Clinical trial NCT05625412: A Study of BMS-986360/CC-90001 Alone and in Combination With Chemotherapy or Nivolumab in Advanced Solid Tumors
Official title: A Phase 1, Open-label, Multicenter Study of BMS-986360/CC-90001 Alone and in Combination With Chemotherapy or Nivolumab in Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Keywords: Solid tumors
Nivolumab
Chemotherapy
BMS-986360
CC-90001
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2022-11-22
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to assess the safety and tolerability of BMS-986360 as monotherapy and in combination with chemotherapy or nivolumab in participants with advanced solid tumors.


Eligibility criteria: Inclusion Criteria:

* Participants in Part 1 must have histologic or cytologic confirmation of non-small cell lung cancer (NSCLC), metastatic triple negative breast cancer (mTNBC), squamous cell carcinoma of head and neck (SCCHN), pancreatic adenocarcinoma (PAAD), renal cell carcinoma (RCC), microsatellite-stable colorectal carcinoma (MSS CRC), or sarcoma, that is advanced (metastatic, recurrent, and/or unresectable) with measurable disease per RECIST v1.1. In Part 2, only participants with histologic confirmation of advanced NSCLC or mTNBC with measurable disease per RECIST v1.1 are eligible.
* In Part 2, archival biopsy collected within 3 months of screening with no intervening therapy (formalin-fixed, paraffin embedded \[FFPE\] blocks or a minimum of 20 freshly cut unstained FFPE slides with an associated pathological report) or fresh biopsy collection at Screening and fresh biopsy collection at cycle 3 day 1 (C3D1) (± 5 days) are mandatory, while it is strongly encouraged but optional at progression. Therefore, the participant in Part 2 must have a suitable tumor lesion for the biopsy procedure, as judged by the investigator, in order to be eligible for the study.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
* Participants resistant/refractory to or intolerant of existing standard therapies known to provide clinical benefit (in addition, participants with NSCLC must be resistant or refractory to anti-PD-(L)1-based immunotherapy)

Exclusion Criteria:

* Participants with primary central nervous system (CNS) disease, or tumors with CNS metastases as the only disease site, will be excluded. Participants with controlled brain metastases, however, will be allowed to enroll. Controlled brain metastases are defined as no radiographic progression for at least 4 weeks following radiation and/or surgical treatment (or 4 weeks of observation if no intervention is clinically indicated), no longer taking steroids for at least 2 weeks prior to first dose of study intervention, and with no new or progressive neurological signs and symptoms.
* Participants with a condition requiring systemic treatment with corticosteroids (\> 10 mg daily prednisone equivalent) within 14 days or other immunosuppressive medications within 30 days of randomization. Inhaled or topical steroids and adrenal replacement steroid doses \> 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease.
* Participants with concurrent malignancy or history of prior malignancy active within 2 years (except history of early-stage basal/squamous cell skin cancer or non-invasive or in situ cancers who have undergone definitive treatment) are excluded unless treatment was completed at least 2 years before randomization and the participant has no evidence of disease.
* Participants with NSCLC with known or not tested for epidermal growth factor receptor (EGFR) or V-raf murine sarcoma viral oncogene homolog B1 (BRAF) V600E mutations, or anaplastic lymphoma kinase (ALK) or receptor tyrosine kinase (ROS1) translocations sensitive to available targeted inhibitor therapy

Other protocol-defined inclusion/exclusion criteria apply.

Primary outcomes:
measure: Number of participants with Adverse Events (AEs)
timeFrame: Up to approximately 2 years
measure: Number of participants with Serious Adverse Events (SAEs)
timeFrame: Up to approximately 2 years
measure: Number of participants with Dose-Limiting Toxicities (DLTs)
timeFrame: Up to approximately 2 years
measure: Number of participants with AEs leading to discontinuation
timeFrame: Up to approximately 2 years
measure: Number of deaths
timeFrame: Up to approximately 2 years
Secondary outcomes:
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Up to approximately 2 years
measure: Time of maximum observed plasma concentration (Tmax)
timeFrame: Up to approximately 2 years
measure: Area under the plasma concentration-time curve (AUC)
timeFrame: Up to approximately 2 years
measure: Part 1: Objective response rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST v1.1) by investigator
timeFrame: Up to approximately 2 years
measure: Part 2: ORR based on RECIST v1.1 by blinded independent central review (BICR) assessment
timeFrame: Up to approximately 2 years
measure: Part 1: Duration of Response (DOR) based on RECIST v1.1 by investigator
timeFrame: Up to approximately 2 years
measure: Part 2: DOR based on RECIST v1.1 by BICR assessment
timeFrame: Up to approximately 2 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Local Institution - 0029
state: California
city: Los Angeles
country: United States
facility: Local Institution - 0051
state: California
city: New Orleans
country: United States
facility: Local Institution - 0026
state: Louisiana
city: Hackensack
country: United States
facility: Local Institution - 0001
state: New Jersey
city: Huntersville
country: United States
facility: Local Institution - 0018
state: North Carolina
city: Nashville
country: United States
facility: Local Institution - 0028
state: Tennessee
city: San Antonio
country: United States
facility: Local Institution - 0027
state: Texas
city: West Valley City
country: United States
facility: Local Institution - 0046
state: Utah
city: Ciudad autónoma de Buenos Aires
country: Argentina
facility: Local Institution - 0033
state: Buenos Aires
city: Caba
country: Argentina
facility: Local Institution - 0030
state: Ciudad Autónoma De Buenos Aires
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Local Institution - 0031
city: Darlinghurst
country: Australia
facility: Local Institution - 0010
state: New South Wales
city: St Leonards
country: Australia
facility: Local Institution - 0061
state: New South Wales
city: Brisbane
country: Australia
facility: Local Institution - 0008
state: Queensland
city: Frankston
country: Australia
facility: Local Institution - 0063
state: Victoria
city: Ottawa
country: Canada
facility: Local Institution - 0003
state: Ontario
city: Toronto
country: Canada
facility: Local Institution - 0005
state: Ontario
city: Santiago
country: Chile
facility: Local Institution - 0047
state: Región Metropolitana De Santiago
city: Santiago
country: Chile
facility: Local Institution - 0035
state: Región Metropolitana De Santiago
city: Santiago
country: Chile
facility: Local Institution - 0034
state: Región Metropolitana De Santiago
city: Marseille
country: France
facility: Local Institution - 0049
state: Provence-Alpes-Côte-d'Azur
city: Villejuif
country: France
facility: Local Institution - 0052
state: Val-de-Marne
city: Paris
country: France
facility: Local Institution - 0048
city: Toulouse
country: France
facility: Local Institution - 0050
city: Rozzano
country: Italy
facility: Local Institution - 0057
state: Milano
city: Candiolo
country: Italy
facility: Local Institution - 0059
state: Torino
city: Padova
country: Italy
facility: Local Institution - 0065
city: Mexico City
country: Mexico
facility: Local Institution - 0038
state: Distrito Federal
city: Zapopan
country: Mexico
facility: Local Institution - 0041
state: Jalisco
city: Monterrey
country: Mexico
facility: Local Institution - 0039
state: Nuevo León
city: Puebla
country: Mexico
facility: Local Institution - 0037
city: Barcelona
country: Spain
facility: Local Institution - 0053
state: Catalunya [Cataluña]
city: Madrid
country: Spain
facility: Local Institution - 0055
state: Madrid, Comunidad De
city: Madrid
country: Spain
facility: Local Institution - 0056
state: Madrid, Comunidad De
city: Sevilla
country: Spain
facility: Local Institution - 0064
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: