Study of Pembrolizumab/Vibostolimab Coformulation (MK-7684A) in Combination With Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Participants With Metastatic Non-Small Cell Lung Cancer (MK-7684A-007/KEYVIBE-007)

Part of paid clinical trials in Colorado Springs, Colorado.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT05226598
Phase
PHASE3
Status
Completed

Conditions

  • Metastatic Non-Small Cell Lung Cancer

Eligibility Criteria

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

Interventions

  • Pembrolizumab/Vibostolimab — BIOLOGICAL
    Co-formulation of pembrolizumab 200 mg/20 mL vial and vibostolimab 200 mg administered as IV infusion for up to 35 administrations
  • Carboplatin — DRUG
    Carboplatin 10 mg/ml administered as IV infusion Q3W for 4 administrations
  • Cisplatin — DRUG
    Cisplatin 1 mg/ml administered as IV infusion Q3W for 4 administrations
  • Paclitaxel — DRUG
    Paclitaxel 6mg/ml administered as IV infusion Q3W for 4 administrations
  • Nab-paclitaxel — DRUG
    Nab-paclitaxel 100 mg/vial administered as IV infusion Days 1, 8, and 15 of each 21-day cycle for 4 administrations
  • Pemetrexed — DRUG
    Pemetrexed 500 mg/vial administered as IV infusion Q3W until progression, intolerable adverse event (AE), or participant or physician decision
  • Pembrolizumab — BIOLOGICAL
    Pembrolizumab 25 mg/mL administered as IV infusion Q3W for up to 35 administrations

Study Details

The primary hypothesis is that pembrolizumab/vibostolimab (MK-7684A) in combination with chemotherapy is superior to pembrolizumab in combination with chemotherapy with respect to overall survival (OS) in participants with programmed cell death-ligand 1 (PD-L1) tumor proportion score (TPS) ≥1%.

Key Dates

Start date
Mar 24, 2022
Status verified
Jan 2026
Primary completion
Sep 24, 2024
Completion
Jan 9, 2026

Study Design

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

Arms

  • Experimental: MK-7684A + Chemotherapy
    Participants receive pembrolizumab/vibostolimab (co-formulation of 200mg pembrolizumab and 200 mg vibostolimab) via intravenous (IV) infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to \~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for Squamous NSCLC; PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for Non-squamous.
  • Active Comparator: Pembrolizumab + Chemotherapy
    Participants receive pembrolizumab 200 mg via IV infusion on Day 1 of each cycle (cycle length = 3 weeks) for up to 35 cycles (up to \~2 years) PLUS paclitaxel IV (on Day 1 of each cycle) OR nab-paclitaxel IV (on Days 1, 8, and 15 of each cycle) and carboplatin IV (on Day 1 of each cycle) for 4 cycles for Squamous NSCLC; PLUS carboplatin IV (on Day 1 of each cycle) Or cisplatin IV (on Day 1 of each cycle) for 4 cycles and pemetrexed IV (on Day 1 of each cycle) until progression, intolerable adverse events, or participant/physician decision for Non-squamous.

Primary Outcome Measure

Overall Survival (OS) in Participants With Programmed Cell Death-Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1% [ Time Frame: Up to approximately 29 months ]

Locations (12)

FacilityCityStateZIPSite coordinators
UCHealth Memorial Hospital-Heme Onc ( Site 0003)Colorado SpringsColorado80909-
University of Colorado Health - Harmony-Cancer Care and Hematology - Ft. Collins ( Site 0031)Fort CollinsColorado80528-
Mayo Clinic in Florida ( Site 0022)JacksonvilleFlorida32224-
Mount Sinai Hospital ( Site 0011)ChicagoIllinois60608-
University of Chicago Medical Center ( Site 0015)ChicagoIllinois60637-
New England Cancer Specialists ( Site 0008)ScarboroughMaine04074-
Cancer and Hematology Centers of Western Michigan ( Site 0002)Grand RapidsMichigan49503-
Mayo Clinic in Rochester, Minnesota ( Site 0030)RochesterMinnesota55905-
Stony Brook University-Cancer Center ( Site 0013)Stony BrookNew York11794-
Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0012)LancasterPennsylvania17604-
Charleston Oncology ( Site 0019)CharlestonSouth Carolina29414-
University of Virginia Cancer Center ( Site 0018)CharlottesvilleVirginia22903-

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Find similar trials in Colorado Springs, CO

By research site
UCHealth Memorial Hospital-Heme Onc· Colorado Springs, COUniversity of Colorado Health - Harmony-Cancer Care and Hematology - Ft. Collins· Fort Collins, COMayo Clinic in Florida· Jacksonville, FLMount Sinai Hospital· Chicago, ILUniversity of Chicago Medical Center· Chicago, ILNew England Cancer Specialists· Scarborough, ME

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