Non-small Cell Lung Cancer Clinical Trial
Official title:
A Phase 1b/2 Study of BMS-986442 in Combination With Nivolumab or Nivolumab and Chemotherapies in Participants With Advanced Solid Tumors and Non-small Cell Lung Cancer
| Verified date | June 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 BMS-986442 in combination with nivolumab (with or without chemotherapy) for its antitumor efficacy and benefit to participants.
| Status | Active, not recruiting |
| Enrollment | 225 |
| Est. completion date | July 17, 2024 |
| Est. primary completion date | July 17, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Participants in all parts of the study must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. - Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. - Participants must have a life expectancy of at least 3 months at the time of first dose. Exclusion Criteria: - Untreated symptomatic central nervous system metastases or leptomeningeal metastases. - Concurrent malignancy (present during screening) requiring treatment, or history of prior malignancy active within 2 years prior to randomization in study Part B1 or treatment assignment in all other study parts. - Participants with an active, known, or suspected autoimmune disease. Other protocol-defined inclusion/exclusion criteria apply. |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Local Institution - 0002 | Clayton | Victoria |
| Australia | Local Institution - 0018 | Darlinghurst | New South Wales |
| Australia | Local Institution - 0084 | Murdoch | Western Australia |
| Australia | Local Institution - 0086 | Southport | Queensland |
| Australia | Local Institution - 0001 | Westmead | New South Wales |
| Italy | Istituto di Candiolo | Candiolo | Torino |
| Italy | Local Institution - 0065 | Milan | Milano |
| Italy | Local Institution - 0062 | Napoli | |
| Italy | Azienda Ospedaliero Universitaria Senese | Siena | Toscana |
| Poland | Local Institution - 0069 | Bydgoszcz | |
| Poland | Local Institution - 0073 | Gdansk | Pomorskie |
| Poland | Local Institution - 0067 | Warszawa | Mazowieckie |
| Spain | Local Institution - 0080 | Barcelona | Barcelona [Barcelona] |
| Spain | Local Institution - 0079 | Madrid | Madrid, Comunidad De |
| Spain | Local Institution - 0083 | Madrid | Madrid, Comunidad De |
| Spain | Local Institution - 0082 | Málaga | |
| Spain | Local Institution - 0087 | Sevilla | |
| Spain | Local Institution - 0081 | València | |
| United States | Local Institution - 0046 | Allentown | Pennsylvania |
| United States | University of Cincinnati Medical Center | Cincinnati | Ohio |
| United States | Local Institution - 0096 | Costa Mesa | California |
| United States | Local Institution - 0029 | Fort Wayne | Indiana |
| United States | Local Institution - 0005 | Grand Rapids | Michigan |
| United States | Local Institution - 0003 | Hackensack | New Jersey |
| United States | Local Institution - 0016 | Houston | Texas |
| United States | Carolina BioOncology Institute | Huntersville | North Carolina |
| United States | Mayo Clinic in Florida | Jacksonville | Florida |
| United States | Local Institution - 0022 | New Orleans | Louisiana |
| United States | University of California, Irvine (UCI) Health - UC Irvine Medical Center | Orange | California |
| United States | Local Institution - 0027 | Orlando | Florida |
| United States | Mayo Clinic in Arizona - Phoenix | Phoenix | Arizona |
| United States | Mayo Clinic in Rochester, Minnesota | Rochester | Minnesota |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States, Australia, Italy, Poland, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of Adverse Events (AEs) | Up to 119 Weeks | ||
| Primary | Incidence of Serious Adverse Events (SAEs) | Up to 119 Weeks | ||
| Primary | Incidence of AEs meeting protocol-defined Dose Limiting Toxicity (DLT) criteria | Up to 119 Weeks | ||
| Primary | Incidence of AEs leading to discontinuation | Up to 119 Weeks | ||
| Primary | Incidence of AEs leading to death | Up to 119 Weeks | ||
| Secondary | Maximum observed plasma concentration (Cmax) | Up to 119 Weeks | ||
| Secondary | Time of maximum observed concentration (Tmax) | Up to 119 Weeks | ||
| Secondary | Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration (AUC[0-T]) | Up to 119 Weeks | ||
| Secondary | Incidence of Anti-drug Antibodies (ADAs) to BMS-986442 | Up to 119 Weeks | ||
| Secondary | Objective Response Rate (ORR) | At 6 months and 12 months | ||
| Secondary | Duration of Response (DOR) | At 6 months and 12 months | ||
| Secondary | Disease Control Rate (DCR) | At 6 months and 12 months | ||
| Secondary | Progression-free Survival Rate (PFSR) | At 6 months and 12 months |
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