Phase 2
Completed N=106
BMS-986012 in Relapsed/Refractory SCLC
Source: ClinicalTrials.gov NCT02247349 ↗Enrolled (actual)
106
Serious AEs
67.9%
Results posted
Mar 2024
Primary outcomePrimary: Number of Participants With Adverse Events (AEs) — 7; 6; 29; 35 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs) |
7; 6; 29; 35; 21; 8 | — |
| PRIMARY Number of Participants With Serious Adverse Events (SAEs) |
7; 4; 21; 24; 11; 5 | — |
| PRIMARY Number of Participants With Adverse Events (AEs) Leading to Discontinuation |
0; 1; 2; 5; 3; 2 | — |
| PRIMARY Number of Participants Who Died |
3; 2; 10; 16; 2; 4 | — |
| PRIMARY Number of Participants With Abnormal Hepatic Test |
0; 0; 0; 1; 1; 2 | — |
| SECONDARY BMS-986012 Maximum Observed Serum Concentration (Cmax) |
27.5; 53.8; 121; 276; 111; 339 | — |
| SECONDARY BMS-986012 Time of Maximum Observed Serum Concentration (Tmax) |
2.08; 2.02; 2.00; 1.58; 4.00; 1.53 | — |
| SECONDARY BMS-986012 Area Under the Serum Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC (0-T)) |
3997; 5584; 18456; 36223; 16527; 45126 | — |
| SECONDARY BMS-986012 Area Under the Serum Concentration-time Curve in One Dosing Interval AUC (TAU) |
4300; 8356; 19865; 40979; 18161; 49031 | — |
| SECONDARY BMS-986012 Observed Serum Concentration at the End of a Dosing Interval (Ctau) |
3.44; 6.24; 17.4; 30.2; 14.6; 39.5 | — |
| SECONDARY BMS-986012 Total Body Clearance (CLT) |
16.3; 19.1; 20.1; 24.4; 22.0; 20.4 | — |
| SECONDARY BMS-986012 Trough Observed Serum Concentration (Ctrough) |
4186; 7211; 18810; 36990; 14544; 36391 | — |
| SECONDARY BMS-986012 Average Concentration Over a Dosing Interval (Css-avg) |
13.9; 22.0; 82.1; 119 | — |
| SECONDARY BMS-986012 Accumulation Index (AI_AUC) |
1.56; 1.55; 1.62; 1.39 | — |
| SECONDARY BMS-986012 Cmax Accumulation Index (AI_Cmax) |
0.994; 1.47; 1.22; 0.940 | — |
| SECONDARY BMS-986012 Ctau Accumulation Index (AI_Ctau) |
1.81; 2.31; 1.76; 1.08 | — |
| SECONDARY BMS-986012 Effective Elimination (T-HALFeff) |
342; 319; 384; 583 | — |
| SECONDARY Best Overall Response (BOR) |
1; 0; 0; 0; 1; 0 | — |
| SECONDARY Objective Response Rate (ORR) |
14.3; 0; 3.4; 2.9; 42.9; 25.0 | — |
| SECONDARY Duration of Response (DoR) |
120.57 | — |
| SECONDARY Progression Free Survival (PFS) |
5.50; 5.86; 5.79; 5.36; 17.71; 5.71 | — |
| SECONDARY Progression Free Survival Rate (PFSR) |
NA; NA; 21.4; 20.6; 55.0; NA | — |
| SECONDARY Number of Participants With Anti-BMS-986012 Antibodies (ADA) |
0; 0; 0; 1; 0; 0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02247349). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.