The goal of this clinical trial is to learn about the effectiveness and safety of the
bispecific antibody acasunlimab (also known as DuoBody®-PD-L1x4-1BB) when given either
alone or together with the cancer drug pembrolizumab in participants with locally
advanced or metastatic melanoma of the skin. All participants will receive active drugs;
no one will be given a placebo.
The trial duration will be approximately 15 months for each participant, including a
28-day screening period and estimated 4-month treatment and 10-month follow-up periods;
however, the duration of the treatment and follow-up periods may vary for each
participant.
Participants will have regular check-ups while on treatment, with visits every week
initially, and then every 3 weeks later in the trial.
Additional locations may be listed on ClinicalTrials.gov for NCT06984328.
Locations matching your search criteria
United States
California
San Francisco
University of California San FranciscoStatus: Approved
Contact: UCSF Clinical Trials
Phone: 877-827-3222
This is a Phase 2, randomized, open-label, multicenter trial evaluating the efficacy and
safety of acasunlimab as monotherapy and in combination with pembrolizumab in adult
participants with relapsed/refractory, unresectable locally advanced or metastatic
cutaneous melanoma who progressed on or after prior checkpoint inhibitor (CPI)-containing
therapy. Participants will be randomized in a 1:1 ratio to receive acasunlimab and
pembrolizumab or acasunlimab alone.
Eligible participants must have received a minimum of 2 cycles of an approved
anti-programmed cell death protein 1 (PD-1) containing therapy. Participants whose tumor
harbors a B-Raf proto-oncogene, serine/threonine kinase (BRAF) V600 mutation are eligible
for the trial if they have received a BRAF-directed therapy (with or without a
mitogen-activated protein kinase [MEK] inhibitor) prior to enrollment in the trial,
unless the investigator has deemed a BRAF-directed therapy not clinically indicated. BRAF
V600 mutational status must be determined by local assessment and documented.