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

460 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

460 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: Etoposide

Drug: Saline placebo

Drug: Carboplatin

Biological: Pembrolizumab/Vibostolimab Co-Formulation

Drug: Cisplatin

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: Etoposide

Drug: Saline placebo

Drug: Carboplatin

Biological: Atezolizumab

Drug: Cisplatin