Cemiplimab + Fianlimab for Head and Neck Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether the combination of two drugs, cemiplimab and fianlimab, is more effective than cemiplimab alone for treating head and neck cancer linked to Human Papillomavirus (HPV). Participants will receive various combinations of these drugs with chemotherapy and radiation to determine the most effective method. This trial suits adults with HPV-positive head and neck cancer who have not yet received treatment. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss your specific medications with the trial team to get a clear answer.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have shown that cemiplimab is safe and well-tolerated, even by older patients with other health conditions. In one study, more than half of the patients responded positively to the treatment.
Research indicates that the combination of cemiplimab and fianlimab is generally safe, though some risks exist. About 44% of patients experienced severe side effects, and around 33% had serious side effects. Despite these risks, the combination has proven effective for many patients.
Both treatments have shown promise in clinical studies, but it's important to weigh the potential benefits and risks. Always consult a healthcare provider to understand what this might mean for individual circumstances.12345Why are researchers excited about this trial's treatments?
Unlike the standard treatments for head and neck cancer, which typically involve chemotherapy and radiation, the combination of Cemiplimab and Fianlimab introduces new possibilities. Cemiplimab is a PD-1 inhibitor that helps the immune system recognize and attack cancer cells more effectively. Fianlimab, another exciting component, may enhance this immune response by targeting LAG-3, a protein that can suppress immune activity. Researchers are particularly excited because this dual approach could potentially offer a more powerful and targeted attack against cancer cells, possibly leading to better outcomes for patients.
What evidence suggests that this trial's treatments could be effective for HPV-positive head and neck cancer?
Research has shown that cemiplimab, a type of drug, is approved for treating certain head and neck cancers that have recurred or spread. However, its benefits are considered modest. This trial will study one arm with cemiplimab combined with chemotherapy, and another arm with cemiplimab combined with both fianlimab and chemotherapy. Studies indicate that combining cemiplimab with fianlimab shows signs of lasting positive effects in patients. This combination may improve outcomes for people with head and neck cancer. Initial studies suggest that this combination could be more effective than using cemiplimab alone.678910
Who Is on the Research Team?
Ari arirosenberg@bsd.uchicago.edu
Principal Investigator
University of Chicago
Are You a Good Fit for This Trial?
Adults with advanced HPV-positive head and neck cancer who haven't had treatment yet. They should have a specific stage of tumor growth, no prior radiation or chemo for this cancer, and measurable disease. Surgery is okay if there's still some disease left. Participants need to be over 18 with good performance status and organ function.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Induction Treatment
Participants receive Cemiplimab in combination with chemotherapy (paclitaxel and carboplatin) for 3 cycles
Chemoradiation
Participants undergo chemoradiation with Cisplatin and Radiotherapy
Maintenance Treatment
Cemiplimab is administered for an additional 6 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cemiplimab
- Fianlimab
Trial Overview
The trial tests if adding fianlimab to cemiplimab improves outcomes compared to just cemiplimab in treating head and neck cancer. It involves patients receiving radiation, carboplatin, paclitaxel along with the study drugs.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants assigned to this arm will receive Cemiplimab and Fianlimab in combination with chemotherapy (paclitaxel and carboplatin) for 3 cycles (9 weeks). This will be followed by Chemoradiation with Cisplatin and Radiotherapy for 7 weeks. Cemiplimab will then be given for an additional 6 months.
Participants assigned to this arm will receive Cemiplimab in combination with chemotherapy (paclitaxel and carboplatin) for 3 cycles (9 weeks). This will be followed by Chemoradiation with Cisplatin and Radiotherapy for 7 weeks. Cemiplimab will then be given for an additional 6 months.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Chicago
Lead Sponsor
Citations
A phase 1 study of fianlimab (anti–LAG-3) in combination ...
Conclusions: Fianlimab + cemiplimab in pts with HNSCC showed signs of clinical activity with durable responses among pts with anti–PD-1/PD-L1- ...
NCT06769698 | A Study to See if Giving Fianlimab and ...
The study is focused on participants with head and neck cancers who have not been previously treated for head and neck cancer that has come back or spread to ...
A phase 2 study of fianlimab (anti–LAG-3) plus cemiplimab ...
In a multicohort study, fianlimab (anti–LAG-3) plus cemiplimab (anti–PD-1) showed signs of clinical activity with durable responses and a ...
Safety and Activity Profile of Fianlimab (Anti–LAG-3) in ...
Anti–PD-1 is approved for the treatment of recurrent and/or metastatic (R/M) head and neck squamous cell carcinomas (HNSCC), but the benefit is modest.
Safety and Activity Profile of Fianlimab (Anti–LAG-3) in ...
In the Phase 1 study, 15 pts were enrolled and treated with fianlimab + cemiplimab. 80% of pts were male and 53% were White. All pts had ...
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newsroom.regeneron.com
newsroom.regeneron.com/news-releases/news-release-details/libtayor-cemiplimab-phase-3-data-adjuvant-treatment-postLibtayo® (cemiplimab) Phase 3 Data in the Adjuvant ...
Libtayo demonstrated a 68% reduction in the risk of disease recurrence or death, the primary endpoint of the trial (p<0.0001).
High response rate with extended dosing of cemiplimab in ...
These data demonstrate substantial antitumor activity, rapid and durable responses, and an acceptable safety profile with an extended dosing ...
Phase 3 trial of adjuvant cemiplimab (cemi) versus placebo ...
Conclusions: Cemiplimab is the first systemic therapy to demonstrate a statistically significant and clinically meaningful reduction in disease ...
LIBTAYO® (cemiplimab-rwlc) Study Results | High-Risk CSCC
Discover study results and possible side effects of the adjuvant treatment of LIBTAYO® (cemiplimab-rwlc) in adults with high-risk CSCC.
Real-world data on tolerability and clinical response of ...
Cemiplimab demonstrated to be well-tolerated, even in elderly patients with severe comorbidities, achieving an objective response in 52% of patients.
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