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A Study of BMS-986012 in Combination With Carboplatin, Etoposide, and Nivolumab as First-line Therapy in Extensive-stage Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT04702880
Recruitment Status : Recruiting
First Posted : January 11, 2021
Last Update Posted : July 12, 2021
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
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 17, 2021
Estimated Primary Completion Date : September 24, 2023
Estimated Study Completion Date : September 7, 2024


Arm Intervention/treatment
Experimental: Arm A: Carboplatin + Etoposide + Nivolumab + BMS-986012 Biological: BMS-986012
Specified dose on specified days
Other Name: Fucosyl-GM1 Antibody

Drug: Carboplatin
Specified dose on specified days

Drug: Etoposide
Specified dose on specified days

Biological: Nivolumab
Specified dose on specified days
Other Name: BMS-936558

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
Other Name: BMS-936558




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 ]


Information from the National Library of Medicine

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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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04702880


Contacts
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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
Show Show 34 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT04702880    
Other Study ID Numbers: CA001-050
2020-001863-10 ( EudraCT Number )
U1111-1250-4427 ( Registry Identifier: WHO )
First Posted: January 11, 2021    Key Record Dates
Last Update Posted: July 12, 2021
Last Verified: July 2021

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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:
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Small Cell Lung Carcinoma
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Carboplatin
Nivolumab
Etoposide
Antineoplastic Agents
Antineoplastic Agents, Immunological
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors