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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
2015-004366-28
Secondary ID [2] 0 0
EMR 200647-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Dose-escalation: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
Timepoint [1] 0 0
From start of study drug administration up to 139 weeks
Primary outcome [2] 0 0
Dose-escalation: Number of Participants With Treatment-Related TEAEs, Treatment-Related Serious TEAEs and Treatment-related TEAEs Leading to Death
Timepoint [2] 0 0
From start of study drug administration up to 139 weeks
Primary outcome [3] 0 0
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
Timepoint [3] 0 0
From start of study drug administration up to 139 weeks
Primary outcome [4] 0 0
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
Timepoint [4] 0 0
From start of study drug administration up to 21 days
Primary outcome [5] 0 0
Dose-expansion: Number of Participants With Best Overall Response (BOR) as Assessed by Independent Endpoint Review Committee (IRC)
Timepoint [5] 0 0
From date of randomization up to Week 66
Primary outcome [6] 0 0
Dose-expansion: Disease Control Rate According to Response Assessment in Neuro-Oncology (RANO) as Adjudicated by the IRC for Participants With Glioblastoma
Timepoint [6] 0 0
From date of randomization up to Week 66
Secondary outcome [1] 0 0
Maximum Concentration (Cmax) of M7824 in Plasma
Timepoint [1] 0 0
0 hours (pre-dose), 1, 4, 10, 25, 72, 168, 240, 336 hours post-dose
Secondary outcome [2] 0 0
Area Under the Concentration-Time Curve From Time Zero up to Time Tau (AUCtau) of M7824
Timepoint [2] 0 0
0 hours (pre-dose), 1, 4, 10, 25, 72, 168, 240, 336 hours post-dose post-dose
Secondary outcome [3] 0 0
Apparent Terminal Half Life (t1/2) of M7824
Timepoint [3] 0 0
Pre-dose, 0, 1, 4, 10, 25, 72, 168, 240, 336 hours post-dose
Secondary outcome [4] 0 0
Trough Plasma Concentration (Ctrough) of M7824
Timepoint [4] 0 0
0 hours (Pre-dose), 1, 4, 10, 25, 72, 168, 240, 336 hours post-dose
Secondary outcome [5] 0 0
Apparent Plasma Clearance (CL) of M7824
Timepoint [5] 0 0
0 hours (Pre-dose), 1, 4, 10, 25, 72, 168, 240, 336 hours post-dose
Secondary outcome [6] 0 0
Number of Participants With Positive Anti-Drug Antibody (ADA) of M7824
Timepoint [6] 0 0
Predose, up to Week 52
Secondary outcome [7] 0 0
Number of Participants With Best Overall Response (BOR) as Assessed by Investigator
Timepoint [7] 0 0
From date of randomization up to Week 66
Secondary outcome [8] 0 0
Dose Expansion: Number of Participants With TEAEs and Serious TEAEs
Timepoint [8] 0 0
From start of study drug administration up to 200 weeks
Secondary outcome [9] 0 0
Dose Expansion: Number of Participants With Treatment-Related TEAEs, Treatment-Related Serious TEAEs and Treatment-related TEAE Leading to Death
Timepoint [9] 0 0
From start of study drug administration up to 200 weeks
Secondary outcome [10] 0 0
Dose Expansion: Number of Participants With TEAEs and Related TEAEs Based on Severity According to NCI-CTCAE Version 4.03
Timepoint [10] 0 0
From start of study drug administration up to 200 weeks

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/08/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/05/2022
Sample size
Target
Accrual to date
Final
600
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Blacktown Hospital - Blacktown
Recruitment hospital [2] 0 0
St George Hospital - Kogarah
Recruitment hospital [3] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [4] 0 0
Port Macquarie Base Hospital - Port Macquarie
Recruitment hospital [5] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [6] 0 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [7] 0 0
Gallipoli Medical Research Foundation Ltd - Greenslopes
Recruitment hospital [8] 0 0
Tasman Oncology Research Ltd - Southport
Recruitment hospital [9] 0 0
The Queen Elizabeth Hospital - Woodville South
Recruitment hospital [10] 0 0
Peter MacCallum Cancer Centre-East Melbourne - East Melbourne
Recruitment hospital [11] 0 0
Cabrini Hospital Malvern - Malvern
Recruitment hospital [12] 0 0
Border Medical Oncology Research Unit - Wodonga
Recruitment hospital [13] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [14] 0 0
Linear Clinical Research Limited - Nedlands
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2170 - Liverpool
Recruitment postcode(s) [4] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [5] 0 0
2065 - St Leonards
Recruitment postcode(s) [6] 0 0
2298 - Waratah
Recruitment postcode(s) [7] 0 0
4120 - Greenslopes
Recruitment postcode(s) [8] 0 0
4216 - Southport
Recruitment postcode(s) [9] 0 0
5011 - Woodville South
Recruitment postcode(s) [10] 0 0
3002 - East Melbourne
Recruitment postcode(s) [11] 0 0
3144 - Malvern
Recruitment postcode(s) [12] 0 0
3690 - Wodonga
Recruitment postcode(s) [13] 0 0
6150 - Murdoch
Recruitment postcode(s) [14] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
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California
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United States of America
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Colorado
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Connecticut
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Florida
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United States of America
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Georgia
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United States of America
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Louisiana
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Maryland
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Massachusetts
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Michigan
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Missouri
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Ohio
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Pennsylvania
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Texas
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Virginia
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Washington
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Belgium
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Bruxelles
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Belgium
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Charleroi
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Belgium
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Edegem
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Belgium
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Gent
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Belgium
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Libramont
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Belgium
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Liège
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Belgium
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Wilrijk
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Canada
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Alberta
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France
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Alpes Maritimes
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Bas Rhin
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Gironde
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Isere
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France
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Germany
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Niedersachsen
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Germany
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Nordrhein Westfalen
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Germany
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Sachsen
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Germany
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Berlin
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Torino
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Milano
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Napoli
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Pavia
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Pisa
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Roma
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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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Korea, Republic of
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Chungcheongbuk-do
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Gyeonggi-do
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Busan
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Seoul
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Badajoz
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Barcelona
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Madrid
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Sevilla
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Valencia
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Taiwan
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Taipei
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Greater London
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Greater Manchester
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United Kingdom
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Hampshire
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United Kingdom
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Strathclyde
Country [70] 0 0
United Kingdom
State/province [70] 0 0
Tyne & Wear
Country [71] 0 0
United Kingdom
State/province [71] 0 0
West Midlands

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
EMD Serono Research & Development Institute, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Merck KGaA, Darmstadt, Germany
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Responsible
Address 0 0
EMD Serono Research & Development Institute, Inc, an affiliate of MerckKGaA, Darmstadt, Germany
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents


Results are available at https://clinicaltrials.gov/study/NCT02517398