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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)

RecruitingPhase 1, Phase 2Ages 18 Years - anyAllMerck Sharp & Dohme LLC
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In plain words

What the trial is, and whether it could suit you

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 S

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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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What it tests

  • Gocatamig
  • Ifinatamab Deruxtecan (I-DXd)
  • Durvalumab
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Where

48 sites
University of Colorado Anschutz Medical Campus ( Site 1110)
Aurora, United States
University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 1111)
Miami, United States
University of Chicago ( Site 1108)
Chicago, United States
Dana Farber Cancer Institute ( Site 1105)
Boston, United States
John Theurer Cancer Center at Hackensack University Medical Center ( Site 1103)
Hackensack, United States
Roswell Park Cancer Institute ( Site 1107)
Buffalo, United States
Providence Portland Medical Center ( Site 1101)
Portland, United States
Sarah Cannon Research Institute ( Site 7001)
Nashville, United States

โ€ฆand 40 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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