IDE196 (Darovasertib) in Combination With Crizotinib as First-line Therapy in Metastatic Uveal Melanoma

Overview

Información sobre este estudio

The purpose of this study is to compare IDE196 + crizotinib to investigator’s choice of treatment with respect to PFS per RECIST 1.1 as assessed by blinded independent central review (BICR), and to compare IDE196 + crizotinib to investigator’s choice of treatment with respect to OS

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:

- Histological or cytological confirmed Metastatic Uveal Melanoma

- HLA-A*02:01 negative

- No prior systemic therapy in the metastatic or advanced setting, regional or
liver-directed therapy, ablations or surgical resection of oligometastatic disease, or
neoadjuvant or adjuvant therapy is allowed

- Measurable disease per RECIST 1.1

- Able to be safely administered and absorb study therapy

- ECOG performance status 0 or 1

- Life expectancy of ≥3 months

- Adequate organ function

Exclusion Criteria:

- Previous treatment with a PKC inhibitor (including prior treatment with IDE196), an
inhibitor directly targeting MET, or an inhibitor directly targeting GNAQ/11

- Concurrent malignant disease

- AEs from prior anti-cancer therapy that have not resolved to Grade ≤1

- Symptomatic or untreated central nervous system (CNS) metastases, or CNS metastases
that require corticosteroids

- Active HIV infection or Hep B/C

- Active adrenal insufficiency, active colitis, or active inflammatory bowel disease

- History of interstitial lung disease, active pneumonitis, or history of pneumonitis

- Active infection requiring systemic antibiotic therapy

- Use of hematopoietic colony-stimulating factors (CSF) prior to start of study drug

- Females who are pregnant or breastfeeding

- History of severe hypersensitivity reactions (eg, anaphylaxis) to other biologic drugs
or monoclonal antibodies

- Contraindication for treatment with investigator's choice therapies as per applicable
labelling

- Has any other condition that may increase the risk associated with study participation
or may interfere with the interpretation of study results and, in the opinion of the
investigator, would make the participant inappropriate for entry into the study

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 11/13/23. Questions regarding updates should be directed to the study team contact.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Arkadiusz Dudek, M.D., Ph.D.

Comunícate con nosotros para obtener el estatus más reciente

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publicaciones

Publications are currently not available
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CLS-20567688

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