Clinical trial · Interventional
A Study of BMS-986484 Alone and Combination Therapy in Participants With Advanced Solid Tumors
A Phase 1/1b First-in-human Trial of BMS-986484 as Monotherapy and Combination Therapy in Participants With Advanced Solid Malignancies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to assess the safety and tolerability of BMS-986484 administered alone, in combination with nivolumab in participants with advanced/metastatic solid tumors including non-small cell lung cancer (NSCLC), microsatellite stable (MSS) colorectal carcinoma (CRC), pancreatic ductal adenocarcinoma (PDAC), gastric/gastroesophageal junction adenocarcinoma (G/GEJC), and squamous cell carcinoma of the head and neck (SCCHN).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BMS-986484 | Drug | — | UNRESOLVED |
| Calcium folinate | Drug | Immunomodulatory Oligonucleotide | ALIAS |
| Capecitabine | Drug | Capecitabine | ALIAS |
| Fluorouracil | Drug | Fluorouracil | ALIAS |
| Nivolumab | Biological | Nivolumab | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (8)
- type
- EXPERIMENTAL
- label
- Part 1A: BMS-986484 Dose Escalation
- interventionNames
- Drug: BMS-986484
- type
- EXPERIMENTAL
- label
- Part 1B: BMS-986484 + Nivolumab Dose Escalation
- interventionNames
- Drug: BMS-986484
- Biological: Nivolumab
- type
- EXPERIMENTAL
- label
- Part 2A: BMS-986484 Dose Expansion
- interventionNames
- Drug: BMS-986484
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Locally advanced unresectable, metastatic, or recurrent malignant tumors including non-small cell lung cancer (NSCLC), pancreatic ductal adenocarcinoma (PDAC), gastric/gastroesophageal junction adenocarcinoma (G/GEJC), microsatellite stable colorectal cancer (MSS CRC), and squamous cell carcinoma of the head and neck (SCCHN). * Must have measurable disease by response evaluation criteria in solid tumors version 1.1 (RECIST v1.1). * Must have an Eastern Cooperative Oncology Group Performance Status of 0 or 1. Exclusion Criteria: * History of or with active interstitial lung disease or pulmonary fibrosis. * Active, known, or suspected autoimmune disease. * Serious uncontrolled medical disorders. * New onset, non-catheter-associated venous thromboembolism within the past 6 months. * Other protocol-defined Inclusion/Exclusion criteria apply.
References
Publications (0)
Data not yet available