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Clinical Trials/2023-503501-11-00
2023-503501-11-00
Recruiting
Phase 3

An Open-label, Multicenter, Phase 3 Randomized, Active-Comparator- Controlled Clinical Study of Pembrolizumab (MK-3475) in Combination With Sacituzumab Govitecan Versus MK-3475 Monotherapy as First-line Treatment in Participants With PD L1 TPS Greater than or Equal to 50% Metastatic Non-small Cell Lung Cancer (KEYNOTED46/EVOKE-03)

Merck Sharp & Dohme LLC37 sites in 8 countries166 target enrollmentStarted: October 20, 2023Last updated:
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Overview

Phase
Phase 3
Status
Recruiting
Enrollment
166
Locations
37
Primary Endpoint
Progression-Free Survival (PFS)
OverviewEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

  1. To compare pembrolizumab in combination with sacituzumab govitecan with pembrolizumab alone with respect to progression-free survival per RECIST 1.1 as assessed by blinded independent central review
  2. To compare pembrolizumab in combination with sacituzumab govitecan with pembrolizumab alone with respect to overall survival

Eligibility Criteria

Ages
18 years to 65+ years (18-64 Years, 65+ Years)
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Has a histologically or cytologically confirmed diagnosis of metastatic non-small cell lung cancer (NSCLC)
  • •Has confirmation that epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase 1 (ALK-1), or ROS proto-oncogene 1 (ROS-1)-directed therapy is not indicated as primary therapy
  • •Has provided tumor tissue that demonstrates PD-L1 tumor proportion score (TPS) ≥50% of tumor cells as assessed by immunohistochemistry (IHC) at a central laboratory
  • •Has a life expectancy of at least 3 months

Exclusion Criteria

  • •Has history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years
  • •Has active chronic inflammatory bowel disease
  • •Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication
  • •Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • •Has severe hypersensitivity (≥Grade 3) to pembrolizumab or sacituzumab govitecan and/or any of their excipients
  • •Has active autoimmune disease that has required systemic treatment in past 2 years except replacement therapy
  • •History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
  • •Has active infection requiring systemic therapy
  • •Has history of human immunodeficiency virus (HIV) infection
  • •History of hepatitis B or known active hepatitis C virus infection

Outcomes

Primary Outcomes

Progression-Free Survival (PFS)

Progression-Free Survival (PFS)

Overall Survival (OS)

Overall Survival (OS)

Secondary Outcomes

  • Objective Response (OR)
  • Duration of Response (DOR)
  • Change from Baseline in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30
  • Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30
  • Change from Baseline in Role Functioning (Items 6-7) Combined Score on the EORTC QLQ-C30
  • Change from Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30
  • Change from Baseline in Cough Score (Item 31) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer 13 (EORTC QLQ-LC13)
  • Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ-LC13
  • Time to Deterioration (TTD) in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the EORTC QLQ-C30
  • TTD in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30
  • TTD in Role Functioning (Items 6-7) Combined Score on the EORTC QLQ-C30
  • TTD in Dyspnea Score (Item 8) on the EORTC QLQ-C30
  • TTD in Cough Score (Item 31) on the EORTC QLQ-LC13
  • TTD in in Chest Pain Score (Item 40) on the EORTC QLQ-LC13
  • Number of Participants Who Experience an Adverse Event (AE)
  • Number of Participants Who Discontinue Study Treatment Due to an AE

Investigators

Sponsor Class
Pharmaceutical company
Responsible Party
Principal Investigator
Principal Investigator

Renata Eiras Martins

Scientific

Merck Sharp & Dohme LLC

Study Sites (37)

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