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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02517398
Registration number
NCT02517398
Ethics application status
Date submitted
30/07/2015
Date registered
7/08/2015
Date last updated
3/05/2024
Titles & IDs
Public title
MSB0011359C (M7824) in Metastatic or Locally Advanced Solid Tumors
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Scientific title
A Phase I, Open-label, Multiple-ascending Dose Trial to Investigate the Safety, Tolerability, PK, Biological and Clinical Activity of MSB0011359C in Subjects With Metastatic or Locally Advanced Solid Tumors and Expansion to Selected Indications
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Secondary ID [1]
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2015-004366-28
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Secondary ID [2]
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EMR 200647-001
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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:
Solid Tumors
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - MSB0011359C
Experimental: MSB0011359C (M7824) -
Treatment: Drugs: MSB0011359C
Subjects would receive intravenous infusion of MSB0011359C once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or investigational medicinal product (IMP) occurs.
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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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Dose-escalation: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
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Assessment method [1]
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Adverse event (AE): any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. Serious AE: an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAE: AE with onset after start of treatment or with onset date before the treatment start date but worsening after the treatment start date. TEAEs included both serious and non-serious TEAEs.
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Timepoint [1]
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From start of study drug administration up to 139 weeks
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Primary outcome [2]
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Dose-escalation: Number of Participants With Treatment-Related TEAEs, Treatment-Related Serious TEAEs and Treatment-related TEAEs Leading to Death
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Assessment method [2]
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Treatment-related TEAEs are any untoward medical occurrence in a participant who received study drug with causal relationship with the investigational product as assessed by the investigator. Related TEAEs were events with relationship missing, unknown or yes. Number of participants With treatment-related TEAEs, treatment-related serious TEAEs and treatment-related TEAE leading to death were reported.
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Timepoint [2]
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From start of study drug administration up to 139 weeks
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Primary outcome [3]
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Number of Participants With TEAEs and Related TEAEs Based on Severity According to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE) Version 4.03
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Assessment method [3]
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AEs were graded according to severity using NCI-CTCAE Version 4.03. Severity of TEAEs were graded as Grade 1: mild (not causing any significant problem, dose adjustment not required), Grade 2: moderate (caused problem that does not interfere significantly with usual activities or the clinical status, dose adjustment needed due to adverse event), Grade 3: Severe (caused problem that interferes significantly with usual activities or the clinical status, study drug stopped due to adverse event), Grade 4: Life-threatening, Grade 5: Death. Number of Participants with TEAEs and Related TEAEs Based on Severity having Grade greater than or equal to (>=) 3 and Grade >=4 were reported.
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Timepoint [3]
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From start of study drug administration up to 139 weeks
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Primary outcome [4]
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Dose-escalation: Number of Participants With Dose-Limiting Toxicities According to the National Cancer Institute Common Terminology Criteria For Adverse Events(NCI-CTCAE), v4.03
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Assessment method [4]
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A DLT was defined as any grade >= 3 Adverse Event (AE) suspected to be related to IMP by the Investigator and / or Sponsor occurring in the DLT evaluation period confirmed by the Safety Monitoring Committee (SMC) to be relevant for the IMP treatment. According to the NCI-CTCAE, v4.03, occurring in the DLT evaluation period and assessed to be related to study treatment by the Investigator and / or Sponsor confirmed by the safety monitoring committee to be relevant for the study treatment.
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Timepoint [4]
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From start of study drug administration up to 21 days
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Primary outcome [5]
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Dose-expansion: Number of Participants With Best Overall Response (BOR) as Assessed by Independent Endpoint Review Committee (IRC)
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Assessment method [5]
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BOR according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 and as adjudicated by the Independent Endpoint Review Committee (IRC). BOR is defined as sum of complete response and partial response (CR+PR). For target lesions (TLs), CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the sum of largest diameter (SLD) of the TLs, taking as a reference the baseline SLD.
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Timepoint [5]
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From date of randomization up to Week 66
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Primary outcome [6]
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Dose-expansion: Disease Control Rate According to Response Assessment in Neuro-Oncology (RANO) as Adjudicated by the IRC for Participants With Glioblastoma
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Assessment method [6]
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DCR is defined as the percentage of participants with a confirmed CR+PR+SD+ Non-CR/non-PD at any time as per RANO criteria. A responder is a participant with a Complete Response (CR) or Partial Response (PR), and a non-responder is a participant with Stable Disease (SD) or Progressive Disease (PD) assessed by the RANO criteria. CR is no T1 gadolinium enhancing disease, no new lesions, or corticosteroids, and stable or decreasing T2-weighted-Fluid-Attenuated Inversion Recovery (T2/FLAIR). PR is =50% decrease in T1 gadolinium enhancing disease, no new lesions, stable or decreasing T2/FLAIR or corticosteroids, and stable or increasing clinical status. SD is <50% decrease in T1 gadolinium enhancing disease but < 25% increase, no new lesions, stable or decreasing T2/FLAIR or corticosteroids, and stable or increase in clinical status. PD is =25% increase in T1 gadolinium enhancing disease.
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Timepoint [6]
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From date of randomization up to Week 66
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Secondary outcome [1]
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Maximum Concentration (Cmax) of M7824 in Plasma
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Assessment method [1]
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Cmax was obtained directly from the concentration versus time curve.
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Timepoint [1]
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0 hours (pre-dose), 1, 4, 10, 25, 72, 168, 240, 336 hours post-dose
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Secondary outcome [2]
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Area Under the Concentration-Time Curve From Time Zero up to Time Tau (AUCtau) of M7824
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Assessment method [2]
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Area under the concentration-time curve from time zero up to time Tau, where Tau is the dosing interval (336 hours).
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Timepoint [2]
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0 hours (pre-dose), 1, 4, 10, 25, 72, 168, 240, 336 hours post-dose post-dose
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Secondary outcome [3]
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Apparent Terminal Half Life (t1/2) of M7824
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Assessment method [3]
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Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life is calculated by dividing the natural logarithm to the base e (Log e) multiplied by (*) 2/ ?z, where '?z' is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
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Timepoint [3]
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Pre-dose, 0, 1, 4, 10, 25, 72, 168, 240, 336 hours post-dose
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Secondary outcome [4]
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Trough Plasma Concentration (Ctrough) of M7824
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Assessment method [4]
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Ctrough is the plasma concentration of a drug prior to administration.
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Timepoint [4]
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0 hours (Pre-dose), 1, 4, 10, 25, 72, 168, 240, 336 hours post-dose
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Secondary outcome [5]
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Apparent Plasma Clearance (CL) of M7824
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Assessment method [5]
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CL is defined as the time it takes for the study drug to be completely removed from the body's plasma.
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Timepoint [5]
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0 hours (Pre-dose), 1, 4, 10, 25, 72, 168, 240, 336 hours post-dose
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Secondary outcome [6]
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Number of Participants With Positive Anti-Drug Antibody (ADA) of M7824
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Assessment method [6]
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The detection of antibodies to M7824 was performed using a validated immunoassay method with tiered testing of screening, confirmatory and titration. Number of participants with positive ADA of M7824 were reported.
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Timepoint [6]
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Predose, up to Week 52
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Secondary outcome [7]
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Number of Participants With Best Overall Response (BOR) as Assessed by Investigator
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Assessment method [7]
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BOR according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 and as adjudicated by the Investigator. BOR is defined as sum of complete response and partial response (CR+PR). For target lesions (TLs), CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the sum of largest diameter (SLD) of the TLs, taking as a reference the baseline SLD.
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Timepoint [7]
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From date of randomization up to Week 66
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Secondary outcome [8]
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Dose Expansion: Number of Participants With TEAEs and Serious TEAEs
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Assessment method [8]
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An Adverse Event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. TEAEs were defined as events with onset date or worsening during the on-treatment period. Serious Adverse Event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. Any TEAE included participants with both serious and non-serious AEs.
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Timepoint [8]
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From start of study drug administration up to 200 weeks
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Secondary outcome [9]
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Dose Expansion: Number of Participants With Treatment-Related TEAEs, Treatment-Related Serious TEAEs and Treatment-related TEAE Leading to Death
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Assessment method [9]
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Treatment-related TEAEs are any untoward medical occurrence in a participant who received study drug with causal relationship with the investigational product as assessed by the investigator. Related TEAEs were events with relationship missing, unknown or yes. Number of participants with treatment-related TEAEs, treatment-related serious TEAEs and treatment-related TEAE leading to death were reported.
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Timepoint [9]
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From start of study drug administration up to 200 weeks
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Secondary outcome [10]
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Dose Expansion: Number of Participants With TEAEs and Related TEAEs Based on Severity According to NCI-CTCAE Version 4.03
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Assessment method [10]
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AEs were graded according to severity using NCI-CTCAE Version 4.03. Severity of TEAEs were graded as Grade 1: mild (not causing any significant problem, dose adjustment not required), Grade 2: moderate (caused problem that does not interfere significantly with usual activities or the clinical status, dose adjustment needed due to adverse event), Grade 3: Severe (caused problem that interferes significantly with usual activities or the clinical status, study drug stopped due to adverse event), Grade 4: Life-threatening, Grade 5: Death. Number of Participants with TEAEs and Related TEAEs Based on Severity having Grade >= 3 and Grade >=4 TEAEs were reported.
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Timepoint [10]
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From start of study drug administration up to 200 weeks
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Eligibility
Key inclusion criteria
- Ability to understand the purpose of the study, provide signed and dated informed
consent, and able to comply with all procedures
- In Japan, if a subject is < 20 years, the written informed consent from his/her parent
or guardian will be required in addition to the subject's written consent
- Male or female subjects aged greater than or equal to (>=) 18 years
- Life expectancy >= 12 weeks as judged by the Investigator
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at trial entry
- Disease must be measurable with at least 1 uni dimensional measurable lesion by
Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Adequate hematological, hepatic and renal function as defined in the protocol
- Effective contraception for both male and female subjects if the risk of conception
exists
Other protocol-defined inclusion criteria could apply.
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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
- Concurrent treatment with non-permitted drugs and other interventions
- Anticancer treatment within 28 days before the start of trial treatment, for example
cyto reductive therapy, radiotherapy (with the exception of palliative radiotherapy
delivered in a normal organ-spearing technique), immune therapy, or cytokine therapy
- Major surgery within 28 days before the start of trial treatment (prior diagnostic
biopsy is permitted)
- Systemic therapy with immunosuppressive agents within 7 days before the start of trial
treatment; or use of any investigational drug within 28 days before the start of trial
treatment
- Previous malignant disease (other than the target malignancy to be investigated in
this trial) within the last 3 years. Subjects with history of cervical carcinoma in
situ, superficial or non invasive bladder cancer or basal cell or squamous cell cancer
in situ previously treated with curative intent are NOT excluded. Subjects with other
localized malignancies treated with curative intent need to be discussed with the
Medical Monitor.
- Rapidly progressive disease which, in the opinion of the Investigator, may predispose
to inability to tolerate treatment or trial procedures
- Subjects with active central nervous system (CNS) metastases causing clinical symptoms
or metastases that require therapeutic intervention are excluded
- Receipt of any organ transplantation, including allogeneic stem-cell transplantation,
but with the exception of transplants that do not require immunosuppression (eg,
corneal transplant, hair transplant)
Other protocol-defined exclusion criteria could apply
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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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
Single group
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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
31/08/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
23/05/2022
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Sample size
Target
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Accrual to date
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Final
600
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Blacktown Hospital - Blacktown
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St George Hospital - Kogarah
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Liverpool Hospital - Liverpool
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Port Macquarie Base Hospital - Port Macquarie
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Royal North Shore Hospital - St Leonards
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Calvary Mater Newcastle - Waratah
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Gallipoli Medical Research Foundation Ltd - Greenslopes
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Tasman Oncology Research Ltd - Southport
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The Queen Elizabeth Hospital - Woodville South
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Peter MacCallum Cancer Centre-East Melbourne - East Melbourne
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Cabrini Hospital Malvern - Malvern
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Border Medical Oncology Research Unit - Wodonga
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Fiona Stanley Hospital - Murdoch
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Recruitment hospital [14]
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Linear Clinical Research Limited - Nedlands
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Recruitment postcode(s) [1]
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2148 - Blacktown
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2217 - Kogarah
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2170 - Liverpool
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2444 - Port Macquarie
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2065 - St Leonards
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2298 - Waratah
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4120 - Greenslopes
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4216 - Southport
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5011 - Woodville South
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3002 - East Melbourne
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3144 - Malvern
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3690 - Wodonga
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6150 - Murdoch
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Recruitment postcode(s) [14]
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6009 - Nedlands
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Recruitment outside Australia
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Bruxelles
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Siena
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Japan
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Chiba-Ken
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Japan
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Osaka-Fu
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Chungcheongbuk-do
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Gyeonggi-do
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Busan
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Spain
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Madrid
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Spain
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Sevilla
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Spain
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Valencia
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Taiwan
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Taipei
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United Kingdom
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Greater London
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United Kingdom
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Greater Manchester
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Country [68]
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United Kingdom
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State/province [68]
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Hampshire
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Country [69]
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United Kingdom
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State/province [69]
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Strathclyde
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United Kingdom
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Tyne & Wear
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United Kingdom
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West Midlands
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
EMD Serono Research & Development Institute, Inc.
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Merck KGaA, Darmstadt, Germany
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Address [1]
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Ethics approval
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Summary
Brief summary
The main purpose of this Phase I study was to test MSB0011359C (M7824) at different dose
levels to see if it is safe and well tolerated when given once every 2 weeks. Phase I means
the study drug has not previously been given to humans or has only been given to a limited
number of people, although it has been extensively studied in animals. Based on this
information, it is hoped to find out which dose could be best for the treatment of patients.
There are two parts of this research study: a dose-escalation part and an expansion part.
Dose escalation means that the first people taking part in the study will receive low doses
of the study drug, and as more people take part, the additional participants will receive a
higher dose. This is done to find the safest dose for the study drug. Expansion means that
after the dose-escalation part of the study has looked at the safety and effectiveness of
different doses, many more people will be invited to take part in the study and will receive
the study drug at the safest dose. Additional purposes of the study are to find out whether
the study drug has anti-cancer effects and how the study drug is processed by the body.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02517398
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Medical Responsible
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EMD Serono Research & Development Institute, Inc, an affiliate of MerckKGaA, Darmstadt, Germany
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02517398
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