A Study of BMS-986449 With and Without Nivolumab in Participants With Advanced Solid Tumors

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05888831
• Collaborator: (none)
• Enrollment: 100
• Locations: 20
• Arms: 3
• Anticipated Duration (Months): 49
• Patients Per Site: 5
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Advanced Solid Tumors	Drug: BMS-986449; Drug: Nivolumab	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 1/2 Study of BMS-986449 Alone and in Combination With Nivolumab in Participants With Advanced Solid Tumors
• Anticipated Study Start Date: Jun 1, 2023
• Anticipated Primary Completion Date: May 21, 2025
• Anticipated Study Completion Date: Jul 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dose Escalation: BMS-986449 monotherapy	Drug: BMS-986449; Specified dose on specified days
Experimental: Dose Escalation: BMS-986449 + nivolumab	Drug: BMS-986449; Specified dose on specified days; Drug: Nivolumab; Specified dose on specified days; Other Names: OPDIVO® BMS-936558
Experimental: Dose Escalation: BMS-986449 monotherapy pharmacodynamic (PD) cohorts	Drug: BMS-986449; Specified dose on specified days

Outcome Measures

Primary Outcome Measures

1. Number of participants with Dose-Limiting Toxicities (DLTs) [Up to approximately 4 years]

2. Number of participants with Adverse Events (AEs) [Up to approximately 4 years]

3. Number of participants with Serious Adverse Events (SAEs) [Up to approximately 4 years]

4. Number of participants with AEs leading to discontinuation [Up to approximately 4 years]

5. Number of deaths [Up to approximately 4 years]

Secondary Outcome Measures

1. Maximum observed plasma concentration (Cmax) [Up to approximately 4 years]

2. Time of maximum observed concentration within a dosing interval (Tmax) [Up to approximately 4 years]

3. Area under the concentration-time curve within a dosing interval (AUC[TAU]) [Up to approximately 4 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Angeles Clinic and Research Institute - West Los Angeles Office	Los Angeles	California	United States	90025
2	R.J. Zuckerberg Cancer Center	Lake Success	New York	United States	11042
3	Local Institution - 0016	Brussels	Bruxelles-Capitale, Région De	Belgium	1200
4	Local Institution - 0017	Gent	Oost-Vlaanderen	Belgium	9000
5	Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest	Bordeaux	Aquitaine	France	33076
6	Gustave Roussy	Villejuif	Paris	France	94800
7	Institut Paoli-Calmettes	Marseille	Provence-Alpes-Côte-d'Azur	France	13273
8	Centre Leon Berard	Lyon CEDEX 08	Rhône-Alpes	France	69373
9	Local Institution - 0023	Rozzano	Milano	Italy	20089
10	Local Institution - 0024	Siena	Toscana	Italy	53100
11	Local Institution - 0026	Bergamo		Italy	24127
12	Local Institution - 0025	Roma		Italy	00168
13	Local Institution - 0020	Nijmegen	Gelderland	Netherlands	6525 GA
14	Local Institution - 0030	Amsterdam		Netherlands	1066 CX
15	Local Institution - 0018	Groningen		Netherlands	9714 CZ
16	Local Institution - 0015	Málaga	Andalucía	Spain	29010
17	Local Institution - 0013	Badalona	Barcelona [Barcelona]	Spain	08916
18	Local Institution - 0012	Pamplona	Navarra	Spain	31008
19	Local Institution - 0014	Madrid		Spain	28040
20	Local Institution - 0011	Madrid		Spain	28050

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT05888831
• Other Study ID Numbers: CA120-1001; 2023-503484-42; U1111-1287-3575
• First Posted: Jun 5, 2023
• Last Update Posted: Jun 5, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Bristol-Myers Squibb: BMS-986449; Nivolumab; Cancer; Solid Tumors; Non-Small Cell Lung Cancer (NSCLC); Triple Negative Breast Cancer (TNBC)
• Additional relevant MeSH terms: Neoplasms; Nivolumab

Study Results

No Results Posted as of Jun 5, 2023