Nivo800 for Head and Neck Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new method to visualize head and neck cancer more clearly during surgery using a special version of the drug nivolumab. Researchers aim to ensure that this fluorescently labeled form of nivolumab, called nivo800, is safe as a molecular imaging agent. The trial explores different doses to determine the safest and most effective amount. Individuals with head and neck cancer scheduled for surgery might be suitable candidates for this study. 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 this innovative approach.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that nivolumab, often called "nivo," is generally safe for people with head and neck cancer. Studies have found it can be used safely in these patients, with manageable side effects. In Japan, real-world studies reported expected side effects without any new or severe problems.
The FDA has already approved nivolumab for treating head and neck cancer, supporting its safety for patients. Researchers are now testing a new form, nivo800, for imaging purposes. Based on the known safety of regular nivolumab, it is expected to be safe. However, since this is an early phase 1 trial, the primary goal is to monitor safety closely and determine the best dose. Researchers will carefully watch participants for any side effects to ensure the treatment remains safe.12345Why are researchers excited about this trial's treatments?
Researchers are excited about Nivo800 for head and neck cancer because it combines nivolumab with a novel component, potentially enhancing the immune system's ability to fight cancer. Unlike traditional treatments such as surgery, radiation, and chemotherapy, which physically remove or destroy cancer cells, Nivo800 works by boosting the body's own immune response. This innovative approach could lead to more effective outcomes and potentially fewer side effects, offering new hope for patients with this challenging condition.
What evidence suggests that Nivo800 might be an effective treatment for head and neck cancer?
Research has shown that nivolumab effectively treats head and neck cancer. Studies have found that it extends patients' lives compared to standard chemotherapy. It is the first immunotherapy to benefit patients whose cancer did not respond to platinum-based treatments. In this trial, participants will receive varying doses of nivolumab and Nivo800, which researchers are studying for their potential to enhance treatment outcomes. Combining nivolumab with other treatments, such as chemoradiotherapy, can lower the risk of cancer recurrence. Patients with advanced head and neck cancer have achieved better results with nivolumab. These findings suggest that nivolumab could be a promising treatment option for head and neck cancer.678910
Who Is on the Research Team?
Eben Rosenthal, MD
Principal Investigator
Vanderbilt University/Ingram Cancer Center
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive an infusion of nivolumab followed by an infusion of nivo800 prior to standard-of-care surgical resection
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Nivo800
- Nivolumab
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Participants will receive nivolumab and nivo800 prior to their standard of care surgery.
Participants will receive nivolumab and nivo800 prior to their standard of care surgery.
Participants will receive nivolumab and nivo800 prior to their standard of care surgery.
All participants will receive 10mg of unlabeled nivolumab and nivo800.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vanderbilt-Ingram Cancer Center
Lead Sponsor
Citations
A real-world population-based descriptive study
In this real-world study, the survival outcomes of nivolumab were similar to those observed in CheckMate-141 trial.
Real-world effectiveness and healthcare utilization of ...
Background: Nivolumab was the first immunotherapy to have shown efficacy in platinum-resistant recurrent and/or metastatic squamous cell ...
A real-world population-based descriptive study
Nivolumab was the first immunotherapy to have shown efficacy in platinum-resistant recurrent and/or metastatic squamous cell carcinoma of head and neck (R/M ...
Adding Nivolumab to Adjuvant Chemoradiotherapy ...
“The outcome for patients with locoregionally advanced head and neck cancers remains generally poor,” said lead study author Jean Bourhis ...
Nivolumab for Recurrent Squamous-Cell Carcinoma of ...
Patient-reported outcomes, including symptoms and health-related quality of life, were exploratory end points and were evaluated with the use of ...
6.
targetedonc.com
targetedonc.com/view/post-operative-nivolumab-significantly-improves-dfs-in-head-and-neck-cancerPost-Operative Nivolumab Significantly Improves DFS in ...
Post-operative nivolumab significantly improved disease-free survival in resected locally advanced head and neck cancer, meeting the primary end point of the ...
Effectiveness and safety of nivolumab in patients with head ...
Effectiveness and safety of nivolumab in patients with head and neck cancer in Japanese real-world clinical practice: a multicenter retrospective clinical study
Safety and Treatment Outcomes of Nivolumab for the ...
Nivolumab in recurrent/metastatic HNSCC is well tolerated and may be more efficacious in patients who develop IRT. Keywords: head and neck ...
Effectiveness and Safety of Nivolumab in Participants That ...
Efficacy and Safety of Nivolumab in Recurrent or Metastatic Head and Neck Cancer (HNC) Patients - Japanese Real-world Data Through Clinical Chart Review.
A safety study of nivolumab in patients with recurrent and/ ...
Conclusions: The interim analysis of the TOPNIVO study shows no additional toxicities of N compared to what has been described previously, ...
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