This is a phase 3, randomized, controlled study of brenetafusp (IMC-F106C) plus nivolumab compared to standard nivolumab regimens in HLA-A\*02:01-positive participants with previously untreated advanced melanoma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
680
Soluble PRAME-specific T cell receptor with anti-CD3 scFV concentrate for solution for intravenous (IV) infusion at a unit dose of 0.2 mg/mL.
Concentrate for solution for infusion at a unit dose of 10 mg/mL.
Concentrate for solution for infusion at a unit dose of 16 mg/mL.
Progression-Free Survival (PFS)
PFS as assessed by blinded independent central review (BICR) according to Response Evaluation Criteria in Solid Tumours (RECIST 1.1).
Time frame: Up to ~45 months
Overall Survival (OS)
OS is the time from randomization to time of death from any cause.
Time frame: Up to ~57 months
Overall Response Rate (ORR)
ORR as assessed by BICR according to RECIST 1.1.
Time frame: Up to ~45 months
Number of Participants Experiencing ≥1 Adverse Event (AE)
An AE is defined as the appearance of (or worsening of any pre-existing) undesirable sign, symptom, or medical condition that occur in the study.
Time frame: Up to ~57 months
Number of Participants Experiencing ≥1 Serious Adverse Event (SAE)
An SAE is any untoward medical consequence that results in death; requires inpatient hospitalization or prolongs existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or any other important medical event in the opinion of the Investigator.
Time frame: Up to ~57 months
Number of Participants Experiencing a Dose Interruption, Reduction, or Discontinuation
The number of participants with a dose interruption, reduction, or discontinuation due to AE will be reported.
Time frame: Up to ~45 months
Maximum Plasma Concentration (Cmax) of IMC-F106C
The Cmax of IMC-F106C will be reported.
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University of Arizona
Tucson, Arizona, United States
RECRUITINGUniversity of California - San Diego
La Jolla, California, United States
RECRUITINGThe Angeles Clinic and Research Institute- West Los Angeles
Los Angeles, California, United States
RECRUITINGESC Norris Comprehensive Cancer Center
Los Angeles, California, United States
RECRUITINGUCLA Hematology/Oncology
Los Angeles, California, United States
RECRUITINGStanford Cancer Institute - Stanford Cancer Center Palo Alto
Palo Alto, California, United States
RECRUITINGSaint John's Health Center - John Wayne Cancer Institute (JWCI)
Santa Monica, California, United States
RECRUITINGUniversity of Colorado, Anschutz Medical Campus
Aurora, Colorado, United States
RECRUITINGUConn Health-Farmington (University of Connecticut Health Center (UCHC))
Farmington, Connecticut, United States
RECRUITINGGeorgetown University
Washington D.C., District of Columbia, United States
RECRUITING...and 164 more locations
Time frame: Day 1 of Weeks 1, 2, and 3: Predose and 0.5 and 4 hours postdose
Incidence of anti-IMC-F106C Antibodies
The incidence of anti-IMC-F106C antibodies, including neutralizing antibodies, will be reported.
Time frame: Up to ~45 months
Association between PFS and Intra-Tumor Immune Cells
The potential association between the effect of IMC-F106C on efficacy and intra-tumor environment will be explored. Intra-tumor environment is estimated as the ratio of CD3+ to CD163+ cells and the correlation with PFS will be estimated by the hazard ratio (+/- 95% CI) from a Cox model. This analysis will be restricted to subjects randomized to receive IMC-F106C.
Time frame: Up to ~45 months
Health-Related Quality of Life
The change from baseline over time and between treatments of health-related quality of life will be reported.
Time frame: Up to ~45 months