Advanced Solid Tumors Clinical Trial
Official title:
A Phase 1/2 Study of BMS-986449 Alone and in Combination With Nivolumab in Participants With Advanced Solid Tumors
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.
| Status | Recruiting |
| Enrollment | 100 |
| Est. completion date | July 1, 2027 |
| Est. primary completion date | May 21, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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). Exclusion Criteria: - 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. |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Cliniques universitaires Saint-Luc | Brussels | Bruxelles-Capitale, Région De |
| Belgium | UZ Gent | Gent | Oost-Vlaanderen |
| France | Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest | Bordeaux | Aquitaine |
| France | Centre Leon Berard | Lyon CEDEX 08 | Rhône-Alpes |
| France | Institut Paoli-Calmettes | Marseille | Provence-Alpes-Côte-d'Azur |
| France | Gustave Roussy | Villejuif | Paris |
| Italy | Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII | Bergamo | |
| Italy | Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore | Roma | |
| Italy | Humanitas | Rozzano | Milano |
| Italy | Azienda Ospedaliero Universitaria Senese | Siena | Toscana |
| Netherlands | Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL) | Amsterdam | |
| Netherlands | University Medical Center Groningen | Groningen | |
| Spain | Institut Català d'Oncologia (ICO) - Badalona | Badalona | Barcelona [Barcelona] |
| Spain | Hospital Universitario Fundación Jiménez Díaz | Madrid | |
| Spain | Hospital Universitario HM Sanchinarro | Madrid | |
| Spain | Hospital Universitario Virgen de la Victoria | Málaga | Andalucía |
| Spain | Clinica Universidad de Navarra | Pamplona | Navarra |
| United States | Hackensack University Medical Center | Hackensack | New Jersey |
| United States | John Theurer Cancer Center at Hackensack University Medical Center | Hackensack | New Jersey |
| United States | R.J. Zuckerberg Cancer Center | Lake Success | New York |
| United States | The Angeles Clinic and Research Institute - West Los Angeles Office | Los Angeles | California |
| United States | Yale New Haven Hospital-Smilow Cancer Center | New Haven | Connecticut |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States, Belgium, France, Italy, Netherlands, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of participants with Dose-Limiting Toxicities (DLTs) | Up to approximately 4 years | ||
| Primary | Number of participants with Adverse Events (AEs) | Up to approximately 4 years | ||
| Primary | Number of participants with Serious Adverse Events (SAEs) | Up to approximately 4 years | ||
| Primary | Number of participants with AEs leading to discontinuation | Up to approximately 4 years | ||
| Primary | Number of deaths | Up to approximately 4 years | ||
| Secondary | Maximum observed plasma concentration (Cmax) | Up to approximately 4 years | ||
| Secondary | Time of maximum observed concentration within a dosing interval (Tmax) | Up to approximately 4 years | ||
| Secondary | Area under the concentration-time curve within a dosing interval (AUC[TAU]) | Up to approximately 4 years |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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