The goal of this clinical trial is to test if the addition of botensilimab to standard chemotherapy improves the efficacy compared to just chemotherapy alone in participants with metastatic pancreatic cancer. One group of participants will only receive chemotherapy while a second group of participants will receive botensilimab and chemotherapy.
This will be a prospective, multicenter, clinical trial of botensilimab in combination with nab-paclitaxel + gemcitabine or nab-paclitaxel + gemcitabine alone. The trial will be conducted in 2 parts. Part 1 will be a safety lead-in to establish the safety and dose of botensilimab for Part 2. Part 2 will be a randomized, open-label assessment of botensilimab (at the dose level determined in Part 1).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
81
A fully human fragment crystallizable-enhanced monoclonal cytotoxic T lymphocyte antigen 4 antibody administered intravenously.
Standard-of-care chemotherapy administered intravenously.
Standard-of-care chemotherapy administered intravenously.
Progression-free Survival as Assessed by Investigator
Progression-free survival will be defined as the time from the date of randomization to the date of the first objectively documented tumor progression, assessed by investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), or death, whichever occurs first.
Time frame: Up to 2 years
Number of Participants with Treatment-emergent Adverse Events
Time frame: First study dose through up 1 year
Overall Survival
Overall survival will be defined as the time from the date of randomization to the date of death due to any cause.
Time frame: Up to 2 years
Complete Response
Complete response will be defined by RECIST 1.1 criteria and carbohydrate antigen 19-9 down to normal limits (from at least \> 2 x upper limit of normal \[ULN\]). Cancer antigen 125 or carcinoembryonic antigen will be evaluated for non-expressors of carbohydrate antigen 19-9.
Time frame: Up to 2 years
Overall Response Rate
Overall response rate will be defined as the proportion of participants whose best overall response is complete response or partial response assessed by investigator per RECIST v1.1.
Time frame: Up to 2 years
Duration of Response
Duration of response will be defined as the time from the first determination of an objective response assessed by investigator per RECIST v1.1, until the first documentation of progression or death, whichever occurs first.
Time frame: Up to 2 years
Change From Baseline in Carbohydrate Antigen 19-9
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HonorHealth
Scottsdale, Arizona, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
USC Norris Oncology
Newport Beach, California, United States
UCLA Health - Santa Monica Cancer Care
Santa Monica, California, United States
Medical Oncology Hematology Consultants (MOHC) - Helen F. Graham Cancer Center
Newark, Delaware, United States
Florida Cancer Specialist South
Fort Myers, Florida, United States
Cancer Care Centers of Brevard
Palm Bay, Florida, United States
Florida Cancer Specialist North
St. Petersburg, Florida, United States
Illinois Cancer Specialists
Arlington Heights, Illinois, United States
Maryland Oncology Hematology
Columbia, Maryland, United States
...and 26 more locations
Change in carbohydrate antigen 19-9 will be evaluated until progressive disease, death, date of last tumor assessment, or start of new anti-cancer therapy. Cancer antigen 125 or carcinoembryonic antigen will be evaluated for non-expressors of carbohydrate antigen 19-9.
Time frame: Baseline, 2 years
Rates of Normalization of Carbohydrate Antigen 19-9
Carbohydrate antigen 19-9 normalization will be defined as a value of carbohydrate antigen 19-9 down to normal limits (from at least \> 2 x ULN). Cancer antigen 125 or carcinoembryonic antigen will be evaluated for non-expressors of carbohydrate antigen 19-9.
Time frame: Up to 2 years