The purpose of this study is to determine a safe and tolerable dose(s) of JNJ-86974680 for further research in combination with cetrelimab and radiation therapy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
126
JNJ-86974680 will be administered.
Cetrelimab will be administered.
Radiation therapy will be administered.
City of Hope 1
Newnan, Georgia, United States
RECRUITINGHackensack University Medical Center
Hackensack, New Jersey, United States
Number of Participants with Adverse Events (AEs) by Severity
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. 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) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.
Time frame: Up to 2 years 5 months
Number of Participants with Dose Limiting Toxicities (DLTs)
The DLTs are specific adverse events and are defined as any of the following: non-hematologic toxicity and hematological toxicity.
Time frame: Up to 2 years 5 months
Maximum Observed Plasma Concentration (Cmax) of JNJ-86974680
Cmax is defined as maximum observed plasma concentration of JNJ-86974680.
Time frame: Up to 2 years 5 months
Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC0-t) of JNJ-86974680
(AUC0-t) is defined as area under the plasma concentration of JNJ-86974680 versus time curve from the time of dose administration to time of last quantifiable concentration (0-t).
Time frame: Up to 2 years 5 months
Part 2: Overall Response Rate (ORR)
ORR is defined as the percentage of participants who have a best response of complete response (CR) or partial response (PR) according to response evaluation criteria in solid tumors (RECIST) version (v)1.1, maintained for at least 4 weeks.
Time frame: Up to 2 years 5 months
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Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States
RECRUITINGHerbert Irving Comprehensive Cancer Center Columbia University Medical Center
New York, New York, United States
RECRUITINGProvidence Portland Medical Center
Portland, Oregon, United States
RECRUITINGThomas Jefferson University
Philadelphia, Pennsylvania, United States
RECRUITINGNext Virginia
Fairfax, Virginia, United States
RECRUITINGCharite Research Organisation GmbH
Berlin, Germany
COMPLETEDUniversitaetsklinikum Giessen und Marburg GmbH
Giessen, Germany
RECRUITINGSeverance Hospital Yonsei University Health System
Seoul, South Korea
RECRUITING...and 5 more locations
Part 2: Complete Response Rate (CRR)
CRR is defined as the proportion of participants with a best response of CR.
Time frame: Up to 2 years 5 months
Part 2: Duration of Response (DOR)
DoR is defined as the time from the date of first initial documentation of a response to the date of first documented evidence of progression of disease according to immunotherapy response evaluation criteria in solid tumors (iRECIST) or death due to any cause, whichever occurs first.
Time frame: Up to 2 years 5 months
Part 2: Disease Control Rate (DCR)
DCR is defined as the percentage of participants who achieve a best of response of PR, CR, or stable disease using RECIST v1.1.
Time frame: Up to 2 years 5 months