Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JNJ-90301900 · 3 trials · 3 indications
PFS is defined as time from randomization to local-regional progression (including recurrence), distant progression, or death from any cause, whichever occurs first.
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 using ICR assessments.
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.
| Arm | Type | Description |
|---|---|---|
| Arm A: JNJ-90301900 (NBTXR3) | EXPERIMENTAL | JNJ-90301900 (NBTXR3), as an intratumoral/intranodal injection, activated by investigator's choice of RT alone or RT in combination with cetuximab. JNJ-90301900 (NBTXR3) is given as a dose of 33% of the Gross Tumor Volume. |
| Arm B: RT alone or RT in combination with cetuximab | ACTIVE_COMPARATOR | Investigator's choice of RT alone or RT in combination with cetuximab. |
| Part 1: Cohort A and Cohort B | EXPERIMENTAL | Participants will receive JNJ-90301900 injected intratumorally and/or intranodally (cohort A: 22% gross tumor volume \[GTV\] and cohort B: 33% GTV) along with cCRT (concurrent chemotherapy with radiation therapy) followed by consolidation immunotherapy (cIT) to evaluate feasibility of JNJ-90301900 injection procedure. |
| Part 2: Arm A and Arm B | EXPERIMENTAL | Participants will receive JNJ-90301900 injected intratumorally and/or intranodally (Arm A: 22% GTV and Arm B: 33% GTV) along with cCRT followed by cIT to evaluate the efficacy and safety of JNJ-90301900. |
| Part 2: Arm C: (Control treatment) | ACTIVE_COMPARATOR | Participants will receive treatment with cCRT followed by cIT as control treatment to evaluate the efficacy and safety of JNJ-90301900. |
| JNJ-90301900 + Concurrent Chemoradiation Therapy (cCRT) | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| JNJ-90301900 (NBTXR3) | DRUG | Suspension of inert, crystalline hafnium oxide particles, designed to generate oxygen free radicals to destroy cancer cells after activation by ionizing radiation. |
| Cetuximab | DRUG | Solution for infusion |
| Radiation Therapy | RADIATION | Intensity-modulated radiation therapy (IMRT): 70 Gray in 35 fractions over a 7-week period. |
| JNJ-90301900 | DRUG | JNJ-90301900 will be injected intratumorally and/or intranodally. |
| Durvalumab | BIOLOGICAL | Durvalumab will be administered as intravenous (IV) infusion as cIT. |
| Concurrent Chemo/Radiation Therapy (cCRT) | RADIATION | Radiation by intensity modulated radiation therapy (IMRT) will be administered. |
| Concurrent Chemo/Radiation Therapy (cCRT): Carboplatin | DRUG | Carboplatin will be administered as IV infusion as platinum-based doublet chemotherapy. |
| Concurrent Chemo/Radiation Therapy (cCRT): Paclitaxel | DRUG | Paclitaxel will be administered as IV infusion as platinum-based doublet chemotherapy. |
| Cisplatin | DRUG | Cisplatin will be administered intravenously. |
| Intensity Modulated Radiation Therapy (IMRT) | RADIATION | IMRT radiation therapy will be administered. |
| Carboplatin | DRUG | Carboplatin will be administered intravenously. |
| Paclitaxel | DRUG | Paclitaxel will be administered intravenously. |
Inclusion Criteria: * Age greater than or equal to (\>=) 60 years old * Biopsy-confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or supraglottic larynx and a candidate for definitive radiation therapy with or without cetuximab * Clinical stage T3-4 NX or T2 N2-3 disease...