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Study Assessing Safety and Efficacy of Combination of BL-8040 and Pembrolizumab in Metastatic Pancreatic Cancer Patients

NCT02826486 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-08-28

Study results available
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Summary

This study will assess the efficacy and safety of BL-8040 in combination with pembrolizumab (Keytruda®) and BL-8040/ Pembrolizumab in combination with liposomal irinotecan (Onivyde®)/5-fluorouracil/leucovorin (5-FU/LV) in subjects with metastatic pancreatic adenocarcinoma.

Conditions

  • Metastatic Pancreatic Adenocarcinoma

Interventions

DRUG

BL-8040

BL-8040 subcutaneous (SC) injections

DRUG

Pembrolizumab

Pembrolizumab will be given as a 30-minute IV infusion

DRUG

Chemotherapy

• IV Onivyde® followed by IV leucovorin (LV), followed by IV fluorouracil (5-FU), every 2 weeks.

Sponsors & Collaborators

Principal Investigators

  • Abi Vainstein, MD · BioLineRx, Ltd.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2022-09-06
Completion
2022-09-06

Countries

  • United States
  • Israel
  • South Korea
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT02826486 on ClinicalTrials.gov