RECRUITING

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)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2025-02-27
Study Completion:2029-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06780137

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Must be able to provide archival tumor tissue sample or fresh biopsy tissue sample
  3. * Human immunodeficiency virus (HIV) infected participants must have well controlled HIV on antiretroviral therapy (ART)
  1. * Pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedure
  2. * History of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD, and or suspected ILD/pneumonitis
  3. * Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
  4. * Active or history of immune deficiency with the exception of HIV-infected participants with well controlled HIV on ART
  5. * 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
  6. * History of arterial thrombosis (eg, stroke or transient ischemic attack) within 6 months before the first dose of study intervention
  7. * Active clinically significant infection requiring systemic therapy
  8. * History of allogeneic tissue/solid organ transplant
  9. * History of leptomeningeal disease
  10. * Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids
  11. * 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
  12. * Known additional malignancy that is progressing or has required active treatment within the past 3 years
  13. * Untreated or symptomatic brain metastases
  14. * 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.
  15. * Part 1 only: Radiation therapy to the lung \>30 Gy within 6 months before the start of study intervention
  16. * Part 1 only: Abdominal radiation within 4 weeks before start of study intervention
  17. * Part 1 only: Anticancer hormonal treatment (except luteinizing hormone-releasing hormone \[LHRH\]) within 2 weeks before start of study intervention
  18. * Part 1 only: Systemic anticancer therapy (except antibody-based anticancer therapy) or investigational agents within 3 weeks or 5 half-lives, whichever is longer
  19. * Part 1 only: Antibody-based cancer therapy within 3 weeks before start of study intervention
  20. * Part 1 only: Chloroquine/hydroxychloroquine within 2 weeks before start of study intervention
  21. * Part 1 only: Clinically significant corneal disease
  22. * Part 1 only: Has other uncontrolled or significant protocol-specified cardiovascular disease

Contacts and Locations

Study Contact

Toll Free Number
CONTACT
1-888-577-8839
Trialsites@msd.com

Principal Investigator

Medical Director
STUDY_DIRECTOR
Merck Sharp & Dohme LLC

Study Locations (Sites)

Dana Farber Cancer Institute ( Site 1105)
Boston, Massachusetts, 02215
United States
John Theurer Cancer Center at Hackensack University Medical Center ( Site 1103)
Hackensack, New Jersey, 07601
United States
Sarah Cannon Research Institute ( Site 7001)
Nashville, Tennessee, 37203
United States

Collaborators and Investigators

Sponsor: Merck Sharp & Dohme LLC

  • Medical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-27
Study Completion Date2029-08-31

Study Record Updates

Study Start Date2025-02-27
Study Completion Date2029-08-31

Terms related to this study

Additional Relevant MeSH Terms

  • Small Cell Lung Cancer