Broad Solid Tumor Clinical Trial
Official title:
Phase 1/2a First-In-Human Study of BMS-986207 Monoclonal Antibody Alone and in Combination With Nivolumab or With Nivolumab and Ipilimumab in Advanced Solid Tumors
| Verified date | March 2024 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to evaluate the safety and effectiveness of experimental medication BMS-986207 by itself, in combination with Nivolumab, and in combination with both nivolumab and ipilimumab in participants with solid cancers that are advanced or have spread.
| Status | Completed |
| Enrollment | 101 |
| Est. completion date | January 25, 2024 |
| Est. primary completion date | January 25, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Must have pre-existing or prior programmed death-ligand 1 (PD-L1) immunohistochemistry (IHC) results within 3 months of enrollment from testing of tumor tissue; PD-L1 expression must be tumor cell positive = 1% for a participant to be eligible for enrollment - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria; radiographic tumor assessment performed within 28 days before randomization Exclusion Criteria: - Primary central nervous system (CNS) disease, or tumors with CNS metastases as the only site of disease. Controlled brain metastases will be allowed to enroll - Other active malignancy requiring concurrent intervention - Uncontrolled or significant cardiovascular disease - Active, known, or suspected autoimmune disease - NSCLC without prior treatment in the advanced or metastatic setting (Part 2C) Other protocol-defined inclusion/exclusion criteria apply |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Local Institution - 0022 | Buenos Aires | Distrito Federal |
| Argentina | Local Institution - 0023 | Caba | Ciudad Autónoma De Buenos Aires |
| Argentina | Local Institution - 0019 | Córdoba | Cordoba |
| Australia | Local Institution - 0006 | Nedlands | Western Australia |
| Canada | Local Institution - 0008 | Ottawa | Ontario |
| Canada | Local Institution - 0007 | Toronto | Ontario |
| Chile | Local Institution - 0021 | Santiago | Metropolitana |
| Japan | Local Institution - 0005 | Chuo-ku | Tokyo |
| Japan | Local Institution - 0004 | Kashiwa-shi | Chiba |
| Romania | Local Institution - 0017 | Bucharest | |
| Romania | Local Institution - 0016 | Cluj | |
| Romania | Local Institution - 0018 | Craiova | |
| Romania | Local Institution - 0015 | Flore?ti | |
| Singapore | Local Institution - 0020 | Singapore | |
| United States | Local Institution - 0001 | Hackensack | New Jersey |
| United States | Local Institution - 0003 | New York | New York |
| United States | Local Institution - 0002 | Philadelphia | Pennsylvania |
| United States | Local Institution - 0012 | Philadelphia | Pennsylvania |
| United States | Local Institution - 0009 | Pittsburgh | Pennsylvania |
| United States | Local Institution - 0010 | Salt Lake City | Utah |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb | Ono Pharmaceutical Co. Ltd |
United States, Argentina, Australia, Canada, Chile, Japan, Romania, Singapore,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of Adverse Events (AEs) | Up to 27 months | ||
| Primary | Incidence of Serious Adverse Events (SAEs) | Up to 27 months | ||
| Primary | Incidence of AEs meeting protocol-defined dose limiting toxicity (DLT) criteria | Up to 6 weeks | ||
| Primary | Incidence of AEs leading to discontinuation | Up to 27 months | ||
| Primary | Incidence of deaths | Up to 27 months | ||
| Primary | Number of participants with laboratory abnormalities | Up to 27 months | ||
| Primary | Objective response rate (ORR) | Up to 36 months | ||
| Primary | Median duration of response (mDOR) | Up to 36 months | ||
| Primary | Progression-free survival rate (PFSR) at 24 weeks by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator | At 24 weeks | ||
| Secondary | Objective response rate (ORR) | Up to 36 months | ||
| Secondary | Median duration of response (mDOR) | Up to 36 months | ||
| Secondary | Progression-free survival rate (PFSR) at 24 weeks by RECIST v1.1 | At 24 Weeks | ||
| Secondary | Maximum observed serum concentration (Cmax) | Up to 27 months | ||
| Secondary | Time of maximum observed serum concentration (Tmax) | Up to 27 months | ||
| Secondary | Area under the serum concentration-time curve from time zero to time of last quantifiable concentration AUC(0-T) | Up to 27 months | ||
| Secondary | Incidence of anti-drug antibody (ADA) | Up to 27 months |