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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05625412




Registration number
NCT05625412
Ethics application status
Date submitted
15/11/2022
Date registered
22/11/2022

Titles & IDs
Public title
A Study of BMS-986360/CC-90001 Alone and in Combination With Chemotherapy or Nivolumab in Advanced Solid Tumors
Scientific 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
Secondary ID [1] 0 0
2022-500930-27
Secondary ID [2] 0 0
IM043-004
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BMS-986360
Treatment: Drugs - Docetaxel
Treatment: Drugs - Nivolumab
Treatment: Drugs - Capecitabine

Experimental: BMS-986360 -

Experimental: BMS-986360 + Docetaxel -

Experimental: BMS-986360 + Nivolumab -

Experimental: BMS-986360 + Capecitabine -


Treatment: Drugs: BMS-986360
Specified dose on specified days

Treatment: Drugs: Docetaxel
Specified dose on specified days

Treatment: Drugs: Nivolumab
Specified dose on specified days

Treatment: Drugs: Capecitabine
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with Adverse Events (AEs)
Timepoint [1] 0 0
Up to approximately 2 years
Primary outcome [2] 0 0
Number of participants with Serious Adverse Events (SAEs)
Timepoint [2] 0 0
Up to approximately 2 years
Primary outcome [3] 0 0
Number of participants with Dose-Limiting Toxicities (DLTs)
Timepoint [3] 0 0
Up to approximately 2 years
Primary outcome [4] 0 0
Number of participants with AEs leading to discontinuation
Timepoint [4] 0 0
Up to approximately 2 years
Primary outcome [5] 0 0
Number of deaths
Timepoint [5] 0 0
Up to approximately 2 years
Secondary outcome [1] 0 0
Maximum observed plasma concentration (Cmax)
Timepoint [1] 0 0
Up to approximately 2 years
Secondary outcome [2] 0 0
Time of maximum observed plasma concentration (Tmax)
Timepoint [2] 0 0
Up to approximately 2 years
Secondary outcome [3] 0 0
Area under the plasma concentration-time curve (AUC)
Timepoint [3] 0 0
Up to approximately 2 years
Secondary outcome [4] 0 0
Part 1: Objective response rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST v1.1) by investigator
Timepoint [4] 0 0
Up to approximately 2 years
Secondary outcome [5] 0 0
Part 2: ORR based on RECIST v1.1 by blinded independent central review (BICR) assessment
Timepoint [5] 0 0
Up to approximately 2 years
Secondary outcome [6] 0 0
Part 1: Duration of Response (DOR) based on RECIST v1.1 by investigator
Timepoint [6] 0 0
Up to approximately 2 years
Secondary outcome [7] 0 0
Part 2: DOR based on RECIST v1.1 by BICR assessment
Timepoint [7] 0 0
Up to approximately 2 years

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/12/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/07/2027
Actual
Sample size
Target
220
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
St Vincent's Hospital - The Kinghorn Cancer Center - Darlinghurst
Recruitment hospital [2] 0 0
GenesisCare North Shore - St Leonards
Recruitment hospital [3] 0 0
Gallipoli Medical Research Ltd - Brisbane
Recruitment hospital [4] 0 0
Frankston Hospital - Frankston
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
4120 - Brisbane
Recruitment postcode(s) [4] 0 0
3199 - Frankston
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Hawaii
Country [3] 0 0
United States of America
State/province [3] 0 0
Louisiana
Country [4] 0 0
United States of America
State/province [4] 0 0
New Jersey
Country [5] 0 0
United States of America
State/province [5] 0 0
North Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
Tennessee
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
United States of America
State/province [8] 0 0
Utah
Country [9] 0 0
Argentina
State/province [9] 0 0
Buenos Aires
Country [10] 0 0
Argentina
State/province [10] 0 0
Ciudad Autónoma De Buenos Aires
Country [11] 0 0
Argentina
State/province [11] 0 0
Ciudad Autónoma de Buenos Aires
Country [12] 0 0
Canada
State/province [12] 0 0
Ontario
Country [13] 0 0
Chile
State/province [13] 0 0
Región Metropolitana De Santiago
Country [14] 0 0
France
State/province [14] 0 0
Provence-Alpes-Côte-d'Azur
Country [15] 0 0
France
State/province [15] 0 0
Val-de-Marne
Country [16] 0 0
France
State/province [16] 0 0
Paris
Country [17] 0 0
France
State/province [17] 0 0
Toulouse
Country [18] 0 0
Italy
State/province [18] 0 0
Milano
Country [19] 0 0
Italy
State/province [19] 0 0
Torino
Country [20] 0 0
Italy
State/province [20] 0 0
Padova
Country [21] 0 0
Mexico
State/province [21] 0 0
Distrito Federal
Country [22] 0 0
Mexico
State/province [22] 0 0
Jalisco
Country [23] 0 0
Mexico
State/province [23] 0 0
Nuevo León
Country [24] 0 0
Mexico
State/province [24] 0 0
Puebla
Country [25] 0 0
Spain
State/province [25] 0 0
Catalunya [Cataluña]
Country [26] 0 0
Spain
State/province [26] 0 0
Madrid, Comunidad De
Country [27] 0 0
Spain
State/province [27] 0 0
Sevilla

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
BMS Study Connect Contact Center www.BMSStudyConnect.com
Address 0 0
Country 0 0
Phone 0 0
855-907-3286
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05625412