← Back to Search

Other

BL-8040 for Pancreatic Cancer (COMBAT Trial)

Phase 2
Waitlist Available
Research Sponsored by BioLineRx, Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have measurable disease (≥ 1 measurable lesion) based on Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 as determined by the site study team. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
Previous treatment lines
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 2 years, and follow-up until date of death up to 100 weeks.
Awards & highlights

COMBAT Trial Summary

This trial will study two different combinations of drugs to treat metastatic pancreatic cancer. The first combination is of BL-8040 with pembrolizumab, and the second is of BL-8040 with liposomal irinotecan, 5-fluorouracil, and leucovorin. The trial will assess the safety and efficacy of these combinations.

COMBAT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

COMBAT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 2 years, and follow-up until date of death up to 100 weeks.
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 2 years, and follow-up until date of death up to 100 weeks. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective response rate (ORR) assessed by imaging according to RECIST 1.1 criteria
Secondary outcome measures
Disease Control
Objective response rate (ORR) assessed by imaging according to irRECIST
Overall survival
+1 more
Other outcome measures
Incidence of early discontinuation due to adverse events.
Incidence of early discontinuation of subjects.
Safety as measured by number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment with BL-8040 alone or in combination with pembrolizumab
+1 more

COMBAT Trial Design

2Treatment groups
Experimental Treatment
Group I: BL-8040 plus pembrolizumab (Keytruda®) plus Onivyde chemoExperimental Treatment3 Interventions
BL-8040 monotherapy 1.25 mg/kg subcutaneous(SC) injections daily on days 1-5 of week 1 of treatment. Combination therapy period begins following monotherapy treatment and consists of: IV Onivyde® 70 mg/m2 over 90 minutes followed by IV leucovorin (LV) 400 mg/m2 over 30 minutes or according to local standard, followed by IV fluorouracil (5-FU) 2400 mg/m2 over 46 hours, every 2 weeks. Pembrolizumab 200mg once every three weeks. Beginning on Day 10, BL-8040 twice a week and following the chemotherapy dosing.
Group II: BL-8040 plus pembrolizumab (Keytruda®)Experimental Treatment2 Interventions
BL-8040 monotherapy 1.25 mg/kg subcutaneous(SC) injections daily on days 1-5 of week 1 of treatment. Combination therapy period begins following monotherapy treatment and consists of: Pembrolizumab 200mg once every three weeks. Beginning on Day 10, BL-8040 three times a week
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BL-8040
2014
Completed Phase 2
~220
Pembrolizumab
2017
Completed Phase 2
~1950
Chemotherapy of Onivyde
2016
Completed Phase 2
~80

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
3,862 Previous Clinical Trials
5,049,620 Total Patients Enrolled
BioLineRx, Ltd.Lead Sponsor
21 Previous Clinical Trials
2,040 Total Patients Enrolled
Abi Vainstein, MDStudy ChairBioLineRx, Ltd.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you elaborate on the typical applications of Pembrolizumab?

"Pembrolizumab is an effective pharmacological solution for malignant neoplasms, unresectable melanoma, and those with microsatellite instability high."

Answered by AI

Has Pembrolizumab met the criteria to receive authorization from the FDA?

"The team at Power has assigned pembrolizumab a rating of 2, given that this is a Phase 2 clinical trial and there have been some findings indicating safety but no evidence backing efficacy."

Answered by AI

Could you delineate the past experiments involving Pembrolizumab?

"Presently, 1346 clinical trials are available to test the efficacy of Pembrolizumab. Among those studies, 225 are currently in their final testing phase (Phase 3). This treatment is being tested at 52547 medical sites across the United States with a concentration near Houston, Texas."

Answered by AI

How many facilities are engaged in the management of this clinical trial?

"This clinical study is currently enrolling patients across 15 different sites. Some of the primary locations are Massachusetts General Hospital (MGH) in Boston, Beth Israel Deaconess Medical Center (BIDMAC) in Scottsdale and Honor Health in Phoenix."

Answered by AI

Is there still an opportunity to join this medical experiment?

"Unfortunately, this trial is not accepting participants at this time. It was initially posted on September 1st 2016 and most recently amended on April 27th 2022. If you are seeking other studies, 45 clinical trials for neoplasm metastasis and 1346 Pembrolizumab studies are currently recruiting patients."

Answered by AI

What is the enrollment quota for this medical investigation?

"This trial is no longer open for enrolment. It was first posted on September 1st 2016 and last edited April 27th 2022. If you're looking to join other studies, there are 45 trials actively searching for patients with neoplasm metastasis and 1346 related to Pembrolizumab that require volunteers."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
Mayo Clinic
Honor Health
What portion of applicants met pre-screening criteria?
Met criteria
~9 spots leftby Mar 2025