Estudio de fase 3, aleatorizado y controlado de IMC-F106C más nivolumab frente a regímenes con nivolumab en participantes HLA-A*02:01 positivos con melanoma avanzado no tratado previamente (PRISM-MEL-301)

ReclutandoFase 3ClinicalTrials.gov

ID: NCT06112314Tipo: INTERVENTIONALInicio: 5 de jun de 2024Fin estimado: 16 de oct de 2027

Resumen

Se trata de un estudio de fase 3, aleatorizado y controlado de brenetafusp (IMC-F106C) más nivolumab en comparación con regímenes estándar de nivolumab en participantes HLA-A\*02:01 positivos con melanoma avanzado no tratado previamente.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Participants must be HLA-A\*02:01-positive
Participants must have histologically confirmed Stage IV or unresectable Stage III melanoma
Archived or fresh tumor tissue sample that must be confirmed as adequate
Participants must have measurable disease per RECIST 1.1
Participant must have BRAF V600 mutation status determined
Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
Male and female participants of childbearing potential who are sexually active with a non-sterilized partner must agree to use highly effective methods of birth control from the study screening date until 5 months after the final dose of study intervention

Criterios de exclusión

Participants with a history of a malignant disease other than those being treated in this study
Participants with untreated, active, or symptomatic central nervous system (CNS) metastases or carcinomatous meningitis
Hypersensitivity to IMC-F106C, nivolumab, relatlimab, or any associated excipients
Participants with clinically significant pulmonary disease or impaired lung function
Participants with clinically significant cardiac disease or impaired cardiac function
Participants with active autoimmune disease requiring immunosuppressive treatment
Participants with any medical condition that is poorly controlled or that would, in the Investigator's or Sponsor's judgment, adversely impact the participant's participation in the clinical study due to safety concerns, compliance with clinical study procedures, or interpretation of study results
Participants who received prior systemic anticancer therapy for unresectable or metastatic melanoma
Participants with a history of a life-threatening AE related to prior anti-PD-(L)1 or anti-LAG-3

Intervenciones

drug

Brenetafusp

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.

drug

Nivolumab

Concentrate for solution for infusion at a unit dose of 10 mg/mL.

drug

Nivolumab + Relatlimab

Concentrate for solution for infusion at a unit dose of 16 mg/mL.

Ubicaciones

Sanatorio Finochietto

Caba, Buenos Aires, Argentina

Dr. Gabriela Cinat · gabriela_cinat@yahoo.com.ar · 541158216233

RECRUITING

Clínica Adventista Belgrano - Sector Investigación

Caba, Buenos Aires, Argentina

Aldo A. Perfetti · aaperfetti@yahoo.com.ar · 5491132682903

RECRUITING

Hospital Italiano de Buenos Aires (HIBA)

Buenos Aires, Argentina

RECRUITING

Instituto Alexander Fleming

CABA, Argentina

RECRUITING

CEMAIC (Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica

Córdoba, Argentina

Dra. Laura Nardone · lauranardone@cemaicsas.com.ar · 54 9 351 678-3938

RECRUITING

Clinica Viedma

Viedma, Argentina

Ruben Kowalyszyn · kowar@rnonline.com.ar · 542920601693

RECRUITING

Patrocinadores

PrincipalImmunocore Ltd

Contactos

Immunocore Medical Information

CONTACT

medical.information@immunocore.com 844-466-8661

Immunocore Medical Information EU

CONTACT

medinfo.eu@immunocore.com +00 800-744-51111

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

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