A Study of BMS-986012 in Combination With Carboplatin, Etoposide, and Nivolumab as First-line Therapy in Extensive-stage Small Cell Lung Cancer
Clinicaltrials.gov identifier recruitment status First Posted Last update posted
NCT04702880 Recruiting January 11, 2021 July 12, 2021

study description
Brief Summary

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).

Condition or Disease: Extensive-stage Small Cell Lung Cancer
Intervention/treatment: Biological: BMS-986012
Drug: Carboplatin
Drug: Etoposide
Biological: Nivolumab
Phase: Phase 2
Detailed Description

N/A


study design
Study Type: Interventional
Estimated Enrollment : 120 participants
Intervention Model : Parallel Assignment
Masking: None (Open Label) ()
Primary Purpose: Treatment
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
Actual Study Start Date: March 2021
Estimated Primary Completion Date: September 2023
Estimated Study Completion Date: September 2024

Arms and interventions
Arm Intervention/treatment
Experimental: Arm A: Carboplatin + Etoposide + Nivolumab + BMS-986012
Biological: BMS-986012
Specified dose on specified days

Drug: Carboplatin
Specified dose on specified days

Drug: Etoposide
Specified dose on specified days

Biological: Nivolumab
Specified dose on specified days
Experimental: Arm B: Carboplatin + Etoposide + Nivolumab
Drug: Carboplatin
Specified dose on specified days

Drug: Etoposide
Specified dose on specified days

Biological: Nivolumab
Specified dose on specified days
outcome measures
Primary Outcome Measures: 1. Incidence of adverse events (AEs) [ Time Frame: Up to 2 years and 100 days ]
2. Incidence of serious adverse events (SAEs) [ Time Frame: Up to 2 years and 128 days ]
3. Incidence of AEs leading to discontinuation [ Time Frame: Up to 2 years and 128 days ]
4. Incidence of deaths [ Time Frame: Up to 2 years and 128 days ]
5. Progression-free survival (PFS) by blinded independent central review (BICR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria [ Time Frame: Up to 2 years ]
Secondary Outcome Measures: 1. Progression-free survival rate (PFSR) [ Time Frame: 6 and 12 months ]
PFS by BICR based on RECIST v1.1 criteria
2. PFS by investigator based on RECIST v1.1 criteria [ Time Frame: Up to 2 years ]
3. PFSR [ Time Frame: 6 and 12 months ]
PFS by investigator based on RECIST v1.1 criteria
4. Objective response rate (ORR) based on RECIST v1.1 criteria [ Time Frame: Up to 2 years ]
5. Time to response (TTR) based on RECIST v1.1 criteria [ Time Frame: Up to 2 years ]
6. Duration of response (DOR) based on RECIST v1.1 criteria [ Time Frame: Up to 2 years ]
7. Overall survival (OS) [ Time Frame: Up to 3 years ]
By arm
8. Overall survival rate (OSR) [ Time Frame: Up to 3 years ]
By arm
9. Measures of tumor fucosyl-GM1 (fuc-GM1) expression by immunohistochemistry (IHC) [ Time Frame: Up to 2 years ]
10. 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 ]
11. Measures of tumor fucosyl-GM1 (fuc-GM1) expression by targeted mass spectrometry [ Time Frame: Up to 2 years ]
12. 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 ]
13. Measures of tumor programmed cell death-ligand 1 (PD-L1) expression combined positive score (CPS) at baseline [ Time Frame: Up to 2 years ]
14. 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 ]
15. 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 ]

Eligibility Criteria
Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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


Contacts and Locations
Contacts

Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com

Contact: First line of the email MUST contain NCT # and Site #.

Locations
United States, Kentucky Local Institution Lexington
United States, New Jersey John Theurer Cancer Center Hackensack
United States, North Carolina Local Institution Durham
United States, Ohio Local Institution Cincinnati
United States, Texas Local Institution Dallas
Australia, New South Wales Westmead Hospital-Department of Medical Oncology Westmead
Australia, Victoria Local Institution Melbourne
Australia, Western Australia St. John of God Murdoch Hospital-Medical Oncology Murdoch
Australia Gallipoli Medical Research Foundation-GMRF CTU Queensland
Belgium Local Institution Charleroi
Belgium Local Institution Gent
Belgium Local Institution Liège
Canada, Alberta Local Institution Edmonton
Canada, Ontario Local Institution Brampton
Greece Local Institution Athens
Greece Local Institution Athens
Greece Local Institution Irakleio
Italy Local Institution Peschiera Del Garda
Italy Local Institution Pisa
Italy Local Institution Rozzano
Japan, Osaka Local Institution Takatsuki
Netherlands Local Institution Amsterdam
Netherlands Local Institution Arnhem
Netherlands Local Institution Groningen
Netherlands Local Institution Nijmegen
Poland Local Institution Gdansk
Poland Instytut Centrum Zdrowia Matki Polki-Klinika Onkologii Lodz
Romania Local Institution Bucharest
Romania Local Institution Cluj-Napoca
Romania Local Institution Craiova
Spain Local Institution Barcelona
Spain Local Institution Madrid
Spain Local Institution Majadahonda
Spain Local Institution Malaga
Sponsors and Collaborators
Bristol-Myers Squibb
Investigator
Study Director : Bristol-Myers Squibb Bristol-Myers Squibb
More Information
Responsible Party : Bristol-Myers Squibb
ClinicalTrials.gov Identifier : NCT04702880     
Other Study ID Numbers : CA001-050, 2020-001863-10, U1111-1250-4427
First Posted : January 11, 2021
Last Update Posted : July 12, 2021
Last Verified : July 2021
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bristol-Myers Squibb: BMS-986012
Carboplatin
Etoposide
Extensive-stage small cell lung cancer
Fucosyl
Nivolumab
Targeted SCLC therapy
Additional relevant MeSH terms :
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms