A Study of Botensilimab (AGEN1181) for the Treatment of Advanced Melanoma

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Agenus Inc.
Study ID
NCT05529316
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Advanced Melanoma

Eligibility Criteria

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

Interventions

  • Botensilimab — DRUG
    An anti-CTLA-4 monoclonal antibody
  • Balstilimab — DRUG
    An anti-PD-1 monoclonal antibody

Study Details

This study is an open-label, 2-part, Phase 2, multicenter study to evaluate the efficacy, safety, tolerability, and pharmacokinetic profiles of botensilimab as monotherapy and in combination with balstilimab in participants with advanced cutaneous melanoma refractory to checkpoint inhibitor therapy.

Key Dates

Start date
Dec 12, 2022
Status verified
Jan 2026
Primary completion
Feb 29, 2028
Completion
Feb 29, 2028

Study Design

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

Arms

  • Experimental: Part 1 Cohort A: Botensilimab
    Participants refractory to PD-(L)1 therapy will receive botensilimab intravenously (IV).
  • Experimental: Part 1 Cohort B: Botensilimab
    Participants refractory to PD-(L)1 and anti-CTLA-4 therapies will receive botensilimab IV.
  • Experimental: Part 2 Cohort A: Botensilimab + Balstilimab
    Participants refractory to PD-(L)1 will receive botensilimab IV in combination with balstilimab IV.
  • Experimental: Part 2 Cohort B: Botensilimab + Balstilimab
    Participants refractory to PD-(L)1 and CTLA-4 will receive botensilimab IV in combination with balstilimab IV.

Primary Outcome Measure

Objective Response Rate [ Time Frame: First dose through up to 3 months ]

Locations (7)

FacilityCityStateZIPSite coordinators
Scottsdale Healthcare Hospitals DBA HonorHealthScottsdaleArizona85258-
Virginia K. Crosson Cancer Center at St. Jude Medical CenterFullertonCalifornia92835-
Providence Saint John's Health CenterSanta MonicaCalifornia90404-
Yale University School of Medicine - Yale Cancer CenterNew HavenConnecticut06520-8028-
Georgetown University Medical CenterWashington D.C.District of Columbia20057-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
John Theurer Cancer Center at Hackensack University Medical CenterHackensackNew Jersey07601-

Find similar trials in Scottsdale, AZ

By research site
Scottsdale Healthcare Hospitals DBA HonorHealth· Scottsdale, AZVirginia K. Crosson Cancer Center at St. Jude Medical Center· Fullerton, CAProvidence Saint John's Health Center· Santa Monica, CAYale University School of Medicine - Yale Cancer Center· New Haven, CTGeorgetown University Medical Center· Washington D.C., DCDana-Farber Cancer Institute· Boston, MA

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