EUCTR2018-000340-26-PLActive, not recruitingPhase 1
A Phase 1/2 Study of BMS-986253 in Combination with Nivolumab or Nivolumab plus Ipilimumab in Advanced Cancers
Bristol-Myers Squibb International Corporation0 sites800 target enrollmentStarted: September 13, 2021Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 800
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •- At least 1 lesion accessible for biopsy
- •- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- •- Non-small cell lung carcinoma (only Part 1A and Part 1 Cohorts 1B1 through 1B5 [enrolled through revised Protocol 03]. Participants with NSCLC will not be allowed in Parts 1B6, 1B7 and 1C as per protocol Amendment 04).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 400
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 400
Exclusion Criteria
- •- Participants with CNS metastases as the only site of active disease (Participants with controlled brain metastases; however, will be allowed to enroll)
- •- Participants with active, known or suspected autoimmune disease
- •- Participants with conditions requiring systemic treatment with either corticosteroids (> 10mg prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment administration
- •- Participants with a known history of testing positive for Human Immunodeficiency Virus (HIV) or known Acquired Immunodeficiency Syndrome (AIDS)
- •- Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy
Investigators
Similar Trials
Active, not recruiting
Phase 1
An Investigational Immuno-Therapy Study of Experimental Medication BMS-986253 Given in Combination with Nivolumab or Nivolumab plus Ipilimumab in Patients with Advanced CancersEUCTR2018-000340-26-DEBristol-Myers Squibb International Corporation800
Active, not recruiting
Phase 1
An Investigational Immuno-Therapy Study of Experimental Medication BMS-986253 Given in Combination with Nivolumab or Nivolumab plus Ipilimumab in Patients with Advanced CancersAdvanced solid tumorsMedDRA version: 21.1Level: LLTClassification code: 10065252Term: Solid tumor Class: 10029104CTIS2023-509061-20-00Bristol Myers Squibb International Corporation639
Active, not recruiting
Phase 1
An Investigational Immuno-Therapy Study of Experimental Medication BMS-986253 Given in Combination with Nivolumab or Nivolumab plus Ipilimumab in Patients with Advanced CancersEUCTR2018-000340-26-BEBristol-Myers Squibb International Corporation800
Active, not recruiting
Phase 1
An Investigational Immuno-Therapy Study of Experimental Medication BMS-986253 Given in Combination with Nivolumab in Patients with Advanced CancersEUCTR2018-000340-26-GBBristol-Myers Squibb International Corporation800
Active, not recruiting
Phase 1
An Investigational Immuno-Therapy Study of Experimental Medication BMS-986253 Given in Combination with Nivolumab in Patients with Advanced CancersEUCTR2018-000340-26-ITBRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIO800