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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05590377
Registration number
NCT05590377
Ethics application status
Date submitted
19/10/2022
Date registered
21/10/2022
Titles & IDs
Public title
A Study of Modakafusp Alfa Together With Daratumumab Adults With Relapsed or Refractory Multiple Myeloma
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Scientific title
A Phase 1/2a Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Modakafusp Alfa in Combination With Daratumumab Subcutaneous in Patients With Relapsed or Refractory Multiple Myeloma
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Secondary ID [1]
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0
2022-002169-14
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Secondary ID [2]
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TAK-573-2001
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Universal Trial Number (UTN)
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Trial acronym
iinnovate-3
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma
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Condition category
Condition code
Cancer
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0
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Other cancer types
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Modakafusp Alfa
Treatment: Drugs - Daratumumab
Experimental: Phase 1 Dose Escalation - Modakafusp alfa 60 to 240 mg, infusion, intravenously, once every 4 weeks (Q4W) with daratumumab 1800 mg, subcutaneously (SC), once weekly (QW) in Cycles 1 and 2, twice weekly (Q2W) in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression.
Experimental: Phase 2a Dose Finding: Modakafusp Alfa (DL1) + Daratumumab - Modakafusp alfa at dose level 1 (DL1) \[selected from Phase 1 Dose Escalation\] with daratumumab SC 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression.
Experimental: Phase 2a Dose Finding: Modakafusp Alfa (DL2) + Daratumumab - Modakafusp alfa at dose level 2 (DL2) \[selected from Phase 1 Dose Escalation\] with daratumumab SC 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression.
Treatment: Drugs: Modakafusp Alfa
Modakafusp alfa intravenous infusion
Treatment: Drugs: Daratumumab
Daratumumab SC injection
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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 1: Number of Participants with Dose Limiting Toxicities (DLT)
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Assessment method [1]
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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 National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0.
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Timepoint [1]
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Cycle 1 (cycle length=28 days)
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Primary outcome [2]
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Phase 1: Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs) and Per Severity
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Assessment method [2]
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An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. Severity grades for TEAEs will be evaluated as per the NCI CTCAE Version 5.0.
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Timepoint [2]
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Up to 60 months
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Primary outcome [3]
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Phase 2a: Overall Response Rate (ORR)
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Assessment method [3]
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ORR is defined as the percentage of participants who achieve a confirmed partial response (PR) or better during the study in the safety population. ORR will be assessed by the investigator per International Myeloma Working Group (IMWG) criteria.
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Timepoint [3]
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Up to 60 months
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Secondary outcome [1]
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Phase 1: Cmax: Single-Dose Maximum Observed Serum Concentration for Modakafusp Alfa
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Assessment method [1]
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Timepoint [1]
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Days 1, 8, 15, and 22 of Cycles 1 and 2: Pre-dose, and at multiple time points up to 4 hours post-dose; Day 2 of Cycles 1 and 2: Post-dose (cycle length=28 days)
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Secondary outcome [2]
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Phase 1: Tmax: Time to First Occurrence of Maximum Serum Concentration (Cmax) for Modakafusp Alfa
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Assessment method [2]
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Timepoint [2]
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Days 1, 8, 15, and 22 of Cycles 1 and 2: Pre-dose, and at multiple time points up to 4 hours post-dose; Day 2 of Cycles 1 and 2: Post-dose (cycle length=28 days)
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Secondary outcome [3]
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Phase 1: AUC8: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for Modakafusp Alfa
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Assessment method [3]
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Timepoint [3]
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Days 1, 8, 15, and 22 of Cycles 1 and 2: Pre-dose, and at multiple time points up to 4 hours post-dose; Day 2 of Cycles 1 and 2: Post-dose (cycle length=28 days)
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Secondary outcome [4]
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Phase 1: AUClast: Area Under the Serum Concentration-time Curve from Time 0 to Time of the Last Quantifiable Concentration
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Assessment method [4]
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Timepoint [4]
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Days 1, 8, 15, and 22 of Cycles 1 and 2: Pre-dose, and at multiple time points up to 4 hours post-dose; Day 2 of Cycles 1 and 2: Post-dose (cycle length=28 days)
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Secondary outcome [5]
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Phase 1: Apparent Serum Terminal Disposition Rate Constant for Modakafusp Alfa
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Assessment method [5]
0
0
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Timepoint [5]
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Days 1, 8, 15, and 22 of Cycles 1 and 2: Pre-dose, and at multiple time points up to 4 hours post-dose; Day 2 of Cycles 1 and 2: Post-dose (cycle length=28 days)
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Secondary outcome [6]
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Phase 1: Apparent Serum Terminal Disposition Phase Half-life for Modakafusp Alfa
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Assessment method [6]
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Timepoint [6]
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Days 1, 8, 15, and 22 of Cycles 1 and 2: Pre-dose, and at multiple time points up to 4 hours post-dose; Day 2 of Cycles 1 and 2: Post-dose (cycle length=28 days)
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Secondary outcome [7]
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Phase 1: Total Clearance After Intravenous Administration for Modakafusp Alfa
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Assessment method [7]
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Timepoint [7]
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Days 1, 8, 15, and 22 of Cycles 1 and 2: Pre-dose, and at multiple time points up to 4 hours post-dose; Day 2 of Cycles 1 and 2: Post-dose (cycle length=28 days)
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Secondary outcome [8]
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Phase 1: Volume of Distribution at Steady State After Intravenous Administration for Modakafusp Alfa
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Assessment method [8]
0
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Timepoint [8]
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Days 1, 8, 15, and 22 of Cycles 1 and 2: Pre-dose, and at multiple time points up to 4 hours post-dose; Day 2 of Cycles 1 and 2: Post-dose (cycle length=28 days)
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Secondary outcome [9]
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Phase 1: Cmax: Single-Dose Maximum Observed Serum Concentration for Daratumumab
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Assessment method [9]
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Timepoint [9]
0
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Days 1, 8, 15, and 22 of Cycles 1 and 2: Pre-dose, and at multiple time points up to 4 hours post-dose; Day 2 of Cycles 1 and 2: Post-dose (cycle length=28 days)
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Secondary outcome [10]
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Phase 1: Tmax: Time to First Occurrence of Maximum Serum Concentration (Cmax) for Daratumumab
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Assessment method [10]
0
0
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Timepoint [10]
0
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Days 1, 8, 15, and 22 of Cycles 1 and 2: Pre-dose, and at multiple time points up to 4 hours post-dose; Day 2 of Cycles 1 and 2: Post-dose (cycle length=28 days)
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Secondary outcome [11]
0
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Phase 1: Ctrough: Single-Dose and Multiple-dose Observed Concentration at the End of a Dosing Interval for Daratumumab
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Assessment method [11]
0
0
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Timepoint [11]
0
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Days 1, 8, 15, and 22 of Cycles 1 and 2: Pre-dose, and at multiple time points up to 4 hours post-dose; Day 2 of Cycles 1 and 2: Post-dose (cycle length=28 days)
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Secondary outcome [12]
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Phase 1: AUC8: Area Under the Serum Concentration-time Curve from Time 0 to Infinity for Daratumumab
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Assessment method [12]
0
0
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Timepoint [12]
0
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Days 1, 8, 15, and 22 of Cycles 1 and 2: Pre-dose, and at multiple time points up to 4 hours post-dose; Day 2 of Cycles 1 and 2: Post-dose (cycle length=28 days)
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Secondary outcome [13]
0
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Phase 1: AUClast: Area Under the Serum Concentration-time Curve from Time 0 to Time of the Last Quantifiable Concentration for Daratumumab
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Assessment method [13]
0
0
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Timepoint [13]
0
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Days 1, 8, 15, and 22 of Cycles 1 and 2: Pre-dose, and at multiple time points up to 4 hours post-dose; Day 2 of Cycles 1 and 2: Post-dose (cycle length=28 days)
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Secondary outcome [14]
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Phase 1: Overall Response Rate (ORR)
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Assessment method [14]
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ORR is defined as the percentage of participants who achieved a confirmed PR or better during the study in the safety population. ORR will be assessed by the investigator per IMWG criteria.
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Timepoint [14]
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Up to 60 months
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Secondary outcome [15]
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0
Phase 1 and Phase 2a: Duration of Response (DOR)
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Assessment method [15]
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DOR is defined as the time from the date of first documentation of a confirmed PR or better to the date of first documentation of confirmed progressive disease or death due to any cause, whichever occurs first. DOR will be calculated for confirmed responders only (PR or better). DOR will be assessed by the investigator as per IMWG criteria.
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Timepoint [15]
0
0
Up to 60 months
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Secondary outcome [16]
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Phase 1 and Phase 2a: Progression Free Survival (PFS)
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Assessment method [16]
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PFS is defined as the time from the date of the first dose administration of any study drug to the first documentation of confirmed progressive disease or death due to any cause, whichever occurs first. PFS will be assessed by the investigator as per IMWG criteria.
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Timepoint [16]
0
0
up to 60 months
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Secondary outcome [17]
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Phase 1 and Phase 2a: Overall Survival (OS)
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Assessment method [17]
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OS is defined as the time from the date of the first dose administration of any study drug to the documentation of death due to any cause. OS will be assessed by the investigator as per IMWG criteria.
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Timepoint [17]
0
0
Up to 60 months
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Secondary outcome [18]
0
0
Phase 1 and Phase 2a: Number of Participants With Anti-drug Antibodies
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Assessment method [18]
0
0
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Timepoint [18]
0
0
Up to 60 months
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Secondary outcome [19]
0
0
Phase 1 and Phase 2a: Titer of Anti-drug Antibodies
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Assessment method [19]
0
0
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Timepoint [19]
0
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Up to 60 months
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Secondary outcome [20]
0
0
Phase 1 and Phase 2a: Number of Participants With Neutralizing Antibodies (NAb) Against Study Drug
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Assessment method [20]
0
0
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Timepoint [20]
0
0
Up to 60 months
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Secondary outcome [21]
0
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Phase 1 and Phase 2a: Rate of Measurable [Minimal] Residual Disease Negative (MRD[-]) Complete Response (CR)
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Assessment method [21]
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MRD\[-\] CR rate is defined as the percentage of participants who achieve confirmed CR assessed by the investigator and MRD\[-\] status using a threshold of 10\^-5. The analysis will be based on the response-evaluable population.
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Timepoint [21]
0
0
Up to 60 months
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Secondary outcome [22]
0
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Phase 1 and Phase 2a: Duration of Measurable [Minimal] Residual Disease (MRD) Negativity
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Assessment method [22]
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Duration of MRD negativity for participants achieving MRD negativity is defined as the time from the date of first documentation of MRD negativity to the first documentation of MRD positivity or confirmed progressive disease, whichever occurs first. It will be calculated for participants achieving MRD negativity only.
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Timepoint [22]
0
0
Up to 60 months
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Secondary outcome [23]
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Phase 2a: Clinical Benefit Rate (CBR)
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Assessment method [23]
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CBR is defined as the percentage of participants who had a confirmed response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), or minimal response based on investigators' disease assessment per IMWG criteria.
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Timepoint [23]
0
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Up to 60 months
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Secondary outcome [24]
0
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Phase 2a: Duration of Clinical Benefit (DCB)
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Assessment method [24]
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DCB is defined as the time from the date of first documentation of a minimal response or better to the date of first documentation of confirmed progressive disease or death due to any cause, whichever occurs first. DCB will be calculated for only participants who achieved a minimal response or better. DCB will be assessed by the investigator as per IMWG criteria.
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Timepoint [24]
0
0
Up to 60 months
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Secondary outcome [25]
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Phase 2a: Disease Control Rate (DCR)
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Assessment method [25]
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DCR is defined as the percentage of participants with a confirmed response of sCR, CR, VGPR, PR, minimal response, or stable disease (SD) based on investigators' disease assessment per IMWG criteria.
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Timepoint [25]
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Up to 60 months
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Secondary outcome [26]
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Phase 2a: Duration of Disease Control
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Assessment method [26]
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Duration of disease control is defined as the time from date of first documentation of SD or better to the date of first documentation of confirmed progressive disease or death due to any cause. Duration of disease control will be calculated for only patients who achieved SD or better. It will be assessed by the investigator per IMWG criteria.
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Timepoint [26]
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Up to 60 months
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Secondary outcome [27]
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Phase 2a: Time to Progression (TTP)
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Assessment method [27]
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TTP is defined as the time from the date of randomization to the first documentation of confirmed progressive disease as defined by IMWG criteria, assessed by the investigator. Participants without documentation of confirmed progression will be censored at the date of last adequate disease assessment. The analysis will be based on the intent-to-treat (ITT) population.
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Timepoint [27]
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Up to 60 months
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Secondary outcome [28]
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Phase 2a: Time to Response (TTR)
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Assessment method [28]
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TTR is defined as time from the date of first dose administration of any study drug to the date of the first documentation of a confirmed PR or better. TTR will be calculated for responders only. TTR will be assessed by the investigator per IMWG criteria.
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Timepoint [28]
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0
Up to 60 months
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Secondary outcome [29]
0
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Phase 2a: Time to Next Treatment (TTNT)
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Assessment method [29]
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TTNT is defined as the time from the date of first dose administration of any study drug to the date of the first dose initiation of the next line of anticancer therapy for any reason or death from any cause, whichever comes first. Participants who have not started the next-line therapy will be censored at the date last known to be alive before subsequent anticancer therapy.
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Timepoint [29]
0
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Up to 60 months
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Secondary outcome [30]
0
0
Phase 2a: Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs) and Per Severity
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Assessment method [30]
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An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. Severity grades for TEAEs will be evaluated as per the NCI CTCAE Version 5.0.
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Timepoint [30]
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Up to 60 months
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Eligibility
Key inclusion criteria
1. Documented multiple myeloma (MM) diagnosis per IMWG criteria.
2. Measurable disease, defined as at least 1 of the following:
1. Serum M protein =0.5 grams per deciliter [g/dL] (=5 g/L) on serum protein electrophoresis (SPEP).
2. Urine M protein =200 mg/24 hours on urine protein electrophoresis (UPEP).
3. Serum free light chain (FLC) assay with involved FLC level =10 mg/dL (=100 mg/L) provided serum FLC ratio is abnormal.
3. For participants in the Phase 1 Dose Escalation only:
Must have received at least 3 prior lines of therapy, including at least 1 proteosome inhibitor (PI), 1 immunomodulatory imide drug (IMiD), and 1 anti-CD38 monoclonal antibody (mAb) drug; or who are triple refractory to a PI, an IMiD, and an anti-CD38 mAb drug, regardless of the number of prior line(s) or therapy.
4. For participants in Phase 2a Dose Finding only:
1. Received 1 to 3 prior line(s) of antimyeloma therapy.
2. Must be refractory to prior lenalidomide treatment.
3. Participants must be sensitive (nonrefractory) or naïve to prior anti-CD38 mAb treatment.
4. Documented progressive disease on or after the last regimen.
5. Participants must have PR or better to at least 1 line of prior therapy.
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 at screening.
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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. Prior exposure to modakafusp alfa.
2. Participant has polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome, solitary plasmacytoma, amyloidosis, Waldenström macroglobulinemia, plasma cell leukemia, or lymphoplasmacytic lymphoma.
3. Participant has not recovered from adverse reactions to prior myeloma treatment or procedures (chemotherapy, immunotherapy, radiation therapy) to NCI CTCAE, Version 5 Grade =1 or baseline, except for alopecia.
4. Previous allogeneic stem cell transplant at any time or autologous stem cell transplant (ASCT) within 12 weeks of planned start of dosing.
5. Seropositive for hepatitis B, or known history of seropositivity for hepatitis C or of seropositivity for human immunodeficiency virus (HIV).
6. Participant has congestive heart failure (New York Heart Association Grade =II), cardiac myopathy, active ischemia, or any other uncontrolled cardiac condition such as angina pectoris, clinically significant arrhythmia requiring therapy including anticoagulants, or clinically significant uncontrolled hypertension.
7. Participant has QT interval corrected by the Fridericia method >480 milliseconds [msec] (Grade =2).
8. Participant has a chronic condition that will require the chronic use of systemic corticosteroids >10 milligrams per day (mg/d) of prednisone or equivalent on top of any required corticosteroids for multiple myeloma (MM).
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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
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
Active, not recruiting
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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
26/01/2023
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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
4/03/2025
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Actual
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Sample size
Target
58
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
0
0
Concord Repatriation General Hospital - Concord
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Recruitment hospital [2]
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0
The Alfred Hospital - Melbourne
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Recruitment postcode(s) [1]
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0
2139 - Concord
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Recruitment postcode(s) [2]
0
0
3004 - Melbourne
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Arizona
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Country [2]
0
0
United States of America
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State/province [2]
0
0
California
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Indiana
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Kansas
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Louisiana
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Massachusetts
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Missouri
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Nebraska
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Country [9]
0
0
United States of America
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State/province [9]
0
0
New Jersey
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Country [10]
0
0
United States of America
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State/province [10]
0
0
New York
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Country [11]
0
0
United States of America
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State/province [11]
0
0
Ohio
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Country [12]
0
0
United States of America
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State/province [12]
0
0
Texas
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Country [13]
0
0
Canada
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State/province [13]
0
0
Quebec
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Country [14]
0
0
China
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State/province [14]
0
0
Guangdong
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Country [15]
0
0
China
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State/province [15]
0
0
Hubei
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Country [16]
0
0
China
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State/province [16]
0
0
Tianjin
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Country [17]
0
0
China
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State/province [17]
0
0
Zhejiang
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Country [18]
0
0
France
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State/province [18]
0
0
Hauts-de-France
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Country [19]
0
0
France
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State/province [19]
0
0
Provence-Alpes-Cote d'Azur
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Country [20]
0
0
Korea, Republic of
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State/province [20]
0
0
Jeollanam-do
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Country [21]
0
0
Korea, Republic of
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State/province [21]
0
0
Seoul
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Country [22]
0
0
Spain
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State/province [22]
0
0
Barcelona
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Country [23]
0
0
Spain
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State/province [23]
0
0
Salamanca
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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
The main aim of this study is to determine safety and tolerability of modakafusp alfa given together with daratumumab to find out the best treatment dose. Another aim of this study is to learn more about the characteristics of modakafusp alfa.
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Trial website
https://clinicaltrials.gov/study/NCT05590377
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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
0
0
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
0
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Email
0
0
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
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)
Query!
When will data be available (start and end dates)?
Query!
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.
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/takeda/
Query!
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/NCT05590377