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Trial record 1 of 1 for:    MK2870-007
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MK-2870 in Combination With Pembrolizumab Versus Pembrolizumab Alone in Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥ 50% (MK-2870-007)

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ClinicalTrials.gov Identifier: NCT06170788
Recruitment Status : Recruiting
First Posted : December 14, 2023
Last Update Posted : April 5, 2024
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Brief Summary:

The primary objective of the study is to compare MK-2870 combined with pembrolizumab to pembrolizumab alone with respect to overall survival (OS). The primary hypothesis is that the combination of MK-2870 and pembrolizumab is superior to pembrolizumab alone with respect to OS.

All participants who have completed the first course of pembrolizumab may be eligible for up to an additional 9 cycles of pembrolizumab monotherapy if there is blinded independent central review (BICR)-verified progressive disease by Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) after initial treatment.


Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer (NSCLC) Biological: MK-2870 Biological: Pembrolizumab Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 614 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Phase 3 Study of MK-2870 in Combination With Pembrolizumab Compared to Pembrolizumab Monotherapy in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer With PD-L1 TPS Greater Than or Equal to 50%
Actual Study Start Date : December 15, 2023
Estimated Primary Completion Date : January 25, 2028
Estimated Study Completion Date : May 27, 2030

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MK-2870 + Pembrolizumab
Participants receive MK-2870 via intravenous (IV) infusion on Days 1, 15 and 29 of each 6-week cycle + 400 mg Pembrolizumab every 6 weeks (q6w) via IV infusion on Day 1 of each 6-week cycle for 18 cycles. Additionally, participants receive diphenhydramine (or equivalent), an H2 antagonist of investigator's choice, acetaminophen (or equivalent), and dexamethasone (or equivalent) per each drug's product label prior to the first 4 infusions of MK-2870. At subsequent infusions, the H2 antagonist and dexamethasone are optional, at the discretion of the investigator.
Biological: MK-2870
IV infusion
Other Name: SKB264

Biological: Pembrolizumab
IV infusion
Other Names:
  • MK-3475
  • KEYTRUDA®
  • SCH 900475

Active Comparator: Pembrolizumab
Participants receive 400 mg Pembrolizumab via IV infusion q6w on Day 1 of each 6-week cycle for 18 cycles
Biological: Pembrolizumab
IV infusion
Other Names:
  • MK-3475
  • KEYTRUDA®
  • SCH 900475




Primary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Up to approximately 48 months ]
    OS is defined as the time from randomization to death from any cause.


Secondary Outcome Measures :
  1. Progression free survival (PFS) [ Time Frame: Up to approximately 48 months ]
    PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on BICR or death due to any cause, whichever occurs first

  2. Objective Response (OR) [ Time Frame: Up to approximately 48 months ]
    The OR is defined as a confirmed complete response (CR) or partial response (PR) per RECIST 1.1 as assessed by BICR.

  3. Duration of Response (DOR) [ Time Frame: Up to approximately 48 months ]
    For participants who demonstrate confirmed CR or PR per RECIST 1.1 as assessed by BICR, duration of response is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.

  4. Change from Baseline in Global Health Status/Quality of Life (QOL) [European Organisation for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30) 29 Items and 30] Score [ Time Frame: Baseline and up to approximately 24 months ]
    Change from baseline in the score of EORTC QLQ-C30 Items 29 and 30 will be presented. The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome.

  5. Change From Baseline in Dyspnea (EORTC QLQ-C30 Item 8) Score [ Time Frame: Baseline and up to approximately 24 months ]
    Change from baseline in the score of EORTC QLQ-C30 Item 8 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea.

  6. Change From Baseline in Cough (EORTC QLQ-LC13 Item 31) Score [ Time Frame: Baseline and up to approximately 24 months ]
    Change from baseline in the score of EORTC QLQ-C13 Item 31 will be presented. The EORTC QLQ-C13 is a lung cancer specific health-related quality-of life (QoL) questionnaire. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing.

  7. Change From Baseline in Chest Pain (EORTC QLQ-LC13 item 40) Score [ Time Frame: Baseline and up to approximately 24 months ]
    The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant responses to the question "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in chest pain (EORTC QLQ-LC13 Item 40) score will be presented. A lower score indicates a better outcome.

  8. Time to Deterioration (TTD) Based on Change From Baseline in Global Health Status (GHS)/ QOL Score (EORTC QLQ-C30 Item 29 and 30) [ Time Frame: Up to approximately 24 months ]
    The TTD in GHS/QOL score (EORTC QLQ-C30 Items 29 and 30) will be presented. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). A higher score indicates a better overall outcome. TTD as assessed based on a negative change (decrease in score) from Baseline in GHS/QOL score. A longer TTD indicates a better outcome.

  9. Time to Deterioration (TTD) Based on Change From Baseline in Dyspnea Score (EORTC QLQ-C30 Item 8) [ Time Frame: Up to approximately 24 months ]
    The TTD in Dyspnea score (EORTC QLQ-C30 Item 8) will be presented. Participant response to the question "Were you short of breath?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of dyspnea. TTD is assessed based on the time to a negative change (increase in score) from baseline. A longer TTD indicates a better outcome.

  10. Time to Deterioration (TTD) Based on Change From Baseline in Cough Score (EORTC QLQ-LC13 Item 31). [ Time Frame: Up to approximately 24 months ]
    The TTD in Cough score (EORTC QLQ-LC13 Item 31) will be presented. Participant response to the question "Have you coughed?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates more frequent coughing. TTD is assessed based on the time to a negative change (increase in score) from baseline. A longer TTD indicates a better outcome.

  11. Time to Deterioration (TTD) Based on Change From Baseline in Chest Pain Score (EORTC QLQ-LC13 Item 40) [ Time Frame: Up to approximately 24 months ]
    The TTD in Chest Pain score (EORTC QLQ-LC13 Item 40) will be presented. Participant response to the question "Have you had pain in your chest?" is scored on a 4-point scale (1=Not at All to 4=Very Much). A higher score indicates a worse level of chest pain. TTD is assessed based on the time to a negative change (increase in score) from baseline. A longer TTD indicates a better outcome.

  12. Percentage of Participants That Experience at Least 1 Adverse Event [ Time Frame: Up to approximately 27 months ]
    An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of participants who experience an AE will be presented.

  13. Percentage of Participants Who Discontinue Study Treatment Due to an AE [ Time Frame: Up to approximately 24 months ]
    The percentage of participants who discontinue study treatment due to an AE will be presented.



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.


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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:

  • Histologically or cytologically confirmed diagnosis of squamous or nonsquamous NSCLC

    • Confirmation that epidermal growth factor receptor- (EGFR-), anaplastic lymphoma kinase- (ALK-), or proto-oncogene tyrosine-protein kinase ROS (ROS1-) directed therapy is not indicated as primary therapy
    • Provided tumor tissue that demonstrates programmed cell death ligand 1 (PD-L1) expression in ≥50% of tumor cells as assessed by an immunohistochemistry (IHC) central laboratory
    • An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization.
    • A life expectancy of at least 3 months.
    • Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)

Exclusion Criteria:

  • Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements.
  • Has Grade ≥2 peripheral neuropathy.
  • History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing.
  • Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea).
  • Has uncontrolled, significant cardiovascular disease or cerebrovascular disease within the 6 months preceding study intervention.
  • Received prior systemic anticancer therapy for their metastatic NSCLC.
  • Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor Note: Prior treatment with an anti-PD-1, anti-PD- L1, or anti-PD-L2 agent in the neoadjuvant or adjuvant setting for nonmetastatic resectable NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC.
  • Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
  • Received radiation therapy to the lung that is >30 Gy within 6 months of start of study intervention.
  • Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids.
  • Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
  • Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
  • Known additional malignancy that is progressing or has required active treatment within the past 3 years.
  • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • Known intolerance to MK-2870 or pembrolizumab and/or any of their excipients; for pembrolizumab, severe hypersensitivity (≥Grade 3) is exclusionary.
  • Known hypersensitivity to MK-2870 or other biologic therapy.
  • Active autoimmune disease that has required systemic treatment in the past 2 years.
  • History of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD.
  • Active infection requiring systemic therapy
  • Concurrent active Hepatitis B and Hepatitis C virus infection.
  • Human immunodeficiency virus (HIV)-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
  • History of allogeneic tissue/solid organ transplant.
  • Requires treatment with a strong inhibitor or inducer of Cytochrome P450 3A4 (CYP3A4) at least 14 days before the first dose of study intervention and throughout the study.

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): NCT06170788


Contacts
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Contact: Toll Free Number 1-888-577-8839 Trialsites@merck.com

Locations
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United States, Georgia
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0106) Recruiting
Marietta, Georgia, United States, 30060
Contact: Study Coordinator    770-281-5100      
United States, Minnesota
Allina Health Cancer Institute - Abbott Northwestern Hospital ( Site 0115) Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Study Coordinator    651-241-7025      
United States, Mississippi
Hattiesburg Clinic Hematology/Oncology ( Site 0104) Recruiting
Hattiesburg, Mississippi, United States, 39401
Contact: Study Coordinator    601-261-1700      
United States, Nevada
Renown Regional Medical Center-Renown Health Medical Oncology ( Site 0134) Recruiting
Reno, Nevada, United States, 89502
Contact: Study Coordinator    775-985-4000      
United States, Oregon
Good Samaritan Regional Medical Center-Samaritan Pastega Regional Cancer Center ( Site 0117) Recruiting
Corvallis, Oregon, United States, 97330
Contact: Study Coordinator    541-768-4950      
Australia, New South Wales
Port Macquarie - Mid North Coast Cancer Institute-Medical Oncology ( Site 3002) Recruiting
Port Macquarie, New South Wales, Australia, 2444
Contact: Study Coordinator    61265801820      
Westmead Hospital-Department of Medical Oncology ( Site 3000) Recruiting
Westmead, New South Wales, Australia, 2145
Contact: Study Coordinator    61247343500      
Australia, Victoria
Grampians Health-Medical Oncology ( Site 3001) Recruiting
Ballarat Central, Victoria, Australia, 3350
Contact: Study Coordinator    61(03)53208500      
Northern Hospital ( Site 3003) Recruiting
Epping, Victoria, Australia, 3076
Contact: Study Coordinator    61421000364      
Denmark
Odense Universitetshospital ( Site 1200) Recruiting
Odense, Syddanmark, Denmark, 5000
Contact: Study Coordinator    +4523612809      
Taiwan
National Cheng Kung University Hospital-Clinical Trial Center ( Site 3903) Recruiting
Tainan, Taiwan, 704
Contact: Study Coordinator         
Turkey
Medipol Mega Universite Hastanesi-oncology ( Site 2508) Recruiting
Stanbul, Istanbul, Turkey, 34214
Contact: Study Coordinator    905325280486      
Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 2507) Recruiting
Adana, Turkey, 01140
Contact: Study Coordinator    905056166338      
Hacettepe Universite Hastaneleri-oncology hospital ( Site 2501) Recruiting
Ankara, Turkey, 06230
Contact: Study Coordinator    +905334318506      
Memorial Ankara Hastanesi-Medical Oncology ( Site 2505) Recruiting
Ankara, Turkey, 06520
Contact: Study Coordinator    905067521275      
Ankara Bilkent Şehir Hastanesi ( Site 2500) Recruiting
Ankara, Turkey, 06800
Contact: Study Coordinator    05333262405      
Sponsors and Collaborators
Merck Sharp & Dohme LLC
Investigators
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Study Director: Medical Director Merck Sharp & Dohme LLC
Additional Information:
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Responsible Party: Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier: NCT06170788    
Other Study ID Numbers: 2870-007
MK-2870-007 ( Other Identifier: Merck )
2023-503376-24-00 ( Other Identifier: European Union )
First Posted: December 14, 2023    Key Record Dates
Last Update Posted: April 5, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Merck Sharp & Dohme LLC:
Programmed Cell Death-1 (PD1, PD-1)
Programmed Cell Death 1 Ligand 1(PDL1, PD-L1)
Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)
Additional relevant MeSH terms:
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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
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action