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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04157517
Registration number
NCT04157517
Ethics application status
Date submitted
6/11/2019
Date registered
8/11/2019
Titles & IDs
Public title
A Study of Modakafusp Alfa (TAK-573) Given by Itself and Together With Pembrolizumab in Adults With Advanced or Metastatic Solid Tumors
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Scientific title
An Open-Label, Dose-Escalation Phase 1b/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of Modakafusp Alfa (TAK-573) as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Advanced or Metastatic Solid Tumors
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Secondary ID [1]
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U1111-1238-9163
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Secondary ID [2]
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TAK-573-1001
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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:
Neoplasms
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0
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Melanoma
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0
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Condition category
Condition code
Cancer
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0
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Malignant melanoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Modakafusp Alfa
Treatment: Drugs - Pembrolizumab
Experimental: Phase 1b SA Dose Escalation - Modakafusp alfa 0.1 to 6 milligram per kilogram (mg/kg), infusion, intravenously, once on Day 1 of each 21-days treatment cycle for up to 1 year.
Experimental: Phase 2 Safety Lead-in Dose Expansion: Modakafusp Alfa + Pembrolizumab - Melanoma with primary resistance to prior anti-PD1, acquired resistance to prior anti-PD1 or naïve to anti-PD1.
Modakafusp alfa, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once every 6 weeks for up to 2 years. The starting dose of modakafusp alfa for dose expansion safety lead-in phase will be the RP2D determined in the previous Phase 1b dose escalation phase.
Experimental: Phase 2 Dose Expansion: Modakafusp Alfa + Pembrolizumab (Melanoma With Primary Resistance) - Melanoma With Primary Resistance to prior anti-PD1. Modakafusp alfa, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once every 6 weeks for up to 2 years, in participants with unresectable/metastatic cutaneous melanoma with primary resistance to no more than 2 prior lines of anti-PD1 containing treatments in the metastatic setting. The dose of modakafusp alfa for dose expansion phase will be the modakafusp alfa RP2D in combination with pembrolizumab determined in the previous Phase 2 dose expansion safety-lead in phase.
Experimental: Phase 2 Dose Expansion: Modakafusp Alfa + Pembrolizumab (Melanoma With Acquired Resistance) - Melanoma With Acquired Resistance to prior anti-PD1. Modakafusp alfa, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once every 6 weeks for up to 2 years, in participants with unresectable/metastatic cutaneous melanoma with acquired resistance to no more than 2 prior lines of anti-PD1 containing treatments in the metastatic setting. The dose of modakafusp alfa for dose expansion phase will be the modakafusp alfa RP2D in combination with pembrolizumab determined in the previous Phase 2 dose expansion safety lead-in phase.
Experimental: Phase 2 Dose Expansion: Modakafusp Alfa + Pembrolizumab (Melanoma naïve to anti-PD1) - Modakafusp alfa, infusion, intravenously, once on Day 1 of each 21-days treatment cycle and pembrolizumab 400 mg infusion, intravenously, once every 6 weeks for up to 2 years, in participants with unresectable/metastatic cutaneous melanoma naive to prior line of anti-PD1 containing treatments in the metastatic setting. The dose of modakafusp alfa for dose expansion phase will be the modakafusp alfa RP2D in combination with pembrolizumab determined in the previous Phase 2 dose expansion safety lead-in phase.
Treatment: Drugs: Modakafusp Alfa
Modakafusp alfa intravenous infusion.
Treatment: Drugs: Pembrolizumab
Pembrolizumab intravenous infusion.
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Intervention code [1]
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Treatment: Drugs
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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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Phase 1b and Phase 2 Safety Lead-in: Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs)
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Assessment method [1]
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AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. A TEAE is any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days (90 days for immune-related adverse event \[irAE\]) of the last administration of study drug.
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Timepoint [1]
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Up to 55 months
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Primary outcome [2]
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Phase 1b and Phase 2 Safety Lead-in: Number of Participants with Grade 3 or Higher TEAEs
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Assessment method [2]
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TEAEs Grades will be evaluated as per the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0. (NCI CTCAE v5).
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Timepoint [2]
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0
Up to 55 months
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Primary outcome [3]
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Phase 1b and Phase 2 Safety Lead-in: Number of Participants With Dose Limiting Toxicities (DLTs)
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Assessment method [3]
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DLT will be defined as any of the TEAEs that occur during Cycle 1 and are considered by the investigator to be at least possibly related to modakafusp alfa. Toxicity will be evaluated according to NCI CTCAE v5.
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Timepoint [3]
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0
Cycle 1 (Cycle length is equal to [=] 21 days)
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Primary outcome [4]
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Phase 1b and Phase 2 Safety Lead-in: Number of Participants Reporting one or More Serious Adverse Event (SAEs)
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Assessment method [4]
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SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect or is considered to be an important medical event that may not result in death, be immediately life-threatening, or require hospitalization but may be considered serious when, based on appropriate medical judgment, the event may jeopardize the participant or may require medical or surgical intervention.
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Timepoint [4]
0
0
Up to 55 months
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Primary outcome [5]
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Phase 1b and Phase 2 Safety Lead-in: Number of Participants With one or More TEAEs Leading to Dose Modifications and Treatment Discontinuations
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Assessment method [5]
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TEAE is defined as any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days (90 days for irAE) of the last administration of study drug.
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Timepoint [5]
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0
Up to 55 months
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Primary outcome [6]
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Phase 2 Expansion: Overall Response Rate (ORR)
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Assessment method [6]
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ORR is defined as the percentage of participants who achieve complete response (CR) or partial response (PR) during the study in response-evaluable population. ORR will be assessed as per Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1 for melanoma participants.
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Timepoint [6]
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Up to 55 months
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Secondary outcome [1]
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Phase 1b: Maximum Tolerated Dose (MTD) or Pharmacologically Active Dose (PAD)
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Assessment method [1]
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Timepoint [1]
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Cycle 1 (Cycle length is equal to [=] 21 days)
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Secondary outcome [2]
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Phase 1b and Phase 2 Safety Lead-in: Recommended Phase 2 Dose (RP2D) for Single Agent (SA) and in Combination With Pembrolizumab
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Assessment method [2]
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The RP2D may be either MTD based on dose limiting toxicities or a pharmacologically active dose defined by the PK/pharmacodynamic model or exposure-response (ER) analysis in place.
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Timepoint [2]
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Cycle 1 (Cycle length is equal to [=] 21 days)
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Secondary outcome [3]
0
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Phase 2 Expansion: Number of Participants Reporting one or More TEAEs
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Assessment method [3]
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TEAE is defined as any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days (90 days for irAE) of the last administration of study drug.
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Timepoint [3]
0
0
Up to 55 months
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Secondary outcome [4]
0
0
Phase 2 Expansion: Number of Participants With Grade 3 or Higher TEAEs
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Assessment method [4]
0
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TEAEs Grades will be evaluated as per the NCI CTCAE v5.
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Timepoint [4]
0
0
Up to 55 months
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Secondary outcome [5]
0
0
Phase 2 Expansion: Number of Participants Reporting one or More SAEs
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Assessment method [5]
0
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SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect or is considered to be an important medical event that may not result in death, be immediately life-threatening, or require hospitalization but may be considered serious when, based on appropriate medical judgment, the event may jeopardize the participant or may require medical or surgical intervention.
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Timepoint [5]
0
0
Up to 55 months
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Secondary outcome [6]
0
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Phase 2 Expansion: Number of Participants With one or More TEAEs Leading to Dose Modifications and Treatment Discontinuations
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Assessment method [6]
0
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TEAE is defined as any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days (90 days for irAE) of the last administration of study drug.
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Timepoint [6]
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0
Up to 55 months
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Secondary outcome [7]
0
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Phase 1b and Phase 2 Safety Lead-in: Cmax: Maximum Observed Serum Concentration for Modakafusp Alfa
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Assessment method [7]
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Timepoint [7]
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Phase 1b (Cycles 1-2) and Phase 2 (Cycle 1 and Cycle 3) Day 1: predose, at multiple timepoints (up to 72 hours (hrs) or up to 6 hrs (Phase 1b, Cycles 3-6) or up to 24 hrs (Phase 2, Cycle 2 and Cycle 4 onwards) postdose (cycle length=21 days)
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Secondary outcome [8]
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Phase 1b and Phase 2 Safety Lead-in: Tmax: Time to Reach the Maximum Serum Concentration (Cmax) for Modakafusp Alfa
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Assessment method [8]
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0
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Timepoint [8]
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Phase 1b (Cycles 1-2) and Phase 2 (Cycle 1 and Cycle 3) Day 1: predose, at multiple timepoints (up to 72 hours (hrs) or up to 6 hrs (Phase 1b, Cycles 3-6) or up to 24 hrs (Phase 2, Cycle 2 and Cycle 4 onwards) postdose (cycle length=21 days)
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Secondary outcome [9]
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Phase 1b and Phase 2 Safety Lead-in: AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to Time t for Modakafusp Alfa
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Assessment method [9]
0
0
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Timepoint [9]
0
0
Phase 1b (Cycles 1-2) and Phase 2 (Cycle 1 and Cycle 3) Day 1: predose, at multiple timepoints (up to 72 hours (hrs) or up to 6 hrs (Phase 1b, Cycles 3-6) or up to 24 hrs (Phase 2, Cycle 2 and Cycle 4 onwards) postdose (cycle length=21 days)
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Secondary outcome [10]
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0
Phase 1b and Phase 2 Safety Lead-in: AUCinf: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for Modakafusp Alfa
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Assessment method [10]
0
0
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Timepoint [10]
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Phase 1b (Cycles 1-2) and Phase 2 (Cycle 1 and Cycle 3) Day 1: predose, at multiple timepoints (up to 72 hours (hrs) or up to 6 hrs (Phase 1b, Cycles 3-6) or up to 24 hrs (Phase 2, Cycle 2 and Cycle 4 onwards) postdose (cycle length=21 days)
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Secondary outcome [11]
0
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Phase 1b and Phase 2 Safety Lead-in: t1/2z: Terminal Disposition Phase Half-life for Modakafusp Alfa
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Assessment method [11]
0
0
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Timepoint [11]
0
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Phase 1b (Cycles 1-2) and Phase 2 (Cycle 1 and Cycle 3) Day 1: predose, at multiple timepoints (up to 72 hours (hrs) or up to 6 hrs (Phase 1b, Cycles 3-6) or up to 24 hrs (Phase 2, Cycle 2 and Cycle 4 onwards) postdose (cycle length=21 days)
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Secondary outcome [12]
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Phase 1b and Phase 2 Safety Lead-in: CL: Total Clearance After Intravenous Administration for Modakafusp Alfa
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Assessment method [12]
0
0
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Timepoint [12]
0
0
Phase 1b (Cycles 1-2) and Phase 2 (Cycle 1 and Cycle 3) Day 1: predose, at multiple timepoints (up to 72 hours (hrs) or up to 6 hrs (Phase 1b, Cycles 3-6) or up to 24 hrs (Phase 2, Cycle 2 and Cycle 4 onwards) postdose (cycle length=21 days)
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Secondary outcome [13]
0
0
Phase 1b and Phase 2 Safety Lead-in: Vss: Volume of Distribution at Steady State for Modakafusp Alfa
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Assessment method [13]
0
0
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Timepoint [13]
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0
Phase 1b (Cycles 1-2) and Phase 2 (Cycle 1 and Cycle 3) Day 1: predose, at multiple timepoints (up to 72 hours (hrs) or up to 6 hrs (Phase 1b, Cycles 3-6) or up to 24 hrs (Phase 2, Cycle 2 and Cycle 4 onwards) postdose (cycle length=21 days)
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Secondary outcome [14]
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Phase 1b: Overall Response Rate (ORR)
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Assessment method [14]
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ORR is defined as the percentage of participants who achieve CR or PR during the study in response-evaluable population. ORR will be assessed as per RECIST v1.1. for participants in dose escalation.
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Timepoint [14]
0
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Up to 55 months
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Secondary outcome [15]
0
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Phase 1b and Phase 2: Disease Control Rate (DCR)
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Assessment method [15]
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DCR is defined as the percentage of participants who achieve CR, PR, or stable disease (SD) (determined by the investigator) during the study in response-evaluable population. The DCR will be assessed as per RECIST v1.1.
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Timepoint [15]
0
0
Up to 55 months
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Secondary outcome [16]
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Phase 1b and Phase 2: Duration of Response (DOR)
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Assessment method [16]
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DOR is the time from the date of first documentation of a PR or better to the date of first documentation of PD for responders (PR or better). Responders without documentation of PD will be censored at the date of last response assessment that is SD or better. DOR will be assessed as per RECIST v1.1.
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Timepoint [16]
0
0
Up to 55 months
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Secondary outcome [17]
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Phase 1b and Phase 2: Time to Progression (TTP)
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Assessment method [17]
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TTP is defined as the time from the date of the first dose of study drug to the date of the first documentation of PD according to RECIST v1.1.
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Timepoint [17]
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Up to 55 months
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Secondary outcome [18]
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Phase 1b and Phase 2: Progression Free Survival (PFS)
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Assessment method [18]
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PFS is defined as the time from the date of the first dose of study drug to the date of first documentation of progressive disease according to RECIST v.1.1, or death due to any cause, whichever occurs first. Participants without documentation of PD or death will be censored at the date of the last response assessment that is SD or better.
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Timepoint [18]
0
0
Up to 55 months
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Secondary outcome [19]
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Phase 1b and Phase 2: Overall Survival (OS)
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Assessment method [19]
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OS is defined as the time from the date of first dose of study drug to the date of death due to any cause. Participants without documentation of death at the time of analysis will be censored at the date last known to be alive. OS will be assessed as per RECIST v1.1.
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Timepoint [19]
0
0
Up to 55 months
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Secondary outcome [20]
0
0
Phase 2 Expansion: ORR Based on Immune Response Evaluation Criteria in Solid Tumors (iRECIST)
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Assessment method [20]
0
0
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Timepoint [20]
0
0
Up to 55 months
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Secondary outcome [21]
0
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Phase 2 Expansion: DCR Based on iRECIST
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Assessment method [21]
0
0
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Timepoint [21]
0
0
Up to 55 months
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Secondary outcome [22]
0
0
Phase 2 Expansion: DOR Based on iRECIST
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Assessment method [22]
0
0
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Timepoint [22]
0
0
Up to 55 months
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Secondary outcome [23]
0
0
Phase 2 Expansion: TTP Based on iRECIST
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Assessment method [23]
0
0
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Timepoint [23]
0
0
Up to 55 months
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Secondary outcome [24]
0
0
Phase 2 Expansion: PFS Based on iRECIST
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Assessment method [24]
0
0
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Timepoint [24]
0
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Up to 55 months
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Secondary outcome [25]
0
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Phase 1b and Phase 2: Number of Participants With Anti-Modakafusp Alfa Antibodies
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Assessment method [25]
0
0
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Timepoint [25]
0
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Up to 55 months
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Secondary outcome [26]
0
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Phase 1b and Phase 2: Titer of Anti-Modakafusp Alfa Antibodies
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Assessment method [26]
0
0
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Timepoint [26]
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Up to 55 months
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Eligibility
Key inclusion criteria
1. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
2. For both the dose escalation and expansion cohort phases of the study, eligible participants must have histologically confirmed advanced (locoregionally recurrent, not amenable to curative therapy) or metastatic solid tumors.
3. Measurable disease per RECIST v1.1. At least 1 target lesion amenable for biopsy is required for enrollment in phase 1b. A minimum of 1 target lesion for response assessment is required for enrollment in phase 2. A separate lesion amenable for biopsy is required for enrollment in phase 2 for cohorts I and II post futility analysis and for all participants (safety lead-in and expansion) with subgroup III melanoma.
4. Phase 1b Dose Escalation: Participants with histologically confirmed advanced locally (locoregionally recurrent, not amenable to curative therapy) or metastatic solid tumors.
Phase 2 Dose Expansion:
The combination cohorts, including participants in the safety-lead phase, will enroll participants with unresectable/metastatic melanoma in the following subgroups:
I. Unresectable/metastatic histologically confirmed cutaneous melanoma with primary resistance to no more than 2 prior lines of anti-PD1 containing treatments in the metastatic setting.
II. Unresectable/metastatic histologically confirmed cutaneous melanoma with acquired resistance to no more than 2 prior lines of anti-PD1 containing treatments in the metastatic setting.
III. Unresectable/metastatic histologically confirmed cutaneous melanoma naive to prior anti-PD1 containing treatments in the metastatic setting.
* Participants with BRAF V600E mutant melanoma may have received prior BRAF inhibitor therapy.
* For the expansion cohorts I and II, there is no limitation of total number of prior line(s) of therapy, but the number of prior line(s) containing anti-PD1 must be =2 in the metastatic setting.
* For the expansion cohort III, participants who received an anti-PD-1 treatment in the adjuvant setting must have completed that treatment at least 6 months prior to enrollment and must not have progressed on the anti-PD1 adjuvant treatment.
* Primary resistance is defined as a best response of PD or SD less than (<) 6 months to an anti-PD1 alone or in combination with other agents (that is, CTLA4) in the initial anti-PD1 containing treatment.
* Acquired resistance is defined as a progression following a best response of CR, PR or SD>6 months to a prior anti-PD1 alone or in combination with other agents (that is, CTLA4).
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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
1. Persistent toxicity from previous treatments that has not resolved to less than or equal to (<=) CTCAE version 5.0 Grade 1 prior to administration of modakafusp alfa, except for alopecia, Grade 2 neuropathy, and Grade 2 asthenia/fatigue, or autoimmune endocrinopathies with stable replacement therapy.
2. History of any of the following <=6 months before first dose modakafusp alfa: New York Heart Association (NYHA) Grade III or IV congestive heart failure, unstable angina, myocardial infarction, unstable symptomatic ischemic heart disease, any ongoing symptomatic cardiac arrhythmias of Grade >2, pulmonary embolism, or symptomatic cerebrovascular events, or any other serious cardiac condition (example, symptomatic pericardial effusion or restrictive cardiomyopathy). Chronic, stable atrial fibrillation on stable anticoagulant therapy, including low molecular-weight heparin, is allowed.
3. Baseline QT interval with Fridericia's correction (QTcF) greater than (>) 480 millisecond (msec) (Grade >=2), history of congenital long QT syndrome, or torsades de pointes.
4. Patients with acral lentiginous melanoma are excluded in phase 2 except for the safety lead-in phase.
5. Ongoing or active infection.
6. Known history of human immunodeficiency virus (HIV) infection or any other relevant congenital or acquired immunodeficiency. Testing during screening period is required only if indicated by specific local regulations or investigator's criteria.
7. Known hepatitis B (HBV) surface antigen seropositive or detectable hepatitis C infection viral load. Note: Participants with a positive HBV core antibody can be enrolled but must have an undetectable hepatitis B viral load.
8. Autoimmune disease requiring systemic immunosuppressive therapy. Participants with immune mediated endocrine deficiency from previous therapy with stable hormone replacement are exceptions.
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Study design
Purpose of the study
Other
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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
Other
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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
Completed
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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
12/12/2019
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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
4/11/2023
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Sample size
Target
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Accrual to date
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Final
45
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Recruitment in Australia
Recruitment state(s)
SA,VIC
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Recruitment hospital [1]
0
0
The Queen Elizabeth Hospital - Woodville South
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Recruitment hospital [2]
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0
Ballarat Regional Integrated Cancer Center - Ballarat
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Recruitment postcode(s) [1]
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0
5011 - Woodville South
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Recruitment postcode(s) [2]
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0
3350 - Ballarat
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
California
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Colorado
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Florida
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Country [4]
0
0
United States of America
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State/province [4]
0
0
New Hampshire
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Country [5]
0
0
United States of America
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State/province [5]
0
0
New Jersey
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Ohio
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Pennsylvania
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Country [8]
0
0
United States of America
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State/province [8]
0
0
South Dakota
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Tennessee
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Country [10]
0
0
United States of America
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State/province [10]
0
0
Texas
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Country [11]
0
0
United States of America
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State/province [11]
0
0
Utah
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Country [12]
0
0
United States of America
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State/province [12]
0
0
West Virginia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Takeda
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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
This study has 2 phases. The main aims of Phase 1b are: * to check for side effects from modakafusp alfa in adults with locally advanced or metastatic solid tumors. * to learn how much modakafusp alfa adults can receive without getting any major side effects from it. The main aims of Phase 2 are: * to check for side effects from modakafusp alfa when given together with pembrolizumab in adults with metastatic cutaneous melanoma which cannot be completely removed by surgery. * to learn how these medicines improve their symptoms. Participants will receive modakafusp alfa for up to 1 year (Phase 1b) or modakafusp alfa given together with pembrolizumab for up to 2 years (Phase 2). Those whose symptoms improve might continue treatment for longer. In both phases of the study, participants will revisit the study clinic within 30 days after their last dose or before they start other cancer treatment, whichever happens first.
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Trial website
https://clinicaltrials.gov/study/NCT04157517
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Study Director
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Address
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Takeda
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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
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
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When will data be available (start and end dates)?
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Available to whom?
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/takeda/
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04157517