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M7824 in Combination With Chemotherapy in Stage IV Non-small Cell Lung Cancer (NSCLC)

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ClinicalTrials.gov Identifier: NCT03840915
Recruitment Status : Recruiting
First Posted : February 15, 2019
Last Update Posted : September 10, 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 February 12, 2019
First Posted Date  ICMJE February 15, 2019
Last Update Posted Date September 10, 2019
Actual Study Start Date  ICMJE March 14, 2019
Estimated Primary Completion Date October 28, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 12, 2019)
  • Incidence of Dose Limiting Toxicities (DLTs) [ Time Frame: Day 1 to Day 21 (Cycle 1) ]
  • Incidence of Treatment Emergent Adverse Events (TEAEs) and Treatment Related Adverse Events [ Time Frame: Up to 3 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03840915 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2019)
  • Confirmed Objective Response as Assessed by Investigator According to Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1 [ Time Frame: Up to 3 years ]
  • Progression-Free Survival (PFS) as Assessed by Investigator According to Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1 [ Time Frame: Up to 3 years ]
  • Overall Survival (OS) [ Time Frame: Up to 3 years ]
  • Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1 [ Time Frame: Up to 3 years ]
  • Concentration of M7824 Observed Immediately at the End of Infusion (Ceoi) [ Time Frame: Up to 3 years ]
  • Concentration of M7824 Observed Immediately Before Next Dosing (Ctrough) [ Time Frame: Up to 3 years ]
  • Area Under the Serum Concentration-Time Curve From Time Zero to Last Sampling Time at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) of M7824 [ Time Frame: Up to 3 years ]
  • Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of M7824 [ Time Frame: Up to 3 years ]
  • Maximum Observed Serum Concentration (Cmax) of M7824 [ Time Frame: Up to 3 years ]
  • Time to Reach Maximum Serum Concentration (Tmax) of M7824 [ Time Frame: Up to 3 years ]
  • Apparent Terminal Half-life (t1/2) of M7824 [ Time Frame: Up to 3 years ]
  • Immunogenicity of M7824, as Assessed by Anti-drug Anti-body (ADA) Assay [ Time Frame: Up to 3 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE M7824 in Combination With Chemotherapy in Stage IV Non-small Cell Lung Cancer (NSCLC)
Official Title  ICMJE A Phase Ib/II, Open-Label Study of M7824 in Combination With Chemotherapy in Participants With Stage IV Non-small Cell Lung Cancer
Brief Summary The main purpose of the study is to evaluate the safety and tolerability of M7824 in combination with chemotherapy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Non-Small-Cell Lung
Intervention  ICMJE
  • Drug: Cisplatin
    Cisplatin will be administered intravenously at a dose of 75 milligrams per meter square (mg/m^2) over 60 minutes every 21 days for 4 cycles (each cycle is 21 days).
  • Drug: Carboplatin
    Carboplatin will be administered at area under the concentration-time Curve (AUC) 5 when combined with pemetrexed over 30 to 60 minutes every 21 days for 4 cycles (each cycle is 21 days).
  • Drug: Pemetrexed
    Pemetrexed will be administered intravenously at a dose of 500 mg/ m^2 over 10 minutes every 21 days.
  • Drug: Nab-paclitaxel
    Nab-paclitaxel will be administered intravenously at as dose of 100 mg/m^2 over 30 minutes in a 21 days cycle on Day 1, 8, and 15 in each cycle for 4 cycles (each cycle is 21 days).
  • Drug: Gemcitabine
    Gemcitabine will be administered intravenously at a dose of 1250 mg/m^2 over 30 minutes in a 21 days cycle on Day 1, and 8, in each cycle for 4 cycles (each cycle is 21 days).
  • Drug: Docetaxel
    Docetaxel will be administered intravenously at a dose of 75 mg/m^2 over 60 minutes every 21 days for 4 cycles (each cycle is 21 days).
  • Drug: M7824
    M7824 will be administered intravenously at a dose of 2400 mg every 21 days in combination with chemotherapy for 4 cycles (each cycle is 21 days) followed by up to 31 cycles in maintenance with M7824 and pemetrexed.
  • Drug: Carboplatin
    Carboplatin will be administered at area under the concentration-time Curve (AUC) 6 when combined with nab-paclitaxel over 30 to 60 minutes every 21 days for 4 cycles (each cycle is 21 days).
  • Drug: Carboplatin
    Carboplatin will be administered at area under the concentration-time Curve (AUC) 5 when combined with gemcitabine over 30 to 60 minutes every 21 days for 4 cycles (each cycle is 21 days).
  • Drug: M7824
    M7824 will be administered intravenously at a dose of 2400 mg every 21 days in combination with chemotherapy for 4 cycles (each cycle is 21 days) followed by up to 31 cycles in maintenance with M7824 alone.
Study Arms  ICMJE
  • Experimental: Cohort A: Cisplatin or Carboplatin + Pemetrexed + M7824
    Interventions:
    • Drug: Cisplatin
    • Drug: Carboplatin
    • Drug: Pemetrexed
    • Drug: M7824
  • Experimental: Cohort B: Carboplatin + Nab-paclitaxel + M7824
    Interventions:
    • Drug: Nab-paclitaxel
    • Drug: Carboplatin
    • Drug: M7824
  • Experimental: Cohort C: Cisplatin or Carboplatin + Gemcitabine + M7824
    Interventions:
    • Drug: Cisplatin
    • Drug: Gemcitabine
    • Drug: Carboplatin
    • Drug: M7824
  • Experimental: Cohort D: Docetaxel + M7824
    Interventions:
    • Drug: Docetaxel
    • Drug: M7824
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: February 12, 2019)
64
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 28, 2021
Estimated Primary Completion Date October 28, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participants greater than or equals to (>=) 18 years of age inclusive at the time of signing the informed consent
  • Participants who have histologically confirmed diagnosis of Stage IV NSCLC:

    1. Participants in Cohort A, B, and C must not have received prior systemic therapy treatment for their Stage IV NSCLC
    2. Participants who had disease progression on previous treatment with Programmed death-ligand 1 (PD- L1) inhibitors in combination with platinum-based chemotherapy are enrolled in Cohort D, as long as therapy was completed at least 28 days of the first study intervention.
  • Have measurable disease based on Response evaluation criteria in solid tumors (RECIST) 1.1
  • Have a life expectancy of at least 3 months
  • Availability of archived tumor material (less than [<] 6 months old) adequate for biomarker analysis is mandatory at Screening, central laboratory confirmation is required. Fresh biopsies should be collected if archived tumor material is not available
  • Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 at study entry and date of first dose

Exclusion Criteria:

  • The participant's tumor harbors an epidermal growth factor receptor (EGFR) sensitizing (activating) mutation,ROS1 rearrangement, or BRAF V600E mutation or anaplastic lymphoma kinase (ALK) positive, if targeted therapy is locally approved
  • Mixed small cell with NSCLC cancer histology
  • Has received major surgery within 4 weeks prior to the first dose of study intervention; received thoracic radiation therapy (RT) of > 30 gray (Gy) within 6 months prior to the first dose of study intervention
  • Previous malignant disease (other than the target malignancy to be investigated in this study) within the last 3 years
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are clinically stable for at least 2 weeks after the end of the RT and, have no evidence of new or enlarging brain metastases evaluated by imaging, preferably brain magnetic resonance imaging (MRI)
  • Known severe hypersensitivity to study intervention or any components in their formulations
  • For participants in Cohort A, B and C: Has received prior systemic therapy for Stage IV NSCLC, including anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
  • Unable to tolerate computed tomography (CT) or MRI in the opinion of the Investigator and/or allergy to contrast material.
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 Belgium,   France,   United States
Removed Location Countries Germany
 
Administrative Information
NCT Number  ICMJE NCT03840915
Other Study ID Numbers  ICMJE MS200647_0024
2018-004040-28 ( 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
Plan to Share IPD: Yes
Plan Description: Per company policy, following approval of a new product or a new indication for an approved product in both the EU and the US, EMD Serono will share study protocols, anonymized patient level and study level data and redacted clinical study reports from clinical trials in patients with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be is found on our website https://www.emdgroup.com/en/research/our-approach-to-research-and-development/healthcare/clinical-trials/commitment-responsible-data-sharing.html
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