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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03110107
Registration number
NCT03110107
Ethics application status
Date submitted
7/04/2017
Date registered
12/04/2017
Date last updated
24/04/2025
Titles & IDs
Public title
First-In-Human Study of Monoclonal Antibody BMS-986218 by Itself and in Combination With Nivolumab in Participants With Advanced Solid Tumors
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Scientific title
Phase 1/2a First-In-Human Study of BMS-986218 Monoclonal Antibody Alone and in Combination With Nivolumab in Advanced Solid Tumors
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Secondary ID [1]
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0
2017-000597-11
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Secondary ID [2]
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0
CA022-001
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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:
Advanced Cancer
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0
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - Ipilimumab
Treatment: Other - BMS-986218
Treatment: Other - Nivolumab
Experimental: Part 1A: Monotherapy (BMS-986218) -
Experimental: Part 1B: Combination Therapy (BMS-986218 + Nivolumab) -
Experimental: Part 2A: Monotherapy (BMS-986218 OR Ipilimumab) -
Experimental: Part 2B: Monotherapy (BMS-986218) -
Experimental: Part 2C: Expansion Combination Therapy (BMS-986218 + Nivolumab) -
Experimental: Part 2D: Expansion Combination Therapy (BMS-986218 + Nivolumab) -
Treatment: Other: Ipilimumab
Specified dose on specified days
Treatment: Other: BMS-986218
Specified dose on specified days
Treatment: Other: Nivolumab
Specified dose on specified days
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Intervention code [1]
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0
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 Adverse Events (AEs)
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Assessment method [1]
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An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
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Timepoint [1]
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From first dose of study medication through 100 days following last dose of study treatment (assessed for an average of 8 months up to a max of approximately 28 months)
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Primary outcome [2]
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Number of Participants With Serious Adverse Events (SAEs)
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Assessment method [2]
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Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization.
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Timepoint [2]
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From first dose of study medication through 100 days following last dose of study treatment (assessed for an average of 8 months up to a max of approximately 28 months)
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Primary outcome [3]
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0
Number of Participants With Adverse Events (AEs) Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria
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Assessment method [3]
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Dose-Limiting Toxicities (DLTs) are effects of a treatment that are serious enough to prevent an increase in dose of that treatment. Grade 1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening, 5=Death Gastrointestinal DLT: * Grade 2 colitis \>5 days * Grade =3 diarrhea/colitis Hepatic DLT: * Grade 4 serum transaminases (AST \& ALT), alkaline phosphatase (ALP), or total bilirubin elevations * Grade 3 serum AST, ALT, or ALP elevations lasting \>5 days or with clinical symptoms or bilirubin \> 2×ULN without cholestasis Hematologic DLT: * Grade 4 neutropenia =7 days * Grade 4 thrombocytopenia Dermatologic DLT: * Grade 4 rash * Grade 3 rash if no improvement after 1-2-week infusion delay Other DLTs: * Grade 2 drug-related uveitis, episcleritis, iritis, eye pain, or blurred vision that doesn't respond to treatment, doesn't improve within the re-treatment period OR requires systemic treatment * Grade 3 drug-related uveitis, episcleritis, iritis, pneumonitis, bronchospasm, or neurologic toxicity
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Timepoint [3]
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From first dose of study medication through 60 days following last dose of study treatment (assessed for an average of 7 months up to a max of approximately 27 months)
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Primary outcome [4]
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Number of Participants With Adverse Events (AEs) Leading to Discontinuation
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Assessment method [4]
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0
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
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Timepoint [4]
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0
From first dose of study medication through 100 days following last dose of study treatment (assessed for an average of 8 months up to a max of approximately 28 months)
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Primary outcome [5]
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Number of Participants Who Died
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Assessment method [5]
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Number of participants who died during the study
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Timepoint [5]
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From randomization (Part 2A and 2B) or first dose (Part 1, 2C and 2D) until study closure (Up to approximately 83 months)
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Primary outcome [6]
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Objective Response Rate (ORR) for Part 2 Only
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Assessment method [6]
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Objective response rate (ORR) is defined as the percent of all treated participants whose best overall response (BOR) is either complete response (CR) or partial response (PR) by Investigator per Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) 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 the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm (Note: The appearance of 1or more new lesions is also considered progression).
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Timepoint [6]
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From the start of the study treatment until disease progression, or the last response recorded, taking into account any requirement for confirmation and censoring rules regarding subsequent therapy (Up to approximately 83 months)
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Primary outcome [7]
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Median Duration of Response (mDOR) for Part 2 Only
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Assessment method [7]
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Duration of response (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 or death, whichever occurs first. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) 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 the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition, the sum must also demonstrate an absolute increase of at least 5mm (Note: The appearance of 1or more new lesions is also considered progression). Based on Kaplan-Meier estimates of duration of response
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Timepoint [7]
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From the date of first dose to the date of the first objectively documented tumor progression, or death, whichever occurs first (Up to approximately 83 months)
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Primary outcome [8]
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Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part 2 Only
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Assessment method [8]
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Progression-free survival (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. Based on Kaplan-Meier estimates of progression-free survival rate Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm (Note: The appearance of 1or more new lesions is also considered progression).
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Timepoint [8]
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0
At 24, 36, and 48 weeks
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Secondary outcome [1]
0
0
Objective Response Rate (ORR) for Part1A and Part1B Only
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Assessment method [1]
0
0
Objective response rate (ORR) is defined as the percent of all treated participants whose best overall response (BOR) is either complete response (CR) or partial response (PR) by Investigator per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) 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 the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm (Note: The appearance of 1or more new lesions is also considered progression).
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Timepoint [1]
0
0
From the start of the study treatment until disease progression, or the last response recorded, taking into account any requirement for confirmation and censoring rules regarding subsequent therapy (Up to approximately 83 months)
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Secondary outcome [2]
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Median Duration of Response (mDOR) for Part1A and Part1B Only
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Assessment method [2]
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0
Duration of response (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 or death, whichever occurs first. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) 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 the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition, the sum must also demonstrate an absolute increase of at least 5mm (Note: The appearance of 1or more new lesions is also considered progression). Based on Kaplan-Meier estimates of duration of response
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Timepoint [2]
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0
From the date of first dose to the date of the first objectively documented tumor progression, or death, whichever occurs first (Up to approximately 83 months)
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Secondary outcome [3]
0
0
Progression-free Survival Rate (PFSR) at 24, 36, and 48 Weeks for Part1A and Part1B Only
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Assessment method [3]
0
0
Progression-free survival (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. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition, the sum must also demonstrate an absolute increase of at least 5mm (Note: The appearance of 1or more new lesions is also considered progression). Based on Kaplan-Meier estimates of progression-free survival rate
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Timepoint [3]
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0
At 24, 36, and 48 weeks
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Secondary outcome [4]
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Maximum Observed Serum Concentration (Cmax) for BMS-986218
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Assessment method [4]
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Cmax is the maximum observed serum concentration for BMS-986218.
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Timepoint [4]
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On Cycle 1 Day 1, Cycle 1 Day 15, Cycle 3 Day 1, Cycle 3 Day 15 (Each Cycle is of 28 Days)
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Secondary outcome [5]
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Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for BMS-986218
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Assessment method [5]
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Tmax is the time taken to reach the maximum observed serum concentration (Cmax) for BMS-986218.
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Timepoint [5]
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On Cycle 1 Day 1, Cycle 1 Day 15, Cycle 3 Day 1, Cycle 3 Day 15 (Each Cycle is of 28 Days)
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Secondary outcome [6]
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Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] for BMS-986218
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Assessment method [6]
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AUC (TAU) is the area measured under the concentration-time curve taken over the dosing interval for BMS-986218.
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Timepoint [6]
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On Cycle 1 Day 1, Cycle 1 Day 15, Cycle 3 Day 1, Cycle 3 Day 15 (Each Cycle is of 28 Days)
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Secondary outcome [7]
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Observed Concentration at the End of a Dosing Interval (Ctau) for BMS-986218
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Assessment method [7]
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Ctau is the observed serum concentration at the end of the dosing interval for BMS-986218.
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Timepoint [7]
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On Cycle 1 Day 1, Cycle 1 Day 15, Cycle 3 Day 1, Cycle 3 Day 15 (Each Cycle is of 28 Days)
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Secondary outcome [8]
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Total Body Clearance (CLT/F) for BMS-986218
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Assessment method [8]
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Timepoint [8]
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At Cycle 3 Day 1 (Each Cycle is of 28 Days)
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Secondary outcome [9]
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Average Concentration Over a Dosing Interval (AUC[TAU]/Tau) at Steady State (Css-avg) for BMS-986218
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Assessment method [9]
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Timepoint [9]
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At Cycle 3 Day 1 (Each Cycle is of 28 Days)
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Secondary outcome [10]
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Ratio of an Exposure Measure at Steady State to That After the First Dose (Exposure Measure Includes Cmax) (AI_Cmax) for BMS-986218
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Assessment method [10]
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Timepoint [10]
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At Cycle 3 Day 1 (Each Cycle is of 28 Days)
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Secondary outcome [11]
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Accumulation Index Ratio of AUC at Steady State to That After the First Dose (AI_AUC) for BMS-986218
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Assessment method [11]
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Timepoint [11]
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At Cycle 3 Day 1 (Each Cycle is of 28 Days)
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Secondary outcome [12]
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Terminal Serum Half-life (T-HALF) for BMS-986218
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Assessment method [12]
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Timepoint [12]
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At Cycle 3 Day 1 (Each Cycle is of 28 Days)
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Secondary outcome [13]
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Time of Maximum Observed Concentration (Tmax) for BMS-986218
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Assessment method [13]
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Tmax is the time taken to reach the maximum observed serum concentration (Cmax) for BMS-986218.
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Timepoint [13]
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On Cycle 1 Day 1, Cycle 1 Day 15, Cycle 3 Day 1, Cycle 3 Day 15 (Each Cycle is of 28 Days)
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Secondary outcome [14]
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Trough Observed Plasma Concentration (Ctrough) for BMS-986218
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Assessment method [14]
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Ctrough is the lowest observed serum concentration for BMS-986218.
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Timepoint [14]
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At Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Cycle 3 Day 1, Cycle 3 Day 15, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 7 Day 1, Cycle 9 Day 1, Cycle 13 Day 1, Cycle 17 Day 1, Cycle 21 Day 1 (Each Cycle is of 28 Days)
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Secondary outcome [15]
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Number of Participants With Anti-drug Antibodies (ADA) to BMS-986218
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Assessment method [15]
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Baseline ADA Positive: Participant with baseline ADA-positive sample ADA Positive: Participant with at least one ADA-positive sample relative to baseline (ADA negative at baseline or ADA titer to be at least 4-fold or greater (\>=) than baseline positive titer) at any time after initiation of treatment Persistent Positive (PP): ADA-positive sample at 2 or more consecutive timepoints, where the first and last ADA-positive samples are at least 16weeks apart Not PP-Last Sample Positive: Not persistent but with ADA-positive sample at the last sampling timepoint Other Positive: Not persistent but some ADA-positive samples with the last sample being negative ADA Negative: Participant with no ADA-positive sample after initiation of treatment
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Timepoint [15]
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From first dose of study medication through 100 days following last dose of study treatment (assessed for an average of 8 months up to a max of approximately 28 months)
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Eligibility
Key inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
* Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent and/or unresectable)
* Eastern Cooperative Oncology Group Performance Status of 0 or 1
* Participants must have received, and then progressed, relapsed, or been intolerant to at least 2 standard treatment regimens with proven survival benefit in the advanced or metastatic setting according to tumor type, if such a therapy exists
* Advanced stage cutaneous melanoma who have received standard therapies with proven survival benefit including prior immunotherapy with an anti-programmed cell death 1 (anti-PD-1) or anti-programmed death ligand 1 (anti-PD-L1) (For Part 2A)
* Non-small cell lung cancer (NSCLC) (adenocarcinoma or squamous cell carcinoma) who have received standard therapies with proven survival benefit including prior immunotherapy with an anti-PD-1 or anti-PD-L1 (For Parts 2B & 2C)
* Microsatellite Stable Colorectal Cancer (MSS CRC) who have received standard therapies with proven survival benefit (Part 2D)
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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 primary CNS malignancies, or tumors with CNS metastases as the only site of disease, will be excluded
* Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy
* Prior anti-cancer treatments such as chemotherapy, radiotherapy, hormonal, or immunotherapy (including anti-PD-1/PD-L1) are permitted
Other protocol-defined inclusion/exclusion criteria apply
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled 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
4/05/2017
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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
4/04/2024
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Sample size
Target
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Accrual to date
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Final
376
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Recruitment in Australia
Recruitment state(s)
NSW,WA
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Recruitment hospital [1]
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Local Institution - 0026 - Northmead
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Recruitment hospital [2]
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0
Local Institution - 0006 - Wollstonecraft
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Recruitment hospital [3]
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0
Local Institution - 0049 - Murdoch
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Recruitment postcode(s) [1]
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0
2152 - Northmead
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Recruitment postcode(s) [2]
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0
2065 - Wollstonecraft
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Recruitment postcode(s) [3]
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6150 - Murdoch
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Georgia
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Massachusetts
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Country [3]
0
0
United States of America
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State/province [3]
0
0
New Jersey
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Country [4]
0
0
United States of America
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State/province [4]
0
0
New York
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Pennsylvania
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Country [6]
0
0
United States of America
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State/province [6]
0
0
South Dakota
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Country [7]
0
0
Argentina
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State/province [7]
0
0
Buenos Aires
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Country [8]
0
0
Argentina
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State/province [8]
0
0
Ciudad Autónoma De Buenos Aires
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Country [9]
0
0
Argentina
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State/province [9]
0
0
Cordoba
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Country [10]
0
0
Argentina
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State/province [10]
0
0
Distrito Federal
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Country [11]
0
0
Belgium
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State/province [11]
0
0
Gent
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Country [12]
0
0
Canada
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State/province [12]
0
0
Alberta
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Country [13]
0
0
Canada
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State/province [13]
0
0
British Columbia
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Country [14]
0
0
Canada
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State/province [14]
0
0
Ontario
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Country [15]
0
0
Chile
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State/province [15]
0
0
Metropolitana
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Country [16]
0
0
Chile
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State/province [16]
0
0
Valparaiso
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Country [17]
0
0
Finland
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State/province [17]
0
0
Helsinki
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Country [18]
0
0
France
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State/province [18]
0
0
Lyon Cedex 08
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Country [19]
0
0
France
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State/province [19]
0
0
Toulouse Cedex 9
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Country [20]
0
0
France
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State/province [20]
0
0
Villejuif
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Country [21]
0
0
Germany
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State/province [21]
0
0
Dresden
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Country [22]
0
0
Germany
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State/province [22]
0
0
Essen
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Country [23]
0
0
Israel
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State/province [23]
0
0
Haifa
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Country [24]
0
0
Israel
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State/province [24]
0
0
Ramat Gan
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Country [25]
0
0
Italy
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State/province [25]
0
0
Napoli
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Country [26]
0
0
Italy
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State/province [26]
0
0
Rozzano
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Country [27]
0
0
Italy
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State/province [27]
0
0
Siena
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Country [28]
0
0
Netherlands
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State/province [28]
0
0
Amsterdam
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Country [29]
0
0
Netherlands
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State/province [29]
0
0
Nijmegen
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Country [30]
0
0
Norway
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State/province [30]
0
0
Oslo
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Country [31]
0
0
Poland
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State/province [31]
0
0
Warszawa
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Country [32]
0
0
Romania
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State/province [32]
0
0
Cluj Napoca
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Country [33]
0
0
Romania
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State/province [33]
0
0
Craiova
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Country [34]
0
0
Spain
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State/province [34]
0
0
Barcelona
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Country [35]
0
0
Spain
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State/province [35]
0
0
Madrid
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Country [36]
0
0
Spain
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State/province [36]
0
0
Malaga
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Country [37]
0
0
Spain
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State/province [37]
0
0
Pamplona
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Country [38]
0
0
Switzerland
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State/province [38]
0
0
Lausanne
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Country [39]
0
0
Switzerland
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State/province [39]
0
0
Zuerich
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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 whether BMS-986218 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of advanced solid tumors.
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Trial website
https://clinicaltrials.gov/study/NCT03110107
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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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0
Bristol Myers Squibb
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Address
0
0
Bristol-Myers Squibb
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
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Address
0
0
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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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
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/07/NCT03110107/Prot_SAP_000.pdf
Statistical analysis plan
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/07/NCT03110107/Prot_SAP_000.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT03110107
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