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A Study of BMS-986340 as Monotherapy and in Combination With Nivolumab in Participants With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT04895709
Recruitment Status : Recruiting
First Posted : May 20, 2021
Last Update Posted : June 14, 2021
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The purpose of this study is to assess the safety, tolerability, and recommended dose(s) of BMS-986340 as monotherapy and in combination with nivolumab in participants with advanced solid tumors. This study is a first-in-human (FIH) study of BMS-986340 in participants with advanced solid tumors.

Condition or disease Intervention/treatment Phase
Cervical Cancer Gastric/Gastroesophageal Junction Adenocarcinoma Microsatellite Stable Colorectal Cancer Non-Small-Cell Lung Cancer Squamous Cell Carcinoma of Head and Neck Drug: BMS-986340 Drug: BMS-936558-01 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 185 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Study of BMS-986340 as Monotherapy and in Combination With Nivolumab in Participants With Advanced Solid Tumors
Actual Study Start Date : May 27, 2021
Estimated Primary Completion Date : March 27, 2024
Estimated Study Completion Date : August 23, 2025


Arm Intervention/treatment
Experimental: Part 1A: BMS-986340 Dose Escalation Drug: BMS-986340
Specified dose on specified days

Experimental: Part 2A: BMS-986340 Dose Expansion Drug: BMS-986340
Specified dose on specified days

Experimental: Part 1B: BMS-986340 + Nivolumab Dose Escalation Drug: BMS-986340
Specified dose on specified days

Drug: BMS-936558-01
Specified dose on specified days
Other Name: Nivolumab

Experimental: Part 2B: BMS-986340 + Nivolumab Dose Expansion Drug: BMS-986340
Specified dose on specified days

Drug: BMS-936558-01
Specified dose on specified days
Other Name: Nivolumab




Primary Outcome Measures :
  1. Incidence of adverse events (AEs) [ Time Frame: Up to 120 weeks ]
  2. Incidence of serious adverse events (SAEs) [ Time Frame: Up to 120 weeks ]
  3. Incidence of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria [ Time Frame: Up to 120 weeks ]
  4. Incidence of AEs leading to discontinuation [ Time Frame: Up to 120 weeks ]
  5. Incidence of AEs leading to death [ Time Frame: Up to 120 weeks ]
  6. Incidence of clinically significant changes in clinical laboratory results: Hematology tests [ Time Frame: Up to 120 weeks ]
  7. Incidence of clinically significant changes in clinical laboratory results: Chemistry panel tests [ Time Frame: Up to 120 weeks ]
  8. Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests [ Time Frame: Up to 120 weeks ]

Secondary Outcome Measures :
  1. Pharmacokinetic (PK) parameters of BMS-986340 administered as monotherapy: Maximum concentration (Cmax) [ Time Frame: Up to 120 weeks ]
  2. PK parameters of BMS-986340 administered as monotherapy: Time to maximum concentration (Tmax) [ Time Frame: Up to 120 weeks ]
  3. PK parameters of BMS-986340 administered as monotherapy: Area under the concentration-time curve 1 dosing interval (AUC (TAU)) [ Time Frame: Up to 120 weeks ]
  4. PK parameters of BMS-986340 administered as monotherapy: Observed concentration at the end of the dosing interval (Ctau) [ Time Frame: Up to 120 weeks ]
  5. PK parameters of BMS-986340 administered in combination with nivolumab: Maximum concentration (Cmax) [ Time Frame: Up to 120 weeks ]
  6. PK parameters of BMS-986340 administered in combination with nivolumab: Time to maximum concentration (Tmax) [ Time Frame: Up to 120 weeks ]
  7. PK parameters of BMS-986340 administered in combination with nivolumab: Area under the concentration-time curve in 1 dosing interval (AUC(TAU)) [ Time Frame: Up to 120 weeks ]
  8. PK parameters of BMS-986340 administered in combination with nivolumab: Observed concentration at the end of the dosing interval (Ctau) [ Time Frame: Up to 120 weeks ]
  9. Incidence of anti-drug antibodies to BMS- 986340 when administered as monotherapy [ Time Frame: Up to 120 weeks ]
  10. Incidence of anti-drug antibodies to BMS- 986340 when administered in combination with nivolumab [ Time Frame: Up to 120 weeks ]
  11. Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator [ Time Frame: At 6 months, 12 months ]
  12. Disease control rate (DCR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator [ Time Frame: At 6 months, 12 months ]
  13. Duration of response (DOR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator [ Time Frame: At 6 months, 12 months ]
  14. Progression-free survival rate (PFSR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator [ Time Frame: At 6 months, 12 months ]


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:

  • Fresh pre-treatment and on-treatment tumor biopsy must be provided for biomarker analysis
  • Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and at least 1 lesion accessible for biopsy
  • Eastern Cooperative Oncology Group Performance Status of 0 or 1
  • Radiographically documented progressive disease on or after the most recent therapy
  • Received standard-of-care therapies, including an available programmed death (ligand)-1 inhibitor known to be effective in the tumor type for which they are being evaluated
  • Parts 1A, 1B, and 2A: Advanced or metastatic non-small cell lung cancer, squamous cell carcinoma of head and neck, microsatellite stable colorectal cancer, gastric/ gastroesophageal junction adenocarcinoma, or cervical cancer, and have received, be refractory to, not be a candidate for, or be intolerant of existing therapies known to provide clinical benefit for the condition of the participant

Exclusion Criteria:

  • Women who are pregnant or breastfeeding
  • Primary central nervous system (CNS) malignancy
  • Untreated CNS metastases
  • Leptomeningeal metastases
  • Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study treatment
  • Active, known, or suspected autoimmune disease
  • Condition requiring systemic treatment with either corticosteroids within 14 days or other immunosuppressive medications within 30 days of the first dose of study treatment
  • Prior organ or tissue allograft
  • Uncontrolled or significant cardiovascular disease
  • Major surgery within 4 weeks of study drug administration
  • History of or with active interstitial lung disease or pulmonary fibrosis

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): NCT04895709


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
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United States, New Jersey
Local Institution Not yet recruiting
Hackensack, New Jersey, United States, 07601
Contact: Site 0007         
United States, New York
Columbia University Medical Center-CUIMC Herbert Irving Comprehensive Cancer Center Clinical Protoco Recruiting
New York, New York, United States, 10065
Contact: Richard Carvajal, Site 0006    212-342-5162      
Local Institution Not yet recruiting
New York, New York, United States, 10065
Contact: Site 0002         
United States, Oregon
Local Institution Not yet recruiting
Portland, Oregon, United States, 97213
Contact: Site 0001         
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: NCT04895709    
Other Study ID Numbers: CA052-002
2021-001188-26 ( EudraCT Number )
U1111-1265-4508 ( Registry Identifier: WHO )
First Posted: May 20, 2021    Key Record Dates
Last Update Posted: June 14, 2021
Last Verified: June 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-986340
Cervical Cancer
CRC
First-in-human
GEJ
Gastric/Gastroesophageal Junction Adenocarcinoma
HNSCC
Microsatellite Stable Colorectal Cancer
MSS CRC
Nivolumab
Non-Small-Cell Lung Cancer
NSCLC
SCCHN
Squamous Cell Carcinoma of Head and Neck
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Carcinoma, Squamous Cell
Adenocarcinoma
Uterine Cervical Neoplasms
Esophageal Neoplasms
Squamous Cell Carcinoma of Head and Neck
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplasms, Squamous Cell
Uterine Neoplasms
Genital Neoplasms, Female