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)
Recruiting · NCT06780137 · Interventional (participants receive a specific treatment) · Lead sponsor: Merck Sharp & Dohme LLC
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
48 locations listed across 9 US states.
- University of Colorado Anschutz Medical Campus ( Site 1110) - Aurora, Colorado, United States
- University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 1111) - Miami, Florida, United States
- University of Chicago ( Site 1108) - Chicago, Illinois, United States
- Dana Farber Cancer Institute ( Site 1105) - Boston, Massachusetts, United States
- John Theurer Cancer Center at Hackensack University Medical Center ( Site 1103) - Hackensack, New Jersey, United States
- Roswell Park Cancer Institute ( Site 1107) - Buffalo, New York, United States
- Providence Portland Medical Center ( Site 1101) - Portland, Oregon, United States
- Sarah Cannon Research Institute ( Site 7001) - Nashville, Tennessee, United States
- Medical College of Wisconsin ( Site 1112) - Milwaukee, Wisconsin, United States
- Hacettepe Universite Hastaneleri ( Site 3410) - Ankara, Turkey (Türkiye)
- Ankara Bilkent Sehir Hastanesi ( Site 3412) - Ankara, Turkey (Türkiye)
- Hospital Universitari Vall d'Hebron ( Site 3311) - Barcelona, Spain
- Rambam Health Care Campus ( Site 3202) - Haifa, Israel
- Shaare Zedek Medical Center ( Site 3200) - Jerusalem, Israel
- The Clatterbridge Cancer Centre ( Site 3903) - Liverpool, United Kingdom
- Hospital Universitario Fundación Jiménez Díaz-START Madrid-FJD ( Site 3315) - Madrid, Spain
- Hospital Universitario HM Sanchinarro ( Site 3313) - Madrid, Spain
- The Christie NHS Foundation Trust ( Site 3901) - Manchester, United Kingdom
- Hospital Universitario Virgen de la Victoria ( Site 3312) - Málaga, Spain
- Rabin Medical Center ( Site 3203) - Petah Tikva, Israel
- Sheba Medical Center ( Site 3201) - Ramat Gan, Israel
- Seoul National University Hospital ( Site 5100) - Seoul, South Korea
- Severance Hospital, Yonsei University Health System ( Site 5102) - Seoul, South Korea
- Samsung Medical Center ( Site 5101) - Seoul, South Korea
- National Cheng Kung University Hospital ( Site 5202) - Tainan, Taiwan
- Taipei Medical University Hospital ( Site 5201) - Taipei, Taiwan
- Aichi Cancer Center ( Site 5000) - Nagoya, Aichi-ken, Japan
- HOSPITAL CLÍNIC DE BARCELONA ( Site 3310) - Eixample, Barcelona, Spain
- Institut Català d'Oncologia - L'Hospitalet ( Site 3317) - L'Hospitalet de Llobregat, Barcelona, Spain
- Beijing Cancer Hospital ( Site 5401) - Beijing, Beijing Municipality, China
- Hospital Universitario Austral ( Site 2204) - Pilar, Buenos Aires, Argentina
- National Cancer Center Hospital East ( Site 5001) - Kashiwa, Chiba, Japan
- Fujian Cancer Hospital ( Site 5413) - Fuzhou, Fujian, China
- Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Oncology ( Site 5403) - Nanjing, Jiangsu, China
- National Institute for Health Research UCLH Clinical Research Facility ( Site 3902) - London, London, City of, United Kingdom
- Hospital Clinico San Carlos... ( Site 3316) - Madrid, Madrid, Comunidad de, Spain
- Kansai Medical University Hospital ( Site 5004) - Hirakata, Osaka, Japan
- Princess Alexandra Hospital ( Site 5300) - Woolloongabba, Queensland, Australia
- FALP ( Site 2100) - Santiago, Region M. de Santiago, Chile
- Pontificia Universidad Catolica de Chile ( Site 2102) - Santiago, Region M. de Santiago, Chile
- Bradfordhill ( Site 2101) - Santiago, Region M. de Santiago, Chile
- Sanatorio Parque ( Site 2203) - Rosario, Santa Fe Province, Argentina
- Shanghai Chest Hospital ( Site 5400) - Shanghai, Shanghai Municipality, China
- Shanghai Pulmonary Hospital ( Site 5405) - Shanghai, Shanghai Municipality, China
- West China Hospital of Sichuan University ( Site 5416) - Chengdu, Sichuan, China
- Cancer Institute Hospital of JFCR ( Site 5002) - Koto, Tokyo, Japan
- Monash Health ( Site 5301) - Clayton, Victoria, Australia
- The First Affiliated Hospital, Zhejiang University ( Site 5404) - Hangzhou, Zhejiang, China