Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    MS200647_0024
Previous Study | Return to List | Next Study

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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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. )

Brief Summary:
The main purpose of the study is to evaluate the safety and tolerability of M7824 in combination with chemotherapy.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: Cisplatin Drug: Carboplatin Drug: Pemetrexed Drug: Nab-paclitaxel Drug: Gemcitabine Drug: Docetaxel Drug: M7824 Phase 1 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase Ib/II, Open-Label Study of M7824 in Combination With Chemotherapy in Participants With Stage IV Non-small Cell Lung Cancer
Actual Study Start Date : March 14, 2019
Estimated Primary Completion Date : October 28, 2021
Estimated Study Completion Date : October 28, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cohort A: Cisplatin or Carboplatin + Pemetrexed + M7824 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: 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.

Experimental: Cohort B: Carboplatin + Nab-paclitaxel + M7824 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: 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: 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.

Experimental: Cohort C: Cisplatin or Carboplatin + Gemcitabine + M7824 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: 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: 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.

Experimental: Cohort D: Docetaxel + M7824 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 alone.




Primary Outcome Measures :
  1. Incidence of Dose Limiting Toxicities (DLTs) [ Time Frame: Day 1 to Day 21 (Cycle 1) ]
  2. Incidence of Treatment Emergent Adverse Events (TEAEs) and Treatment Related Adverse Events [ Time Frame: Up to 3 years ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Overall Survival (OS) [ Time Frame: Up to 3 years ]
  4. Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1 [ Time Frame: Up to 3 years ]
  5. Concentration of M7824 Observed Immediately at the End of Infusion (Ceoi) [ Time Frame: Up to 3 years ]
  6. Concentration of M7824 Observed Immediately Before Next Dosing (Ctrough) [ Time Frame: Up to 3 years ]
  7. 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 ]
  8. Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of M7824 [ Time Frame: Up to 3 years ]
  9. Maximum Observed Serum Concentration (Cmax) of M7824 [ Time Frame: Up to 3 years ]
  10. Time to Reach Maximum Serum Concentration (Tmax) of M7824 [ Time Frame: Up to 3 years ]
  11. Apparent Terminal Half-life (t1/2) of M7824 [ Time Frame: Up to 3 years ]
  12. Immunogenicity of M7824, as Assessed by Anti-drug Anti-body (ADA) Assay [ Time Frame: Up to 3 years ]


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:

  • 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.

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): NCT03840915


Contacts
Layout table for location contacts
Contact: US Medical Information 888-275-7376 service@emdgroup.com
Contact: Communication Center +49 6151 72 5200 service@emdgroup.com

Locations
Layout table for location information
United States, California
California Cancer Associates for Research & Excellence, Inc. Recruiting
San Marcos, California, United States, 92069
Contact       emcclay@ccare.com   
Principal Investigator: Edward F McClay         
Research Site Recruiting
San Marcos, California, United States, 92069
United States, Florida
Hematology - Oncology Associates of Treasure Coast - Hematology-Oncology Associates of Treasure Coast Recruiting
Port Saint Lucie, Florida, United States, 34952
Contact       mwertheim@hemoncfl.com   
Principal Investigator: Michael S Wertheim         
Research Site Recruiting
Port Saint Lucie, Florida, United States, 34952
United States, Kentucky
Research Site Recruiting
Lexington, Kentucky, United States, 40503
United States, Maryland
Research Site Not yet recruiting
Baltimore, Maryland, United States, 21201
RCCA MD LLC - Bethesda Recruiting
Bethesda, Maryland, United States, 20817
Contact       rboccia@regionalcancercare.org   
Principal Investigator: Ralph V Boccia         
Research Site Recruiting
Bethesda, Maryland, United States, 20817
United States, Michigan
Research Site Not yet recruiting
Detroit, Michigan, United States, 48202
United States, Tennessee
Research Site Not yet recruiting
Nashville, Tennessee, United States, 37232-8805
Belgium
Research Site Not yet recruiting
Bruxelles, Belgium
Research Site Recruiting
Edegem, Belgium
Research Site Recruiting
Gent, Belgium
Research Site Recruiting
Liège, Belgium
Research Site Recruiting
Mechelen, Belgium
France
Research Site Recruiting
Nice cedex 02, Alpes Maritimes, France
Research Site Recruiting
Marseille cedex 5, Bouches-du-Rhône, France
Research Site Recruiting
Dijon cedex, Côte-d'Or, France
Research Site Not yet recruiting
Bordeaux cedex, Gironde, France
Research Site Recruiting
Saint Herblain, Loire Atlantique Saint Herblain, France
Research Site Not yet recruiting
Paris Cedex 05, Paris, France
Sponsors and Collaborators
EMD Serono Research & Development Institute, Inc.
Merck KGaA, Darmstadt, Germany
Investigators
Layout table for investigator information
Study Director: Medical Responsible Merck KGaA, Darmstadt, Germany

Layout table for additonal information
Responsible Party: EMD Serono Research & Development Institute, Inc.
ClinicalTrials.gov Identifier: NCT03840915     History of Changes
Other Study ID Numbers: MS200647_0024
2018-004040-28 ( EudraCT Number )
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by EMD Serono ( EMD Serono Research & Development Institute, Inc. ):
Non-small Cell Lung Cancer
Bintrafusp alfa (proposed INN)
M7824
Stage IV
INTR@PID LUNG 024
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Gemcitabine
Paclitaxel
Docetaxel
Albumin-Bound Paclitaxel
Cisplatin
Carboplatin
Pemetrexed
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors