JNJ-90301900 + Chemoradiation for Head and Neck Cancer

(LUMIRAY Trial)

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Johnson & Johnson Enterprise Innovation Inc.

Disqualifiers: Non-squamous histology, Stages 0, I, II, IVC, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to approximately 2 years 14 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called JNJ-90301900 for people with head and neck cancer. Researchers aim to determine if injecting this treatment directly into tumors is safe and effective when combined with standard chemotherapy and radiation therapy. This trial targets individuals with head and neck squamous cell cancer who qualify for these combined treatments. Participants should have a cancer diagnosis in the mouth or throat area and be prepared for intensive chemotherapy and radiation. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive it.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that JNJ-90301900 is likely to be safe for humans?

Researchers are investigating the safety of JNJ-90301900 for people with head and neck cancer. Earlier studies tested JNJ-90301900 with radiation, similar to the current trial. These studies found that JNJ-90301900 is generally well-tolerated.

Some patients experienced side effects, usually mild or moderate. Common side effects included tiredness, nausea, and skin reactions. Serious side effects were less common, indicating that most people could handle the treatment without major issues.

The safety results so far appear promising, but the current trial will provide more information about the safety and effectiveness of JNJ-90301900 when combined with chemotherapy and radiation. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for head and neck cancer involve chemotherapy and radiation, often with drugs like cisplatin. But JNJ-90301900 works differently, targeting the tumor directly by being injected right into it or the nearby lymph nodes. Researchers are excited because this direct delivery method can potentially enhance the effectiveness of the existing chemoradiation therapy, specifically by intensifying the impact on cancer cells while possibly reducing side effects. This innovative approach could offer a more potent and precise attack on the cancer, improving outcomes for patients with head and neck cancer.

What evidence suggests that JNJ-90301900 might be an effective treatment for head and neck cancer?

Research shows that JNJ-90301900, which participants in this trial will receive, has promising early results in treating tumors. Earlier studies found that it controlled the disease well, with 95% of treated tumors not growing. This treatment is injected directly into tumors, potentially increasing its effectiveness. Although more information is needed, these early results suggest it could be a strong option for head and neck cancer. ^{1 2 6 7 8}

Who Is on the Research Team?

Johnson & Johnson Enterprise Innovation, Inc. Clinical Trial

Principal Investigator

Johnson & Johnson Enterprise Innovation Inc.

Are You a Good Fit for This Trial?

This trial is for adults with advanced head and neck squamous cell carcinoma who can undergo chemoradiation. They must have a certain stage of cancer (III, IVA, or IVB), at least one measurable tumor, and be in good physical condition (ECOG PS 0 or 1).

Inclusion Criteria

My cancer is confirmed in the mouth, throat, or upper voice box and is not HPV-related.

My cancer is at stage III, IVA, or IVB.

I am eligible for combined chemotherapy and radiation as decided by my doctor.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive JNJ-90301900 administered intratumorally and/or intranodally, in combination with concurrent chemoradiation therapy (cCRT) consisting of cisplatin and intensity-modulated radiation therapy (IMRT)

Up to approximately 2 years 14 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment until the end of study, radiographic disease progression, study discontinuation, or study completion

Up to approximately 2 years 14 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cisplatin
• Intensity Modulated Radiation Therapy (IMRT)
• JNJ-90301900

Trial Overview The study tests JNJ-90301900 injected into tumors combined with standard chemotherapy (Cisplatin) and radiation therapy (IMRT) to see if it's safe and effective for treating head and neck cancer.

How Is the Trial Designed?

Group I: JNJ-90301900 + Concurrent Chemoradiation Therapy (cCRT) Experimental Treatment 3 Interventions

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.

Who Is Running the Clinical Trial?

Johnson & Johnson Enterprise Innovation Inc.

Lead Sponsor

Trials

5

Recruited

910+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07219212

NCT07219212 | A Study of JNJ-90301900 in Combination ... 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 ...

2. clinicaltrials.jnj.com clinicaltrials.jnj.com/en/study-detail/NCT04892173

J&J Study NCT04892173 - J&J Clinical Trials This is a global, open-label, randomized, 2-arm, Investigator's choice Phase 3 (Pivotal Stage) study to investigate the efficacy and safety of JNJ-90301900 ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04892173

Study Details | NCT04892173 | JNJ-90301900 (NBTXR3) ... This is a global, open-label, randomized, 2-arm, Investigator's choice Phase 3 (Pivotal Stage) study to investigate the efficacy and safety of JNJ-90301900 ...

4. ir.nanobiotix.com ir.nanobiotix.com/news-releases/news-release-details/nanobiotix-announces-updated-phase-1-results-continuing-support

Release Details Overall, these results show strong local control, with an aggregate DCR of 95% (86/91) in JNJ-1900 (NBTXR3)-injected lesions in evaluable ...

5. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/head-and-neck-squamous-cell-carcinoma

UCSF Head and Neck Squamous Cell Carcinoma Clinical Trials The main purpose of this study is to assess the efficacy and safety of volrustomig compared to observation in participants with unresected ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04892173

Study Details | NCT04892173 | JNJ-90301900 (NBTXR3) ... This is a global, open-label, randomized, 2-arm, Investigator's choice Phase 3 (Pivotal Stage) study to investigate the efficacy and safety of JNJ-90301900 ...

7. clin.larvol.com clin.larvol.com/trial-detail/NCT04892173

JNJ-90301900 (NBTXR3) Activated by Radiotherapy With ... A pivotal phase III global registration study evaluating NBTXR3 as a single-agent activated by radiotherapy for patients with LA-HNSCC expected late in the ...

8. cancer.gov cancer.gov/clinicaltrials/NCI-2021-09147

JNJ-90301900 (NBTXR3) Activated by Radiotherapy With ... This is a global, open-label, randomized, 2-arm, Investigator's choice Phase 3 (Pivotal Stage) study to investigate the efficacy and safety of JNJ-90301900 ...