Description:
The purpose of this study is to demonstrate that treatment with BMS-986012 in combination
with carboplatin, etoposide, and nivolumab will have acceptable safety and tolerability and
will improve progression-free survival compared with carboplatin, etoposide, and nivolumab
alone in newly diagnosed participants with extensive-stage small cell lung cancer (ES-SCLC).
Title
- Brief Title: A Study of BMS-986012 in Combination With Carboplatin, Etoposide, and Nivolumab as First-line Therapy in Extensive-stage Small Cell Lung Cancer
- Official Title: A Randomized, Open-label Phase 2 Clinical Trial of BMS-986012 in Combination With Carboplatin, Etoposide, and Nivolumab as First-line Therapy in Extensive-stage Small Cell Lung Cancer
Clinical Trial IDs
- ORG STUDY ID:
CA001-050
- SECONDARY ID:
2020-001863-10
- SECONDARY ID:
U1111-1250-4427
- NCT ID:
NCT04702880
Conditions
- Extensive-stage Small Cell Lung Cancer
Interventions
Drug | Synonyms | Arms |
---|
BMS-986012 | Fucosyl-GM1 Antibody | Arm A: Carboplatin + Etoposide + Nivolumab + BMS-986012 |
Carboplatin | | Arm A: Carboplatin + Etoposide + Nivolumab + BMS-986012 |
Etoposide | | Arm A: Carboplatin + Etoposide + Nivolumab + BMS-986012 |
Nivolumab | BMS-936558 | Arm A: Carboplatin + Etoposide + Nivolumab + BMS-986012 |
Purpose
The purpose of this study is to demonstrate that treatment with BMS-986012 in combination
with carboplatin, etoposide, and nivolumab will have acceptable safety and tolerability and
will improve progression-free survival compared with carboplatin, etoposide, and nivolumab
alone in newly diagnosed participants with extensive-stage small cell lung cancer (ES-SCLC).
Trial Arms
Name | Type | Description | Interventions |
---|
Arm A: Carboplatin + Etoposide + Nivolumab + BMS-986012 | Experimental | | - BMS-986012
- Carboplatin
- Etoposide
- Nivolumab
|
Arm B: Carboplatin + Etoposide + Nivolumab | Experimental | | - Carboplatin
- Etoposide
- Nivolumab
|
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com
Inclusion Criteria:
- Histologically or cytologically documented extensive-stage small cell lung cancer
(ES-SCLC) and extensive-stage disease (American Joint Committee on Cancer, 7th
edition, Stage IV [T any, N any, M1a, or M1b], or T3-4 due to multiple lung nodules
that are too extensive or tumor or nodal volume that is too large to be encompassed in
a tolerable radiation plan)
- Must provide a fresh tumor biopsy from the primary disease site (when possible) or
from any metastatic site when the primary site is not available
- Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1
- At least 1 measurable lesion by computed tomography (CT) or magnetic resonance imaging
(MRI) per Response Evaluation Criteria in Solid Tumors version 1.1 (Response
Evaluation Criteria in Solid Tumors (RECIST) v1.1) criteria
- Adequate hematologic and end organ function
- Must agree to follow specific methods of contraception, if applicable
Exclusion Criteria:
- Women who are pregnant or breastfeeding
- Prior chemotherapy, radiation therapy, or biologic therapy for small cell lung cancer
(SCLC) for first-line treatment
- Symptomatic brain or other central nervous system (CNS) metastases
- Paraneoplastic autoimmune syndrome requiring systemic treatment
- History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, idiopathic
pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening
chest CT scan
- Grade ≥ 2 peripheral sensory neuropathy at study entry
- Significant uncontrolled cardiovascular disease
- Active, known or suspected autoimmune disease or inflammatory disorder
Other protocol-defined inclusion/exclusion criteria apply
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Incidence of adverse events (AEs) |
Time Frame: | Up to 2 years and 100 days |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Progression-free survival rate (PFSR) |
Time Frame: | 6 and 12 months |
Safety Issue: | |
Description: | PFS by BICR based on RECIST v1.1 criteria |
Measure: | PFS by investigator based on RECIST v1.1 criteria |
Time Frame: | Up to 2 years |
Safety Issue: | |
Description: | |
Measure: | PFSR |
Time Frame: | 6 and 12 months |
Safety Issue: | |
Description: | PFS by investigator based on RECIST v1.1 criteria |
Measure: | Objective response rate (ORR) based on RECIST v1.1 criteria |
Time Frame: | Up to 2 years |
Safety Issue: | |
Description: | |
Measure: | Time to response (TTR) based on RECIST v1.1 criteria |
Time Frame: | Up to 2 years |
Safety Issue: | |
Description: | |
Measure: | Duration of response (DOR) based on RECIST v1.1 criteria |
Time Frame: | Up to 2 years |
Safety Issue: | |
Description: | |
Measure: | Overall survival (OS) |
Time Frame: | Up to 3 years |
Safety Issue: | |
Description: | By arm |
Measure: | Overall survival rate (OSR) |
Time Frame: | Up to 3 years |
Safety Issue: | |
Description: | By arm |
Measure: | Measures of tumor fucosyl-GM1 (fuc-GM1) expression by immunohistochemistry (IHC) |
Time Frame: | Up to 2 years |
Safety Issue: | |
Description: | |
Measure: | Measures of tumor fucosyl-GM1 (fuc-GM1) expression association with measures of anti-tumor activity measures (eg, ORR, PFS) (IHC) |
Time Frame: | Up to 2 years |
Safety Issue: | |
Description: | |
Measure: | Measures of tumor fucosyl-GM1 (fuc-GM1) expression by targeted mass spectrometry |
Time Frame: | Up to 2 years |
Safety Issue: | |
Description: | |
Measure: | Measures of tumor fucosyl-GM1 (fuc-GM1) expression association with measures of anti-tumor activity measures (eg, ORR, PFS) (targeted mass spectrometry) |
Time Frame: | Up to 2 years |
Safety Issue: | |
Description: | |
Measure: | Measures of tumor programmed cell death-ligand 1 (PD-L1) expression combined positive score (CPS) at baseline |
Time Frame: | Up to 2 years |
Safety Issue: | |
Description: | |
Measure: | Measures of tumor programmed cell death-ligand 1 (PD-L1) expression association with measures of anti-tumor activity (eg, ORR, PFS) |
Time Frame: | Up to 2 years |
Safety Issue: | |
Description: | |
Measure: | Immunogenicity of BMS-986012 measured by assessment of the presence of specific anti-drug antibodies (ADAs) to BMS-986012 (i.e. incidence of positive ADAs) |
Time Frame: | Up to 2 years |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Bristol-Myers Squibb |
Trial Keywords
- BMS-986012
- Carboplatin
- Etoposide
- Extensive-stage small cell lung cancer
- Fucosyl
- Nivolumab
- Targeted SCLC therapy
Last Updated
July 12, 2021