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Recruiting

An Investigational Immunotherapy Study of BMS-986310 Administered Alone and in Combination With Nivolumab in Patients With Advanced Solid Tumors - CA044-001

Actualizada: 01 October, 2018   |   ClinicalTrials.gov

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Detalles del estudio

  • Phase 1/Phase 2

    Fase

  • Géneros

  • 18+

    Rango de edad

  • Recruiting

Opciones de tratamiento

Brazos del estudio
INTERVENCIÓN ASIGNADA
Experimental: Cohort Expansion
Drug: BMS-986310 Biological: Nivolumab
Experimental: Dose Escalation
Drug: BMS-986310 Biological: Nivolumab

Criterios clave de elegibilidad

Inclusion Criteria: - Patients with measurable disease per RECIST v1.1 and have at least one lesion accessible for biopsy. - ECOG performance status less than or equal to 1 Part 1 and Sub-study B: i) Part 1 participants must have advanced or metastatic disease where no other standard of care treatment option is possible. ii) Sub-study B participants must have advanced or metastatic disease where no other standard of care treatment is possible, and they must have had disease progression on an anti-PD-(L)1 based regimen as their most recent prior therapy Sub-study A: i) Males and females with histologically confirmed TNBC as defined by ASCO/CAP guidelines. ii) Participants must be newly diagnosed, no prior history of treatment for TNBC. iii) Tumor size greater than or equal to 1cm3 iv) Participants must not meet criteria for standard of care neoadjuvant therapy and must be candidates for SOC surgical resection of primary tumor. Part 2 i) Patients with NSCLC ii) Patients with Pancreatic Cancer iii) Patients with TNBC iiii) Patients with CRC Exclusion Criteria: - History of severe adverse drug reactions to nonsteroidal anti-inflammatory drugs (NSAIDs), or those with adverse reactions to an NSAID that is currently prescribed - Participants with an active, known or suspected autoimmune disease.

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