Print

Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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 (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD, and or suspected ILD/pneumonitis - 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

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Part 1 consists of four arms (gocatamig and I-DXd at different dosing intervals). Participants will be randomized to one of the four arms using an interactive response technology (IRT) system. Part 2 consist of three arms (gocatamig monotherapy in participants in Japan, gocatamig monotherapy in participants in China, and gocatamig at different dosing intervals). Part 3 consists of a single arm (gocatamig and durvalumab).
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Part 1 Arm 1: Gocatamig and I-DXd 		Participants will receive gocatamig and I-DXd at a determined dose until documented disease progression or discontinuation criteria are met.
  • Biological: Gocatamig
    IV infusion
    Other names:
    • HPN328
    • MK-6070
  • Biological: Ifinatamab Deruxtecan (I-DXd)
    IV infusion
    Other names:
    • DS-7300a
    • MK-2400
Experimental
Part 1 Arm 2: Gocatamig and I-DXd 		Participants will receive gocatamig and I-DXd at a determined dose until documented disease progression or discontinuation criteria are met.
  • Biological: Gocatamig
    IV infusion
    Other names:
    • HPN328
    • MK-6070
  • Biological: Ifinatamab Deruxtecan (I-DXd)
    IV infusion
    Other names:
    • DS-7300a
    • MK-2400
Experimental
Part 1 Arm 3a: I-DXd Monotherapy 		Participants will receive I-DXd until documented disease progression or discontinuation criteria are met.
  • Biological: Ifinatamab Deruxtecan (I-DXd)
    IV infusion
    Other names:
    • DS-7300a
    • MK-2400
Experimental
Part 1 Arm 3b: Gocatamig and I-DXd 		Participants will receive gocatamig and I-DXd at a determined dose until documented disease progression or discontinuation criteria are met.
  • Biological: Gocatamig
    IV infusion
    Other names:
    • HPN328
    • MK-6070
  • Biological: Ifinatamab Deruxtecan (I-DXd)
    IV infusion
    Other names:
    • DS-7300a
    • MK-2400
Experimental
Part 2 Arm 4: Gocatamig Monotherapy in Japan 		Participants in Japan will receive escalating doses of gocatamig until documented disease progression or discontinuation criteria are met.
  • Biological: Gocatamig
    IV infusion
    Other names:
    • HPN328
    • MK-6070
Experimental
Part 2 Arm 5: Gocatamig Monotherapy in China 		Participants in China will receive escalating doses of gocatamig until documented disease progression or discontinuation criteria are met.
  • Biological: Gocatamig
    IV infusion
    Other names:
    • HPN328
    • MK-6070
Experimental
Part 2 Arm 6: Gocatamig 		Participants will receive gocatamig at a determined dose until documented disease progression or discontinuation criteria are met.
  • Biological: Gocatamig
    IV infusion
    Other names:
    • HPN328
    • MK-6070
Experimental
Part 3 Arm 7: Gocatamig and Durvalumab 		Participants will receive gocatamig and durvalumab at a determined dose until documented disease progression or discontinuation criteria are met.
  • Biological: Gocatamig
    IV infusion
    Other names:
    • HPN328
    • MK-6070
  • Biological: Durvalumab
    IV infusion

Recruiting Locations

University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 1111)
Miami 4164138, Florida 4155751 33136
Contact:
Study Coordinator
305-243-1754

University of Chicago ( Site 1108)
Chicago 4887398, Illinois 4896861 60637
Contact:
Study Coordinator
773-702-6149

Dana Farber Cancer Institute ( Site 1105)
Boston 4930956, Massachusetts 6254926 02215
Contact:
Study Coordinator
888-577-8839

John Theurer Cancer Center at Hackensack University Medical Center ( Site 1103)
Hackensack 5098706, New Jersey 5101760 07601
Contact:
Study Coordinator
551-996-5863

Roswell Park Cancer Institute ( Site 1107)
Buffalo 5110629, New York 5128638 14263
Contact:
Study Coordinator
716-845-3167

Providence Portland Medical Center ( Site 1101)
Portland 5746545, Oregon 5744337 97213
Contact:
Study Coordinator
503-215-5696

Sarah Cannon Research Institute ( Site 7001)
Nashville 4644585, Tennessee 4662168 37203
Contact:
Study Coordinator
844-482-4812

MEDICAL COLLEGE OF WISCONSIN ( Site 1112)
Milwaukee 5263045, Wisconsin 5279468 53226
Contact:
Study Coordinator
414-805-8900

More Details

Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

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

Detailed 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.