Clinical trial · Interventional
BMS-986012 in Relapsed/Refractory SCLC
A Phase 1/2 Multicenter Study of BMS-986012 in Subjects With Relapsed/Refractory Small Cell Lung Cancer
NCT02247349CI-TRIAL-00074693completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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 determine the safety, tolerability, pharmacokinetics, immunogenicity, antitumor activity and pharmacodynamics of BMS-986012 alone and in combination with nivolumab in patients with relapsed/refractory SCLC.
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 |
|---|---|---|---|
| Small Cell Lung Cancer | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BMS-986012 (anti-fucosyl-GM1) | Biological | — | UNRESOLVED |
| Nivolumab | Biological | Nivolumab | ALIAS |
Design
Arms and outcomes
Arms (12)
- type
- EXPERIMENTAL
- label
- Dose Escalation (Monotherapy) Dose -1
- description
- BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity
- interventionNames
- Biological: BMS-986012 (anti-fucosyl-GM1)
- type
- EXPERIMENTAL
- label
- Dose Escalation (Monotherapy) Dose 1
- description
- BMS-986012 (anti-fucosyl-GM1) Intravenous solution once every 3 weeks until disease progression/clinical deterioration or unacceptable toxicity
- interventionNames
- Biological: BMS-986012 (anti-fucosyl-GM1)
- type
- EXPERIMENTAL
- label
- Dose Escalation (Monotherapy) Dose 2
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Histological or cytological confirmed small cell lung cancer (SCLC) * Performance Status 0-1 * Adequate organ function * Measurable disease Exclusion Criteria: * Known or suspected brain metastasis * Small cell cancer not lung in origin * Significant or acute medical illness * Uncontrolled or significant cardiac disease * Infection * ≥ Grade 2 peripheral neuropathy * Concomitant malignancies * HIV related disease or known or suspected HIV+ * Hepatitis B or C infection * ECG abnormalities as defined by the protocol * Allergies or hypersensitivities to monoclonal antibodies, BMS-986012 or related compounds, including fucosyl-GM1 vaccine and Nivolumab Other protocol defined inclusion/exclusion criteria could apply
References
Publications (0)
Data not yet available
No reference posted for this study.