Trial record 1 of 1 for:
CA052-002
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 |
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Recruitment Status :
Recruiting
First Posted : May 20, 2021
Last Update Posted : November 13, 2023
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Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
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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 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
| 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 |
Primary Outcome Measures :
- Incidence of adverse events (AEs) [ Time Frame: Up to 120 weeks ]
- Incidence of serious adverse events (SAEs) [ Time Frame: Up to 120 weeks ]
- Incidence of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria [ Time Frame: Up to 120 weeks ]
- Incidence of AEs leading to discontinuation [ Time Frame: Up to 120 weeks ]
- Incidence of AEs leading to death [ Time Frame: Up to 120 weeks ]
Secondary Outcome Measures :
- Pharmacokinetic (PK) parameters of BMS-986340 administered as monotherapy: Maximum concentration (Cmax) [ Time Frame: Up to 120 weeks ]
- PK parameters of BMS-986340 administered as monotherapy: Time to maximum concentration (Tmax) [ Time Frame: Up to 120 weeks ]
- 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 ]
- PK parameters of BMS-986340 administered as monotherapy: Observed concentration at the end of the dosing interval (Ctau) [ Time Frame: Up to 120 weeks ]
- PK parameters of BMS-986340 administered in combination with nivolumab: Maximum concentration (Cmax) [ Time Frame: Up to 120 weeks ]
- PK parameters of BMS-986340 administered in combination with docetaxel: Cmax [ Time Frame: Up to 120 weeks ]
- PK parameters of BMS-986340 administered in combination with nivolumab: Time to maximum concentration (Tmax) [ Time Frame: Up to 120 weeks ]
- PK parameters of BMS-986340 administered in combination with docetaxel: Tmax [ Time Frame: Up to 120 weeks ]
- 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 ]
- PK parameters of BMS-986340 administered in combination with docetaxel: AUC(TAU) [ Time Frame: Up to 120 weeks ]
- 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 ]
- PK parameters of BMS-986340 administered in combination with docetaxel: Ctau [ Time Frame: Up to 120 weeks ]
- Incidence of anti-drug antibodies to BMS- 986340 when administered as monotherapy [ Time Frame: Up to 120 weeks ]
- Incidence of anti-drug antibodies to BMS- 986340 when administered in combination with nivolumab [ Time Frame: Up to 120 weeks ]
- Incidence of anti-drug antibodies to BMS- 986340 when administered in combination with docetaxel [ Time Frame: Up to 120 weeks ]
- Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator [ Time Frame: At 6 months, 12 months ]
- Disease control rate (DCR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator [ Time Frame: At 6 months, 12 months ]
- Duration of response (DOR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator [ Time Frame: At 6 months, 12 months ]
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| 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
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
| 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
Show 46 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
| 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: | November 13, 2023 |
| Last Verified: | November 2023 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Bristol-Myers Squibb:
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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 |