Resumen

El objetivo primario del estudio es comparar intismeran autógeno más pembrolizumab con placebo más pembrolizumab en participantes con carcinoma de células renales (CCR) con respecto a la supervivencia libre de enfermedad (SLE) evaluada por el investigador. La hipótesis primaria es que intismeran autógeno más pembrolizumab es superior a placebo más pembrolizumab con respecto a la SLE.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Has histologically or cytologically confirmed diagnosis of renal cell carcinoma (RCC) with clear cell or papillary histology.
Has intermediate-high-risk, high-risk, or M1 no evidence of disease (NED) RCC as defined by the following pathological tumor-node metastasis and tumor grading:
Intermediate-high-risk RCC: pT2 Gr4, N0, M0; pT3 Gr3/4, N0, M0
High-risk RCC: pT4, N0, M0; pT any stage, N1, M0
M1 NED RCC participants who present not only with the primary kidney tumor, but also solid, isolated, soft tissue metastases that can be completely resected at 1 of the following: the time of nephrectomy (synchronous), or ≤2 years from nephrectomy (metachronous)
Has undergone complete resection of the primary tumor (partial or radical nephrectomy) and complete resection of solid, isolated, soft tissue metastatic lesion(s) in M1 NED participants.
Must have undergone a nephrectomy and/or metastasectomy ≤12 weeks prior to randomization and recovered from surgery and any post-operative complications before randomization.
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before randomization.

Criterios de exclusión

Has had a major surgery other than nephrectomy plus resection of preexisting metastases for M1 NED participants, within 4 weeks prior to randomization.
Has residual thrombus post nephrectomy in the vena renalis or vena cava.
Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids.
Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
Received prior treatment with a cancer vaccine.
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.
Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
Has a history of brain or bone metastatic lesions.
Has severe hypersensitivity to study medication or any of the substances used to prepare the study medication.
Has an active autoimmune disease that has required systemic treatment in the past 2 years
Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
Has an active infection requiring systemic therapy
History of allogeneic tissue/solid organ transplant
Has not adequately recovered from major surgery or has ongoing surgical complications

Ubicaciones

Hospital Británico de Buenos Aires-Oncology ( Site 1106)

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Instituto Alexander Fleming-Alexander Fleming ( Site 1101)

Buenos Aires, Buenos Aires F.D., Argentina

Asociación de Beneficencia Hospital Sirio Libanés ( Site 1110)

Buenos Aires, Buenos Aires F.D., Argentina

Centro Privado de RMI Rio Cuarto ( Site 1104)

Río Cuarto, Córdoba Province, Argentina

Fundacion Estudios Clinicos ( Site 1111)

Rosario, Santa Fe Province, Argentina

Estudio clínico de fase 2, aleatorizado, doble ciego, de búsqueda de dosis de V940 (mRNA-4157) más pembrolizumab (MK-3475) frente a placebo más pembrolizumab en el tratamiento adyuvante de participantes con carcinoma de células renales (INTerpath-004)

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Intismeran autogene

Pembrolizumab

Placebo