Melanoma Clinical Trial
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
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.
| Status | Recruiting |
| Enrollment | 665 |
| Est. completion date | September 15, 2026 |
| Est. primary completion date | April 10, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Blacktown Hospital | Blacktown | New South Wales |
| Australia | Princess Alexandra Hospital | Brisbane | Queensland |
| Australia | Liverpool Hospital | Liverpool | New South Wales |
| Australia | Cabrini Hospital - Malvern | Malvern | Victoria |
| Australia | St Vincent's Hospital | Melbourne | Victoria |
| Australia | One Clinical Research | Nedlands | Western Australia |
| Canada | Cross Cancer Institute | Edmonton | Alberta |
| Canada | Hamilton Health Sciences-Juravinski Cancer Centre | Hamilton | Ontario |
| Canada | Centre Hospitalier de luniversite de Montreal | Montreal | Quebec |
| Canada | The Ottawa Hospital Cancer Centre | Ottawa | |
| Canada | Local Institution - 0009 | Toronto | Ontario |
| Canada | BC Cancer Vancouver | Vancouver | British Columbia |
| Germany | Universitaetsklinikum Carl Gustav Carus Dresden-University Cancer Center Early Clinical Trial Unit | Dresden | |
| Germany | Universitaetsklinikum Essen | Essen | |
| Germany | Universitatsklinikum Frankfurt | Frankfurt | |
| Germany | Universitaetsklinikum Ulm | Ulm | |
| Germany | Universitaetsklinikum Wuerzburg | Wuerzburg | |
| Israel | Rambam Health Care Campus | Haifa | HaTsafon |
| Israel | Rabin Medical Center | Petah Tikva | HaMerkaz |
| Israel | Local Institution - 0035 | Ramat Gan | HaMerkaz |
| Israel | Sheba Medical Center | Ramat Gan | HaMerkaz |
| Israel | Sourasky Medical Center | Tel Aviv | Tell Abib |
| Italy | Istituto di Candiolo | Candiolo | Torino |
| Italy | Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 | Milan | |
| Italy | Istituto Nazionale Tumori IRCCS Fondazione Pascale | Napoli | |
| Italy | Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore | Roma | |
| Italy | Humanitas | Rozzano | Milano |
| Italy | ospedale le scotte-U.O.C. Immunoterapia Oncologica | Siena | |
| Japan | Local Institution - 0064 | Kashiwa | Chiba |
| Spain | Institut Català d'Oncologia (ICO) - Badalona | Badalona | Barcelona [Barcelona] |
| Spain | Hospital Universitari Vall d'Hebron | Barcelona | Barcelona [Barcelona] |
| Spain | Centro Integral Oncologico Clara Campal-Hospital HM Universitario Sanchinarro-START Madrid-CIOCC | Madrid | |
| Spain | Hospital Universitario 12 de Octubre | Madrid | Madrid, Comunidad De |
| Spain | Hospital Universitario Fundación Jiménez Díaz-START Madrid-FJD | Madrid | |
| Spain | Hospital Universitario Virgen de la Victoria | Málaga | Andalucía |
| Spain | Clinica Universidad de Navarra-oNCOLOGY | Pamplona | |
| United States | Community Cancer Institute | Clovis | California |
| United States | John Theurer Cancer Center | Hackensack | New Jersey |
| United States | Local Institution - 0061 | Houston | Texas |
| United States | University of Iowa | Iowa City | Iowa |
| United States | USC/Norris Comprehensive Cancer Center | Los Angeles | California |
| United States | Local Institution - 0052 | Nashville | Tennessee |
| United States | Local Institution - 0063 | Nashville | Tennessee |
| United States | Columbia University Irving Medical Center | New York | New York |
| United States | Memorial Sloan Kettering Nassau | New York | New York |
| United States | Hoag Memorial Hospital Presbyterian | Newport Beach | California |
| United States | Providence Cancer Center Oncology and Hematology Care- Eastside | Portland | Oregon |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States, Australia, Canada, Germany, Israel, Italy, Japan, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of adverse events (AEs) | Up to 120 weeks | ||
| Primary | Incidence of serious adverse events (SAEs) | Up to 120 weeks | ||
| Primary | Incidence of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria | Up to 120 weeks | ||
| Primary | Incidence of AEs leading to discontinuation | Up to 120 weeks | ||
| Primary | Incidence of AEs leading to death | Up to 120 weeks | ||
| Secondary | Pharmacokinetic (PK) parameters of BMS-986340 administered as monotherapy: Maximum concentration (Cmax) | Up to 120 weeks | ||
| Secondary | PK parameters of BMS-986340 administered as monotherapy: Time to maximum concentration (Tmax) | Up to 120 weeks | ||
| Secondary | PK parameters of BMS-986340 administered as monotherapy: Area under the concentration-time curve 1 dosing interval (AUC (TAU)) | Up to 120 weeks | ||
| Secondary | PK parameters of BMS-986340 administered as monotherapy: Observed concentration at the end of the dosing interval (Ctau) | Up to 120 weeks | ||
| Secondary | PK parameters of BMS-986340 administered in combination with nivolumab: Maximum concentration (Cmax) | Up to 120 weeks | ||
| Secondary | PK parameters of BMS-986340 administered in combination with docetaxel: Cmax | Up to 120 weeks | ||
| Secondary | PK parameters of BMS-986340 administered in combination with nivolumab: Time to maximum concentration (Tmax) | Up to 120 weeks | ||
| Secondary | PK parameters of BMS-986340 administered in combination with docetaxel: Tmax | Up to 120 weeks | ||
| Secondary | PK parameters of BMS-986340 administered in combination with nivolumab: Area under the concentration-time curve in 1 dosing interval (AUC(TAU)) | Up to 120 weeks | ||
| Secondary | PK parameters of BMS-986340 administered in combination with docetaxel: AUC(TAU) | Up to 120 weeks | ||
| Secondary | PK parameters of BMS-986340 administered in combination with nivolumab: Observed concentration at the end of the dosing interval (Ctau) | Up to 120 weeks | ||
| Secondary | PK parameters of BMS-986340 administered in combination with docetaxel: Ctau | Up to 120 weeks | ||
| Secondary | Incidence of anti-drug antibodies to BMS- 986340 when administered as monotherapy | Up to 120 weeks | ||
| Secondary | Incidence of anti-drug antibodies to BMS- 986340 when administered in combination with nivolumab | Up to 120 weeks | ||
| Secondary | Incidence of anti-drug antibodies to BMS- 986340 when administered in combination with docetaxel | Up to 120 weeks | ||
| Secondary | Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator | At 6 months, 12 months | ||
| Secondary | Disease control rate (DCR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator | At 6 months, 12 months | ||
| Secondary | Duration of response (DOR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator | At 6 months, 12 months | ||
| Secondary | Progression-free survival rate (PFSR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator | At 6 months, 12 months |
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