A Study to Evaluate the Safety and Efficacy of Gocatamig (MK-6070) and Ifinatamab Deruxtecan (I-DXd) in Participants With Relapsed/Refractory Extensive-Stage Small Cell Lung Cancer (MK-6070-002)
Sponsor: Merck Sharp & Dohme LLC
ClinicalTrials ID:NCT06780137
This study evaluates the safety and efficacy of gocatamig and I-DXd in treating relapsed/refractory extensive-stage SCLC. It includes two parts: assessing dosing intervals and safety in Japanese participants. Eligible participants must have confirmed extensive-stage SCLC and prior platinum-based chemotherapy. Interventions involve IV infusions of gocatamig and I-DXd.
Patient Parameters
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Program Overview
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
Description
This study will consist of two parts. Part 1 will assess the safety, tolerability, and efficacy of gocatamig and I-DXd at dosing intervals of once every 2 weeks (Q2W) and/or once every 3 weeks (Q3W) at doses determined in study MK-6070-001 (NCT: NCT04471727). Part 2 will assess the safety and tolerability of gocatamig in Japanese participants.
Eligibility Criteria
Inclusion Criteria
- 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 tissue sample or fresh biopsy tissue sample
- Human immunodeficiency virus (HIV) infected participants must have well controlled HIV on antiretroviral therapy (ART)
Exclusion Criteria
- Pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedure
- History of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD, and or suspected ILD/pneumonitis
- Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
- History of clinically significant intracranial bleeding or spinal cord bleeding
- Active neurologic paraneoplastic syndrome
- 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
- Has other uncontrolled or significant protocol-specified cardiovascular disease
- History of arterial thrombosis (eg, stroke or transient ischemic attack) within 6 months before the first dose of study intervention
- Chronic liver disease, including liver cirrhosis of Child-Pugh class B or C
- 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
- Ongoing treatment with immunosuppressive medications, with protocol-specified exceptions
- 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: Other anticancer therapy, including cytotoxic agents, targeted agents, immunotherapies, antibody, retinoid, transplant, or anticancer hormonal treatment (except luteinizing hormone-releasing hormone [LHRH]) within 2 weeks before start of study intervention
- 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
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Dana Farber Cancer Institute ( Site 1105) | 02215 | Boston | Massachusetts |
| John Theurer Cancer Center at Hackensack University Medical Center ( Site 1103) | 07601 | Hackensack | New Jersey |
| Sarah Cannon Research Institute ( Site 7001) | 37203 | Nashville | Tennessee |
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