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

NCT04895709RecruitingPHASE1, PHASE2INTERVENTIONAL

Summary

Key Facts

Lead Sponsor

Bristol-Myers Squibb

Enrollment

949

Start Date

2021-05-27

Completion Date

2028-07-07

Study Type

INTERVENTIONAL

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

Interventions

BMS-986340BMS-936558-01Docetaxel

Conditions

Cervical CancerGastric/Gastroesophageal Junction AdenocarcinomaMicrosatellite Stable Colorectal CancerNon-Small-Cell Lung CancerSquamous Cell Carcinoma of Head and NeckCarcinomaRenal CellUrothelial CarcinomaPancreatic AdenocarcinomaMelanomaOvarian NeoplasmsTriple Negative Breast Neoplasms

Eligibility

Age Range

18 Years+

Sex

ALL

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

Outcome Measures

Primary Outcomes

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 Outcomes

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

Locations

Community Cancer Institute, Clovis, United States

USC/Norris Comprehensive Cancer Center, Los Angeles, United States

Hoag Memorial Hospital Presbyterian, Newport Beach, United States

Local Institution - 0062, Iowa City, United States

John Theurer Cancer Center, Hackensack, United States

Local Institution - 0006, New York, United States

Local Institution - 0002, New York, United States

Local Institution - 0001, Portland, United States

Local Institution - 0063, Nashville, United States

Vanderbilt University Medical Center, Nashville, United States

Houston Methodist Hospital, Houston, United States

Blacktown Hospital, Blacktown, Australia

Liverpool Hospital, Liverpool, Australia

Princess Alexandra Hospital, Brisbane, Australia

Cabrini Hospital - Malvern, Malvern, Australia

St Vincent's Hospital, Melbourne, Australia

One Clinical Research, Nedlands, Australia

Cross Cancer Institute, Edmonton, Canada

BC Cancer Vancouver, Vancouver, Canada

Hamilton Health Sciences-Juravinski Cancer Centre, Hamilton, Canada

Local Institution - 0009, Toronto, Canada

Centre Hospitalier de luniversite de Montreal, Montreal, Canada

The Ottawa Hospital Cancer Centre, Ottawa, Canada

Local Institution - 0067, Beijing, China

Local Institution - 0066, Jinan, China

Local Institution - 0065, Hangzhou, China

Universitaetsklinikum Ulm, Ulm, Germany

Universitaetsklinikum Carl Gustav Carus Dresden-University Cancer Center Early Clinical Trial Unit, Dresden, Germany

Universitaetsklinikum Essen, Essen, Germany

Universitatsklinikum Frankfurt, Frankfurt, Germany

Universitaetsklinikum Wuerzburg, Würzburg, Germany

Rabin Medical Center, Petah Tikva, Israel

Local Institution - 0035, Ramat Gan, Israel

Sheba Medical Center, Ramat Gan, Israel

Rambam Health Care Campus, Haifa, Israel

Sourasky Medical Center, Tel Aviv, Israel

Humanitas, Rozzano, Italy

Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia, Candiolo, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1, Milan, Italy

Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore, Roma, Italy

ospedale le scotte-U.O.C. Immunoterapia Oncologica, Siena, Italy

National Cancer Center Hospital East, Kashiwa, Japan

Hospital Universitario Virgen de la Victoria, Málaga, Spain

Institut Catalan d Oncologia (ICO) - Badalona, Badalona, Spain

Hospital Universitari Vall d'Hebron, Barcelona, Spain

Hospital Universitario 12 de Octubre, Madrid, Spain

Hospital Universitario Fundación Jiménez Díaz-START Madrid-FJD, Madrid, Spain

Centro Integral Oncologico Clara Campal-Hospital HM Universitario Sanchinarro-START Madrid-CIOCC, Madrid, Spain

Clinica Universidad de Navarra-oNCOLOGY, Pamplona, Spain

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