Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    02517398
Previous Study | Return to List | Next Study

MSB0011359C (M7824) in Metastatic or Locally Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02517398
Recruitment Status : Active, not recruiting
First Posted : August 7, 2015
Last Update Posted : April 13, 2020
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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 600 participants
Allocation: N/A
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 : July 31, 2020
Estimated Study Completion Date : July 31, 2020

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
  • 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


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


Locations
Hide Hide 118 study locations
Layout table for location information
United States, Arizona
Arizona Clinical Research Center
Tucson, Arizona, United States, 85715
United States, California
Pacific Oncology Associates
Escondido, California, United States, 92025
University of California Davis Health System
Sacramento, California, United States, 95817
California Pacific Medical Center
San Francisco, California, United States, 94118
Innovative Clinical Research Institute
Whittier, California, United States, 90603
United States, Colorado
Rocky Mountain Cancer Centers, LLP
Denver, Colorado, United States, 80218
United States, Connecticut
Eastern Connecticut Hematology/Oncology Assoc.
Norwich, Connecticut, United States, 06360
United States, Florida
Sylvester Cancer Center
Miami, Florida, United States, 33136
Hematology - Oncology Associates of Treasure Coast
Port Saint Lucie, Florida, United States, 34952
United States, Georgia
University Cancer & Blood Center, LLC
Athens, Georgia, United States, 30607
Southeastern Regional Medical Center
Newnan, Georgia, United States, 30265
United States, Louisiana
Metairie Oncologists, LLC
Metairie, Louisiana, United States, 70006
United States, Maryland
National Cancer Institute
Bethesda, Maryland, United States, 20892
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
Michigan State University
Lansing, Michigan, United States, 48910
United States, Missouri
Washington University
Saint Louis, Missouri, United States, 63110
United States, Nevada
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89169
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
UC Health Clinical Trials Office
Cincinnati, Ohio, United States, 45206
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
Penn State University Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Greenville Hospital System University Medical Center (ITOR)
Greenville, South Carolina, United States, 29605
United States, Tennessee
Tennessee Cancer Specialists
Knoxville, Tennessee, United States, 37909
United States, Texas
Texas Oncology, P.A. - Austin
Austin, Texas, United States, 78705
Mary Crowley Cancer Research Centers
Dallas, Texas, United States, 75230
Texas Oncology, P.A. - Fort Worth
Fort Worth, Texas, United States, 76104
Oncology Consultants, P.A.
Houston, Texas, United States, 77030
University of Texas M. D. Anderson Cancer Center - Investigational Cancer Therapeutics
Houston, Texas, United States, 77030
South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, United States, 78229
Texas Oncology, P.A. - Tyler
Tyler, Texas, United States, 75702
United States, Virginia
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States, 22031
Virginia Oncology Associates - Hampton
Norfolk, Virginia, United States, 23502
United States, Washington
Compass Oncology
Vancouver, Washington, United States, 98684
Australia, New South Wales
Blacktown Hospital
Blacktown, New South Wales, Australia, 2148
St George Hospital
Kogarah, New South Wales, Australia, 2217
Liverpool Hospital
Liverpool, New South Wales, Australia, 2170
Port Macquarie Base Hospital
Port Macquarie, New South Wales, Australia, 2444
Royal North Shore Hospital
St Leonards, New South Wales, Australia, 2065
Calvary Mater Newcastle
Waratah, New South Wales, Australia, 2298
Australia, Queensland
Gallipoli Medical Research Foundation Ltd
Greenslopes, Queensland, Australia, 4120
Tasman Oncology Research Ltd
Southport, Queensland, Australia, 4216
Australia, South Australia
The Queen Elizabeth Hospital
Woodville South, South Australia, Australia, 5011
Australia, Victoria
Peter MacCallum Cancer Centre-East Melbourne
East Melbourne, Victoria, Australia, 3002
Cabrini Hospital Malvern
Malvern, Victoria, Australia, 3144
Border Medical Oncology Research Unit
Wodonga, Victoria, Australia, 3690
Australia, Western Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia, 6150
Linear Clinical Research Limited
Nedlands, Western Australia, Australia, 6009
Belgium
Institut Jules Bordet
Bruxelles, Belgium, 1000
Cliniques Universitaires Saint-Luc
Bruxelles, Belgium, 1200
Grand Hôpital de Charleroi
Charleroi, Belgium, 6000
UZ Antwerpen
Edegem, Belgium, 2650
Universitair Ziekenhuis Gent
Gent, Belgium, 9000
Centre Hospitalier de l'Ardenne
Libramont, Belgium, 6800
C. H. U. Sart Tilman
Liège, Belgium, 4000
GZA Ziekenhuizen - Campus Sint-Augustinus
Wilrijk, Belgium, 2610
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
France
Centre Antoine Lacassagne
Nice cedex 02, Alpes Maritimes, France, 06189
Centre Paul Strauss
Strasbourg Cedex, Bas Rhin, France, 67000
Hôpital de la Timone#
Marseille cedex 5, Bouches-du-Rhône, France, 13385
Centre Georges François Leclerc
Dijon cedex, Côte-d'Or, France, 21079
CHU Bordeaux - Hôpital Saint André
Bordeaux cedex, Gironde, France, 33075
Institut Claudius Regaud-Oncopole
Toulouse cedex 09, Haute Garonne, France, 31059
CHU de Grenoble - Hôpital Nord
Grenoble cedex 9, Isere, France, 38043
ICO - Site René Gauducheau
Saint Herblain, Loire Atlantique, France, 44805
Centre Oscar Lambret
Lille cedex, Nord, France, 59020
Institut Curie - Centre de Lutte Contre le Cancer (CLCC) de Paris
Paris Cedex 05, Paris, France, 75248
Hôpital Saint-Louis
Paris Cedex 10, Paris, France, 75475
Groupe Hospitalier Pitie-Salpetriere
Paris cedex 12, Paris, France, 75571
Centre Hospitalier de la Croix Rousse
Lyon Cedex 04, Rhone, France, 69317
Centre Léon Bérard
Lyon, Rhone, France, 69008
Hôpital Henri Mondor
Créteil Cedex, Val De Marne, France, 94010
Institut Régional du Cancer de Montpellier
Montpellier, France, 34298
Germany
Medizinische Hochschule Hannover
Hannover, Niedersachsen, Germany, 30625
Cellex Koeln
Koeln, Nordrhein Westfalen, Germany, 50670
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden, Sachsen, Germany, 01307
Charite Universitaetsmedizin Berlin - Campus Charite Mitte
Berlin, Germany, 10117
Italy
Fondazione del Piemonte per l'Oncologia IRCC Candiolo
Candiolo, Torino, Italy, 10060
Ospedale San Raffaele
Milano, Italy, 20132
Fondazione IRCCS Istituto Nazionale dei Tumori
Milano, Italy, 20133
IEO Istituto Europeo di Oncologia
Milano, Italy, 20141
Istituto Nazionale Tumori Fondazione G. Pascale
Napoli, Italy, 80131
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy, 27100
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy, 56126
Policlinico Universitario Agostino Gemelli
Roma, Italy, 00168
A.O.U. Senese Policlinico Santa Maria alle Scotte
Siena, Italy, 53100
Japan
National Cancer Center Hospital East
Kashiwa-shi, Chiba-Ken, Japan, 277-8577
Kindai University Hospital
Osakasayama-shi, Osaka-Fu, Japan, 589-8511
Korea, Republic of
Chungbuk National University Hospital
Cheongju-si, Chungcheongbuk-do, Korea, Republic of, 28644
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
Pusan National University Hospital
Busan, Korea, Republic of, 49241
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Asan Medical Center
Seoul, Korea, Republic of, 05505
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Spain
Hospital Infanta Cristina
Badajoz, Spain, 06080
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Hospital Clinic i Provincial de Barcelona
Barcelona, Spain, 08036
Hospital General Universitario Gregorio Marañon
Madrid, Spain, 28007
Hospital Universitario Ramon y Cajal
Madrid, Spain, 28034
Hospital Universitario Clinico San Carlos
Madrid, Spain, 28040
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Centro Integral Oncologico Clara Campal
Madrid, Spain, 28050
Hospital Universitario Virgen Macarena
Sevilla, Spain, 41009
Hospital Universitario Virgen del Rocio
Sevilla, Spain, 41013
Hospital Clinico Universitario de Valencia
Valencia, Spain, 46010
Hospital Universitari i Politecnic La Fe
Valencia, Spain, 46026
Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 100
Mackay Memorial Hospital
Taipei, Taiwan, 104
Taipei Medical University Hospital
Taipei, Taiwan, 110
United Kingdom
Guy's Hospital
London, Greater London, United Kingdom, SE1 9RT
University College London Hospitals
London, Greater London, United Kingdom, WC1E 6AG
The Christie
Manchester, Greater Manchester, United Kingdom, M20 4BX
Southampton General Hospital
Southampton, Hampshire, United Kingdom, SO16 6YD
Beatson West of Scotland Cancer Centre
Glasgow, Strathclyde, United Kingdom, G12 OYN
Northern Centre for Cancer Care
Newcastle upon Tyne, Tyne & Wear, United Kingdom, NE7 7DN
Queen Elizabeth Hospital
Birmingham, West Midlands, United Kingdom, B15 2TG
Sponsors and Collaborators
EMD Serono Research & Development Institute, Inc.
Merck KGaA, Darmstadt, Germany
Investigators
Layout table for investigator information
Study Director: Medical Responsible EMD Serono Research & Development Institute, Inc, an affiliate of MerckKGaA, Darmstadt, Germany
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: EMD Serono Research & Development Institute, Inc.
ClinicalTrials.gov Identifier: NCT02517398    
Other Study ID Numbers: EMR 200647-001
2015-004366-28 ( EudraCT Number )
First Posted: August 7, 2015    Key Record Dates
Last Update Posted: April 13, 2020
Last Verified: April 2020
Keywords provided by EMD Serono ( EMD Serono Research & Development Institute, Inc. ):
Solid tumor
MSB0011359C (M7824)
Metastatic or Locally Advanced Solid Tumors
Bintrafusp alfa
INTR@PID
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms