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)

Merck Sharp & Dohme (MSD)

Status and phase: Active, not recruiting; Phase 3

Conditions: Small Cell Lung Carcinoma

Treatments: Drug: Cisplatin; Biological: Atezolizumab; Biological: Pembrolizumab/Vibostolimab Co-Formulation; Drug: Carboplatin; Drug: Saline placebo; Drug: Etoposide

Study type: Interventional

Funder types: Industry

Identifiers

NCT05224141

MK-7684A-008 (Other Identifier)

jRCT2021220008 (Registry Identifier)

7684A-008

KEYVIBE-008 (Other Identifier)

U1111-1287-4436 (Other Identifier)

2021-005034-42 (EudraCT Number)

2023-503517-30 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 450 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Has histologically or cytologically confirmed diagnosis of ES-SCLC in need of first-line therapy
• Has ES-SCLC defined as Stage IV (T any, N any, M1a/b/c) by the American Joint Committee on Cancer, Eighth Edition or T3-T4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan
• Males agree to use contraception, refrain from donating sperm, and abstain from heterosexual intercourse
• Females are not pregnant or breastfeeding, is not a woman of childbearing potential (WOCBP) or is a WOCBP who uses a highly effective contraceptive method, or is abstinent from heterosexual intercourse
• Has measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
• Has a predicted life expectancy of >3 months

Exclusion criteria

• Is considered a poor medical risk due to a serious, uncontrolled medical disorder or non-malignant systemic disease
• Has received prior treatment for Small Cell Lung Cancer (SCLC)
• Is expected to require any other form of antineoplastic therapy for SCLC while on study
• Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
• Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
• Has a 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 a known additional malignancy that is progressing or has required active treatment within the past 3 years
• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
• Has a history of severe hypersensitivity reaction (≥Grade 3) to any study intervention and/or any of its excipients
• Has an active autoimmune disease that has required systemic treatment in past 2 years
• Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
• Has a known history of, or active, neurologic paraneoplastic syndrome
• Has an active infection requiring systemic therapy
• Has a known history of human immunodeficiency virus (HIV) infection
• Has a known history of Hepatitis B or known active Hepatitis C virus infection
• Has had an allogenic tissue/solid organ transplant
• Has had major surgery within prior 3 weeks or has not recovered adequately from toxicity and/or complications from an intervention prior to receiving the first dose of study intervention
• Has symptomatic ascites or pleural effusion

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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450 participants in 2 patient groups

Pembrolizumab/Vibostolimab

Experimental group

Description:

Participants will receive 4 cycles (each cycle is 3 weeks) of a fixed-dose coformulation of 200 mg pembrolizumab and 200 mg vibostolimab (MK-7684A) every 3 weeks (Q3W), 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 Q3W 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.

Treatment:

Drug: Cisplatin

Drug: Carboplatin

Drug: Saline placebo

Biological: Pembrolizumab/Vibostolimab Co-Formulation

Drug: Etoposide

Atezolizumab

Active Comparator group

Description:

Participants will receive 4 cycles (each cycle is 3 weeks) of 1200 mg atezolizumab Q3W, 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 Q3W 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.

Treatment:

Drug: Cisplatin

Drug: Carboplatin

Drug: Saline placebo

Biological: Atezolizumab

Drug: Etoposide