A Study of Botensilimab in Participants With Metastatic Pancreatic Cancer

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Agenus Inc.
Study ID
NCT05630183
Phase
PHASE2
Status
Completed

Conditions

  • Metastatic Pancreatic Ductal Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Botensilimab — DRUG
    A fully human fragment crystallizable-enhanced monoclonal cytotoxic T lymphocyte antigen 4 antibody administered intravenously.
  • Gemcitabine — DRUG
    Standard-of-care chemotherapy administered intravenously.
  • Nab-paclitaxel — DRUG
    Standard-of-care chemotherapy administered intravenously.

Study Details

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.

Key Dates

Start date
Mar 27, 2023
Status verified
Jun 2026
Primary completion
Jan 5, 2026
Completion
Jan 5, 2026

Study Design

Enrollment
81 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: Combination (Safety Lead-in Phase)
    Participants will receive botensilimab in combination with standard-of-care chemotherapy (nab-paclitaxel + gemcitabine).
  • Experimental: Part 2: Combination
    Participants will receive botensilimab in combination standard-of-care chemotherapy (nab-paclitaxel + gemcitabine).
  • Active Comparator: Part 2: Standard of Care
    Participants will receive standard-of-care chemotherapy (nab-paclitaxel + gemcitabine).

Primary Outcome Measure

Progression-free Survival as Assessed by Investigator [ Time Frame: Up to 2 years ]

Locations (36)

FacilityCityStateZIPSite coordinators
HonorHealthScottsdaleArizona85258-
USC Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
USC Norris OncologyNewport BeachCalifornia92663-
UCLA Health - Santa Monica Cancer CareSanta MonicaCalifornia90404-
Medical Oncology Hematology Consultants (MOHC) - Helen F. Graham Cancer CenterNewarkDelaware19713-
Florida Cancer Specialist SouthFort MyersFlorida33901-
Cancer Care Centers of BrevardPalm BayFlorida32909-
Florida Cancer Specialist NorthSt. PetersburgFlorida22705-
Illinois Cancer SpecialistsArlington HeightsIllinois60005-
Maryland Oncology HematologyColumbiaMaryland21044-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
Rogel Cancer Center, University of Michigan MedicineAnn ArborMichigan48109-
Minnesota OncologyMinneapolisMinnesota55404-
Nebraska Medicine-Nebraska Medical CenterOmahaNebraska68198-
Comprehensive Cancer Centers of Nevada - Summerlin Medical Center II*Las VegasNevada89144-
John Theurer Cancer Center at HackensackHackensackNew Jersey07601-
Atlantic Health Systems, MorristownMorristownNew Jersey07960-
Overlook Medical CenterSummitNew Jersey07901-
Icahn School of Medicine at Mount Sinai Tisch Cancer InstituteNew YorkNew York10128-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Weill Cornell Medicine Sandra and Edward Meyer Cancer CenterNew YorkNew York10065-
Weill Cornell Medicine-New York Presbyterian HospitalNew YorkNew York10021-
Oncology Hematology Care - EastgateCincinnatiOhio45245-
Sarah Cannon Research Institute at Tennessee OncologyCincinnatiOhio45245-
LifespanProvidenceRhode Island02903-
Sarah Cannon Research Institute at Tennessee OncologyNashvilleTennessee37203-
Texas OncologyCarrolltonTexas75010-
Baylor Charles A. Sammons Cancer CenterDallasTexas75247-
TxO - Denison Cancer CenterDenisonTexas75020-
The Center for Cancer & Blood Disorders: Fort WorthFort WorthTexas76104-
Northeast Texas Cancer & Research InstituteTylerTexas75702-
Virginia Cancer SpecialistsFairfaxVirginia22031-
Virginia Oncology Associates - Brock Cancer CenterNorfolkVirginia23502-
Shenandoah OncologyWinchesterVirginia22601-
Swedish Cancer InstituteSeattleWashington98104-

Find similar trials in Scottsdale, AZ

By research site
HonorHealth· Scottsdale, AZUSC Norris Comprehensive Cancer Center· Los Angeles, CAUSC Norris Oncology· Newport Beach, CAUCLA Health - Santa Monica Cancer Care· Santa Monica, CAMedical Oncology Hematology Consultants (MOHC) - Helen F. Graham Cancer Center· Newark, DEFlorida Cancer Specialist South· Fort Myers, FL

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