Brenetafusp
DrugSoluble 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.
Other names: IMC-F106C
NCT Number: NCT06112314
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 3
Clínica Adventista Belgrano - Sector Investigación, Caba, Buenos Aires, Argentina
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: IMC-F106C
Concentrate for solution for infusion at a unit dose of 10 mg/mL.
Other names: OPDIVO
Concentrate for solution for infusion at a unit dose of 16 mg/mL.
Other names: OPDUALAG
Time frame: Up to ~45 months
PFS as assessed by blinded independent central review (BICR) according to Response Evaluation Criteria in Solid Tumours (RECIST 1.1).
Time frame: Up to ~57 months
OS is the time from randomization to time of death from any cause.
Time frame: Up to ~45 months
ORR as assessed by BICR according to RECIST 1.1.
Time frame: Up to ~57 months
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
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 ~45 months
The number of participants with a dose interruption, reduction, or discontinuation due to AE will be reported.
Time frame: Day 1 of Weeks 1, 2, and 3: Predose and 0.5 and 4 hours postdose
The Cmax of IMC-F106C will be reported.
Time frame: Up to ~45 months
The incidence of anti-IMC-F106C antibodies, including neutralizing antibodies, will be reported.
Time frame: Up to ~45 months
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
The change from baseline over time and between treatments of health-related quality of life will be reported.
Contact information is provided by the study sponsor or research team.
Immunocore Medical Information
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Immunocore Medical Information EU
CONTACT
Immunocore Ltd
Industry
A Phase 3 Randomized, Controlled Study of IMC-F106C Plus Nivolumab Versus Nivolumab Regimens in HLA-A*02:01-Positive Participants With Previously Untreated Advanced Melanoma (PRISM-MEL-301
Acronym: PRISM-MEL-301
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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