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Etapa actual del estudio en Chile: Reclutamiento (buscando participantes para el estudio clínico)

DESCRIPCIÓN

El propósito de este estudio es evaluar la seguridad y la eficacia del PEMBROLIZUMAB combinado con LENVATINIB en comparación con el PEMBROLIZUMAB solo (con PLACEBO para LENVATINIB) como tratamiento de primera línea en adultos sin tratamiento previo terapia para su Melanoma avanzado.

Las hipótesis principales del estudio son:

1.- La combinación de PEMBROLIZUMAB + LENVATINIB es superior a PEMBROLIZUMAB + PLACEBO según lo evaluado por la Sobrevida libre de progresión (SLP) según los criterios de evaluación de respuesta en tumores sólidos versión 1.1 (RECIST 1.1).

2.- La combinación de PEMBROLIZUMAB + LENVATINIB es superior a PEMBROLIZUMAB + PLACEBO según lo evaluado por la Sobrevida general (SG). Para este estudio, RECIST 1.1 se ha modificado para seguir un máximo de 10 lesiones objetivo y un máximo de 5 lesiones objetivo por órgano.

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Tumor Primario: Melanoma

Fase: 3

Ramas de tratamiento: 

  • A) PEMBROLIZUMAB + LENVATINIB
  • B) PEMBROLIZUMAB + PLACEBO

Criterios de inclusión: EIV  o irresecable

Inclusion Criteria:

  • Has histologically or cytologically confirmed melanoma
  • Has unresectable Stage III or Stage IV melanoma, as per American Joint Committee on Cancer guidelines, not amenable to local therapy
  • Has been untreated for advanced or metastatic disease except as follows: a. proto-oncogene B-Raf (BRAF) V600 mutation-positive melanoma may have received standard of care targeted therapy as first-line therapy for advanced or metastatic disease. b. Prior adjuvant or neoadjuvant therapy, with targeted therapy or immunotherapy (such as anti-cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], anti-programmed cell death 1 [anti-PD-1] therapy or Interferon) will only be permitted if relapse did not occur during active treatment or within 6 months of treatment discontinuation.
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
  • Has the presence of ≥1 measurable lesion by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST 1.1
  • Provides a tumor biopsy. Participants must submit tumor sample during Screening for confirmation of adequacy of tumor tissue at a central pathology laboratory. Participants who do not submit a tumor tissue sample will not be randomized. The tumor biopsy may not be obtained from a lone target lesion. Confirmation of presence of tumor tissue is not required prior to randomization.
  • Has resolution of toxic effect(s) of the most recent prior therapy to Grade 1 or less (except alopecia). If participant received major surgery or radiation therapy of >30 Gray (Gy), they must have recovered from the toxicity and/or complications from the intervention.
  • Male participants must agree to use contraception during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period
  • Female participants must not be pregnant, not breastfeeding, and ≥1 of the following conditions applies: a. Not a woman of childbearing potential (WOCBP) OR b. A WOCBP who agrees to use study-approved contraception during the treatment period and for at least 120 days after the last dose of study treatment
  • Has adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ≤150/90 mmHg at screening and no change in antihypertensive medications within 1 week before Cycle 1 Day 1
  • Has adequate organ function

CENTROS DE INVESTIGACIÓN

Este es un estudio multicéntrico a nivel global y se desarrolla en los siguientes centros de investigación de Chile:

Centro de Investigación: FALP

Investigador Principal: Dr. Mauricio Mahave