Informations générales (source: ClinicalTrials.gov)
A Phase 1/2 Study of BMS-986449 Alone and in Combination With Nivolumab in Participants With Advanced Solid Tumors
Interventional
Phase 1/Phase 2
Bristol-Myers Squibb (Voir sur ClinicalTrials)
juin 2023
juillet 2027
10 mai 2025
The purpose of this study is to evaluate the safety and efficacy of BMS-986449 alone and
in combination with nivolumab in participants with advanced solid tumors.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Antoine HOLLEBECQUE | 18/06/2024 13:41:35 | 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 | |||||
| Institut Bergonie Centre Regional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest - 33076 - Bordeaux - France | Antoine Italiano, Site 0003 | Contact (sur clinicalTrials) | |||
| Institut Paoli-Calmettes - 13273 - Marseille - Provence-Alpes-Côte-d'Azur - France | Cecile Vicier, Site 0004 | Contact (sur clinicalTrials) | |||
| Local Institution - 0009 - 69373 - Lyon CEDEX 08 - Rhône-Alpes - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- All participants must have a histologically or cytologically confirmed, advanced,
unresectable/metastatic, solid malignancy (measurable by Response Evaluation
Criteria in Solid Tumors [RECIST] v1.1), and have received, be refractory to,
ineligible for, or intolerant of existing therapy(ies) known to provide clinical
benefit for the condition of the participant.
- Part 1A may have a solid malignancy of any histology.
- Part 1B is restricted to participants with Non-small cell lung cancer (NSCLC).
- Part 1C is restricted to participants with Triple-negative breast cancer
(TNBC).
- Tumor biopsy must be obtained for all participants (unless medically precluded).
- All participants must have a histologically or cytologically confirmed, advanced,
unresectable/metastatic, solid malignancy (measurable by Response Evaluation
Criteria in Solid Tumors [RECIST] v1.1), and have received, be refractory to,
ineligible for, or intolerant of existing therapy(ies) known to provide clinical
benefit for the condition of the participant.
- Part 1A may have a solid malignancy of any histology.
- Part 1B is restricted to participants with Non-small cell lung cancer (NSCLC).
- Part 1C is restricted to participants with Triple-negative breast cancer
(TNBC).
- Tumor biopsy must be obtained for all participants (unless medically precluded).
- History of Grade ≥ 3 toxicity related to prior T-cell agonist or checkpoint
inhibitor therapy (eg, anti-cytotoxic T-lymphocyte-associated antigen 4 [CTLA-4], or
anti-PD- 1/programmed death-ligand 1 [PD-L1] treatment, or any other antibody or
drug specifically targeting T-cell co-stimulation or other immune checkpoint
pathways) except those that are unlikely to re-occur with standard countermeasures.
- Current or recent (within 3 months of study intervention administration)
gastrointestinal disease or gastrointestinal surgery (eg, intestinal/gastric/colon
resection) that could impact the absorption of study intervention.
- Any significant acute or chronic medical illness which would interfere with study
intervention or follow-up in the opinion of the investigator.
Other protocol-defined criteria may apply.