A Phase Ib/II Open-Label Clinical Study to Evaluate the Safety and Efficacy of MK-6070 and Ifinatamab Deruxtecan (I-DXd) in Participants With Relapsed/Refractory Extensive-Stage Small Cell Lung Cancer
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Study Summary
Researchers are looking for new ways to treat people with extensive-stage small cell lung cancer (SCLC) that has relapsed or is refractory. Gocatamig is a new type of immunotherapy that uses a person's immune system to find and destroy cancer cells. Ifinatamab deruxtecan (also known as I-DXd) is a drug which binds to a specific target on cancer cells and delivers treatment to destroy those cells. Researchers want to know if giving gocatamig and/or I-DXd can treat SCLC that did not respond or stopped responding to a prior treatment. The goals of this study are to learn: If gocatamig and I-DXd are safe and well tolerated If people who receive gocatamig and I-DXd have their SCLC get smaller or go away Main objective: Part 1: To evaluate the safety and tolerability of MK-6070 in combination with ifinatamab deruxtecan (I-DXd) administered at various schedules or I-DXd monotherapy administered every 2 weeks 2. Part 1: To evaluate ORR, per RECIST 1.1, of MK-6070 in combination with I-DXd administered at various schedules or I-DXd monotherapy administered every 2 weeks 3
- Has histologically or cytologically confirmed SCLC that is extensive stage (defined as Stage IV (T any, N any, M1a/b/c) following at least 1 prior line of systemic therapy that included platinum-based chemotherapy Must be able to provide archival tumor tissue sample or fresh biopsy tissue sample Human immunodeficiency virus (HIV) infected participants must have well controlled HIV on antiretroviral therapy (ART) Adults ≥18 years old with ES SCLC and ECOG PS 0 or 1 who had prior platinum-based chemotherapy (with or without PD-(L)1 inhibitors) are eligible.
- Pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedure
- History of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use or has current or suspected pneumonitis/ILD that cannot be ruled out by imaging at screening
- Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
- Active or history of immune deficiency with the exception of HIV-infected participants with well controlled HIV on ART
- History within 6 months before the first dose of study intervention of coronary/peripheral artery bypass graft and/or any coronary/peripheral angioplasty or clinically significant cardiovascular disease such as myocardial infarction, symptomatic congestive heart failure (CHF) (New York Heart Association > class II), and/or uncontrolled cardiac arrhythmia
- History of arterial thrombosis (eg, stroke or transient ischemic attack) within 6 months before the first dose of study intervention
- Active clinically significant infection requiring systemic therapy
- History of allogeneic tissue/solid organ transplant
- History of leptomeningeal disease
- Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids
- Receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of chronic immunosuppressive therapy within 7 days prior to the first dose of study intervention
- Known additional malignancy that is progressing or has required active treatment within the past 3 years
- Untreated or symptomatic brain metastases
- Active viral hepatitis, defined as hepatitis A (hepatitis A virus immunoglobulin M [IgM] positive in the setting of associated signs/symptoms), hepatitis B (hepatitis B virus surface antigen [HbsAg] positive and/or detectable hepatitis B virus [HBV] deoxyribonucleic acid [DNA]), or hepatitis C (hepatitis C virus [HCV] antibody positive and detectable HCV ribonucleic acid). Participants with HBV with undetectable viral load after treatment are eligible. Participants with HCV with undetectable virus after treatment are eligible.
- Part 1 only: Radiation therapy to the lung >30 Gy within 6 months before the start of study intervention
- Part 1 only: Abdominal radiation within 4 weeks before start of study intervention
- Part 1 only: Anticancer hormonal treatment (except luteinizing hormone-releasing hormone [LHRH]) within 2 weeks before start of study intervention
- Part 1 only: Systemic anticancer therapy (except antibody-based anticancer therapy) or investigational agents within 3 weeks or 5 half-lives, whichever is longer
- Part 1 only: Antibody-based cancer therapy within 3 weeks before start of study intervention
- Part 1 only: Chloroquine/hydroxychloroquine within 2 weeks before start of study intervention
- Part 1 only: Clinically significant corneal disease
- Part 1 only: Has other uncontrolled or significant protocol-specified cardiovascular disease
Clinical Study Information for Healthcare Providers
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