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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03446040




Registration number
NCT03446040
Ethics application status
Date submitted
21/02/2018
Date registered
26/02/2018
Date last updated
3/04/2024

Titles & IDs
Public title
An Investigational Immunotherapy Study of BMS-986258 Alone and in Combination With Nivolumab in Participants With Solid Cancers That Are Advanced or Have Spread
Scientific title
A Phase 1/2 First-in-Human Study of BMS-986258 Alone and in Combination With Nivolumab in Advanced Malignant Tumors
Secondary ID [1] 0 0
2019-000442-35
Secondary ID [2] 0 0
CA031-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - BMS-986258
Other interventions - Nivolumab
Treatment: Drugs - rHuPH20

Experimental: Part A Dose Escalation: BMS-986258 -

Experimental: Part A1: BMS-986258 + Recombinant human hyaluronidase PH20 (rHuPH20) -

Experimental: Part B Dose Escalation: BMS-986258 + nivolumab -

Experimental: Part C Cohort Expansion: BMS-986258 + nivolumab -


Other interventions: BMS-986258
Specified dose on specified days

Other interventions: Nivolumab
Specified dose on specified days

Treatment: Drugs: rHuPH20
Specified dose on specified days
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of adverse events (AEs)
Timepoint [1] 0 0
Approximately 2 years
Primary outcome [2] 0 0
Incidence of serious adverse events (SAEs)
Timepoint [2] 0 0
Approximately 2 years
Primary outcome [3] 0 0
Incidence of AEs leading to discontinuation
Timepoint [3] 0 0
Approximately 2 years
Primary outcome [4] 0 0
Incidence of AEs leading to death
Timepoint [4] 0 0
Approximately 2 years
Primary outcome [5] 0 0
Incidence of AEs meeting protocol defined dose-limiting toxicities (DLTs) criteria
Timepoint [5] 0 0
Approximately 2 years
Secondary outcome [1] 0 0
Objective response rate (ORR)
Timepoint [1] 0 0
Up to 12 months
Secondary outcome [2] 0 0
Median duration of response (mDOR)
Timepoint [2] 0 0
Up to 12 months
Secondary outcome [3] 0 0
Progression free survival (PFS) rate
Timepoint [3] 0 0
Up to 12 months
Secondary outcome [4] 0 0
Maximum observed serum concentration (Cmax)
Timepoint [4] 0 0
Approximately 2 years
Secondary outcome [5] 0 0
Time of maximum observed concentration (Tmax)
Timepoint [5] 0 0
Approximately 2 years
Secondary outcome [6] 0 0
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]
Timepoint [6] 0 0
Approximately 2 years
Secondary outcome [7] 0 0
Observed concentration at the end of a dosing interval (Ctau)
Timepoint [7] 0 0
Approximately 2 years
Secondary outcome [8] 0 0
Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)]
Timepoint [8] 0 0
Approximately 2 years
Secondary outcome [9] 0 0
Trough observed serum concentration at the end of the dosing interval (Ctrough)
Timepoint [9] 0 0
Approximately 2 years
Secondary outcome [10] 0 0
Concentration at the end of infusion (Ceoi)
Timepoint [10] 0 0
Approximately 2 years
Secondary outcome [11] 0 0
Incidence of anti-drug antibody (ADA) to BMS-986258
Timepoint [11] 0 0
Approximately 2 years

Eligibility
Key inclusion criteria
- Histologic confirmation of one of the 5 tumors [renal cell carcinoma (RCC), colorectal
cancer (CRC), non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head
and neck (SCCHN), triple negative breast cancer (TNBC)] (metastatic, recurrent, and/or
unresectable), with measurable disease per response evaluation criteria in solid
tumors v1.1 (RECIST v1.1)

- Eastern Cooperative Oncology Group Performance Status of 0 or 1

- Participants must have received, and then progressed, relapsed, or been intolerant to,
at least 1 standard treatment regimen in the advanced or metastatic setting according
to solid tumor histologies

- Women must agree to follow specific methods of contraception, if applicable
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Active, known or suspected autoimmune disease

- Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior
anti-cancer therapy and initiation of study therapy

- Other active malignancy requiring concurrent intervention

Other protocol-defined inclusion/exclusion criteria apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/03/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/04/2025
Actual
Sample size
Target
Accrual to date
Final
92
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Local Institution - 0013 - Westmead
Recruitment hospital [2] 0 0
Local Institution - 0015 - Melbourne
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
3084 - Melbourne
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
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Iowa
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
New Hampshire
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Pennsylvania
Country [8] 0 0
United States of America
State/province [8] 0 0
Tennessee
Country [9] 0 0
Canada
State/province [9] 0 0
Alberta
Country [10] 0 0
Canada
State/province [10] 0 0
British Columbia
Country [11] 0 0
Japan
State/province [11] 0 0
Hyogo
Country [12] 0 0
Japan
State/province [12] 0 0
Tokyo

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine whether BMS-986258 both monotherapy and in
combination with Nivolumab is safe and tolerable in the treatment of advanced malignant
tumors.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03446040
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03446040