A Phase 1b/2 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
Merck Sharp & Dohme LLC
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. 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
Description
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 * History of interstitial lung disease (ILD…
Interventions
- BiologicalGocatamig
IV infusion
- BiologicalIfinatamab Deruxtecan (I-DXd)
IV infusion
- BiologicalDurvalumab
IV infusion
Locations (48)
- University of Colorado Anschutz Medical Campus ( Site 1110)Aurora, Colorado
- University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 1111)Miami, Florida
- University of Chicago ( Site 1108)Chicago, Illinois
- Dana Farber Cancer Institute ( Site 1105)Boston, Massachusetts
- John Theurer Cancer Center at Hackensack University Medical Center ( Site 1103)Hackensack, New Jersey
- Roswell Park Cancer Institute ( Site 1107)Buffalo, New York