CTIS2023-503651-10-00RecruitingPhase 1
A Phase 1/2 Study of BMS-986340 as Monotherapy and in Combination with Nivolumab orDocetaxel in Participants with Advanced Solid Tumors - CA052-002
Bristol Myers Squibb International Corporation0 sites277 target enrollmentStarted: June 30, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Enrollment
- 277
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 65+ (—)
- Sex
- All
Inclusion Criteria
- •Fresh pre-treatment and on-treatment tumor biopsy must be provided for biomarker analysis, Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and at least 1 lesion accessible for biopsy, Eastern Cooperative Oncology Group Performance Status of 0 or 1, Radiographically documented progressive disease on or after the most recent therapy, Received standard-of-care therapies, including an available programmed death (ligand)-1 inhibitor known to be effective in the tumor type for which they are being evaluated (except for Part 1C, where participants with prior docetaxel use for the advanced/metastatic setting will be excluded), Participants must have advanced or metastatic disease, and have received, be refractory to, not be a candidate for, or be intolerant to existing therapies known to provide clinical benefit for the condition of the participant. Eligible tumor types for each Part are listed below: - Parts 1A and 1B: NSCLC, SCCHN, MSS-CRC, gastric/GEJ adenocarcinoma, cervical cancer (SCC or adenocarcinoma), RCC, UC, PDAC, melanoma, OC, or TNBC. - Parts 2A and 2B: NSCLC, SCCHN, gastric/GEJ adenocarcinoma, or up to 3 additional tumor types from Parts 1A and 1B may be considered based on emerging data. - Part 1C: NSCLC, SCCHN, gastric/GEJ adenocarcinoma, OC, or TNBC. Other protocol-defined inclusion criteria apply.
Exclusion Criteria
- •Women who are pregnant or breastfeeding, Major surgery within 4 weeks of study drug administration, History of or with active interstitial lung disease or pulmonary fibrosis Other protocol-defined exclusion criteria apply, Primary central nervous system (CNS) malignancy, Untreated CNS metastases, Leptomeningeal metastases, Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study treatment, Active, known, or suspected autoimmune disease, Condition requiring systemic treatment with either corticosteroids within 14 days or other immunosuppressive medications within 30 days of the first dose of study treatment, Prior organ or tissue allograft, Uncontrolled or significant cardiovascular disease
Investigators
Similar Trials
Active, not recruiting
Phase 1
CA052002 is a Phase 1/2, multi-center, open-label study of BMS-986340 administered as a single agent and in combination with nivolumab in participants with select advanced solid tumorsMale and female participants = 18 years of age with advanced or metastatic cancers .EUCTR2021-001188-26-ESBristol-Myers Squibb International Corporation105
Active, not recruiting
Phase 1
CA052002 is a Phase 1/2, multi-center, open-label study of BMS-986340 administered as a single agent and in combination with nivolumab or docetaxel in participants with select advanced solid tumorsMale and female participants = 18 years of age with advanced or metastatic cancersMedDRA version: 21.0Level: LLTClassification code 10048683Term: Advanced cancerSystem Organ Class: 100000004864EUCTR2021-001188-26-DEBristol-Myers Squibb International Corporation277
Active, not recruiting
Phase 1
A Phase 1b/2 Study of BMS-986158 Monotherapy and Combination with either Ruxolitinib or Fedratinib in Intermediate or High Risk MyelofibrosisDIPSS-Intermediate or High Risk MyelofibrosisMedDRA version: 21.0Level: LLTClassification code 10000879Term: Acute myelofibrosisSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10028537Term: MyelofibrosisSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2020-002071-35-DEBristol-Myers Squibb International Corporation248
Active, not recruiting
Phase 1
A Phase 1b/2 Study of BMS-986158 Monotherapy and Combination with either Ruxolitinib or Fedratinib in Intermediate or High Risk MyelofibrosisDIPSS-Intermediate or High Risk MyelofibrosisMedDRA version: 20.0Level: PTClassification code: 10028537Term: Myelofibrosis Class: 100000004864MedDRA version: 21.0Level: LLTClassification code: 10000879Term: Acute myelofibrosis Class: 10029104CTIS2023-509635-89-00Bristol Myers Squibb International Corporation248
Active, not recruiting
Phase 1
A Phase 1b/2 Study of BMS-986158 Monotherapy and Combination with either Ruxolitinib or Fedratinib in Intermediate or High Risk MyelofibrosisDIPSS-Intermediate or High Risk MyelofibrosisMedDRA version: 21.0Level: LLTClassification code 10000879Term: Acute myelofibrosisSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10028537Term: MyelofibrosisSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2020-002071-35-GRBristol-Myers Squibb International Corporation248