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)

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

  • Small Cell Lung Cancer

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.