An Investigational Immunotherapy Study of BMS-986288 Alone and in Combination With Nivolumab in Advanced Solid Cancers
Key facts
- Where
- Barcelona, Madrid, Majadahonda, Sevilla és Valencia, SpanyolországSee the 6 sites
- Phase
- 1/2. fázis
Where in Spanyolország
- Hospital Clinic de BarcelonaBarcelona, SpanyolországNo longer taking part
- Vall D'hebron Institut De RecercaBarcelona, SpanyolországNo longer taking part
- Hospital Universitario 12 de OctubreMadrid, SpanyolországNo longer taking part
- Hospital Universitario Puerta de Hierro de MajadahondaMajadahonda, SpanyolországNo longer taking part
- University Hospital Virgen Del Rocio S.L.Sevilla, SpanyolországNo longer taking part
- Hospital Universitario Y Politecnico La FeValencia, SpanyolországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Bristol Myers Squibb International Corporation
- Trial code
- EU 2023-508954-25-00
- Record updated
- 2024. június 19.
- Original description
For Part 1, 2A, 2B: To characterize the safety, tolerability, and Dose-Limiting Toxicities (DLTs) and to determine the Maximum Tolerated Dose (MTD)/ Recommended Phase 2 Dose (RP2D) of BMS-986288 administered as monotherapy and in combination with nivolumab in participants with select advanced solid tumors. For Part 2C: To compare the efficacy of BMS-986288 in combination with nivolumab vs regorafenib in the 3L/4L MSS CRC setting.Read full original descriptionShow less
A Phase 1/2 First-in-human Study of BMS-986288 Alone and in Combination with Nivolumab in Advanced Malignant Tumors
For Part 1, 2A, 2B: To characterize the safety, tolerability, and Dose-Limiting Toxicities (DLTs) and to determine the Maximum Tolerated Dose (MTD)/ Recommended Phase 2 Dose (RP2D) of BMS-986288 administered as monotherapy and in combination with nivolumab in participants with select advanced solid tumors. For Part 2C: To compare the efficacy of BMS-986288 in combination with nivolumab vs regorafenib in the 3L/4L MSS CRC setting.
Inclusion: Histologic or cytologic confirmation of select solid tumor that is advanced (metastatic, recurrent, and/or unresectable) with measurable disease and have at least 1 lesion accessible for biopsy; Eastern Cooperative Oncology Group Performance Status of 0 or 1; Participants must have received, and then progressed, relapsed, or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting according to select solid tumor histologies.
Exclusion: Participants with other active malignancy requiring concurrent intervention; Participants with active, known or suspected autoimmune disease; Participants with primary CNS malignancies or tumors with CNS metastasis as the only site of disease, will be excluded.