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NCT02826486 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by BioLineRx.

Completed
Registry status
Phase 2
Development phase
80
Enrollment target

NCT02826486: Completed Phase 2 study, sponsored by BioLineRx.

NCT02826486 is a Phase 2 study that has completed, run by BioLineRx. The registered enrollment target is 80 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT02826486, a Phase 2 study, has completed, sponsored by BioLineRx.

COMPLETED
Registry status
Phase 2
Development phase
80 participants
Enrollment target

Study 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.

Primary Outcome

Response is determined by assessment of target lesions identified in CT or MRI imaging. The ORR is assessed according to RECIST 1.1, defined as the sum of PRs (Partial Responses) and CRs (Complete Responses) determined according to best response RECIST 1.1 criteria. PR is defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. CR is defined as disappearance of all target lesions.

Interventions

  • DRUG Pembrolizumab
  • DRUG Chemotherapy
  • DRUG BL-8040

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2016-09
Est. Completion 2022-09-06
Phase Phase 2
BioLineRx

8 total trials

What the finished NCT02826486 record still lists

NCT02826486 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower).

The record links to 0 conditions, and to 3 interventions - of which Pembrolizumab is the first listed.

NCT02826486 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02826486 about?

NCT02826486 is a clinical study titled "Study Assessing Safety and Efficacy of Combination of BL-8040 and Pembrolizumab in Metastatic Pancreatic Cancer Patients". 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.

What is the current status of trial NCT02826486?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2016-09. Estimated completion is 2022-09-06.

What interventions are being tested in trial NCT02826486?

The interventions under investigation include: Pembrolizumab (DRUG), Chemotherapy (DRUG), BL-8040 (DRUG).

Who is sponsoring clinical trial NCT02826486?

This trial is sponsored by BioLineRx, which has 8 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02826486's enrollment target sits among peer trials

80 842nd of 2000 higher than 1,117 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02826486, the US trial registry maintained by the National Library of Medicine. NCT02826486 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.