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)

Merck Sharp & Dohme (MSD)

Status and phase: Active, not recruiting; Phase 3

Conditions: Metastatic Non-Small Cell Lung Cancer

Treatments: Biological: Pembrolizumab; Drug: Cisplatin; Biological: Pembrolizumab/Vibostolimab; Drug: Pemetrexed; Drug: Nab-paclitaxel; Drug: Paclitaxel; Drug: Carboplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT05226598

KEYVIBE-007 (Other Identifier)

U1111-1293-2114 (Other Identifier)

jRCT2031220098 (Registry Identifier)

MK-7684A-007 (Other Identifier)

2023-506074-12 (Registry Identifier)

7684A-007

Details and patient eligibility

About

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 treatment-naïve metastatic participants with non-small cell lung cancer (NSCLC).

Enrollment: 700 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

The main inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria:

• A histologically or cytologically confirmed diagnosis of Stage IV squamous or non-squamous NSCLC
• Has not received prior systemic treatment for metastatic NSCLC
• Has measurable disease based on RECIST 1.1, as determined by the local site assessment
• Has a life expectancy of at least 3 months
• Males: Use contraception unless confirmed to be azoospermic; Females: Women of childbearing potential use highly effective contraceptive method

Exclusion Criteria:

• 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
• Severe hypersensitivity to MK-7684, MK-7684A, pembrolizumab, chemotherapy components, and/or any of its excipients
• Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days before the first dose of study medication
• Active autoimmune disease that has required systemic treatment in past 2 years, except replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid)
• History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
• Has an active infection requiring systemic therapy
• Has a known history of human immunodeficiency virus (HIV), Hepatitis B or/and Hepatitis C virus
• Received prior systemic anticancer therapy for metastatic disease
• Received a live or live attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed
• History of allogeneic tissue/solid organ transplant
• Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose ≤1.3 g/day, for a 5-day period (8-day period for long-acting agents, such as piroxicam)
• Is unable or unwilling to take folic acid or vitamin B12 supplementation
• Currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

700 participants in 2 patient groups

Pembrolizumab/Vibostolimab + Carboplatin + Cisplatin + Paclitaxel + Nab-paclitaxel + Pemetrexed

Experimental group

Description:

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.

Treatment:

Drug: Carboplatin

Drug: Paclitaxel

Drug: Nab-paclitaxel

Drug: Pemetrexed

Biological: Pembrolizumab/Vibostolimab

Drug: Cisplatin

Pembrolizumab + Carboplatin + Cisplatin + Paclitaxel + Nab-paclitaxel + Pemetrexed

Active Comparator group

Description:

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.

Treatment:

Drug: Carboplatin

Drug: Paclitaxel

Drug: Nab-paclitaxel

Drug: Pemetrexed

Drug: Cisplatin

Biological: Pembrolizumab