Phase 1 Study of Intratumoral Administration of JNJ-87704916, an Oncolytic Virus, as Monotherapy and in Combination for Advanced Solid Tumors
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.
Arms & interventions
- DrugJNJ-87704916
JNJ-87704916 will be administered as an intratumoral injection.
- DrugCetrelimab
Cetrelimab will be administered.
- DrugStandard of Care PD(L)-1
Frontline anti-PD(L)-1 antibody therapy will be administered as standard of care treatment.
Outcome measures
Primary
Part 1: Number of Participants with Dose-Limiting Toxicity (DLT)
The DLTs are specific adverse events with defined non-hematological toxicities or hematologic toxicities as per the study protocol.
Time frame: Up to 5 years
Number of Participants with Adverse Events (AEs) by Severity
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.
Time frame: From first dose up to 100 days after last dose of study treatment (up to 5 years)
Secondary
Parts 1 and 2: Percentage of Participants With Objective Response (OR)
Time frame: Up to 5 years
Parts 1 and 2: Percentage of Participants With Disease Control (DC)
Time frame: Up to 5 years
Parts 1 and 2: Duration of Response (DOR)
Time frame: Up to 5 years
Part 2: Progression Free Survival (PFS)
Time frame: From treatment initiation until disease progression or worsening or death due to any cause (up to 5 years)
Part 2: Overall Survival (OS)
Time frame: From treatment initiation until death due to any cause (up to 5 years)
Parts 1 and 2: Number of JNJ-87704916 Genome Copies per Milliliter
Time frame: Up to 5 years
Parts 1 and 2: Payload Concentrations of JNJ-87704916
Time frame: Up to 2 years
Parts 1 and 2: Number of Participants with JNJ-87704916 Antibodies
Time frame: Up to 2 years
Eligibility criteria
Study locations (4)
NYU Langone Health
New York, New York, 10016
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
UPMC Cancer Centers
Pittsburgh, Pennsylvania, 15232
MD Anderson Cancer Center
Houston, Texas, 77030