Clinical trial NCT04895709: A Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants With Advanced Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: 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
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
Carcinoma, Renal Cell
Urothelial Carcinoma
Pancreatic Adenocarcinoma
Melanoma
Ovarian Neoplasms
Triple Negative Breast Neoplasms
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2021-05-20
Enrollment: 905
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Incidence of adverse events (AEs)
timeFrame: Up to 120 weeks
measure: Incidence of serious adverse events (SAEs)
timeFrame: Up to 120 weeks
measure: Incidence of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria
timeFrame: Up to 120 weeks
measure: Incidence of AEs leading to discontinuation
timeFrame: Up to 120 weeks
measure: Incidence of AEs leading to death
timeFrame: Up to 120 weeks
Secondary outcomes:
measure: Pharmacokinetic (PK) parameters of BMS-986340 administered as monotherapy: Maximum concentration (Cmax)
timeFrame: Up to 120 weeks
measure: PK parameters of BMS-986340 administered as monotherapy: Time to maximum concentration (Tmax)
timeFrame: Up to 120 weeks
measure: PK parameters of BMS-986340 administered as monotherapy: Area under the concentration-time curve 1 dosing interval (AUC (TAU))
timeFrame: Up to 120 weeks
measure: PK parameters of BMS-986340 administered as monotherapy: Observed concentration at the end of the dosing interval (Ctau)
timeFrame: Up to 120 weeks
measure: PK parameters of BMS-986340 administered in combination with nivolumab: Maximum concentration (Cmax)
timeFrame: Up to 120 weeks
measure: PK parameters of BMS-986340 administered in combination with docetaxel: Cmax
timeFrame: Up to 120 weeks
measure: PK parameters of BMS-986340 administered in combination with nivolumab: Time to maximum concentration (Tmax)
timeFrame: Up to 120 weeks
measure: PK parameters of BMS-986340 administered in combination with docetaxel: Tmax
timeFrame: Up to 120 weeks
measure: PK parameters of BMS-986340 administered in combination with nivolumab: Area under the concentration-time curve in 1 dosing interval (AUC(TAU))
timeFrame: Up to 120 weeks
measure: PK parameters of BMS-986340 administered in combination with docetaxel: AUC(TAU)
timeFrame: Up to 120 weeks
measure: PK parameters of BMS-986340 administered in combination with nivolumab: Observed concentration at the end of the dosing interval (Ctau)
timeFrame: Up to 120 weeks
measure: PK parameters of BMS-986340 administered in combination with docetaxel: Ctau
timeFrame: Up to 120 weeks
measure: Incidence of anti-drug antibodies to BMS- 986340 when administered as monotherapy
timeFrame: Up to 120 weeks
measure: Incidence of anti-drug antibodies to BMS- 986340 when administered in combination with nivolumab
timeFrame: Up to 120 weeks
measure: Incidence of anti-drug antibodies to BMS- 986340 when administered in combination with docetaxel
timeFrame: Up to 120 weeks
measure: Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator
timeFrame: At 6 months, 12 months
measure: Disease control rate (DCR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator
timeFrame: At 6 months, 12 months
measure: Duration of response (DOR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator
timeFrame: At 6 months, 12 months
measure: Progression-free survival rate (PFSR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator
timeFrame: At 6 months, 12 months
Other outcomes:
Locations:
city: Clovis
country: United States
facility: Community Cancer Institute
state: California
city: Los Angeles
country: United States
facility: USC/Norris Comprehensive Cancer Center
state: California
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital Presbyterian
state: California
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Hackensack
country: United States
facility: John Theurer Cancer Center
state: New Jersey
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
city: New York
country: United States
facility: Local Institution - 0002
state: New York
city: Portland
country: United States
facility: Providence Cancer Center Oncology and Hematology Care- Eastside
state: Oregon
city: Nashville
country: United States
facility: Local Institution - 0063
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Blacktown
country: Australia
facility: Blacktown Hospital
state: New South Wales
city: Liverpool
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: Brisbane
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Malvern
country: Australia
facility: Cabrini Hospital - Malvern
state: Victoria
city: Melbourne
country: Australia
facility: St Vincent's Hospital
state: Victoria
city: Nedlands
country: Australia
facility: One Clinical Research
state: Western Australia
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Vancouver
country: Canada
facility: BC Cancer Vancouver
state: British Columbia
city: Hamilton
country: Canada
facility: Hamilton Health Sciences-Juravinski Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Local Institution - 0009
state: Ontario
city: Montreal
country: Canada
facility: Centre Hospitalier de luniversite de Montreal
state: Quebec
city: Ottawa
country: Canada
facility: The Ottawa Hospital Cancer Centre
city: Ulm
country: Germany
facility: Universitaetsklinikum Ulm
state: Baden-Wurttemberg
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus Dresden-University Cancer Center Early Clinical Trial Unit
city: Essen
country: Germany
facility: Universitaetsklinikum Essen
city: Frankfurt
country: Germany
facility: Universitatsklinikum Frankfurt
city: Wuerzburg
country: Germany
facility: Universitaetsklinikum Wuerzburg
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
state: HaMerkaz
city: Ramat Gan
country: Israel
facility: Local Institution - 0035
state: HaMerkaz
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
state: HaMerkaz
city: Haifa
country: Israel
facility: Rambam Health Care Campus
state: HaTsafon
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center
state: Tell Abīb
city: Rozzano
country: Italy
facility: Humanitas
state: Milano
city: Candiolo
country: Italy
facility: Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia
state: Torino
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Universita Cattolica del Sacro Cuore
city: Siena
country: Italy
facility: ospedale le scotte-U.O.C. Immunoterapia Oncologica
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Málaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
state: Andalucía
city: Badalona
country: Spain
facility: Institut Catalan d Oncologia (ICO) - Badalona
state: Barcelona [Barcelona]
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
state: Barcelona [Barcelona]
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
state: Madrid, Comunidad De
city: Madrid
country: Spain
facility: Hospital Universitario Fundación Jiménez Díaz-START Madrid-FJD
city: Madrid
country: Spain
facility: Centro Integral Oncologico Clara Campal-Hospital HM Universitario Sanchinarro-START Madrid-CIOCC
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra-oNCOLOGY
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: