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).

A Study of JNJ-90301900 in Combination With Chemoradiation Therapy in Participants With Locally Advanced Head and Neck Squamous Cell Carcinoma

Squamous Cell Carcinoma of Head and Neck

Head and Neck Cancer

Cancer

Advanced Solid Malignancies

Advanced Solid Tumor

Advanced Solid Tumors

Solid Tumor, Adult

Neoplasms

Adenocarcinoma

Advanced Stage Solid Tumors

Cisplatin

Carboplatin

Paclitaxel

JNJ-90301900

Intensity Modulated Radiation Therapy (IMRT)

A Study of JNJ-90301900 in Combination With Concurrent Chemoradiation Therapy in Participants With Locally Advanced Head and Neck Squamous Cell Carcinoma

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.

Percentage of participants achieving CR according to RECIST v.1.1 will be reported.

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.

DCR is defined as the percentage of participants achieving CR, PR, or stable disease (SD) as per RECIST v.1.1 criteria.

Response rate will be measured based on total tumor shrinkage compared to baseline among those lesions injected with JNJ-90301900.

Time to LRF is defined as time from enrollment to first failure of LRF using investigator RECIST v.1.1 assessments.

Time to DF is defined as time from enrollment to first failure of DF using investigator RECIST v.1.1 assessments.

PFS is defined as the time from enrollment to radiographic disease progression, or death from any cause, whichever occurs first.

Participants with PRND will be summarized and will continue to be radiographically evaluated for response by RECIST v.1.1.

Participants with post-radiation primary surgery will be summarized and will continue to be radiographically evaluated for response by RECIST v.1.1.

Participants will receive JNJ-90301900 administered intratumorally and/or intranodally, in combination with concurrent chemoradiation therapy (cCRT) consisting of platinum based chemotherapy (cisplatin or carboplatin/paclitaxel) and intensity-modulated radiation therapy (IMRT). Post-treatment follow-up will continue until the end of study (EOS), radiographic disease progression, study discontinuation, or study completion, whichever occurs first.

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).

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.

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.

DCR is defined as the percentage of participants achieving CR, PR, or stable disease (SD)
as per RECIST v.1.1 criteria.

Response rate will be measured based on total tumor shrinkage compared to baseline among
those lesions injected with JNJ-90301900.

Time to LRF is defined as time from enrollment to first failure of LRF using investigator
RECIST v.1.1 assessments.

Time to DF is defined as time from enrollment to first failure of DF using investigator
RECIST v.1.1 assessments.

PFS is defined as the time from enrollment to radiographic disease progression, or death
from any cause, whichever occurs first.

Participants with PRND will be summarized and will continue to be radiographically
evaluated for response by RECIST v.1.1.

Participants with post-radiation primary salvage surgery will be summarized and will
continue to be radiographically evaluated for response by RECIST v.1.1.

Participants will receive JNJ-90301900 administered intratumorally and/or intranodally,
in combination with concurrent chemoradiation therapy (cCRT) consisting of cisplatin and
intensity-modulated radiation therapy (IMRT). Post-treatment follow-up will continue
until the end of study (EOS), radiographic disease progression, study discontinuation, or
study completion, whichever occurs first.

A Study of JNJ-90301900 in Combination With Chemoradiation Therapy in Participants With Locally Advanced Head and Neck Squamous Cell Carcinoma

Trials at a glance

Trials at a glance