Clinical trial NCT05298592: A Study of BMS-986406 as Monotherapy and Combination Therapies in Participants With Advanced Tumors
Official title: A Phase 1 First-in-human Study of BMS-986406 as Monotherapy and Combination Therapies in Participants With Advanced Malignant Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Cancer
Keywords: Opdivo®
Immunotherapy
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2022-03-28
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and tolerability of BMS-986406 administered alone, in combination with nivolumab, or in combination with nivolumab and platinum-doublet chemotherapy (PDCT) in participants with advanced tumors.


Eligibility criteria: Inclusion Criteria:

Parts 1A, 1B, 1C:

* Histologically or cytologically confirmed locally advanced unresectable, metastatic, or recurrent malignant tumor. Eligible tumor types are non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), pancreatic ductal adenocarcinoma (PDAC), gastric/gastroesophageal junction, castration-resistant prostate cancer (CRPC), ovarian, squamous cell carcinoma of the head and neck (SCCHN), bladder, melanoma, mesothelioma, triple negative breast cancer (TNBC), and soft tissue sarcoma, except for participants with tumors with central nervous system (CNS) metastases as the only site of active disease

Part 1D:

* Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) of non-squamous or squamous histology with Stage IV A/B (as defined by the 8th International Association for the Study of Lung Cancer Classification) or recurrent disease following multi-modal therapy for locally advanced disease, who have not had systemic therapy for metastatic or recurrent disease.

All Parts:

* Measurable disease by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), Prostate Cancer Working Group 3 (PCWG3) (for prostate cancer), or modified Response Evaluation Criteria in Solid tumors (mRECIST) (for mesothelioma)
* Eastern Cooperative Oncology Group Performance Status of 0 or 1
* Adequate organ function

Exclusion Criteria:

* Prior organ or tissue allograft
* Leptomeningeal metastases
* Untreated CNS metastases
* Serious or uncontrolled medical disorders

Other protocol-defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: Up to 100 days
measure: Number of participants with serious adverse events (SAEs)
timeFrame: Up to 100 days
measure: Number of participants with AEs meeting protocol defined dose-limiting toxicity (DLT) criteria
timeFrame: Up to 28 days
measure: Number of participants with AEs leading to discontinuation
timeFrame: Up to 100 days
measure: Number of participants with death
timeFrame: Up to 100 days
Secondary outcomes:
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Up to 14 days
measure: Time of maximum observed plasma concentration (Tmax)
timeFrame: Up to 14 days
measure: Trough observed plasma concentration (Ctrough)
timeFrame: Up to 14 days
measure: Incidence of anti-drug antibody (ADAs)
timeFrame: Up to 14 days
measure: Objective response rate (ORR)
timeFrame: Up to 24 months
measure: Disease control rate (DCR)
timeFrame: Up to 24 months
measure: Duration of response (DOR) per tumor appropriate criteria: Modified Response Evaluation Criteria in Solid Tumors (mRECIST) for mesothelioma
timeFrame: Up to 24 months
measure: DOR per tumor appropriate criteria: Prostate Cancer Working Group 3 (PCWG3) for prostate cancer
timeFrame: Up to 24 months
measure: DOR per tumor appropriate criteria: Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) for other solid tumor types
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Local Institution - 0021
state: Alabama
city: La Jolla
country: United States
facility: University California San Diego Moores Cancer Center
state: California
city: Los Angeles
country: United States
facility: The Angeles Clinic and Research Institute, A Cedars-Sinai Affiliate
state: California
city: Los Angeles
country: United States
facility: UCLA Health
state: California
city: Hackensack
country: United States
facility: Local Institution - 0001
state: New Jersey
city: Huntersville
country: United States
facility: Carolina BioOncology Institute, PLLC
state: North Carolina
city: Sioux Falls
country: United States
facility: Sanford Cancer Center
state: South Dakota
city: Dallas
country: United States
facility: Mary Crowley Cancer Research - Medical City Hospital
state: Texas
city: Richmond
country: United States
facility: Local Institution - 0006
state: Virginia
city: Viedma
country: Argentina
facility: Local Institution - 0029
state: Rio Negro
city: Rosario
country: Argentina
facility: Local Institution - 0023
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Local Institution - 0028
city: Cordoba
country: Argentina
facility: Local Institution - 0032
city: Brussel (Jette)
country: Belgium
facility: Local Institution - 0018
state: Brussel
city: Edegem
country: Belgium
facility: Local Institution - 0015
state: MA
city: Brussels
country: Belgium
facility: Local Institution - 0012
city: Kashiwa-shi
country: Japan
facility: Local Institution - 0031
state: Chiba
city: Seongnam
country: Korea, Republic of
facility: Local Institution - 0026
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0024
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0027
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0025
city: Malaga
country: Spain
facility: Local Institution - 0008
state: Andaluca
city: Barcelona
country: Spain
facility: Local Institution - 0030
city: Barcelona
country: Spain
facility: Local Institution - 0017
city: Barcelona
country: Spain
facility: Institut Catala dOncologia ICO - Hospital Duran i Reynals Location
city: Madrid
country: Spain
facility: Local Institution - 0014
city: Madrid
country: Spain
facility: Local Institution - 0009
city: Madrid
country: Spain
facility: Local Institution - 0016
city: Pamplona
country: Spain
facility: Local Institution - 0033
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: