A Study to Evaluate RP1 Monotherapy and Combined with Nivolumab

Overview

Información sobre este estudio

The purpose of this study is to evaluate the dose escalation and expansion of RP1 alone and combined with nivolumab in adult subjects with advanced and/or refractory solid tumors, to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), as well as to evaluate preliminary effectiveness.

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:

- Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.

- At least one measurable and injectable lesion

- Have provided a former tumor pathology specimen or be willing to supply a new tumor
sample from a biopsy

- Have a predicted life expectancy of ≥ 3 months

- Measurable disease, according to Response Evaluation Criteria in Solid Tumors (RECIST)
v1.1 criteria

- Subjects with MSI-H or dMMR tumors: has diagnosis of MSI-H or metatstatic dMMR tumor
(according to protocol definition) for whom anti PD-1 therapy is indicated, or have
refused, become intolerant to or have no further therapy options available

- Subjects with NMSC: has diagnosis of locally advanced or metastatic NMSC that are not
considered treatable by surgery including basal cell carcinoma, cutaneous squamous
cell carcinoma, basosquamous carcinoma, Merkel cell carcinoma and other non-melanoma
skin cancers (per protocol) for whom anti-PD1/PD-L1 therapy is indicated, or have
refused, become intolerant to or have no further therapy options available

- Subjects with anti-PD1 failed cutaneous melanoma: has confirmed progressive disease
while on anti-PD1 treatment for at least 8 weeks and documented BRAF mutation status

- Subjects with anti-PD1 failed NSCLC: has confirmed progressive disease after no more
than two prior systemic treatments including anti-PD1/PD-L1 treatment

Exclusion Criteria:

- Prior treatment with an oncolytic therapy

- History of viral infections according to the protocol

- Prior complications with herpes infections

- Chronic use of anti-virals

- Uncontrolled/untreated brain metastasis

- History of interstitial lung disease

- History of non-infectious pneumonitis

- History of clinically significant cardiovascular disease

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

Robert McWilliams, M.D.

Abierto para la inscripción

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Scottsdale/Phoenix, Ariz.

Investigador principal de Mayo Clinic

Mahesh Seetharam, M.D.

Abierto para la inscripción

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publicaciones

Publications are currently not available

Información adicional de contacto

Formulario de contacto para ensayos sobre cáncer

Teléfono: 855-776-0015 (toll-free)

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