ROSETTA RCC-208: Estudio de fase 1/2, abierto, multicéntrico, aleatorizado de pumitamig solo o en combinación con ipilimumab o cabozantinib en participantes con carcinoma de células renales (CCR) avanzado

ReclutandoFase 2ClinicalTrials.gov

ID: NCT07293351Tipo: INTERVENTIONALInicio: 26 de mar de 2026Fin estimado: 26 de nov de 2031

Resumen

El propósito de este estudio es evaluar la seguridad, tolerabilidad y eficacia de pumitamig solo o en combinación con ipilimumab o cabozantinib en participantes con carcinoma de células renales (CCR) avanzado.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Participants must have a histologically confirmed diagnosis of locally advanced, unresectable (not amenable to curative surgery or radiation therapy) or metastatic Renal Cell Carcinoma (RCC).
Participants must have clear cell RCC (ccRCC) or non-clear cell RCC (nccRCC) may be enrolled in Part 1. Note: Part 2 may only enroll participants with ccRCC.
Participants may have favorable, intermediate or poor risk disease categories.
Participants must not have received prior systemic therapy for metastatic RCC, with the following exceptions:
i) One prior adjuvant or neoadjuvant therapy for completely resectable RCC is allowed if such therapy did not include an agent that targets vascular endothelial growth factor (VEGF) or VEGF receptors and if recurrence occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy.
ii) For Part 1A participants: Prior systemic therapy in the metastatic setting is allowed if the participant has not received any therapy targeting cytotoxic T-lymphocyte antigen 4 (CTLA-4) (e.g., ipilimumab).
iii) For Part 1B participants: Prior systemic therapy in the metastatic setting is allowed if the participant has not received prior treatment with cabozantinib.
\- Participants must have measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Criterios de exclusión

Participants must not have any untreated known CNS metastases.
Participants must not have a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of Cycle 1 Day1 (C1D1).
Participants must not have a history of interstitial lung disease or pneumonitis.
Participants must not have an uncontrolled pleural or pericardial effusion requiring recurrent therapeutic drainage procedures.
Participants must not have significant cardiovascular disease, such as myocardial infarction, unstable angina, arterial thrombosis, cerebrovascular accident within 6 months prior to C1D1, uncontrolled hypertension (≥ 150 systolic, ≥ 90 diastolic mm Hg) despite optimal medical management, or congenital long QT syndrome.
Participants must not have a urine protein ≥ 2+ and 24 hour urine protein ≥ 1 g at baseline.
Participants must not have evidence of major coagulation disorders.
Participants must not have a history of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism within 6 months prior to C1D1.
Participants must not have a history of abdominal fistula or gastrointestinal (GI) perforation within 6 months.
Participants must not have had a major surgery or trauma within 28 days prior to C1D1.

Intervenciones

drug

Pumitamig

Specified dose on specified days

drug

Ipilimumab

Specified dose on specified days

drug

Cabozantinib

Specified dose on specified days

drug

Nivolumab

Specified dose on specified days

Ubicaciones

Local Institution - 0154

Buenos Aires, Argentina

Site 0154

NOT_YET_RECRUITING

Local Institution - 0156

Buenos Aires, Argentina

Site 0156

NOT_YET_RECRUITING

Patrocinadores

PrincipalBristol-Myers Squibb

ColaboradorBioNTech SE

Contactos

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

Clinical.Trials@bms.com 855-907-3286

First line of the email MUST contain NCT # and Site #.

CONTACT

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

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