2022-503108-26-00CompletedPhase 1/2
A Phase 1b/2 Study of BMS-986442 with Nivolumab with or without Chemotherapy in Solid Tumors and Non-small Cell Lung Cancer
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
Source: EU CTIS (euclinicaltrials.eu) · Last updated 23 Jul 2024
Brief summary (registry, in English)
To characterize the safety and tolerability, and to establish the MTD, MAD, and/or RP2D of BMS-986442 in combination with nivolumab or with nivolumab and chemotherapy
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 106 (actual)
- First submitted
- 29 Mar 2023
- Start date
- 6 Nov 2023
- Lead sponsor
- Bristol-Myers Squibb Services Unlimited Company
- Diseases
- Lung cancer
- EU CT number
- 2022-503108-26-00
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 106
- 14 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- Untreated symptomatic central nervous system metastases or leptomeningeal metastases
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (14)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitari Vall d'Hebron | Barcelona | Spain | Completed |
| Hospital Universitario 12 de Octubre | Madrid | Spain | Completed |
| Hospital General Universitario Gregorio Marañón | Madrid | Spain | Completed |
| Hospital Universitario Regional de Málaga | Málaga | Spain | Completed |
| University Hospital Virgen Del Rocio S.L. | Sevilla | Spain | Completed |
| Hospital Universitario Y Politecnico La Fe | Valencia | Spain | Completed |
| Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS | Candiolo | Italy | Completed |
| ASST Grande Ospedale Metropolitano Niguarda | Milan | Italy | Completed |
| IRCCS Istituto Nazionale Tumori Fondazione Pascale | Naples | Italy | Completed |
| Azienda Ospedaliera Universitaria Senese | Siena | Italy | Completed |
| Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy | Bydgoszcz | Poland | Completed |
| Uniwersyteckie Centrum Kliniczne | Gdansk | Poland | Completed |
| Instytut Centrum Zdrowia Matki Polki | Lodz | Poland | Completed |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy | Warsaw | Poland | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.