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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03363776
Registration number
NCT03363776
Ethics application status
Date submitted
1/12/2017
Date registered
6/12/2017
Date last updated
19/12/2020
Titles & IDs
Public title
An Investigational Immuno-Therapy Study of Experimental Medication BMS-986277 Given Alone and in Combination With Nivolumab in Epithelial Cancers
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Scientific title
Phase 1/2a First in Human Study of BMS-986277 Administered Alone and in Combination With Nivolumab in Advanced Epithelial Tumors
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Secondary ID [1]
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2017-002199-24
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Secondary ID [2]
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CA034-001
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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:
Cancer
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - BMS-986277
Treatment: Other - Nivolumab
Experimental: Monotherapy - BMS-986277 administered alone
Experimental: Combination Dose Escalation Therapy - BMS-986277 administered in combination with Nivolumab
Experimental: Combination Expansion Therapy - BMS-986277 monotherapy with option for subsequent Nivolumab therapy
Treatment: Other: BMS-986277
Specified dose on specified days
Treatment: Other: Nivolumab
Specified dose on specified days
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Intervention code [1]
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Treatment: Other
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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 an Adverse Event (AE)
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Assessment method [1]
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Number of participants who experienced an AE during the course of the study.
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Timepoint [1]
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from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)
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Primary outcome [2]
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Number of Participants With a Serious Adverse Event (SAE)
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Assessment method [2]
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Number of participants who experienced a SAE during the course of the study.
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Timepoint [2]
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from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)
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Primary outcome [3]
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Number of Participants With an Adverse Event (AE) Meeting Protocol-defined Dose Limiting Toxicity (DLT) Criteria
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Assessment method [3]
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Number of participants who experienced an AE meeting protocol-defined DLT criteria during the course of the study.
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Timepoint [3]
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from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)
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Primary outcome [4]
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Number of Participants With an Adverse Event (AE) Leading to Discontinuation
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Assessment method [4]
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Number of participants who experienced an AE leading to discontinuation during the course of the study.
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Timepoint [4]
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from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)
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Primary outcome [5]
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Number of Participants With an Adverse Event (AE) Leading to Death
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Assessment method [5]
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Number of participants who experienced an AE leading to death during the course of the study.
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Timepoint [5]
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from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)
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Primary outcome [6]
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Number of Participants With a Clinical Laboratory Test Abnormality
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Assessment method [6]
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Number of participants who experienced a clinical laboratory test abnormality during the course of the study.
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Timepoint [6]
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from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)
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Primary outcome [7]
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Number of Participants With a Vital Sign Abnormality or Other Safety Biomarkers
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Assessment method [7]
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Number of participants who experienced a vital sign abnormality or other safety biomarkers during the course of the study.
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Timepoint [7]
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from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)
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Secondary outcome [1]
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Objective Response Rate (ORR)
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Assessment method [1]
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ORR is defined as the proportion of all treated participants whose BOR is either CR or PR. BOR was determined by investigators for the reported data. Estimate of ORR and corresponding 2-sided exact 95% CI using the Clopper-Pearson method
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Timepoint [1]
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at Weeks 8, 16 and 24
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Secondary outcome [2]
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Disease Control Rate (DCR)
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Assessment method [2]
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DCR includes complete response (CR), partial response (PR), and stable disease (SD). Estimate of DCR and corresponding 2-sided exact 95% CI using the Clopper-Pearson method
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Timepoint [2]
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at Weeks 8, 16 and 24
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Secondary outcome [3]
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Median Duration of Response (mDOR)
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Assessment method [3]
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DOR for a participant with a BOR of CR or PR is defined as the time between the date of first response and the date of the first objectively documented tumor progression per RECIST v1.1/PCWG3 or death, whichever occurs first. Estimate by the Kaplan-Meier method and corresponding 2-sided 95% CI using Brookmeyer and Crowley methodology (using log-log transformation)
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Timepoint [3]
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at Weeks 8, 16 and 24
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Secondary outcome [4]
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Median Progression-Free Survival (mPFS)
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Assessment method [4]
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PFS for a participant is defined as the time from the first dosing date to the date of first objectively documented disease progression or death due to any cause, whichever occurs first. Estimate by the Kaplan-Meier method and corresponding 2-sided 95% CI using Brookmeyer and Crowley methodology (using log-log transformation) for the median and Greenwood formula for the rate.
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Timepoint [4]
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at Weeks 8, 16 and 24, to progression
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Secondary outcome [5]
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Progression-Free Survival Rate (PFSR)
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Assessment method [5]
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PFS for a participant is defined as the time from the first dosing date to the date of first objectively documented disease progression or death due to any cause, whichever occurs first. Estimate by the Kaplan-Meier method and corresponding 2-sided 95% CI using Brookmeyer and Crowley methodology (using log-log transformation) for the median and Greenwood formula for the rate.
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Timepoint [5]
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at Weeks 8, 16 and 24
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Secondary outcome [6]
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Cmax
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Assessment method [6]
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Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. Cmax is defined as the maximum observed blood concentration.
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Timepoint [6]
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Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits
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Secondary outcome [7]
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Tmax
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Assessment method [7]
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Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. Tmax is defined as the time of maximum observed blood concentration.
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Timepoint [7]
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Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits
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Secondary outcome [8]
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AUC(0-T)
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Assessment method [8]
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Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. AUC(0-T) is the area under the blood concentration-time curve from time zero to time of last quantifiable concentration.
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Timepoint [8]
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Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits
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Secondary outcome [9]
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AUC(INF)
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Assessment method [9]
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Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. AUC(INF) is the area under the blood concentration-time curve from time zero extrapolated to infinite time.
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Timepoint [9]
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Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits
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Secondary outcome [10]
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T-HALF
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Assessment method [10]
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Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. T-HALF is defined as the apparent terminal half-life.
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Timepoint [10]
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Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits
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Secondary outcome [11]
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CLT
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Assessment method [11]
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Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. CLT is defined as the total body clearance.
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Timepoint [11]
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Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits
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Secondary outcome [12]
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Vss
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Assessment method [12]
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Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. Vss is defined as the volume of distribution at steady-state.
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Timepoint [12]
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Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits
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Secondary outcome [13]
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Vz
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Assessment method [13]
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Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. Vz is defined as the volume of distribution of the elimination phase.
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Timepoint [13]
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Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits
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Secondary outcome [14]
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AUC(0-48)
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Assessment method [14]
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Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. AUC(0-T) is the area under the blood concentration-time curve from time zero to 48 hours postdose
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Timepoint [14]
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Cycle 1 (from time zero to 48 hours postdose)
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Secondary outcome [15]
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AUC(0-8)
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Assessment method [15]
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Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. AUC(0-T) is the area under the blood concentration-time curve from time zero to 8 hours postdose
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Timepoint [15]
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Cycle 1 (from time zero to 8 hours postdose)
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Secondary outcome [16]
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C48
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Assessment method [16]
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Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. C48 is defined as the blood concentration at 48 hours postdose.
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Timepoint [16]
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Cycle 1 at 48 hours postdose
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Secondary outcome [17]
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Css-avg
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Assessment method [17]
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Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. Css-avg is defined as the average blood concentration over a dosing interval at steady state (AUC\[0-48\]/48).
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Timepoint [17]
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Cycle 1 (from time zero to 48 hours postdose)
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Secondary outcome [18]
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AI_AUC
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Assessment method [18]
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Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. AUC accumulation index; ratio of AUC(0-48) on Cycle 1 Day 19 to AUC(0-48) on Cycle 1 Day 15 for monotherapy.
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Timepoint [18]
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Cycle 1 (Day 19, Day 15)
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Secondary outcome [19]
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AI_Cmax
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Assessment method [19]
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Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. Cmax accumulation index; ratio of Cmax on Cycle 1 Day 19 to Cmax on Cycle 1 Day 15 for monotherapy.
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Timepoint [19]
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Cycle 1 (Day 19, Day 15)
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Secondary outcome [20]
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T-HALFeff
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Assessment method [20]
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Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. T-HALFeff is defined as effective elimination half-life that explains the degree of accumulation observed for a specific exposure measure (exposure measure includes AUC, Cmax)
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Timepoint [20]
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Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits
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Secondary outcome [21]
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Ctrough
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Assessment method [21]
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Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. Ctrough is defined as the trough observed blood concentration.
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Timepoint [21]
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Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits
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Secondary outcome [22]
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Number of Participants With a Positive Antibody-Drug-Antibody (ADA) Response
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Assessment method [22]
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Baseline ADA-positive participant is defined as a participant who has an ADA-detected sample at baseline. ADA-positive participant is a participant with at least 1 ADA-positive sample relative to baseline after initiation of the treatment. Frequency distribution of baseline ADA-positive participants and ADA-positive participants after initiation of the treatment
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Timepoint [22]
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Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visits
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Eligibility
Key inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
* Histological or cytological confirmation of metastatic and/or unresectable metastatic colorectal, prostate, pancreatic, breast, ovarian, or urothelial carcinoma with measureable disease for solid tumors per RECIST v1.1 and for prostate carcinoma per PCWG3
* Presence of at least 2 lesions: at least one with measurable disease as defined by RECIST v1.1 for solid tumors and by PCWG3 for prostate carcinoma for response assessment; at least 1 lesion must be accessible for biopsy in addition to the target lesion
* Participants must have received, and then progressed or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting, if such a therapy exists, and have been considered for all other potentially efficacious therapies prior to enrollment
* ECOG performance status less than or equal to 2
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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
* Participants with active central nervous system (CNS) metastases, untreated CNS metastases, or with the CNS as the only site of disease
* Participants with carcinomatous meningitis
* Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study treatment
* Participants with active, known, or suspected autoimmune disease
Other protocol defined inclusion/exclusion criteria could apply
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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
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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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
6/12/2017
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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
22/11/2019
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Sample size
Target
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Accrual to date
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Final
10
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Recruitment in Australia
Recruitment state(s)
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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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South Dakota
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Country [2]
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Canada
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State/province [2]
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Ontario
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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 investigate experimental medication BMS-986277 given alone and in combination with Nivolumab in patients with epithelial cancers.
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Trial website
https://clinicaltrials.gov/study/NCT03363776
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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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
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/76/NCT03363776/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/76/NCT03363776/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT03363776
Download to PDF