A Study of BMS-986360/CC-90001 Alone and in Combination With Chemotherapy or Nivolumab in Advanced Solid Tumors

Advanced Solid Tumors Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05625412
• Other study ID #: IM043-004
• Secondary ID: 2022-500930-27
• Status: Recruiting
• Phase: Phase 1
• Start date: December 9, 2022
• Est. completion date: July 30, 2027

Study information

• Verified date: May 2024
• Source: Bristol-Myers Squibb
• Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com
• Phone: 855-907-3286
• Email: Clinical.Trials[@]bms.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: July 30, 2027
• Est. primary completion date: May 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Neoplasms

Intervention

Drug:
• BMS-986360
Specified dose on specified days
• Docetaxel
Specified dose on specified days
• Nivolumab
Specified dose on specified days
• Capecitabine
Specified dose on specified days

Locations

Country	Name	City	State
Argentina	Local Institution - 0032	ABB	Ciudad Autónoma De Buenos Aires
Argentina	Clinica Adventista Belgrano	Caba	Ciudad Autónoma De Buenos Aires
Argentina	Hospital Británico de Buenos Aires	Ciudad autónoma de Buenos Aires	Buenos Aires
Argentina	Instituto Alexander Fleming	Ciudad Autónoma de Buenos Aires
Australia	Gallipoli Medical Research Ltd	Brisbane	Queensland
Australia	St Vincent's Hospital - The Kinghorn Cancer Center	Darlinghurst	New South Wales
Australia	Frankston Hospital	Frankston	Victoria
Australia	GenesisCare North Shore	St Leonards	New South Wales
Canada	The Ottawa Hospital - General Campus	Ottawa	Ontario
Canada	Princess Margaret Cancer Centre	Toronto	Ontario
Chile	Bradfordhill	Santiago	Región Metropolitana De Santiago
Chile	FALP	Santiago	Región Metropolitana De Santiago
Chile	Pontificia Universidad Catolica de Chile	Santiago	Región Metropolitana De Santiago
France	Institut Paoli-Calmettes	Marseille	Provence-Alpes-Côte-d'Azur
France	Institut Curie	Paris
France	Institut Claudius Regaud	Toulouse
France	Gustave Roussy	Villejuif	Val-de-Marne
Italy	Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia	Candiolo	Torino
Italy	Istituto Oncologico Veneto IRCCS	Padova
Italy	Humanitas	Rozzano	Milano
Mexico	Local Institution - 0038	Mexico City	Distrito Federal
Mexico	Local Institution - 0039	Monterrey	Nuevo León
Mexico	Local Institution - 0037	Puebla
Mexico	Local Institution - 0041	Zapopan	Jalisco
Spain	Hospital Clínic de Barcelona	Barcelona	Catalunya [Cataluña]
Spain	Hospital Universitario 12 de Octubre	Madrid	Madrid, Comunidad De
Spain	Hospital Universitario Ramón y Cajal	Madrid	Madrid, Comunidad De
Spain	Hospital Universitario Virgen Del Rocio	Sevilla
United States	John Theurer Cancer Center at Hackensack University Medical Center	Hackensack	New Jersey
United States	Local Institution - 0067	Honolulu	Hawaii
United States	Carolina BioOncology Institute	Huntersville	North Carolina
United States	Local Institution - 0019	Los Angeles	California
United States	The Angeles Clinic and Research Institute - West Los Angeles Office	Los Angeles	California
United States	Valkyrie Clinical Trials	Los Angeles	California
United States	SCRI Oncology Partners	Nashville	Tennessee
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	South Texas Accelerated Research Therapeutics (START)	San Antonio	Texas
United States	START Mountain Region	West Valley City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Canada,  Chile,  France,  Italy,  Mexico,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with Adverse Events (AEs)		Up to approximately 2 years
Primary	Number of participants with Serious Adverse Events (SAEs)		Up to approximately 2 years
Primary	Number of participants with Dose-Limiting Toxicities (DLTs)		Up to approximately 2 years
Primary	Number of participants with AEs leading to discontinuation		Up to approximately 2 years
Primary	Number of deaths		Up to approximately 2 years
Secondary	Maximum observed plasma concentration (Cmax)		Up to approximately 2 years
Secondary	Time of maximum observed plasma concentration (Tmax)		Up to approximately 2 years
Secondary	Area under the plasma concentration-time curve (AUC)		Up to approximately 2 years
Secondary	Part 1: Objective response rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST v1.1) by investigator		Up to approximately 2 years
Secondary	Part 2: ORR based on RECIST v1.1 by blinded independent central review (BICR) assessment		Up to approximately 2 years
Secondary	Part 1: Duration of Response (DOR) based on RECIST v1.1 by investigator		Up to approximately 2 years
Secondary	Part 2: DOR based on RECIST v1.1 by BICR assessment		Up to approximately 2 years

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting