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)
Sponsored by Merck Sharp & Dohme LLC
About this study
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. Durvalumab is a different type of immunotherapy that also destroys cancer cells. Researchers want to know if giving gocatamig, I-DXd, and gocatamig with I-DXd or durvalumab can treat SCLC that did not respond or stopped responding to a prior treatment. The goals of this study are to learn: * If gocatamig alone, I-DXd alone, and gocatamig with I-DXd or durvalumab are safe and well tolerated * If people who receive gocatamig alone, I-DXd alone, and gocatamig with I-DXd or durvalumab have their SCLC get smaller or go away
This study will consist of two parts. Part 1 will assess the safety, tolerability, and efficacy of gocatamig and I-DXd at doses determined in study MK-6070-001 (NCT: NCT04471727). Part 2 will assess the safety and tolerability of gocatamig in participants in Japan and China. Part 3 will assess the safety, tolerability, and efficacy of gocatamig with durvalumab.
Where this study is enrolling (9)
- Call 303-724-6268
University of Colorado Anschutz Medical Campus ( Site 1110)
Aurora, Colorado
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- Call 305-243-1754
University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 1111)
Miami, Florida
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University of Chicago ( Site 1108)
Chicago, Illinois
- Call 617-632-6049
Dana Farber Cancer Institute ( Site 1105)
Boston, Massachusetts
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- Call 551-996-5863
John Theurer Cancer Center at Hackensack University Medical Center ( Site 1103)
Hackensack, New Jersey
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Show all 9 locations
- Call 716-845-3167
Roswell Park Cancer Institute ( Site 1107)
Buffalo, New York
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- Call 503-215-5696
Providence Portland Medical Center ( Site 1101)
Portland, Oregon
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- Call 844-482-4812
Sarah Cannon Research Institute ( Site 7001)
Nashville, Tennessee
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- Call 414-805-8900
Medical College of Wisconsin ( Site 1112)
Milwaukee, Wisconsin
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Who can participate
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 tumor 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
- ✕Any history of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use except for a history of radiation pneumonitis that did not require steroids
- ✕Current history of ILD or clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out
- ✕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
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Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.
Trial data sourced from ClinicalTrials.gov.