MSB0011359C (M7824) in Metastatic or Locally Advanced Solid Tumors

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

The main purpose of this Phase I study is 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a Phase I, open-label, dose-escalation trial with consecutive parallel-group expansion in selected solid tumor indications. The current trial is composed of a standard dose escalation "3 + 3" cohort design, for which 3 to 6 subjects will be enrolled at each dose level depending on the occurrence of dose limiting toxicities (DLTs), followed by a consecutive parallel-group expansion in selected solid tumor indications. Cohorts of 3 subjects with metastatic or locally advanced solid tumors, for which no standard effective therapy exists or standard therapy has failed, will receive MSB0011359C (M7824) at escalating dose levels. After determination of the Maximum tolerated dose (MTD), enrollment in several expansion cohorts will be opened to determine the safety, pharmacokinetic (PK) / Pharmacodynamic, and clinical activity of MSB0011359C (M7824). Subjects who have experienced a confirmed complete response (CR) should continue treatment through the end of 12 months, although additional treatment is possible. In the case of progressive disease (PD), subjects should continue treatment through their next tumor assessment. Additional indications will be planned based on emerging data in the field.

Study Type

Interventional

Enrollment (Actual)

600

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New South Wales
      • Blacktown, New South Wales, Australia, 2148
        • Blacktown Hospital
      • Kogarah, New South Wales, Australia, 2217
        • St George Hospital
      • Liverpool, New South Wales, Australia, 2170
        • Liverpool Hospital
      • Port Macquarie, New South Wales, Australia, 2444
        • Port Macquarie Base Hospital
      • St Leonards, New South Wales, Australia, 2065
        • Royal North Shore Hospital
      • Waratah, New South Wales, Australia, 2298
        • Calvary Mater Newcastle
    • Queensland
      • Greenslopes, Queensland, Australia, 4120
        • Gallipoli Medical Research Foundation Ltd
      • Southport, Queensland, Australia, 4216
        • Tasman Oncology Research Ltd
    • South Australia
      • Woodville South, South Australia, Australia, 5011
        • The Queen Elizabeth Hospital
    • Victoria
      • East Melbourne, Victoria, Australia, 3002
        • Peter MacCallum Cancer Centre-East Melbourne
      • Malvern, Victoria, Australia, 3144
        • Cabrini Hospital Malvern
      • Wodonga, Victoria, Australia, 3690
        • Border Medical Oncology Research Unit
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Fiona Stanley Hospital
      • Nedlands, Western Australia, Australia, 6009
        • Linear Clinical Research Limited
      • Bruxelles, Belgium, 1000
        • Institut Jules Bordet
      • Bruxelles, Belgium, 1200
        • Cliniques Universitaires Saint-Luc
      • Charleroi, Belgium, 6000
        • Grand Hôpital de Charleroi
      • Edegem, Belgium, 2650
        • UZ Antwerpen
      • Gent, Belgium, 9000
        • Universitair Ziekenhuis Gent
      • Libramont, Belgium, 6800
        • Centre Hospitalier de l'Ardenne
      • Liège, Belgium, 4000
        • C. H. U. Sart Tilman
      • Wilrijk, Belgium, 2610
        • GZA Ziekenhuizen - Campus Sint-Augustinus
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
      • Montpellier, France, 34298
        • Institut Regional du Cancer de Montpellier
    • Alpes Maritimes
      • Nice cedex 02, Alpes Maritimes, France, 06189
        • Centre Antoine Lacassagne
    • Bas Rhin
      • Strasbourg Cedex, Bas Rhin, France, 67000
        • Centre Paul Strauss
    • Bouches-du-Rhône
      • Marseille cedex 5, Bouches-du-Rhône, France, 13385
        • Hôpital de la Timone#
    • Côte-d'Or
      • Dijon cedex, Côte-d'Or, France, 21079
        • Centre Georges François Leclerc
    • Gironde
      • Bordeaux cedex, Gironde, France, 33075
        • CHU Bordeaux - Hôpital Saint André
    • Haute Garonne
      • Toulouse cedex 09, Haute Garonne, France, 31059
        • Institut Claudius Regaud-Oncopole
    • Isere
      • Grenoble cedex 9, Isere, France, 38043
        • CHU de Grenoble - Hôpital Nord
    • Loire Atlantique
      • Saint Herblain, Loire Atlantique, France, 44805
        • ICO - site Rene Gauducheau
    • Nord
      • Lille cedex, Nord, France, 59020
        • Centre Oscar Lambret
    • Paris
      • Paris Cedex 05, Paris, France, 75248
        • Institut Curie - Centre de Lutte Contre le Cancer (CLCC) de Paris
      • Paris Cedex 10, Paris, France, 75475
        • Hopital Saint-Louis
      • Paris cedex 12, Paris, France, 75571
        • Groupe Hospitalier Pitie-Salpetriere
    • Rhone
      • Lyon, Rhone, France, 69008
        • Centre Léon Berard
      • Lyon Cedex 04, Rhone, France, 69317
        • Centre Hospitalier de la Croix Rousse
    • Val De Marne
      • Créteil Cedex, Val De Marne, France, 94010
        • Hôpital Henri Mondor
      • Berlin, Germany, 10117
        • Charite Universitaetsmedizin Berlin - Campus Charite Mitte
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30625
        • Medizinische Hochschule Hannover
    • Nordrhein Westfalen
      • Koeln, Nordrhein Westfalen, Germany, 50670
        • Cellex Koeln
    • Sachsen
      • Dresden, Sachsen, Germany, 01307
        • Universitaetsklinikum Carl Gustav Carus TU Dresden
      • Milano, Italy, 20132
        • Ospedale San Raffaele
      • Milano, Italy, 20133
        • Fondazione IRCCS Istituto Nazionale dei Tumori
      • Milano, Italy, 20141
        • IEO Istituto Europeo di Oncologia
      • Napoli, Italy, 80131
        • Istituto Nazionale Tumori Fondazione G. Pascale
      • Pavia, Italy, 27100
        • Fondazione IRCCS Policlinico San Matteo
      • Pisa, Italy, 56126
        • Azienda Ospedaliero Universitaria Pisana
      • Roma, Italy, 00168
        • Policlinico Universitario Agostino Gemelli
      • Siena, Italy, 53100
        • A.O.U. Senese Policlinico Santa Maria alle Scotte
    • Torino
      • Candiolo, Torino, Italy, 10060
        • Fondazione Del Piemonte Per L'Oncologia Ircc Candiolo
    • Chiba-Ken
      • Kashiwa-shi, Chiba-Ken, Japan, 277-8577
        • National Cancer Center Hospital East
    • Osaka-Fu
      • Osakasayama-shi, Osaka-Fu, Japan, 589-8511
        • Kindai University Hospital
      • Busan, Korea, Republic of, 49241
        • Pusan National University Hospital
      • Seoul, Korea, Republic of, 135-710
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
    • Chungcheongbuk-do
      • Cheongju-si, Chungcheongbuk-do, Korea, Republic of, 28644
        • Chungbuk National University Hospital
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital
      • Badajoz, Spain, 06080
        • Hospital Infanta Cristina
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Barcelona, Spain, 08036
        • Hospital Clinic I Provincial de Barcelona
      • Madrid, Spain, 28034
        • Hospital Universitario Ramón y Cajal
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Marañon
      • Madrid, Spain, 28040
        • Hospital Universitario Clinico San Carlos
      • Madrid, Spain, 28050
        • Centro Integral Oncológico Clara Campal
      • Sevilla, Spain, 41009
        • Hospital Universitario Virgen Macarena
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen del Rocio
      • Valencia, Spain, 46026
        • Hospital Universitari i Politecnic La Fe
      • Valencia, Spain, 46010
        • Hospital Clinico Universitario de Valencia
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital
      • Taipei, Taiwan, 104
        • Mackay Memorial Hospital
      • Taipei, Taiwan, 110
        • Taipei Medical University Hospital
    • Greater London
      • London, Greater London, United Kingdom, WC1E 6AG
        • University College London Hospitals
      • London, Greater London, United Kingdom, SE1 9RT
        • Guy's Hospital
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom, M20 4BX
        • The Christie
    • Hampshire
      • Southampton, Hampshire, United Kingdom, SO16 6YD
        • Southampton General Hospital
    • Strathclyde
      • Glasgow, Strathclyde, United Kingdom, G12 OYN
        • Beatson West of Scotland Cancer Centre
    • Tyne & Wear
      • Newcastle upon Tyne, Tyne & Wear, United Kingdom, NE7 7DN
        • Northern Centre for Cancer Care
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B15 2TG
        • Queen Elizabeth Hospital
    • Arizona
      • Tucson, Arizona, United States, 85715
        • Arizona Clinical Research Center
    • California
      • Escondido, California, United States, 92025
        • Pacific Oncology Associates
      • Sacramento, California, United States, 95817
        • University of California Davis Health System
      • San Francisco, California, United States, 94118
        • California Pacific Medical Center
      • Whittier, California, United States, 90603
        • Innovative Clinical Research Institute
    • Colorado
      • Denver, Colorado, United States, 80218
        • Rocky Mountain Cancer Centers, LLP
    • Connecticut
      • Norwich, Connecticut, United States, 06360
        • Eastern Connecticut Hematology/Oncology Assoc.
    • Florida
      • Miami, Florida, United States, 33136
        • Sylvester Cancer Center
      • Port Saint Lucie, Florida, United States, 34952
        • Hematology - Oncology Associates of Treasure Coast
    • Georgia
      • Athens, Georgia, United States, 30607
        • University Cancer & Blood Center, LLC
      • Newnan, Georgia, United States, 30265
        • Southeastern Regional Medical Center
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Metairie Oncologists, LLC
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Cancer Institute
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
      • Lansing, Michigan, United States, 48910
        • Michigan State University
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University
    • Nevada
      • Las Vegas, Nevada, United States, 89169
        • Comprehensive Cancer Centers of Nevada
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina at Chapel Hill
    • Ohio
      • Cincinnati, Ohio, United States, 45206
        • UC Health Clinical Trials Office
      • Cleveland, Ohio, United States, 44106
        • Case Comprehensive Cancer Center
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State University Milton S. Hershey Medical Center
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
      • Greenville, South Carolina, United States, 29605
        • Greenville Hospital System University Medical Center (ITOR)
    • Tennessee
      • Knoxville, Tennessee, United States, 37909
        • Tennessee Cancer Specialists
    • Texas
      • Austin, Texas, United States, 78705
        • Texas Oncology, P.A. - Austin
      • Dallas, Texas, United States, 75230
        • Mary Crowley Cancer Research Centers
      • Fort Worth, Texas, United States, 76104
        • Texas Oncology, P.A. - Fort Worth
      • Houston, Texas, United States, 77030
        • Oncology Consultants, P.A.
      • Houston, Texas, United States, 77030
        • University of Texas M. D. Anderson Cancer Center - Investigational Cancer Therapeutics
      • San Antonio, Texas, United States, 78229
        • South Texas Accelerated Research Therapeutics, LLC
      • Tyler, Texas, United States, 75702
        • Texas Oncology, P.A. - Tyler
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Virginia Cancer Specialists, PC
      • Norfolk, Virginia, United States, 23502
        • Virginia Oncology Associates - Hampton
    • Washington
      • Vancouver, Washington, United States, 98684
        • Compass Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MSB0011359C (M7824)
Subjects will 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.
Other Names:
  • M7824

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose-escalation Part: Number of Subjects With Treatment Emergent Adverse Events (TEAEs)
Time Frame: Up to 10 weeks after last treatment
An Adverse Event (AE) is defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. Serious Adverse Event (SAE) is 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. AEs (SAEs and non-SAEs) will be considered TEAEs when emerging on treatment period defined as the time from the first trial drug administration up to 10 weeks after the last drug administration date.
Up to 10 weeks after last treatment
Dose-escalation Part: Number of Subjects With Treatment-Related AEs
Time Frame: Up to 10 weeks after last treatment
Treatment related AEs are any untoward medical occurrence in a subject who received study drug with causal relationship with the investigational product as assessed by the investigator. AEs will be assessed according to severity; mild (not causing any significant problem, dose adjustment not required), moderate (caused problem that does not interfere significantly with usual activities or the clinical status, dose adjustment needed due to adverse event) and severe (caused problem that interferes significantly with usual activities or the clinical status, study drug stopped due to adverse event).
Up to 10 weeks after last treatment
Dose-escalation Part: Number of Treatment Emergent Adverse Events (TEAEs) and Related TEAEs by Severity
Time Frame: Up to 10 weeks after last treatment
Up to 10 weeks after last treatment
Dose-escalation Part: Duration of Treatment Emergent Adverse Events (TEAEs) and Related TEAEs
Time Frame: Up to 10 weeks after last treatment
Up to 10 weeks after last treatment
Dose-escalation Part: Number of Subjects With Dose Limiting Toxicities (DLT)
Time Frame: Up to Week 3
A DLT is defined as any grade greater than or equal to (>=) 3 AE suspected to be related to investigational medicinal product (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.
Up to Week 3
Dose-expansion Part: Best Overall Response (BOR) as Assessed by Independent Endpoint Review Committee (IRC)
Time Frame: Date of randomization up to Week 52
BOR according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 and as adjudicated by the Independent Endpoint Review Committee (IRC).The BOR per IRC adjudication will be determined according to RECIST 1.1 and modified immune related response criteria (irRC), respectively. 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. Overall immune-related complete response: Complete disappearance of all lesions (whether measurable or not) and no new lesions. All measurable lymph nodes also must have a reduction in short axis to 10 mm or less. Overall immune-related partial response (irPR): Sum of the longest diameters of target and new measurable lesions decreases >= 30 percent (%).
Date of randomization up to Week 52
Dose-expansion Part: Disease Control Rate According to Response Assessment in Neuro-Oncology (RANO) as Adjudicated by the IRC for Subjects With Glioblastoma
Time Frame: Up to Week 52
The primary efficacy endpoint for the dose expansion part of the trial is the confirmed BOR according to RECIST 1.1 as adjudicated by the Independent Endpoint Review Committee (IRC) and will be evaluated by confirmed objective response rate (ORR). For glioblastoma, the primary endpoint will be disease control according to RANO as adjudicated by the IRC.
Up to Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose Escalation and Expansion Part: Maximum Concentration (Cmax) of MSB0011359C in Plasma
Time Frame: Predose, 0, 4, and 30 hours post dose
Predose, 0, 4, and 30 hours post dose
Dose Escalation and Expansion Part: Minimum Concentration (Cmin) of MSB0011359C in Plasma
Time Frame: Predose, 0, 4, and 30 hours post dose
Predose, 0, 4, and 30 hours post dose
Dose Escalation and Expansion Part: Area Under the Plasma Concentration Time Curve From Zero to Last Sampling Time (AUC0-t) of MSB0011359C
Time Frame: Predose, 0, 4, and 30 hours post dose
Predose, 0, 4, and 30 hours post dose
Dose Escalation and Expansion Part: Terminal Half Life (t1/2) of MSB0011359C
Time Frame: Predose, 0, 4, and 30 hours post dose
Predose, 0, 4, and 30 hours post dose
Dose Escalation and Expansion Part: Serum Titers of Anti-MSB0011359C Antibodies
Time Frame: Predose, Day 15, Day 43, Day 85 and every 6-weekly until progression or end of the treatment whichever occur first, assessed up to Week 52
Predose, Day 15, Day 43, Day 85 and every 6-weekly until progression or end of the treatment whichever occur first, assessed up to Week 52
Dose Escalation and Expansion Part: Best Overall Response (BOR) as Assessed by Investigator
Time Frame: Date of randomization up to Week 52
BOR according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 and as adjudicated by the Investigator.The BOR per investigator adjudication will be determined according to RECIST 1.1 and modified immune related response criteria (irRC), respectively. 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. Overall immune-related complete response: Complete disappearance of all lesions (whether measurable or not) and no new lesions. All measurable lymph nodes also must have a reduction in short axis to 10 mm or less. Overall immune-related partial response (irPR): Sum of the longest diameters of target and new measurable lesions decreases >= 30%.
Date of randomization up to Week 52
Dose Expansion Part: Number of Subjects With Treatment Emergent Adverse Events (TEAEs)
Time Frame: Time from the first trial drug administration up to 10 weeks last drug administration date
An Adverse Event (AE) is defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. Serious Adverse Event (SAE) is 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. AEs (SAEs and non-SAEs) will be considered TEAEs when emerging on treatment period defined as the time from the first trial drug administration up to 29 days after the last drug administration date or the earliest date of subsequent anticancer drug therapy minus 1 day, whichever occurs first, unless otherwise stated.
Time from the first trial drug administration up to 10 weeks last drug administration date
Dose Expansion Part: Number of Subjects With Treatment-Related AEs
Time Frame: Time from the first trial drug administration up to 10 weeks after the last drug administration date
Treatment related AEs are any untoward medical occurrence in a subject who received study drug with causal relationship with the investigational product as assessed by the investigator. AEs will be assessed according to severity; mild (not causing any significant problem, dose adjustment not required), moderate (caused problem that does not interfere significantly with usual activities or the clinical status, dose adjustment needed due to adverse event) and severe (caused problem that interferes significantly with usual activities or the clinical status, study drug stopped due to adverse event).
Time from the first trial drug administration up to 10 weeks after the last drug administration date
Dose Expansion Part: Number of Treatment Emergent Adverse Events (TEAEs) and Related TEAEs by Severity
Time Frame: Time from the first trial drug administration up to 10 weeks after the last drug administration date
Time from the first trial drug administration up to 10 weeks after the last drug administration date
Dose Expansion Part: Duration of Treatment Emergent Adverse Events (TEAEs) and Related TEAEs
Time Frame: Time from the first trial drug administration up to 10 weeks after the last drug administration date
Time from the first trial drug administration up to 10 weeks after the last drug administration date

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Medical Responsible, EMD Serono Research & Development Institute, Inc, an affiliate of MerckKGaA, Darmstadt, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2015

Primary Completion (Actual)

May 23, 2022

Study Completion (Actual)

May 23, 2022

Study Registration Dates

First Submitted

July 30, 2015

First Submitted That Met QC Criteria

August 4, 2015

First Posted (Estimate)

August 7, 2015

Study Record Updates

Last Update Posted (Actual)

June 15, 2022

Last Update Submitted That Met QC Criteria

June 14, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMR 200647-001
  • 2015-004366-28 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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