2023-508954-25-00CompletedPhase 1/2
An Investigational Immunotherapy Study of BMS-986288 Alone and in Combination With Nivolumab in Advanced Solid Cancers
A Phase 1/2 First-in-human Study of BMS-986288 Alone and in Combination with Nivolumab in Advanced Malignant Tumors
Source: EU CTIS (euclinicaltrials.eu) · Last updated 19 Jun 2024
Brief summary (registry, in English)
For Part 1, 2A, 2B: To characterize the safety, tolerability, and Dose-Limiting Toxicities (DLTs) and to determine the Maximum Tolerated Dose (MTD)/ Recommended Phase 2 Dose (RP2D) of BMS-986288 administered as monotherapy and in combination with nivolumab in participants with select advanced solid tumors. For Part 2C: To compare the efficacy of BMS-986288 in combination with nivolumab vs regorafenib in the 3L/4L MSS CRC setting.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 96 (actual)
- First submitted
- 15 Dec 2023
- Start date
- 11 May 2022
- Lead sponsor
- Bristol Myers Squibb International Corporation
- Diseases
- Bladder cancer, Cervical cancer, Colorectal cancer, Gastric and esophageal cancer, Head and neck cancer, Kidney cancer, Lung cancer, Melanoma, Metastatic breast cancer, Triple-negative breast cancer
- EU CT number
- 2023-508954-25-00
- EudraCT number
- 2021-004284-27
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 96
- 16 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.
Prior treatment
- Participants with other active malignancy requiring concurrent intervention
Other illness
- Participants with active, known or suspected autoimmune disease
- Participants with primary CNS malignancies or tumors with CNS metastasis as the only site of disease, will be excluded
Who the study is looking for
- Histologic or cytologic confirmation of select solid tumor that is advanced (metastatic, recurrent, and/or unresectable) with measurable disease and have at least 1 lesion accessible for biopsy
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- Participants must have received, and then progressed, relapsed, or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting according to select solid tumor histologies
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (16)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Vall D'hebron Institut De Recerca | Barcelona | Spain | Completed |
| Hospital Clinic de Barcelona | Barcelona | Spain | Completed |
| Hospital Universitario 12 de Octubre | Madrid | Spain | Completed |
| Hospital Universitario Puerta de Hierro de Majadahonda | Majadahonda | Spain | Completed |
| University Hospital Virgen Del Rocio S.L. | Sevilla | Spain | Completed |
| Hospital Universitario Y Politecnico La Fe | Valencia | Spain | Completed |
| Centre hospitalier Universitaire de Bordeaux | Bordeaux | France | Completed |
| Hospices Civils de Lyon | Bron | France | Completed |
| Assistance Publique Hôpitaux de Marseille | Marseille | France | Completed |
| CHU Nantes | Nantes | France | Completed |
| Institut Curie | Paris | France | Completed |
| Azienda Ospedaliero-Universitaria delle Marche | Ancona | Italy | Completed |
| ASST Grande Ospedale Metropolitano Niguarda | Milan | Italy | Completed |
| Fondazione IRCCS - Istituto Nazionale dei Tumori | Milan | Italy | Completed |
| Istituto Oncologico Veneto | Padova | Italy | Completed |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Rome | Italy | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.