Study Assessing Safety and Efficacy of Combination of BL-8040 and Pembrolizumab in Metastatic Pancreatic Cancer Patients (COMBAT/KEYNOTE-202) (COMBAT)
|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
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.|