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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/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
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Scientific title
A Phase I/IIa Study of BMS-986148, a Mesothelin Directed Antibody Drug Conjugate, in Subjects With Select Advanced Solid Tumors
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Secondary ID [1]
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2014-002485-70
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Secondary ID [2]
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CA008-002
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Advanced Cancer
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - BMS-986148
Other interventions - Nivolumab
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.
Treatment: Drugs: BMS-986148
Other interventions: Nivolumab
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Adverse Events at Worst CTC Grade
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Assessment method [1]
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Number of participants with adverse events at worst CTC grade including any grade adverse events (AEs), serious adverse events (SAEs), adverse events leading to discontinuations, and deaths grouped by dose + dose regimen.
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Timepoint [1]
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From first dose to up to 100 days post last dose (Up to 6 months)
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Primary outcome [2]
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Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline
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Assessment method [2]
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Number of participants with laboratory test toxicity grade (Grade 0, 1, 2, 3, and 4) in hematology and chemistry shifting from baseline. An increase in baseline indicates a shift of participant to a greater toxicity grade. A decrease in baseline indicates a shift of participant to a lesser toxicity grade. Participants are grouped by dose + dose regimen assessed by NCT CTCAE V 4.03.
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Timepoint [2]
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From first dose to up to 100 days post last dose (Up to 6 months)
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Secondary outcome [1]
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Maximum Observed Serum Concentration (Cmax)
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Assessment method [1]
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Maximum observed serum concentration (Cmax) of BMS-986148 grouped by dose + dose regimen.
Note: The geometric CV was not calculated. Arithmetic % CV is reported instead.
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Timepoint [1]
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PK blood assessed on cycle 1, day 1
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Secondary outcome [2]
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Time of Maximum Observed Serum Concentration (Tmax)
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Assessment method [2]
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Time of maximum observed serum concentration (Tmax) of BMS-986148 grouped by dose + dose regimen.
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Timepoint [2]
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PK blood assessed on cycle 1, day 1
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Secondary outcome [3]
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Concentration at the End of a Dosing Interval (Ctau)
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Assessment method [3]
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Concentration at the end of a dosing interval (Ctau) of BMS-986148 grouped by dose + dose regimen.
Note: The geometric CV was not calculated. Arithmetic % CV is reported instead.
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Timepoint [3]
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PK blood assessed on cycle 1, day 1
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Secondary outcome [4]
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Trough Observed Serum Concentration (Ctrough)
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Assessment method [4]
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Trough observed serum concentration (Ctrough) of BMS-986148 grouped by dose + dose regimen.
Note: The geometric CV was not calculated. Arithmetic % CV is reported instead.
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Timepoint [4]
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PK blood assessment include cycle 2-day 1 and cycle 1-day 8
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Secondary outcome [5]
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Area Under the Concentration-Time Curve From Time Zero to Time T (AUC(0-t))
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Assessment method [5]
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Area under the concentration-time curve from time Zero to time T (AUC(0-t)) of BMS-986148 grouped by dose + dose regimen.
Note: The geometric CV was not calculated. Arithmetic % CV is reported instead.
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Timepoint [5]
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PK blood assessment include cycle 1-day 1
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Secondary outcome [6]
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Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU])
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Assessment method [6]
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Area under the concentration-time curve in one dosing interval (AUC[TAU]) of BMS-986148 grouped by dose + dose regimen Note: The geometric CV was not calculated. Arithmetic % CV is reported instead
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Timepoint [6]
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PK blood assessment include cycle 1-day 1
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Secondary outcome [7]
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Best Overall Response (BOR)
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Assessment method [7]
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Best overall response is defined as the best response designation over the study as a whole, recorded between the dates of first dose until the last tumor assessment prior to subsequent therapy.
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm.
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. The sum must also demonstrate an absolute increase of at least 5 mm.
Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
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Timepoint [7]
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Up to 58 months
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Secondary outcome [8]
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Objective Response Rate (ORR)
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Assessment method [8]
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Objective response rate is defined as the total percentage of participants whose best overall response (BOR) is either a complete response or partial response divided by the total percentage of participants who are grouped by cohorts (Mesothelioma, Pancreatic, Ovarian, Non-smell Cell Lung (NSCL), and Gastric).
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm.
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
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Timepoint [8]
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Up to 58 months
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Secondary outcome [9]
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Duration of Response (DoR)
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Assessment method [9]
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Duration of response is defined as the time between the date of first response and the subsequent date of objectively documented disease progression or death, whichever occurs first. Participants are grouped by cohorts (Mesothelioma, Pancreatic, Ovarian, Non-smell Cell Lung (NSCL), and Gastric).
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Timepoint [9]
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Up to 58 months
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Secondary outcome [10]
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Progression Free Survival (PFS)
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Assessment method [10]
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Progression Free Survival is defined as the time from the first dose of study medication to the date of the first objective documentation of tumor progression or death due to any cause. Progression is defined with at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and the sum must also demonstrate an absolute increase of at least 5 mm. Participants who did not progress nor died will be censored on the date of their last tumor assessment. Participants are grouped by cohorts (Mesothelioma, Pancreatic, Ovarian, Non-smell Cell Lung (NSCL), and Gastric).
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Timepoint [10]
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Up to 58 months
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Secondary outcome [11]
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Progression Free Survival Rate (PFSR) at Week t
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Assessment method [11]
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Progression free survival rate is defined as the proportion of participants who remain progression free and surviving at 't' weeks (t=4-12 months). The proportion will be calculated by the product-limit method (Kaplan-Meier estimate) which takes into account censored data. Participants are grouped by cohorts (Mesothelioma, Pancreatic, Ovarian, Non-smell Cell Lung (NSCL), and Gastric).
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Timepoint [11]
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Total PFS assessed between 4 and 12 months, PFSR at months 4 and 6 to be reported
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Secondary outcome [12]
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Changes in QT Corrected by the Fridericia Formula (QTcF) From Baseline, at Selected Times
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Assessment method [12]
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Changes of participants in QT corrected by the fridericia formula (QTcF) Interval from baseline at <= 30 msec, >30 - <= 60 msec, and > 60 msec grouped by dose + dose regimen
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Timepoint [12]
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Up to 58 months
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Secondary outcome [13]
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Number of Participants With Anti-Drug Antibody (ADA)
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Assessment method [13]
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Number of participants with anti-drug antibody (ADA) status grouped by dose + dose regimen.
Data was not collected for this outcome measure.
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Timepoint [13]
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Up to 58 months
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1/Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
19/06/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
7/05/2020
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Sample size
Target
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Accrual to date
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Final
126
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
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Recruitment hospital [1]
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Local Institution - 0013 - Liverpool
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Recruitment hospital [2]
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Local Institution - 0014 - Adelaide
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Recruitment hospital [3]
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Local Institution - 0004 - Clayton
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Recruitment hospital [4]
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Local Institution - 0015 - Nedlands
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Recruitment postcode(s) [1]
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2170 - Liverpool
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Recruitment postcode(s) [2]
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5000 - Adelaide
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Recruitment postcode(s) [3]
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3168 - Clayton
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Recruitment postcode(s) [4]
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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North Carolina
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Country [3]
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Belgium
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State/province [3]
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Oost-Vlaanderen
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Country [4]
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Belgium
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State/province [4]
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Bruxelles
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Country [5]
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Canada
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State/province [5]
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Alberta
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Country [6]
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Canada
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State/province [6]
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Ontario
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Country [7]
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Italy
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State/province [7]
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Lombardia
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Country [8]
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Italy
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State/province [8]
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Milano
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Country [9]
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Italy
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State/province [9]
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Rozzano (milano)
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Country [10]
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Netherlands
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State/province [10]
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Amsterdam
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Country [11]
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Netherlands
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State/province [11]
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Rotterdam
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Country [12]
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United Kingdom
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State/province [12]
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Hampshire
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Country [13]
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United Kingdom
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State/province [13]
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Lanarkshire
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bristol-Myers Squibb
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to determine the safety, tolerability, pharmacokinetics,
immunogenicity, antitumor activity and pharmacodynamics of BMS-986148 administered alone and
in combination with nivolumab in patients with mesothelioma, non-small cell lung cancer,
ovarian cancer, pancreatic cancer and gastric cancer.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02341625
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Bristol-Myers Squibb
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Address
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Bristol-Myers Squibb
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02341625
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