Informations générales (source: ClinicalTrials.gov)
A Phase 1/2 Study of BMS-986408 Alone and in Combination With Nivolumab or With Nivolumab and Ipilimumab in Participants With Advanced Solid Tumors
Interventional
Phase 1/Phase 2
Bristol-Myers Squibb (Voir sur ClinicalTrials)
août 2022
octobre 2025
23 novembre 2024
The primary purpose of this study is to characterize the safety profile of BMS-986408 as
monotherapy and in combination with nivolumab or nivolumab and ipilimumab to establish
the maximum tolerated dose (MTD). The Recommended Phase 2 Dose (RP2D) that optimizes the
pharmacokinetic/pharmacodynamic (PK/PD) relationship of BMS-986408 will also be
determined.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Cristina SMOLENSCHI | 28/05/2024 10:23:10 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Local Institution - 0014 - 94800 - Villejuif - Paris - France | Contact (sur clinicalTrials) | ||||
| Local Institution - 0015 - 33076 - Bordeaux - Aquitaine - France | Contact (sur clinicalTrials) | ||||
| Local Institution - 0018 - 13385 - Marseille - France | Contact (sur clinicalTrials) | ||||
| Local Institution - 0019 - 31059 - Toulouse - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Participants with a histologically or cytologically confirmed, advanced,
unresectable/metastatic, solid malignancy of any histology measurable by Response
Evaluation Criteria in Solid Tumors (RECIST) v1.1
- Participants who have received, been refractory to, ineligible for, or intolerant of
existing therapy(ies) known to provide clinical benefit for the condition of the
participant
- Participants with melanoma should have documentation of mutation status for B-type
Raf proto-oncogene (BRAF) and neuroblastoma ras viral oncogene homolog (NRAS)
- Participants must have experienced radiographically documented progressive disease
on or after the most recent therapy
- Participants with a histologically or cytologically confirmed, advanced,
unresectable/metastatic, solid malignancy of any histology measurable by Response
Evaluation Criteria in Solid Tumors (RECIST) v1.1
- Participants who have received, been refractory to, ineligible for, or intolerant of
existing therapy(ies) known to provide clinical benefit for the condition of the
participant
- Participants with melanoma should have documentation of mutation status for B-type
Raf proto-oncogene (BRAF) and neuroblastoma ras viral oncogene homolog (NRAS)
- Participants must have experienced radiographically documented progressive disease
on or after the most recent therapy
- An active, known or suspected autoimmune disease
- Conditions requiring systemic treatment with either corticosteroids within 14 days
or other immunosuppressive medications within 30 days of the first dose of study
treatment
- Current or recent gastrointestinal disease or gastrointestinal surgery that could
impact the absorption of study drug
- Untreated central nervous system (CNS) metastases or leptomeningeal metastasis
Other protocol-defined inclusion/exclusion criteria apply