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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-506495-27-00 | Registry Identifier | EUCT number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Dose Escalation | Experimental | Participants with advanced solid tumors will receive JNJ-87704916 alone and in combination with cetrelimab. Ascending dose levels will be sequentially tested. |
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| Part 2: Dose Expansion | Experimental | Part 2 will consist of three cohorts: Cohort A, B and C. Participants in cohort A&B with metastatic non-small cell lung cancer (NSCLC) will receive JNJ-87704916 in combination with cetrelimab at the dose identified in Part 1. Cohort C will evaluate JNJ-87704916 treatment in combination with ongoing Standard of care (SoC) PD(L)-1 antibody therapy in frontline treatment of NSCLC. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-87704916 | Drug | JNJ-87704916 will be administered as an intratumoral injection. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | From first dose up to 100 days after last dose of study treatment (up to 5 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Parts 1 and 2: Percentage of Participants With Objective Response (OR) | OR is defined as the percentage of participants who have best response of Complete Response (CR) or Partial Response (PR) according to response evaluation criteria in solid tumors (RECIST) v1.1. | Up to 5 years |
| Parts 1 and 2: Percentage of Participants With Disease Control (DC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Contact | Contact | 844-434-4210 | Participate-In-This-Study1@its.jnj.com |
| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Enterprise Innovation Inc Clinical Trial | Johnson & Johnson Enterprise Innovation Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | Recruiting | New York | New York | 10016 | United States | |
| Fox Chase Cancer Center |
The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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| Cetrelimab | Drug | Cetrelimab will be administered. |
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| Standard of Care PD(L)-1 | Drug | Frontline anti-PD(L)-1 antibody therapy will be administered as standard of care treatment. |
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DC is defined as the percentage of participants who have achieved complete response, partial response, and stable disease for at least 2 consecutive assessments according to RECIST v1.1. |
| Up to 5 years |
| Parts 1 and 2: Duration of Response (DOR) | DOR will be calculated among responders from the date of initial documentation of a response to the date of first documented evidence of relapse according to RECIST v1.1, or death due to any cause, whichever occurs first. | Up to 5 years |
| Part 2: Progression Free Survival (PFS) | PFS is defined as the time from treatment initiation until disease progression or worsening or death due to any cause. | From treatment initiation until disease progression or worsening or death due to any cause (up to 5 years) |
| Part 2: Overall Survival (OS) | OS is defined as the time from treatment initiation until death due to any cause. | 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 | Viral genome copies of JNJ-87704916 collected from samples (that is, blood, urine, oral mucosa, injection sites, and dressings) will be determined by quantitative polymerase chain reaction (qPCR) assays. | Up to 5 years |
| Parts 1 and 2: Payload Concentrations of JNJ-87704916 | Blood samples will be collected to characterize JNJ-87704916 payload concentrations in blood will be analyzed using immunoassay. | Up to 2 years |
| Parts 1 and 2: Number of Participants with JNJ-87704916 Antibodies | Antibodies against JNJ-87704916 encoded payloads and against herpes simplex virus type-1 (HSV-1) will be analyzed. | Up to 2 years |
| Suspended |
| Philadelphia |
| Pennsylvania |
| 19111 |
| United States |
| UPMC Cancer Centers | Recruiting | Pittsburgh | Pennsylvania | 15232 | United States |
| MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
| Toronto General Hospital | Recruiting | Toronto | Ontario | M5G 2C4 | Canada |
| Centre Hospitalier de l'Universite de Montreal | Recruiting | Montreal | Quebec | H2X 0A9 | Canada |
| Gustave Roussy | Recruiting | Villejuif | 94805 | France |
| Hosp Univ Vall D Hebron | Recruiting | Barcelona | 08035 | Spain |
| Hosp Univ Fund Jimenez Diaz | Recruiting | Madrid | 28040 | Spain |
| Hosp Univ Hm Sanchinarro | Recruiting | Madrid | 28050 | Spain |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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