CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 80 enrolled
Drug / intervention
BL-8040 +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02826486
NCT02826486Phase 2Completed
CompareCT.gov

A Phase IIa, Multicenter, Open-label Study to Assess the Safety and Efficacy of the Combination of BL-8040 and Pembrolizumab in Patients With Metastatic Pancreatic Cancer, the COMBAT Study (KEYNOTE-202)

BioLineRx, Ltd.·interventional·Posted Jul 11, 2016·Updated Aug 28, 2024

In Brief

A Phase 2 clinical trial evaluating BL-8040, Pembrolizumab, and 1 other intervention for Metastatic Pancreatic Adenocarcinoma. Completed, enrolled 80 participants across 31 sites in 4 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Pancreatic Adenocarcinoma
CountriesIsrael, South Korea, Spain, United States
CollaboratorsMerck Sharp & Dohme LLC

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJul 11, 2016
Enrollment StartSep 1, 2016
Primary CompletionSep 6, 2022
TodayJul 2, 2026
Enrollment to primary: 6.0 yearsPosted 10.0 years ago

Interventions

BL-8040drug

BL-8040 subcutaneous (SC) injections

Pembrolizumabdrug

Pembrolizumab will be given as a 30-minute IV infusion

Chemotherapydrug

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