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

DESCRIPCIÓN

El propósito de este estudio es determinal la seguridad y eficacia de la terapia combinada de Pembrolizumab con Lenvatinib en pacientes con enferemdad metastásica previamente tratada con terapia sistémica estándar.

Las cohortes abiertas disponibles son para cáncer:

  • Gástrico, colorrectal, glioblastoma multiforme, vía biliar.

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Tumor Primario: Multitumoral

Fase: 2

Rama única de tratamiento: 

  • A) PEMBROLIZUMAB + LENVATINIB

Criterios de inclusión: EIV ya tratado con terapia estándar

Inclusion Criteria:

  • Has a histologically or cytologically-documented, advanced (metastatic and/or unresectable) solid tumor that is incurable and for which prior standard systemic therapy has failed in one of the following cohorts: TNBC, Ovarian Cancer, Gastric Cancer, Colorectal Cancer, GBM, BTC: intrahepatic, extrahepatic cholangiocarcinoma and gall bladder cancer; excludes Ampulla of Vater
  • Must have progressed on or since the last treatment
  • Has measurable disease per RECIST 1.1 (RANO for the GBM cohort) as assessed by the local site investigator/radiology and confirmed by BICR
  • Has provided a PD-L1 evaluable archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
  • Male participants agree to use approved contraception during the treatment period for at least 30 days after the last dose of lenvatinib, or refrain from heterosexual intercourse during this period
  • Female participants are not pregnant or breastfeeding, and are not a woman of childbearing potential (WOCBP), OR are a WOCBP that agrees to use contraception during the treatment period (or 14 days prior to the initiation of study treatment for oral contraception) and for at least 120 days post pembrolizumab, or 30 days post lenvatinib, whichever occurs last
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 7 days of study treatment initiation
  • Has adequate organ function

For Triple Negative Breast Cancer Participants:

  • Has received one or 2 prior lines of therapy
  • Has Lactate Dehydrogenase (LDH) <2.0 x Upper Limit of Normal (ULN)
  • Has locally determined results for estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 tumor analyses

For Ovarian Cancer Participants:

– Has received 3 prior lines of therapy. Note: The initial 30 participants in this cohort included participants with primary ovarian cancer. The expanded cohort will include participants with primary ovarian cancer, fallopian tube, and peritoneal ovarian cancer.

For Gastric Cancer Participants:

– Has received 2 prior lines of therapy. Note: Gastric cancer will include participants with both gastric and gastroesophageal junction (GEJ) adenocarcinoma. Participants with squamous cell carcinoma histology are not eligible

For Colorectal Cancer Participants:

– Has received 2 prior lines of therapy

For GBM Participants:

  • Has failed initial systemic therapy for newly diagnosed GBM
  • Have the following time periods elapsed before the projected start of scheduled study treatment: 1) at least 3 weeks from prior surgical resection, 2) at least 1 week from stereotactic biopsy, 3) at least 6 months from completion of prior radiotherapy, 4) at least 4 weeks (or 5 half-lives, whichever is shorter) from any investigational agent, 5) at least 4 weeks from cytotoxic therapy, 6) at least 6 weeks from antibodies, 7) at least 4 weeks (or 5 half-lives, whichever is shorter) from other antitumor therapies and 1 week for cancer vaccines
  • Be neurologically stable (e.g. without a progression of neurologic symptoms or requiring escalating doses of systemic steroid therapy within last 2 weeks) and clinically stable
  • Has histologically confirmed World Health Organization (WHO) Grade IV GBM

For Biliary Tract Cancer Participants:

  • Has received 1 prior line of therapy
  • Child-Pugh Score, Class A: well-compensated disease. Child-Pugh Score of 5-6

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: U.C. Centro de cáncer

Investigador Principal: Dr. Marcelo Garrido

Centro de Investigación: FALP

Investigador Principal: Dr. Luis Villanueva