Spots Global Cancer Trial Database for A Study of Botensilimab in Participants With Metastatic Pancreatic Cancer
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Trial Identification
Brief Title: A Study of Botensilimab in Participants With Metastatic Pancreatic Cancer
Official Title: A Randomized, Open-Label, Phase II Trial of Nab-paclitaxel + Gemcitabine With or Without Botensilimab (AGEN1181) in Patients With Metastatic Pancreatic Cancer Who Have Progressed on Prior 5FU + Leucovorin + Irinotecan + Oxaliplatin (FOLFIRINOX)
Study ID: NCT05630183
Study Description
Brief Summary: 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.
Detailed Description: 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).
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, Saint Petersburg, Florida, United States
Illinois Cancer Specialists, Arlington Heights, Illinois, United States
Maryland Oncology Hematology, Columbia, Maryland, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Rogel Cancer Center, University of Michigan Medicine, Ann Arbor, Michigan, United States
Minnesota Oncology, Minneapolis, Minnesota, United States
Nebraska Medicine-Nebraska Medical Center, Omaha, Nebraska, United States
Comprehensive Cancer Centers of Nevada - Summerlin Medical Center II*, Las Vegas, Nevada, United States
John Theurer Cancer Center at Hackensack, Hackensack, New Jersey, United States
Atlantic Health Systems, Morristown, Morristown, New Jersey, United States
Overlook Medical Center, Summit, New Jersey, United States
Weill Cornell Medicine-New York Presbyterian Hospital, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Weill Cornell Medicine Sandra and Edward Meyer Cancer Center, New York, New York, United States
Icahn School of Medicine at Mount Sinai Tisch Cancer Institute, New York, New York, United States
Oncology Hematology Care - Eastgate, Cincinnati, Ohio, United States
Sarah Cannon Research Institute at Tennessee Oncology, Cincinnati, Ohio, United States
Lifespan, Providence, Rhode Island, United States
Sarah Cannon Research Institute at Tennessee Oncology, Nashville, Tennessee, United States
Texas Oncology, Carrollton, Texas, United States
Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States
TxO - Denison Cancer Center, Denison, Texas, United States
The Center for Cancer & Blood Disorders: Fort Worth, Fort Worth, Texas, United States
Northeast Texas Cancer & Research Institute, Tyler, Texas, United States
Virginia Cancer Specialists, Fairfax, Virginia, United States
Virginia Cancer Specialists, Fairfax, Virginia, United States
Virginia Oncology Associates - Brock Cancer Center, Norfolk, Virginia, United States
Shenandoah Oncology, Winchester, Virginia, United States
Swedish Cancer Institute, Seattle, Washington, United States
Contact Details
Name: Medical Director
Affiliation: Agenus Inc.
Role: STUDY_DIRECTOR
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