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Trial record 3 of 12 for:    m7824 | Phase 2

M7824 Versus Pembrolizumab as a First-line (1L) Treatment in Participants With Programmed Death-ligand 1 (PD-L1) Expressing Advanced Non-small Cell Lung Cancer (NSCLC)

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ClinicalTrials.gov Identifier: NCT03631706
Recruitment Status : Recruiting
First Posted : August 15, 2018
Last Update Posted : September 11, 2019
Sponsor:
Collaborator:
Merck KGaA, Darmstadt, Germany
Information provided by (Responsible Party):
EMD Serono ( EMD Serono Research & Development Institute, Inc. )

Tracking Information
First Submitted Date  ICMJE August 9, 2018
First Posted Date  ICMJE August 15, 2018
Last Update Posted Date September 11, 2019
Actual Study Start Date  ICMJE October 19, 2018
Estimated Primary Completion Date October 28, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 23, 2018)
  • Best Overall Response (BOR) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) as Evaluated by Independent Review Committee [ Time Frame: Time from randomization to planned final assessment for unconfirmed BOR, expected at 26 months ]
  • Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) as Evaluated by Independent Review Committee [ Time Frame: Time from randomization to planned final assessment, expected at 37 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 13, 2018)
  • Best Overall Response (BOR) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) as Evaluated by Independent Review Committee [ Time Frame: Time from randomization to planned final assessment for unconfirmed BOR, expected at 26 months ]
  • Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) as Evaluated by Independent Review Committee [ Time Frame: Time from randomization to planned final assessment for PFS after 192 events expected at 37 months ]
Change History Complete list of historical versions of study NCT03631706 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 23, 2018)
  • Occurrences of Treatment-emergent Adverse Events (TEAEs) and Treatment-related AEs According to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 [ Time Frame: Randomization up to the last safety follow-up visit, expected at approximately 47 months ]
  • Overall Survival (OS) Time [ Time Frame: Randomization up to 49 months ]
  • Best Overall Response (BOR) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) as Evaluated by Investigator [ Time Frame: Time from randomization to planned final assessment for unconfirmed BOR, expected at 26 months ]
  • Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) as Evaluated by Investigator [ Time Frame: Time from randomization to planned final assessment, expected at 37 months ]
  • Duration of Response Assessed from Complete Response (CR) or Partial Response (PR) according to RECIST 1.1 Assessed by Independent Review Committee [ Time Frame: Time from CR or PR to planned assessment, expected at 37 months ]
  • Concentration of M7284 at the end of Infusion (Ceoi) [ Time Frame: Pre-dose, 30 minutes post-dose at Week 1, 3, 5, 7 and 6 weekly during treatment up to safety follow-up visit (28 days after last dose, assessed up to 47 months) ]
  • Concentration of M7284 at the end of the Dosing Interval (C trough) [ Time Frame: Pre-dose, 30 minutes post-dose at Week 1, 3, 5, 7 and 6 weekly during treatment up to safety follow-up visit (28 days after last dose, assessed up to 47 months) ]
  • Immunogenicity as measured by Anti-drug Antibodies Concentration [ Time Frame: Randomization up to safety follow-up visit (28 days post last-dose of study drug administration, assessed up to 47 months) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 13, 2018)
  • Occurrences of Treatment-emergent Adverse Events (TEAEs) and Treatment-related AEs According to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 [ Time Frame: Randomization up to the last safety follow-up visit, expected at approximately 47 months ]
  • Overall Survival (OS) Time [ Time Frame: Randomization up to occurrence of 200 OS events expected at 49 months ]
  • Best Overall Response (BOR) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) as Evaluated by Investigator [ Time Frame: Time from randomization to planned final assessment for unconfirmed BOR, expected at 26 months ]
  • Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) as Evaluated by Investigator [ Time Frame: Time from randomization to planned final assessment for PFS after 192 events expected at 37 months ]
  • Duration of Response Assessed from Complete Response (CR) or Partial Response (PR) according to RECIST 1.1 Assessed by Independent Review Committee [ Time Frame: Time from CR or PR to planned assessment after 192 PFS events, expected at 37 months ]
  • Concentration of M7284 at the end of Infusion (Ceoi) [ Time Frame: Pre-dose, 30 minutes post-dose at Week 1, 3, 5, 7 and 6 weekly during treatment up to safety follow-up visit (28 days after last dose, assessed up to 47 months) ]
  • Concentration of M7284 at the end of the Dosing Interval (C trough) [ Time Frame: Pre-dose, 30 minutes post-dose at Week 1, 3, 5, 7 and 6 weekly during treatment up to safety follow-up visit (28 days after last dose, assessed up to 47 months) ]
  • Immunogenicity as measured by Anti-drug Antibodies Concentration [ Time Frame: Randomization up to safety follow-up visit (28 days post last-dose of study drug administration, assessed up to 47 months) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE M7824 Versus Pembrolizumab as a First-line (1L) Treatment in Participants With Programmed Death-ligand 1 (PD-L1) Expressing Advanced Non-small Cell Lung Cancer (NSCLC)
Official Title  ICMJE A Phase II, Multicenter, Randomized, Open-Label, Controlled Study of M7824 Versus Pembrolizumab as a First-line Treatment in Patients With PD-L1 Expressing Advanced Non-small Cell Lung Cancer
Brief Summary The study will evaluate M7824 monotherapy versus pembrolizumab as 1L treatment for participants with advanced NSCLC with high PD-L1-tumor expression.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-small Cell Lung Cancer
Intervention  ICMJE
  • Drug: M7824
    Participants will receive an intravenous infusion of 1200 milligrams (mg) M7824 once every 2 weeks starting from Day 1 up to disease progression.
  • Drug: Pembrolizumab
    Participants will receive an intravenous infusion of 200 mg Pembrolizumab once every 3 weeks starting from Day 1 up to disease progression.
Study Arms  ICMJE
  • Experimental: M7824
    Intervention: Drug: M7824
  • Active Comparator: Pembrolizumab
    Intervention: Drug: Pembrolizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 13, 2018)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 18, 2026
Estimated Primary Completion Date October 28, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically confirmed diagnosis of advanced NSCLC
  • Have not received prior systemic therapy treatment for their advanced/Stage four NSCLC. Completion of treatment with cytotoxic chemotherapy, biological therapy, and/or radiation as part of neoadjuvant/adjuvant therapy is allowed as long as therapy was completed at least 6 months prior to the diagnosis of metastatic disease. Confirmation of resolution of toxic effects of previous neoadjuvant/adjuvant chemotherapy therapy to Grade less than or equal to 1. For radiation toxicity or prior major surgeries, participants should have recovered from side effects and/or complications
  • Have measurable disease based on RECIST 1.1
  • Have a life expectancy of at least 3 months
  • Availability of either tumor archival material (less than 6 months old) or fresh biopsies collected within 28 days (excluding bone biopsies) before the first dose is mandatory to determine PD-L1 expression level prior to enrollment
  • PD-L1 high status as determined by central PD-L1 test or by prior testing using PD-L1 immunohistochemistry 22C3 pharmDx assay
  • Other protocol defined inclusion criteria could apply

Exclusion Criteria:

  • The participant's tumor harbors an epidermal growth factor receptor (EGFR) sensitizing (activating) mutation, anaplastic lymphoma kinase (ALK) translocation, ROS1 rearrangement, or BRAF V600E mutation, if targeted therapy is locally approved
  • Has received major surgery within 4 weeks prior to the first dose of study intervention; received thoracic radiation therapy of greater than 30 units of gray (Gy) within 6 months prior to the first dose of study
  • Known severe hypersensitivity to investigational products (M7824 or pembrolizumab), or any components in their formulations
  • Previous malignant disease (other than the target malignancy to be investigated in this study) within the last 3 years
  • Other protocol defined exclusion criteria could apply
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: US Medical Information 888-275-7376 service@emdgroup.com
Contact: Communication Center +49 6151 72 5200 service@emdgroup.com
Listed Location Countries  ICMJE Argentina,   Belgium,   Brazil,   China,   France,   Greece,   Hong Kong,   Italy,   Japan,   Korea, Republic of,   Netherlands,   Spain,   Taiwan,   Turkey,   Ukraine,   United States
Removed Location Countries Germany
 
Administrative Information
NCT Number  ICMJE NCT03631706
Other Study ID Numbers  ICMJE MS200647_0037
2018-001517-32 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party EMD Serono ( EMD Serono Research & Development Institute, Inc. )
Study Sponsor  ICMJE EMD Serono Research & Development Institute, Inc.
Collaborators  ICMJE Merck KGaA, Darmstadt, Germany
Investigators  ICMJE
Study Director: Medical Responsible Merck KGaA, Darmstadt, Germany
PRS Account EMD Serono
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP