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Trial record 1 of 1 for:    CA052-002
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A Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel 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 : April 1, 2024
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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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 or docetaxel 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 Carcinoma, Renal Cell Urothelial Carcinoma Pancreatic Adenocarcinoma Melanoma Ovarian Neoplasms Triple Negative Breast Neoplasms Drug: BMS-986340 Drug: BMS-936558-01 Drug: Docetaxel Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 665 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 or Docetaxel in Participants With Advanced Solid Tumors
Actual Study Start Date : May 27, 2021
Estimated Primary Completion Date : April 10, 2025
Estimated Study Completion Date : September 15, 2026

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma

Arms and Interventions
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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
Experimental: Part 1C: BMS-986340 + Docetaxel Dose Escalation Drug: BMS-986340
Specified dose on specified days

Drug: Docetaxel
Specified dose on specified days


Outcome Measures
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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 ]

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 docetaxel: Cmax [ Time Frame: Up to 120 weeks ]
  7. PK parameters of BMS-986340 administered in combination with nivolumab: Time to maximum concentration (Tmax) [ Time Frame: Up to 120 weeks ]
  8. PK parameters of BMS-986340 administered in combination with docetaxel: Tmax [ Time Frame: Up to 120 weeks ]
  9. 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 ]
  10. PK parameters of BMS-986340 administered in combination with docetaxel: AUC(TAU) [ Time Frame: Up to 120 weeks ]
  11. 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 ]
  12. PK parameters of BMS-986340 administered in combination with docetaxel: Ctau [ Time Frame: Up to 120 weeks ]
  13. Incidence of anti-drug antibodies to BMS- 986340 when administered as monotherapy [ Time Frame: Up to 120 weeks ]
  14. Incidence of anti-drug antibodies to BMS- 986340 when administered in combination with nivolumab [ Time Frame: Up to 120 weeks ]
  15. Incidence of anti-drug antibodies to BMS- 986340 when administered in combination with docetaxel [ Time Frame: Up to 120 weeks ]
  16. Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator [ Time Frame: At 6 months, 12 months ]
  17. Disease control rate (DCR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator [ Time Frame: At 6 months, 12 months ]
  18. Duration of response (DOR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator [ Time Frame: At 6 months, 12 months ]
  19. Progression-free survival rate (PFSR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator [ Time Frame: At 6 months, 12 months ]

Eligibility Criteria
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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

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. Fine needle biopsy, cytology, and bone lesion biopsies are not acceptable.
  • 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, (except for Part 1C, where participants with prior docetaxel use for the advanced/metastatic setting will be excluded), including an available programmed death (ligand)-1 inhibitor known to be effective in the tumor type for which they are being evaluated
  • Advanced or metastatic disease 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

Contacts and Locations
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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: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.

Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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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: April 1, 2024
Last Verified: March 2024

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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
Carcinoma, Renal Cell
Urothelial Carcinoma
Pancreatic Adenocarcinoma
Melanoma
Ovarian Neoplasms
Triple Negative Breast Neoplasms
Additional relevant MeSH terms:
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Carcinoma
Neoplasms
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Melanoma
Carcinoma, Squamous Cell
Adenocarcinoma
Uterine Cervical Neoplasms
Carcinoma, Transitional Cell
Breast Neoplasms
Esophageal Neoplasms
Ovarian Neoplasms
Carcinoma, Renal Cell
Squamous Cell Carcinoma of Head and Neck
Triple Negative Breast Neoplasms
 Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
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