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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02341625




Registration number
NCT02341625
Ethics application status
Date submitted
14/01/2015
Date registered
19/01/2015
Date last updated
18/08/2022

Titles & IDs
Public title
A Study of BMS-986148 in Patients With Select Advanced Solid Tumors
Scientific title
A Phase I/IIa Study of BMS-986148, a Mesothelin Directed Antibody Drug Conjugate, in Subjects With Select Advanced Solid Tumors
Secondary ID [1] 0 0
2014-002485-70
Secondary ID [2] 0 0
CA008-002
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
Experimental: Part 1: Ascending dose of BMS-986148 - BMS-986148 Intravenous injection at increasing doses on specific days until the maximum tolerated dose is reached. Five cancers will be studied in this part: mesothelioma, pancreatic, ovarian, gastric, and non-small cell lung cancer. Alternate dose and schedules may be explored.

Experimental: Part 2: Expansion dose of BMS-986148 - BMS-986148 Intravenous injection of Maximum tolerated dose (MTD) on specific days. Five cancers will be studied in this part: mesothelioma, pancreatic, ovarian, gastric, and non-small cell lung cancer.

Experimental: Part 3A: Ascending dose of BMS-986148 - Set dose of nivolumab and BMS-986148 intravenous injection at increasing doses on specific days until the maximum tolerated dose is reached. Five cancers will be studied in this part: mesothelioma, pancreatic, ovarian, gastric, and non-small cell lung cancer.

Experimental: Part 3B: Expansion dose of BMS-986148 - Set dose of nivolumab and BMS-986148 intravenous injection at or below maximum tolerated dose on specific days. Five cancers will be studied in this part: mesothelioma, pancreatic, ovarian, gastric, and non-small cell lung cancer.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Adverse Events at Worst CTC Grade
Timepoint [1] 0 0
From first dose to up to 100 days post last dose (Up to 6 months)
Primary outcome [2] 0 0
Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline
Timepoint [2] 0 0
From first dose to up to 100 days post last dose (Up to 6 months)
Secondary outcome [1] 0 0
Maximum Observed Serum Concentration (Cmax)
Timepoint [1] 0 0
PK blood assessed on cycle 1, day 1
Secondary outcome [2] 0 0
Time of Maximum Observed Serum Concentration (Tmax)
Timepoint [2] 0 0
PK blood assessed on cycle 1, day 1
Secondary outcome [3] 0 0
Concentration at the End of a Dosing Interval (Ctau)
Timepoint [3] 0 0
PK blood assessed on cycle 1, day 1
Secondary outcome [4] 0 0
Trough Observed Serum Concentration (Ctrough)
Timepoint [4] 0 0
PK blood assessment include cycle 2-day 1 and cycle 1-day 8
Secondary outcome [5] 0 0
Area Under the Concentration-Time Curve From Time Zero to Time T (AUC(0-t))
Timepoint [5] 0 0
PK blood assessment include cycle 1-day 1
Secondary outcome [6] 0 0
Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU])
Timepoint [6] 0 0
PK blood assessment include cycle 1-day 1
Secondary outcome [7] 0 0
Best Overall Response (BOR)
Timepoint [7] 0 0
Up to 58 months
Secondary outcome [8] 0 0
Objective Response Rate (ORR)
Timepoint [8] 0 0
Up to 58 months
Secondary outcome [9] 0 0
Duration of Response (DoR)
Timepoint [9] 0 0
Up to 58 months
Secondary outcome [10] 0 0
Progression Free Survival (PFS)
Timepoint [10] 0 0
Up to 58 months
Secondary outcome [11] 0 0
Progression Free Survival Rate (PFSR) at Week t
Timepoint [11] 0 0
Total PFS assessed between 4 and 12 months, PFSR at months 4 and 6 to be reported
Secondary outcome [12] 0 0
Changes in QT Corrected by the Fridericia Formula (QTcF) From Baseline, at Selected Times
Timepoint [12] 0 0
Up to 58 months
Secondary outcome [13] 0 0
Number of Participants With Anti-Drug Antibody (ADA)
Timepoint [13] 0 0
Up to 58 months

Eligibility
Key inclusion criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com



* Must have pancreatic, ovarian, gastric, non-small cell cancer or mesothelioma. For dose expansion, must have tumor that is positive for mesothelin
* Expected to have life expectancy of at least 3 months
* Men and women 18 years old or older (or local age of majority)
* Must have measurable tumor per Response Evaluation Criteria In Solid Tumors (RECIST) or modified RECIST for malignant pleural mesothelioma
* ECOG of 0 to 1
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Cancer metastases in the brain
* Moderate eye disorders
* Active infection or past hepatitis B or C infection
* Major surgery less than 1 month before the start of the study
* Uncontrolled heart disease
* Impaired liver or bone marrow function
* History of allergy to mesothelin-directed antibodies, tubulysin, monoclonal antibodies, nivolumab or related compounds

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
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/06/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
7/05/2020
Sample size
Target
Accrual to date
Final
126
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - 0013 - Liverpool
Recruitment hospital [2] 0 0
Local Institution - 0014 - Adelaide
Recruitment hospital [3] 0 0
Local Institution - 0004 - Clayton
Recruitment hospital [4] 0 0
Local Institution - 0015 - Nedlands
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
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
North Carolina
Country [3] 0 0
Belgium
State/province [3] 0 0
Oost-Vlaanderen
Country [4] 0 0
Belgium
State/province [4] 0 0
Bruxelles
Country [5] 0 0
Canada
State/province [5] 0 0
Alberta
Country [6] 0 0
Canada
State/province [6] 0 0
Ontario
Country [7] 0 0
Italy
State/province [7] 0 0
Lombardia
Country [8] 0 0
Italy
State/province [8] 0 0
Milano
Country [9] 0 0
Italy
State/province [9] 0 0
Rozzano (milano)
Country [10] 0 0
Netherlands
State/province [10] 0 0
Amsterdam
Country [11] 0 0
Netherlands
State/province [11] 0 0
Rotterdam
Country [12] 0 0
United Kingdom
State/province [12] 0 0
Hampshire
Country [13] 0 0
United Kingdom
State/province [13] 0 0
Lanarkshire

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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02341625