Pembrolizumab/Vibostolimab (MK-7684A) or Atezolizumab in Combination With Chemotherapy in First Line Treatment of Extensive-Stage Small Cell Lung Cancer (MK-7684A-008/KEYVIBE-008)

Part of paid clinical trials in Mobile, Alabama.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT05224141
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Small Cell Lung Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab/Vibostolimab Co-Formulation — BIOLOGICAL
    Pembrolizumab 200 mg plus vibostolimab 200 mg fixed dose coformulation administered via IV infusion Q3W on Day 1 of each cycle until discontinuation criteria are met.
  • Saline placebo — DRUG
    Saline solution administered via IV infusion on Cycle 1 (and Q3W as needed beyond Cycle 1)
  • Etoposide — DRUG
    Etoposide 100 mg/m\^2 administered via IV infusion Q3W on Days 1 2, 3 of each cycle for up to 4 cycles
  • Cisplatin — DRUG
    Cisplatin 75 mg/m\^2 administered via IV infusion Q3W on Day 1 of each cycle for up to 4 cycles.
  • Atezolizumab — BIOLOGICAL
    Atezolizumab 1200 mg administered via IV infusion Q3W on Day 1 of each cycle until discontinuation criteria are met.
  • Carboplatin — DRUG
    Carboplatin AUC 5 mg/mL/min administered via IV infusion Q3W on Day 1 of each cycle for up to 4 cycles.

Study Details

This study will evaluate the combination of a fixed dose pembrolizumab/vibostolimab co-formulation (MK-7684A) with etoposide/platinum chemotherapy followed by MK-7684A compared to the combination of atezolizumab with etoposide/platinum chemotherapy followed by atezolizumab in the first-line treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC). The primary hypothesis is, with respect to overall survival, MK-7684A in combination with the background therapy of etoposide/platinum followed by MK-7684A, is superior to atezolizumab in combination with the background therapy of etoposide/platinum followed by atezolizumab.

Key Dates

Start date
Mar 24, 2022
Status verified
Jul 2025
Primary completion
Jun 4, 2024
Completion
Jun 7, 2027

Study Design

Enrollment
460 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Pembrolizumab/Vibostolimab
    Participants will receive 4 cycles (each cycle is 3 weeks) of a fixed-dose coformulation (FDC) of 200 mg pembrolizumab and 200 mg vibostolimab (MK-7684A) every 3 weeks (Q3W) via intravenous (IV) infusion, in combination with 100 mg/m\^2 etoposide, and platinum (Area Under the Curve \[AUC\] 5 mg/mL/min carboplatin or 75 mg/m\^2 cisplatin) chemotherapy Q3W for a total of approximately 12 weeks. This will be followed by additional cycles of MK-7684A (200 mg vibostolimab/200 mg pembrolizumab FDC) Q3W via IV infusion, until any of the conditions for discontinuation are met. To maintain the blinding, saline placebo will be administered on cycle 1 day 1 and then Q3W as needed beyond cycle 1.
  • Active Comparator: Atezolizumab
    Participants will receive 4 cycles (each cycle is 3 weeks) of 1200 mg atezolizumab Q3W via IV infusion, in combination with 100 mg/m\^2 etoposide and platinum (AUC 5 mg/mL/min carboplatin or 75 mg/m\^2 cisplatin) chemotherapy Q3W for a total of approximately 12 weeks. This will be followed by additional cycles of atezolizumab (1200mg atezolizumab) Q3W via IV infusion until any of the conditions for discontinuation are met. To maintain the blinding, saline placebo will be administered on cycle 1 day 1 and then Q3W as needed beyond cycle 1.

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: Up to approximately 25 months ]

Locations (11)

FacilityCityStateZIPSite coordinators
Infirmary Cancer Care ( Site 0022)MobileAlabama36607-
Los Angeles Hematology Oncology Medical Group ( Site 0006)Los AngelesCalifornia90017-
VA West Los Angeles Medical Center ( Site 0004)Los AngelesCalifornia90073-
Boca Raton Regional Hospital-Lynn Cancer Institute ( Site 0014)Boca RatonFlorida33486-
Fort Wayne Medical Oncology and Hematology ( Site 0013)Fort WayneIndiana46804-
Dana-Farber Cancer Institute ( Site 0018)BostonMassachusetts02215-
Cancer and Hematology Centers of Western Michigan ( Site 0001)Grand RapidsMichigan49503-
Hattiesburg Clinic Hematology/Oncology ( Site 0003)HattiesburgMississippi39401-
Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0005)LancasterPennsylvania17601-
Blue Ridge Cancer Care ( Site 0015)BlacksburgVirginia24060-
University of Virginia Cancer Center ( Site 0019)CharlottesvilleVirginia22903-

Related coverage on Hipa.ai

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By research site
Infirmary Cancer Care· Mobile, ALLos Angeles Hematology Oncology Medical Group· Los Angeles, CAVA West Los Angeles Medical Center· Los Angeles, CABoca Raton Regional Hospital-Lynn Cancer Institute· Boca Raton, FLFort Wayne Medical Oncology and Hematology· Fort Wayne, INDana-Farber Cancer Institute· Boston, MA

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