This global, open-label, single arm, phase 1b study aims to learn more about whether a treatment called JNJ-90301900 is safe and effective when injected directly into tumors, along with standard chemotherapy and radiation therapy, for participants with head and neck squamous cell cancer (HNSCC; a type of solid tumor that begins in outer tissue layer of the mouth \& throat).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
JNJ-90301900 will administered via intratumoral and/or intranodal injection.
Cisplatin will be administered intravenously.
IMRT radiation therapy will be administered.
Carboplatin will be administered intravenously.
Paclitaxel will be administered intravenously.
University of Alabama at Birmingham
Birmingham, Alabama, United States
RECRUITINGCity of Hope
Duarte, California, United States
RECRUITINGUniversity of California at San Diego Moores Cancer Center
La Jolla, California, United States
RECRUITINGMayo Clinic
Jacksonville, Florida, United States
RECRUITINGMoffit Cancer center
Tampa, Florida, United States
RECRUITINGEmory University
Atlanta, Georgia, United States
RECRUITINGBoston Medical Center
Boston, Massachusetts, United States
RECRUITINGMontefiore Medical Center
The Bronx, New York, United States
RECRUITINGUniversity of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
RECRUITINGUniversity of Pennsylvania
Philadelphia, Pennsylvania, United States
RECRUITING...and 9 more locations
Number of Participants with Adverse Events (AEs) by Severity
An AE is any untoward medical occurrence in a participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment. Severity of AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version (v) 5.0.
Time frame: Up to approximately 2 years 14 weeks
Complete Response (CR) Rate
Percentage of participants achieving CR according to RECIST v.1.1 will be reported.
Time frame: Up to approximately 2 years 14 weeks
Objective Response Rate (ORR) According to RECIST v.1.1
ORR defined as percentage of participants achieving complete response (CR) or partial response (PR) by investigator assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1.
Time frame: Up to approximately 2 years 14 weeks
Disease Control Rate (DCR)
DCR is defined as the percentage of participants achieving CR, PR, or stable disease (SD) as per RECIST v.1.1 criteria.
Time frame: Up to approximately 2 years 14 weeks
Injected Tumor Response Rate
Response rate will be measured based on total tumor shrinkage compared to baseline among those lesions injected with JNJ-90301900.
Time frame: Up to approximately 2 years 14 weeks
Time to Locoregional Failure (LRF)
Time to LRF is defined as time from enrollment to first failure of LRF using investigator RECIST v.1.1 assessments.
Time frame: Up to approximately 2 years 14 weeks
Time to Distant Failure (DF)
Time to DF is defined as time from enrollment to first failure of DF using investigator RECIST v.1.1 assessments.
Time frame: Up to approximately 2 years 14 weeks
Progression Free Survival (PFS)
PFS is defined as the time from enrollment to radiographic disease progression, or death from any cause, whichever occurs first.
Time frame: Up to approximately 2 years 14 weeks
Number of Participants with Post-Radiation Neck Dissection (PRND)
Participants with PRND will be summarized and will continue to be radiographically evaluated for response by RECIST v.1.1.
Time frame: Up to approximately 2 years 14 weeks
Number of Participants with Post-Radiation Primary Surgery
Participants with post-radiation primary surgery will be summarized and will continue to be radiographically evaluated for response by RECIST v.1.1.
Time frame: Up to approximately 2 years 14 weeks
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