, 2 mg/kg intravenous infusion 30 minutes on Day 8 of a 21-day cycle

Study Details

The purpose of this Phase 1b study is to investigate whether intravenous administration of REOLYSIN® in combination with chemotherapy and pembrolizumab is effective and safe in the treatment of pancreatic adenocarcinoma.

Key Dates

Start date
Dec 31, 2015
Status verified
Sep 2018
Primary completion
Mar 31, 2018
Completion
Aug 31, 2018

Study Design

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

Primary Outcome Measure

Determine the safety and DLTs of REOLYSIN® and chemotherapy (gemcitabine OR irinotecan OR 5FU) in combination with pembrolizumab in patients with advanced pancreatic adenocarcinoma who have progressed after (or did not tolerate) first line treatment [ Time Frame: During the first cycle of treatment (3 week cycle) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Cancer Therapy & Research Center at UTHSCSASan AntonioTexas78229-

Find similar trials in San Antonio, TX

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
Cancer Therapy & Research Center at UTHSCSA· San Antonio, TX

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