A Phase 1b/2 Study of BMS-986442 with Nivolumab with or without Chemotherapy in Solid Tumors and Non-small Cell Lung Cancer
Key facts
- Where
- Barcelona, Madrid, Málaga, Sevilla és Valencia, SpanyolországSee the 6 sites
- Phase
- 1/2. fázis
Where in Spanyolország
- Hospital Universitari Vall d'HebronBarcelona, SpanyolországNo longer taking part
- Hospital General Universitario Gregorio MarañónMadrid, SpanyolországNo longer taking part
- Hospital Universitario 12 de OctubreMadrid, SpanyolországNo longer taking part
- Hospital Universitario Regional de MálagaMálaga, 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 Services Unlimited Company
- Trial code
- EU 2022-503108-26-00
- Record updated
- 2024. július 23.
- Original description
To characterize the safety and tolerability, and to establish the MTD, MAD, and/or RP2D of BMS-986442 in combination with nivolumab or with nivolumab and chemotherapyRead full original descriptionShow less
A Phase 1b/2 Study of BMS-986442 in Combination with Nivolumab or Nivolumab and Chemotherapies in Participants with Advanced Solid Tumors and Non-small Cell Lung Cancer
To characterize the safety and tolerability, and to establish the MTD, MAD, and/or RP2D of BMS-986442 in combination with nivolumab or with nivolumab and chemotherapy
Inclusion: Participants in all parts of the study must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1; Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1; Participants must have a life expectancy of at least 3 months at the time of first dose.
Exclusion: Concurrent malignancy (present during screening) requiring treatment, or history of prior malignancy active within 2 years prior to randomization in study Part B1 or treatment assignment in all other study parts; Participants with an active, known, or suspected autoimmune disease. Other protocol-defined inclusion/exclusion criteria apply; Untreated symptomatic central nervous system metastases or leptomeningeal metastases.