JNJ-87704916: JNJ-87704916 will be administered as an intratumoral injection.
Cetrelimab: Cetrelimab will be administered.
Standard of Care PD(L)-1: Frontline anti-PD(L)-1 antibody therapy will be administered as standard of care treatment.
Study summary
The purpose of this study is to determine the safety, feasibility, recommended dose(s) and regimen(s) of JNJ-87704916 as monotherapy and in combination with cetrelimab.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* For Part 1: Individuals with a diagnosis of advanced or metastatic solid tumor exhausting all available standard of care therapy; Part 2: Individuals with histologically or cytologically confirmed metastatic or locally advanced NSCLC
* Have at least 1 injectable tumor
* Eastern cooperative oncology group (ECOG) performance status of grade 0 or 1
* A participant who can have children must have a negative pregnancy test before the first dose of study treatment and during the study
* Thyroid function laboratory values within normal range except for participants on thyroid hormone replacement therapy
Exclusion Criteria:
* Active disease involvement of the CNS (example, primary central nervous system tumors, metastases, leptomeningeal disease). Some exceptions are allowed
* Prior history of, or active, significant herpetic infections (example, herpetic keratitis or encephalitis) or active herpetic infections that require ongoing systemic anti-viral therapy
* Active infection or condition that requires treatment with systemic anti-infective agents (example, antibiotics, antifungals, or antivirals) within 7 days prior to the first dose of study treatment or chronic use of anti-infective agents
* History of solid organ or hematologic stem cell transplantation
* Known positive test result for human immunodeficiency virus (HIV) or other immunodeficiency syndrome
* History of allergy to protein-based therapies or history of any significant drug allergy (such as anaphylaxis, hepatotoxicity, or immune-mediated thrombocytopenia or anemia)
Primary outcome measure(s)
Part 1: Number of Participants with Dose-Limiting Toxicity (DLT) — Up to 5 years The DLTs are specific adverse events with defined non-hematological toxicities or hematologic toxicities as per the study protocol.
Number of Participants with Adverse Events (AEs) by Severity — From first dose up to 100 days after last dose of study treatment (up to 5 years) An adverse event is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the treatment. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life-threatening, and Grade 5: death related to adverse event.
Trial sites (10)
Facility
City
Region
Status
NYU Langone Health
New York
New York
Recruiting
Fox Chase Cancer Center
Philadelphia
Pennsylvania
Suspended
UPMC Cancer Centers
Pittsburgh
Pennsylvania
Recruiting
MD Anderson Cancer Center
Houston
Texas
Recruiting
Toronto General Hospital
Toronto
Ontario
Recruiting
Centre Hospitalier de l'Universite de Montreal
Montreal
Quebec
Recruiting
Gustave Roussy
Villejuif
France
Recruiting
Hosp Univ Vall D Hebron
Barcelona
Spain
Recruiting
Hosp Univ Fund Jimenez Diaz
Madrid
Spain
Recruiting
Hosp Univ Hm Sanchinarro
Madrid
Spain
Recruiting
More Johnson & Johnson Enterprise Innovation Inc. trials in Spain
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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