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MSB0011359C (M7824) in Metastatic or Locally Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT02517398
Recruitment Status : Recruiting
First Posted : August 7, 2015
Last Update Posted : November 19, 2018
Sponsor:
Collaborator:
Merck KGaA, Darmstadt, Germany
Information provided by (Responsible Party):
EMD Serono ( EMD Serono Research & Development Institute, Inc. )

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Solid Tumors Drug: MSB0011359C Phase 1

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  (Clinical Trial)
Estimated Enrollment : 708 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Open-label, Multiple-ascending Dose Trial to Investigate the Safety, Tolerability,Pharmacokinetics, Biological and Clinical Activity of MSB0011359C in Subjects With Metastatic or Locally Advanced Solid Tumors and Expansion to Selected Indications
Actual Study Start Date : August 31, 2015
Estimated Primary Completion Date : June 25, 2019
Estimated Study Completion Date : July 1, 2019

Arm Intervention/treatment
Experimental: MSB0011359C (M7824) Drug: MSB0011359C
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 Name: M7824




Primary Outcome Measures :
  1. 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.

  2. 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).

  3. Dose-escalation Part: Number of Treatment Emergent Adverse Events (TEAEs) and Related TEAEs by Severity [ Time Frame: Up to 10 weeks after last treatment ]
  4. Dose-escalation Part: Duration of Treatment Emergent Adverse Events (TEAEs) and Related TEAEs [ Time Frame: Up to 10 weeks after last treatment ]
  5. 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.

  6. 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 (%).

  7. 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.


Secondary Outcome Measures :
  1. Dose Escalation and Expansion Part: Maximum Concentration (Cmax) of MSB0011359C in Plasma [ Time Frame: Predose, 0, 4, and 30 hours post dose ]
  2. Dose Escalation and Expansion Part: Minimum Concentration (Cmin) of MSB0011359C in Plasma [ Time Frame: Predose, 0, 4, and 30 hours post dose ]
  3. 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 ]
  4. Dose Escalation and Expansion Part: Terminal Half Life (t1/2) of MSB0011359C [ Time Frame: Predose, 0, 4, and 30 hours post dose ]
  5. 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 ]
  6. 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%.

  7. 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.

  8. 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).

  9. 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 ]
  10. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ability to understand the purpose of the study, provide signed and dated informed consent, and able to comply with all procedures
  • 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02517398


Contacts
Contact: US Medical Information 888-275-7376

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Locations
United States, Arizona
Western Regional Medical Ctr. Withdrawn
Goodyear, Arizona, United States, 85338
Arizona Clinical Research Center Recruiting
Tucson, Arizona, United States, 85715
Contact: Jarret Schonbrun    520-290-2510    jschonbrun@acrcresearch.com   
Principal Investigator: Bruce Porterfield         
United States, California
City of Hope Cancer Center Withdrawn
Duarte, California, United States, 91010
Pacific Oncology Associates Recruiting
Escondido, California, United States, 92025
Principal Investigator: Edward McClay         
University of California Davis Health System Recruiting
Sacramento, California, United States, 95817
Contact: Linh Dang-Chu    916-734-5930    ldangchu@ucdavis.edu   
Principal Investigator: Karen Kelly         
California Pacific Medical Center Recruiting
San Francisco, California, United States, 94118
Contact: Brenda Eng    415-600-1775    engb@cpmcri.org   
Principal Investigator: Ari Baron         
Innovative Clinical Research Institute Recruiting
Whittier, California, United States, 90603
Contact: Kirsten Bettino    562-693-4477    kbettino@airesearch.us   
Principal Investigator: Agajanian Richy         
United States, Colorado
Rocky Mountain Cancer Centers, LLP Recruiting
Denver, Colorado, United States, 80218
Principal Investigator: Allen Cohn         
United States, Connecticut
Eastern Connecticut Hematology/Oncology Assoc. Recruiting
Norwich, Connecticut, United States, 06360
Contact: Jeannine Elliott    860-886-8362    jelliott@echoct.com   
Principal Investigator: Dennis Slater         
United States, Florida
Lynn Cancer Institute Center Withdrawn
Boca Raton, Florida, United States, 33486
Sylvester Cancer Center Recruiting
Miami, Florida, United States, 33136
Contact: Karen Blackburn    305-243-0863    k.blackburn@med.miami.edu   
Principal Investigator: Lynn Feun         
Hematology - Oncology Associates of the Treasure Coast Withdrawn
Port Saint Lucie, Florida, United States, 34952
Hematology - Oncology Associates of Treasure Coast Recruiting
Port Saint Lucie, Florida, United States, 34952
Contact: Angela Voldeck    772-408-5164    avoldeck@hemoncfl.com   
Principal Investigator: Michael Wertheim         
United States, Georgia
University Cancer & Blood Center, LLC Terminated
Athens, Georgia, United States, 30607
Winship Cancer Institute Withdrawn
Atlanta, Georgia, United States, 30322
Northside Hospital Withdrawn
Atlanta, Georgia, United States, 30342
Southeastern Regional Medical Center Recruiting
Newnan, Georgia, United States, 30265
Contact: Mittie Mitchell    770-400-7194    mittie.mitchell@ctca-hope.com   
Principal Investigator: Patricia Thompson         
United States, Illinois
Jesse Brown V.A. Withdrawn
Chicago, Illinois, United States, 60612
University of Illinois at Chicago Withdrawn
Chicago, Illinois, United States, 60612
United States, Kansas
University of Kansas Medical Center Research Institute, Inc. Withdrawn
Westwood, Kansas, United States, 66205
United States, Louisiana
Metairie Oncologists, LLC Recruiting
Metairie, Louisiana, United States, 70006
Principal Investigator: Jayne Gurtler         
United States, Maryland
Center for Cancer and Blood Disorders Withdrawn
Bethesda, Maryland, United States, 20817
Rcca Md Llc Withdrawn
Bethesda, Maryland, United States, 20817
National Cancer Institute Recruiting
Bethesda, Maryland, United States, 20892
Principal Investigator: James Gulley         
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Principal Investigator: Osama Rahma         
United States, Michigan
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Principal Investigator: Wang Ding         
Michigan State University Recruiting
Lansing, Michigan, United States, 48910
Contact: Carolyn Krahulik    517-975-9539    carolyn.krahulik@hc.msu.edu   
Principal Investigator: Borys Hrinczenko         
United States, Missouri
Washington University Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Rachel Beck    314-747-5376    rachel.beck@wustl.edu   
Principal Investigator: Benjamin Tan         
United States, Nevada
Comprehensive Cancer Centers of Nevada Recruiting
Las Vegas, Nevada, United States, 89169
Principal Investigator: Fadi Braiteh         
United States, New Hampshire
Dartmouth-Hitchcock Medical Center Withdrawn
Lebanon, New Hampshire, United States, 03756
United States, North Carolina
University of North Carolina at Chapel Hill Terminated
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
UC Health Clinical Trials Office Recruiting
Cincinnati, Ohio, United States, 45206
Contact: Belinda Tuttle    513-584-2951    tuttleba@uc.edu   
Principal Investigator: John Morris         
Case Comprehensive Cancer Center Terminated
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
Penn State University Milton S. Hershey Medical Center Terminated
Hershey, Pennsylvania, United States, 17033
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Principal Investigator: Howard Safran         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Principal Investigator: Carolyn Britten         
Greenville Hospital System University Medical Center (ITOR) Recruiting
Greenville, South Carolina, United States, 29605
Contact: Lisa Johnson    864-455-3735    ljohnson4@ghs.org   
Principal Investigator: William Edenfield         
United States, Tennessee
Tennessee Cancer Specialists Recruiting
Knoxville, Tennessee, United States, 37909
Contact: Krista Tibbs    865-934-2676    ktibbs@biomed-research.com   
Principal Investigator: Russell DeVore         
United States, Texas
Texas Oncology, P.A. - Austin Recruiting
Austin, Texas, United States, 78705
Principal Investigator: Jason Melear         
Mary Crowley Cancer Research Centers Recruiting
Dallas, Texas, United States, 75230
Principal Investigator: Minal Barve         
Texas Oncology, P.A. - Fort Worth Recruiting
Fort Worth, Texas, United States, 76104
Principal Investigator: Stephen Richey         
Oncology Consultants, P.A. Active, not recruiting
Houston, Texas, United States, 77030
University of Texas M. D. Anderson Cancer Center - Investigational Cancer Therapeutics Recruiting
Houston, Texas, United States, 77030
Contact: Alphi Kuriakose    713-794-4625    avkuriakose@mdanderson.org   
Principal Investigator: Aung Naing         
South Texas Accelerated Research Therapeutics, LLC Recruiting
San Antonio, Texas, United States, 78229
Principal Investigator: Kyriakos Papadopoulos         
Cancer Care Network of South Texas - SAT&BC-M oak Withdrawn
San Antonio, Texas, United States, 78258
Texas Oncology, P.A. - Tyler Recruiting
Tyler, Texas, United States, 75702
Principal Investigator: Donald Richards         
United States, Virginia
Virginia Cancer Specialists, PC Recruiting
Fairfax, Virginia, United States, 22031
Contact: Melanie Herrin    703-280-5390    melanie.herrin@usoncology.com   
Principal Investigator: Alexander Spira         
Virginia Oncology Associates - Hampton Recruiting
Norfolk, Virginia, United States, 23502
Contact: Karen McClain    757-213-5658    karen.mcclain@usoncology.com   
Principal Investigator: Paul Conkling         
United States, Washington
Compass Oncology Recruiting
Vancouver, Washington, United States, 98684
Principal Investigator: David Smith         
Australia, New South Wales
Blacktown Hospital Recruiting
Blacktown, New South Wales, Australia, 2148
Contact: Raymond Tangunan,    +61286705070    raymond.tangunan@health.nsw.gov.au   
Principal Investigator: Mark Wong         
Chris O'Brien Lifehouse Withdrawn
Camperdown, New South Wales, Australia, 2050
St George Hospital Recruiting
Kogarah, New South Wales, Australia, 2217
Contact: Lisa Wang    +61291133355 000 000 000    lisa.wang@health.nsw.gov.au   
Principal Investigator: Chee Lee         
Liverpool Hospital Recruiting
Liverpool, New South Wales, Australia, 2170
Contact: Sheela Subramani    +61287389159    sheela.subramani@sswahs.nsw.gov.au   
Principal Investigator: Paul de Souza         
Port Macquarie Base Hospital Recruiting
Port Macquarie, New South Wales, Australia, 2444
Contact: Suzzanna Fettell    +61265801822    suzzanna.fettell@ncahs.health.nsw.gov.au   
Principal Investigator: Stephen Begbie         
Royal North Shore Hospital Recruiting
St Leonards, New South Wales, Australia, 2065
Principal Investigator: Nick Pavlakis         
Calvary Mater Newcastle Recruiting
Waratah, New South Wales, Australia, 2298
Contact: Louise Plowman       louise.plowman@calvarymater.org.au   
Principal Investigator: Craig Gedye         
Australia, Queensland
Gallipoli Medical Research Foundation Ltd Recruiting
Greenslopes, Queensland, Australia, 4120
Contact: Casey Bronwyn    +61733947082    caseybr@ramsayhealth.com.au   
Principal Investigator: Victoria Atkinson         
Tasman Oncology Research Ltd Recruiting
Southport, Queensland, Australia, 4216
Contact: Chelsea Withers    +61756132803    chelsea@tasmanoncology.com.au   
Principal Investigator: Andrew Hill         
Australia, South Australia
The Queen Elizabeth Hospital Recruiting
Woodville South, South Australia, Australia, 5011
Contact: Elizabeth Egan    +61882227411    elizabeth.egan@health.sa.gov.au   
Principal Investigator: Rachel Roberts-Thomson         
Australia, Victoria
Peter MacCallum Cancer Centre-East Melbourne Recruiting
East Melbourne, Victoria, Australia, 3002
Contact: Mei Zhang    +61385597346    mei.zhang@petermac.org   
Principal Investigator: George Au-Yeung         
Cabrini Hospital Malvern Recruiting
Malvern, Victoria, Australia, 3144
Principal Investigator: Gary Richardson         
Border Medical Oncology Research Unit Recruiting
Wodonga, Victoria, Australia, 3690
Contact: Donna Long    +61260515306    dlong@bordermedonc.com.au   
Principal Investigator: Christopher Steer         
Australia, Western Australia
Fiona Stanley Hospital Recruiting
Murdoch, Western Australia, Australia, 6150
Contact: Marie Todd    +61861526537    marie.todd@health.wa.gov.au   
Principal Investigator: Adnan Khattak         
Linear Clinical Research Limited Recruiting
Nedlands, Western Australia, Australia, 6009
Contact: Andrea Lasso    +61863825143    alasso@linear.org.au   
Principal Investigator: Tarek Meniawy         
Belgium
Institut Jules Bordet Recruiting
Bruxelles, Belgium, 1000
Contact: Maureen Billiet    +3225413303    maureen.billiet@bordet.be   
Principal Investigator: Ahmad Awada         
Cliniques Universitaires Saint-Luc Recruiting
Bruxelles, Belgium, 1200
Contact: Valerie Decroes    +3227644297    valerie.decroes@uclouvain.be   
Principal Investigator: Jean-Pascal Machiels         
Grand Hôpital de Charleroi Recruiting
Charleroi, Belgium, 6000
Principal Investigator: Jean-Luc Canon         
UZ Antwerpen Recruiting
Edegem, Belgium, 2650
Principal Investigator: Marika Rasschaert         
Universitair Ziekenhuis Gent Recruiting
Gent, Belgium, 9000
Contact: Carla Vandenabeele    +3293323924    carla.vandenabeele@uzgent.be   
Principal Investigator: Sylvie Rottey         
Centre Hospitalier de l'Ardenne Recruiting
Libramont, Belgium, 6800
Contact: Oumhani Meftahi    +3261622683    oumhani.meftahi@vivalia.be   
Principal Investigator: Frédéric Forget         
C. H. U. Sart Tilman Recruiting
Liège, Belgium, 4000
Principal Investigator: Guy Jerusalem         
GZA Ziekenhuizen - Campus Sint-Augustinus Recruiting
Wilrijk, Belgium, 2610
Contact: Els Willekens    +3234433759    els.willekens@gza.be   
Principal Investigator: Luc Dirix         
Canada, Alberta
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Bonnie Chalmers    7805778128    bonnie.chalmers@ahs.ca   
Principal Investigator: Randeep Sangha         
Canada, Ontario
LHSC - Victoria Hospital Withdrawn
London, Ontario, Canada, N6A 5W9
France
Centre Antoine Lacassagne Recruiting
Nice cedex 02, Alpes Maritimes, France, 06189
Contact: Soukaina Boudouf    +33492031000    soukaina.boudouf@nice.unicancer.fr   
Principal Investigator: Esma Saada-Bouzid         
Centre Paul Strauss Recruiting
Strasbourg Cedex, Bas Rhin, France, 67000
Principal Investigator: Christian Borel         
Hôpital de la Timone# Recruiting
Marseille cedex 5, Bouches-du-Rhône, France, 13385
Principal Investigator: Fabrice Barlesi         
Centre Georges François Leclerc Recruiting
Dijon cedex, Côte-d'Or, France, 21079
Contact: Peggy Philippe    +33345348068    pphilippe@cgfl.fr   
Principal Investigator: Nicolas Isambert         
CHU Bordeaux - Hôpital Saint André Recruiting
Bordeaux cedex, Gironde, France, 33075
Contact: Delphine Pedenon-Peyrichout    +33556794708    delphine.pedenon@chu-bordeaux.fr   
Principal Investigator: Alain Ravaud         
Institut Claudius Regaud-Oncopole Recruiting
Toulouse cedex 09, Haute Garonne, France, 31059
Contact: Jessy Saffore    +33531155821    saffore.jessy@iuct-oncopole.fr   
Principal Investigator: Jean-Pierre Delord         
CHU de Grenoble - Hôpital Nord Recruiting
Grenoble cedex 9, Isere, France, 38043
Principal Investigator: Thomas Decaens         
ICO - Site René Gauducheau Recruiting
Saint Herblain, Loire Atlantique, France, 44805
Contact: Catherine Rabreau    +332406799009166    catherine.rabreau@ico.unicancer.fr   
Principal Investigator: Marie Robert         
Centre Oscar Lambret Recruiting
Lille cedex, Nord, France, 59020
Contact: Julien Lelay    +33320295935    j-lelay@o-lambret.fr   
Principal Investigator: Nicolas Penel         
Institut Curie - Centre de Lutte Contre le Cancer (CLCC) de Paris Terminated
Paris Cedex 05, Paris, France, 75248
Hôpital Saint-Louis Recruiting
Paris Cedex 10, Paris, France, 75475
Contact: Emilie Vallee-Willien    +33142385110    emilie.vallee-willien@sls.aphp.fr   
Principal Investigator: Luis Teixeira         
Groupe Hospitalier Pitie-Salpetriere Recruiting
Paris cedex 12, Paris, France, 75571
Principal Investigator: Olivier Rosmorduc         
Hôpital Cochin Withdrawn
Paris cedex 14, Paris, France, 75679
Centre Hospitalier de la Croix Rousse Recruiting
Lyon Cedex 04, Rhone, France, 69317
Contact: Paule Guilloreau    +33426732736    paule.guilloreau@chu-lyon.fr   
Principal Investigator: Philippe Merle         
Centre Léon Bérard Recruiting
Lyon, Rhone, France, 69008
Contact: Pierre Metral    +33426556844    pierre.metral@lyon.unicancer.fr   
Principal Investigator: Philippe Cassier         
Centre Hospitalier Intercommunal de Créteil Withdrawn
Creteil cedex, Val De Marne, France, 94010
Hôpital Henri Mondor Terminated
Créteil Cedex, Val De Marne, France, 94010
Institut Régional du Cancer de Montpellier Recruiting
Montpellier, France, 34298
Contact: Elodie Delalande    +33467612359    elodie.delalande@icm.unicancer.fr   
Principal Investigator: Diego Tosi         
Germany
Universitaetsklinikum Freiburg Withdrawn
Freiburg, Baden Wuerttemberg, Germany, 79106
Klinikum der Johann Wolfgang Goethe-Universitaet Withdrawn
Frankfurt, Hessen, Germany, 60590
Medizinische Hochschule Hannover Terminated
Hannover, Niedersachsen, Germany, 30625
Cellex Koeln Terminated
Koeln, Nordrhein Westfalen, Germany, 50670
Universitaetsklinikum des Saarlandes Withdrawn
Homburg, Saarland, Germany, 66421
Universitaetsklinikum Carl Gustav Carus TU Dresden Terminated
Dresden, Sachsen, Germany, 01307
Charite Universitaetsmedizin Berlin - Campus Charite Mitte Terminated
Berlin, Germany, 10117
Italy
Istituto Clinico Humanitas Withdrawn
Rozzano, Milano, Italy, 20089
Fondazione del Piemonte per l'Oncologia IRCC Candiolo Recruiting
Candiolo, Torino, Italy, 10060
Principal Investigator: Massimo Aglietta         
Azienda Ospedaliera G. Rummo Withdrawn
Benevento, Italy, 82100
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi Withdrawn
Bologna, Italy, 40138
Ospedale San Raffaele Recruiting
Milano, Italy, 20132
Principal Investigator: Luca Gianni         
Fondazione IRCCS Istituto Nazionale dei Tumori Recruiting
Milano, Italy, 20133
Principal Investigator: Massimo Di Nicola         
IEO Istituto Europeo di Oncologia Recruiting
Milano, Italy, 20141
Principal Investigator: Giuseppe Curigliano         
Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda) Withdrawn
Milano, Italy, 20162
Istituto Nazionale Tumori Fondazione G. Pascale Terminated
Napoli, Italy, 80131
Fondazione IRCCS Policlinico San Matteo Recruiting
Pavia, Italy, 27100
Principal Investigator: Paolo Pedrazzoli         
Azienda Ospedaliero Universitaria Pisana Terminated
Pisa, Italy, 56126
Policlinico Universitario Agostino Gemelli Recruiting
Roma, Italy, 00168
Principal Investigator: Carlo Barone         
A.O.U. Senese Policlinico Santa Maria alle Scotte Recruiting
Siena, Italy, 53100
Principal Investigator: Michele Maio         
Japan
National Cancer Center Hospital East Recruiting
Kashiwa-shi, Chiba-Ken, Japan, 277-8577
Principal Investigator: Masafumi Ikeda         
Kindai University Hospital Recruiting
Osakasayama-shi, Osaka-Fu, Japan, 589-8511
Principal Investigator: Masatoshi Kudo         
Korea, Republic of
Chungbuk National University Hospital Recruiting
Cheongju-si, Chungcheongbuk-do, Korea, Republic of, 28644
Principal Investigator: Ki Hyeong Lee         
National Cancer Center Withdrawn
Goyang-si, Gyeonggi-do, Korea, Republic of, 10408
Seoul National University Bundang Hospital Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
Contact: HyunJin Jeong    +82317878223    r1359@snubh.org   
Principal Investigator: Jee Hyun Kim         
Pusan National University Hospital Recruiting
Busan, Korea, Republic of, 49241
Principal Investigator: Jeong Heo         
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Contact: KyungSun Do    +82220727378    imhereby@naver.com   
Principal Investigator: Dong-Wan Kim         
Severance Hospital, Yonsei University Withdrawn
Seoul, Korea, Republic of, 03722
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 05505
Contact: Hyerim Kwak    +82230102256    aquzima@amc.seoul.kr   
Principal Investigator: Baek-Yeol Ryoo         
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 05505
Principal Investigator: Dae Ho Lee         
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: HyunAh Kim    82234100955    hyunah888.kim@samsung.com   
Principal Investigator: Ho Yeong Lim         
Spain
Hospital Infanta Cristina Terminated
Badajoz, Spain, 06080
Hospital Universitari Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Contact: Sonia Abad    +34934894158    sabad@vhio.net   
Principal Investigator: Enriqueta Felip Font         
Hospital Clinic i Provincial de Barcelona Recruiting
Barcelona, Spain, 08036
Contact: Debora Moreno    34932275400 ext 4615    dmorenof@clinic.cat   
Principal Investigator: Javier Garcia Corbacho         
Hospital General Universitario Gregorio Marañon Recruiting
Madrid, Spain, 28007
Contact: Beatriz Puente Vazquez    +34914269394    beatrizpuente.hgugm@yahoo.es   
Principal Investigator: Miguel Martin Jimenez         
Hospital Universitario Ramon y Cajal Recruiting
Madrid, Spain, 28034
Contact: Susana Moreno Tome    +34913368263    smorenot@salud.madrid.org   
Principal Investigator: Federico Longo Munoz         
Hospital Universitario Clinico San Carlos Active, not recruiting
Madrid, Spain, 28040
Hospital Universitario 12 de Octubre Recruiting
Madrid, Spain, 28041
Contact: María Paz Soriano       unidadfase1.imas12@h12o.es   
Principal Investigator: Luis Paz-Ares Rodriguez         
Centro Integral Oncologico Clara Campal Recruiting
Madrid, Spain, 28050
Contact: Sara Cerdá,       sara.cerda@start.stoh.com   
Principal Investigator: Emiliano Calvo Aller         
Hospital Universitario Virgen Macarena Recruiting
Sevilla, Spain, 41009
Contact: Mónica Suengas Martínez    +34955926578    oncomacarena@gmail.com   
Principal Investigator: David Vicente Baz         
Hospital Universitario Virgen del Rocio Recruiting
Sevilla, Spain, 41013
Contact: Laura Bernal    +34671533374    lauraonco.huvr@gmail.com   
Principal Investigator: Flor Oncala Maria Jose         
Hospital Clinico Universitario de Valencia Recruiting
Valencia, Spain, 46010
Contact: Celia Martinez    +349603862625    cmartinez@incliva.es   
Principal Investigator: Andres Manuel Cervantes Ruiperez         
Hospital Universitari i Politecnic La Fe Recruiting
Valencia, Spain, 46026
Contact: Gemma Gimeno Mateu    +34963131800    sc_oncologia1@iislafe.es   
Principal Investigator: Juan Vidal Oscar         
Taiwan
Kaohsiung Chang Gung Memorial Hospital Withdrawn
Kaohsiung, Taiwan, 83301
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Principal Investigator: Chia-Chi Lin         
Mackay Memorial Hospital Recruiting
Taipei, Taiwan, 104
Principal Investigator: Ruey-Kuen Hsieh         
Taipei Medical University Hospital Recruiting
Taipei, Taiwan, 110
Contact: Wan-Chun Tsai    +886227372181 ext 1663    156089@h.tmu.edu.tw   
Principal Investigator: Her-Shyong Shiah         
Taipei Veterans General Hospital Withdrawn
Taipei, Taiwan, 11217
United Kingdom
Queen Mary University of London Withdrawn
London Olney, Greater London, United Kingdom, EC1M 6BQ
Guy's Hospital Recruiting
London, Greater London, United Kingdom, SE1 9RT
Contact: Yasmine Yau    +440207794050034214    yasmine.yau@gstt.nhs.uk   
Principal Investigator: Debashis Sarker         
Sarah Cannon Research Institute UK Withdrawn
London, Greater London, United Kingdom, W1G 6AD
University College London Hospitals Recruiting
London, Greater London, United Kingdom, WC1E 6AG
Contact: James Wilton    +442034472905    james.wilton@uclh.nhs.uk   
Principal Investigator: Martin Forster         
The Christie Recruiting
Manchester, Greater Manchester, United Kingdom, M20 4BX
Principal Investigator: Matthew Krebs         
Southampton General Hospital Recruiting
Southampton, Hampshire, United Kingdom, SO16 6YD
Contact: Carly Ringrose    +442381205113    lymphomaresearchnurses@soton.ac.uk   
Principal Investigator: Loannis Karydis         
Beatson West of Scotland Cancer Centre Recruiting
Glasgow, Strathclyde, United Kingdom, G12 OYN
Contact: Eileen Soulis    +4401413017218    eileen.soulis@glasgow.ac.uk   
Principal Investigator: Jeff Evans,         
Northern Centre for Cancer Care Recruiting
Newcastle upon Tyne, Tyne & Wear, United Kingdom, NE7 7DN
Contact: Victoria Smith    +441912138452    victoria.smith2@nuth.nhs.uk   
Principal Investigator: Ruth Plummer         
Queen Elizabeth Hospital Terminated
Birmingham, West Midlands, United Kingdom, B15 2TG
Sponsors and Collaborators
EMD Serono Research & Development Institute, Inc.
Merck KGaA, Darmstadt, Germany
Investigators
Study Director: Medical Responsible EMD Serono Research & Development Institute, Inc, an affiliate of MerckKGaA, Darmstadt, Germany

Responsible Party: EMD Serono Research & Development Institute, Inc.
ClinicalTrials.gov Identifier: NCT02517398     History of Changes
Other Study ID Numbers: EMR 200647-001
2015-004366-28 ( EudraCT Number )
First Posted: August 7, 2015    Key Record Dates
Last Update Posted: November 19, 2018
Last Verified: November 2018

Keywords provided by EMD Serono ( EMD Serono Research & Development Institute, Inc. ):
Solid tumor
MSB0011359C (M7824)
Metastatic or Locally Advanced Solid Tumors

Additional relevant MeSH terms:
Neoplasms