Study Assessing Safety and Efficacy of Combination of BL-8040 and Pembrolizumab in Metastatic Pancreatic Cancer Patients (COMBAT/KEYNOTE-202) (COMBAT)
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|ClinicalTrials.gov Identifier: NCT02826486|
Recruitment Status : Active, not recruiting
First Posted : July 11, 2016
Last Update Posted : January 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Pancreatic Adenocarcinoma||Drug: BL-8040 Drug: BL-8040 plus pembrolizumab||Phase 2|
This will be an open-label, single arm, phase IIa study in subjects with metastatic pancreatic adenocarcinoma.
The study will include 30 subjects with unresectable metastatic pancreatic adenocarcinoma.
The study consists of two periods:
- Monotherapy period: One week, with BL-8040 administered daily on days 1-5.
- Combination therapy: Three week cycles of a combination of BL-8040 administered three times a week (TIW) and pembrolizumab administered once every three weeks.
Subjects with metastatic pancreatic adenocarcinoma will be enrolled and receive BL-8040 monotherapy for five days followed by a combination treatment of BL-8040 and pembrolizumab. During the monotherapy period, eligible subjects will receive daily subcutaneous (SC) injections of BL-8040 (1.25 mg/kg) on days 1 - 5.
From Day 8 subjects will begin a combination period consisting of treatment with SC BL-8040 (1.25 mg/kg) three times a week (TIW) and pembrolizumab (200mg) once every three weeks. The combination therapy will continue for up to two years, or until progression, clinical deterioration or early termination, whichever comes first.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II, Multicenter, Open-label Single Arm Study to Assess the Safety and Efficacy of the Combination of BL-8040 and Pembrolizumab in Patients With Metastatic Pancreatic Cancer, the COMBAT Study|
|Actual Study Start Date :||September 2016|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||December 2018|
Experimental: BL-8040 plus pembrolizumab (Keytruda®)
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 repeated 3 week long cycles of 200 mg pembrolizumab administered by intravenous infusion (IV) on day 1 of each cycle plus SC injections of BL-8040 1.25 mg/kg three times a week on non-consecutive days.
BL-8040 1.25 mg/kg subcutaneous(SC) injections
Drug: BL-8040 plus pembrolizumab
pembrolizumab will be given as a 30-minute IV infusion
Other Name: BL-8040 plus keytruda
- Objective response rate (ORR) assessed by imaging according to RECIST 1.1 criteria [ Time Frame: Change in response between screening, end of monotherapy (Day 5), end of cycle 2 (Day 28) and approximately every 63 days until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months. ]response is determined by assessment of target lesions identified in CT or MRI imaging
- Objective response rate (ORR) assessed by imaging according to irRECIST [ Time Frame: Change in response between screening, end of monotherapy (Day 5), end of cycle 2 (Day 28) and every 63 days until the date of confirmed progression assessed up to 2 years, or date of death from any cause. ]repeat imaging will be done for confirmation of initial progressive disease
- Overall survival [ Time Frame: Through study completion, an average of 2 years, and follow-up until date of death up to 100 weeks. ]
- Progression-free survival (PFS) by imaging (RECIST 1.1) [ Time Frame: through study completion, an average of 2 years ]imaging will be assessed according to RECIST 1.1
- Progression-free survival (PFS) by imaging (irRECIST) [ Time Frame: through study completion, an average of 2 years ]imaging will be assessed according to irRECIST
- Duration of response [ Time Frame: through study completion, an average of 2 years, and follow-up until the date of progression up to 100 weeks. ]
- 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 [ Time Frame: study treatment duration, up to 2 years ]safety assessment based on CTCAE version 4.03 criteria for adverse events and clinical laboratory parameters
- Tolerability of BL-8040 as monotherapy and in combination with pembrolizumab by review of adverse events and clinical laboratory parameters [ Time Frame: study treatment duration, up to 2 years ]
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment)
Assessment based on CTCAE version 4.03 criteria for adverse events and clinical laboratory parameters.
- Incidence of early discontinuation of subjects. [ Time Frame: study treatment duration, up to 2 years ]discontinuation of study treatment for any reason
- Incidence of early discontinuation due to adverse events. [ Time Frame: study treatment duration, up to 2 years + 90 days for SAE follow-up ]adverse events will be recorded based on CTCAE version 4.03 criteria and MedDRA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02826486
|United States, Arizona|
|Phoenix, Arizona, United States, 85054|
|Scottsdale, Arizona, United States, 85258|
|United States, Louisiana|
|Ochsner Medical Center|
|New Orleans, Louisiana, United States, 70121|
|United States, Massachusetts|
|Boston, Massachusetts, United States, 02215|
|United States, Missouri|
|Washington University of St Louis|
|Saint Louis, Missouri, United States, 63110|
|United States, Texas|
|Baylor Charles A. Sammons Cancer Center|
|Dallas, Texas, United States, 75246|
|Rambam Medical Center|
|Rabin Medical Center|
|Petaẖ Tiqwa, Israel|
|Chaim Sheba Medical Center|
|Ramat Gan, Israel|
|Sourasky Medical Center|
|Tel Aviv, Israel|
|Study Chair:||Abi Vainstein, MD||BioLineRx, Ltd.|