Description:
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.
Title
- Brief Title: A Study of BMS-986340 as Monotherapy and in Combination With Nivolumab in Participants With Advanced Solid Tumors
- Official Title: A Phase 1/2 Study of BMS-986340 as Monotherapy and in Combination With Nivolumab in Participants With Advanced Solid Tumors
Clinical Trial IDs
- ORG STUDY ID:
CA052-002
- SECONDARY ID:
2021-001188-26
- SECONDARY ID:
U1111-1265-4508
- NCT ID:
NCT04895709
Conditions
- Cervical Cancer
- Gastric/Gastroesophageal Junction Adenocarcinoma
- Microsatellite Stable Colorectal Cancer
- Non-Small-Cell Lung Cancer
- Squamous Cell Carcinoma of Head and Neck
Interventions
Drug | Synonyms | Arms |
---|
BMS-986340 | | Part 1A: BMS-986340 Dose Escalation |
BMS-936558-01 | Nivolumab | Part 1B: BMS-986340 + Nivolumab Dose Escalation |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Part 1A: BMS-986340 Dose Escalation | Experimental | | |
Part 2A: BMS-986340 Dose Expansion | Experimental | | |
Part 1B: BMS-986340 + Nivolumab Dose Escalation | Experimental | | |
Part 2B: BMS-986340 + Nivolumab Dose Expansion | Experimental | | |
Eligibility 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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Incidence of adverse events (AEs) |
Time Frame: | Up to 120 weeks |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Pharmacokinetic (PK) parameters of BMS-986340 administered as monotherapy: Maximum concentration (Cmax) |
Time Frame: | Up to 120 weeks |
Safety Issue: | |
Description: | |
Measure: | PK parameters of BMS-986340 administered as monotherapy: Time to maximum concentration (Tmax) |
Time Frame: | Up to 120 weeks |
Safety Issue: | |
Description: | |
Measure: | 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 |
Safety Issue: | |
Description: | |
Measure: | PK parameters of BMS-986340 administered as monotherapy: Observed concentration at the end of the dosing interval (Ctau) |
Time Frame: | Up to 120 weeks |
Safety Issue: | |
Description: | |
Measure: | PK parameters of BMS-986340 administered in combination with nivolumab: Maximum concentration (Cmax) |
Time Frame: | Up to 120 weeks |
Safety Issue: | |
Description: | |
Measure: | PK parameters of BMS-986340 administered in combination with nivolumab: Time to maximum concentration (Tmax) |
Time Frame: | Up to 120 weeks |
Safety Issue: | |
Description: | |
Measure: | 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 |
Safety Issue: | |
Description: | |
Measure: | 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 |
Safety Issue: | |
Description: | |
Measure: | Incidence of anti-drug antibodies to BMS- 986340 when administered as monotherapy |
Time Frame: | Up to 120 weeks |
Safety Issue: | |
Description: | |
Measure: | Incidence of anti-drug antibodies to BMS- 986340 when administered in combination with nivolumab |
Time Frame: | Up to 120 weeks |
Safety Issue: | |
Description: | |
Measure: | Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator |
Time Frame: | At 6 months, 12 months |
Safety Issue: | |
Description: | |
Measure: | Disease control rate (DCR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator |
Time Frame: | At 6 months, 12 months |
Safety Issue: | |
Description: | |
Measure: | Duration of response (DOR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator |
Time Frame: | At 6 months, 12 months |
Safety Issue: | |
Description: | |
Measure: | Progression-free survival rate (PFSR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator |
Time Frame: | At 6 months, 12 months |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Bristol-Myers Squibb |
Trial Keywords
- 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
Last Updated
June 14, 2021