EUCTR2018-002108-15-ITActive, not recruitingPhase 1
Phase 1/2 Study of BMS-986310 Administered Alone and in Combination with Nivolumab in Participants with Advanced Solid Tumors - NA
BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIO0 sites280 target enrollmentStarted: November 10, 2020Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 280
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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, in one of the
- •following tumor types: Renal cell carcinoma, Melanoma, colorectal
- •cancer (CRC) microsatellite instability (MSI)-High (determined by
- •Clinical Laboratory Improvement Amendments (CLIA) validated assay,
- •testing methodology must be provided), Bladder cancer, Squamous Cell
- •Carcinoma of the Head and Neck (SCCHN), 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) Participants must be newly diagnosed, no prior history of treatment
- •for bladder cancer
- •ii) Participants must not meet criteria for standard of care neoadjuvant
- •therapy and must be candidates for SOC surgical resection of primary
- •iii) Histologically confirmed muscle-Invasive bladder cancer (MIBC) pure
- •or mixed histology urothelial carcinoma
- •Part 2 - Patients with relapsed / refractory solid tumors where no other
- •standard of care treatment option is available
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 168
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 112
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.
Investigators
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