Amivantamab + Hyaluronidase or Cetuximab for Skin Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two treatments to determine which is more effective for skin squamous cell carcinoma that has returned or spread. One group receives amivantamab (a monoclonal antibody) and hyaluronidase, which may inhibit cancer cell growth. The other group receives cetuximab, which also targets cancer growth. Individuals with skin squamous cell carcinoma that has recurred or spread and who are immunocompromised (such as those with certain cancers, autoimmune diseases, or organ transplants) might be suitable for this trial. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive medications or have certain conditions, you may need to discuss this with the study team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that using amivantamab and hyaluronidase together has been studied for safety in other conditions. In one study, 92% of patients experienced at least one side effect, with more serious side effects occurring in 47% of patients. Notably, systemic adverse reactions, such as allergic reactions, were much lower when the drug was administered as a shot under the skin—only 13% of people experienced it, compared to 66% when given through an IV.
Cetuximab, another treatment in this trial, is well-known in cancer care. It targets specific proteins on cancer cells and helps stop their growth. While generally considered safe, some patients might experience side effects like skin rashes or infections.
Overall, previous studies have shown that both treatments are relatively well-tolerated. It's important to remember that while side effects are possible, medical professionals carefully supervise the treatments.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for skin cancer because they offer distinct approaches compared to current therapies. Amivantamab, when combined with hyaluronidase, is delivered subcutaneously, which can be less invasive and more convenient than traditional intravenous methods. This combination also targets specific cancer cell receptors, potentially leading to more precise and effective treatment. On the other hand, Cetuximab is an established monoclonal antibody that targets the epidermal growth factor receptor (EGFR), helping to slow cancer cell growth. These unique mechanisms of action have researchers hopeful for improved outcomes in skin cancer management.
What evidence suggests that this trial's treatments could be effective for skin cancer?
This trial will compare two treatments for skin cancer: amivantamab with hyaluronidase and cetuximab. Research has shown that amivantamab, when combined with hyaluronidase, yields promising results for certain cancers. In earlier studies, about 45% of patients responded positively, with tumors shrinking in 82% of these cases. This indicates that amivantamab can effectively target and reduce cancer growth. Conversely, cetuximab blocks a protein called EGFR on cancer cells, potentially stopping their growth. Both treatments have shown potential, but amivantamab with hyaluronidase might provide a longer-lasting response.36789
Who Is on the Research Team?
Paul L Swiecicki
Principal Investigator
SWOG Cancer Research Network
Are You a Good Fit for This Trial?
This trial is for people with advanced skin cancer that has returned or spread, and who have a weakened immune system due to conditions like leukemia, lymphoma, multiple myeloma, or organ transplants. They must have a confirmed diagnosis of cutaneous squamous cell carcinoma and measurable disease as per specific criteria.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either amivantamab and hyaluronidase or cetuximab. Amivantamab and hyaluronidase are administered subcutaneously on days 1, 8, 15, and 22 of cycle 1 and day 1 of subsequent cycles. Cetuximab is administered intravenously on days 1 and 15 of each cycle. Cycles repeat every 28 days for 24 cycles.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion, with follow-up lasting up to 3 years.
Long-term follow-up
Participants are monitored for organ rejection and overall survival, with follow-up lasting up to 5 years.
What Are the Treatments Tested in This Trial?
Interventions
- Amivantamab
- Cetuximab
Trial Overview
The trial compares amivantamab plus hyaluronidase against cetuximab in treating locally recurrent or metastatic cutaneous squamous cell carcinoma. Amivantamab may inhibit tumor growth by targeting antigens; hyaluronidase helps it last longer in the body. Cetuximab targets EGFR on cancer cells.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Patients receive amivantamab and hyaluronidase SC over at least 5 minutes on days 1, 8, 15 and 22 of cycle 1 and day 1 of subsequent cycles. Cycles repeat every 28 days for 24 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection on study and CT scan and/or MRI throughout the study.
Patients receive cetuximab IV over 60-120 minutes on days 1 and 15 of each cycle. Cycles repeat every 28 days for 24 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection on study and CT and/or MRI throughout the study.
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Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor
Citations
Subcutaneous amivantamab delivers promising 45 percent ...
Responses were rapid and durable, and tumor shrinkage was observed in 82 percent of patients New findings from this investigational study ...
2.
oncologynewscentral.com
oncologynewscentral.com/nsclc/cancer-immunotherapy-given-early-in-the-day-improves-survival-phase-3-data-suggestCancer Immunotherapy Given Early in the Day Improves ...
The data also show improved clinical outcomes with the subcutaneous formulation. The overall response rate was 30% (95% confidence interval [CI] ...
3.
cancernetwork.com
cancernetwork.com/view/subcutaneous-amivantamab-displays-activity-in-recurrent-metastatic-hnsccSubcutaneous Amivantamab Displays Activity in Recurrent ...
The investigator-assessed confirmed objective response rate was 45%, with a confirmed clinical benefit rate of 76%. Subcutaneous amivantamab ...
4.
cancertherapyadvisor.com
cancertherapyadvisor.com/news/rybrevant-faspro-receives-fda-approval-for-all-amivantamab-indications/Rybrevant Faspro Receives FDA Approval for All ...
At a median follow-up of 7 months, the overall response rates were 30% (95% CI, 24-37) and 33% (95% CI, 26-39) in the SC and IV arms, ...
Subcutaneous Versus Intravenous Amivantamab, Both ... - PMC
Phase III studies of intravenous amivantamab demonstrated efficacy across epidermal growth factor receptor (EGFR)–mutated advanced non–small cell lung cancer ( ...
6.
jnjmedicalconnect.com
jnjmedicalconnect.com/products/rybrevant-faspro/medical-content/safety-information-for-rybrevant-faspro-dermatologic-adverse-reactionsSafety Information for RYBREVANT FASPRO
A summary of safety data regarding the occurrence of dermatologic adverse reactions in patients receiving RYBREVANT FASPRO™ (amivantamab and ...
U.S. FDA Approval of RYBREVANT FASPRO™ ...
At a median follow-up of 37.8 months, RYBREVANT® plus LAZCLUZE® showed a statistically significant reduction in the risk of death compared to ...
NCT07042295 | Treatment With Amivantamab and ...
Giving amivantamab and hyaluronidase may be as effective as cetuximab for the treatment of locally recurrent or metastatic cutaneous squamous cell carcinoma.
FDA approves amivantamab and hyaluronidase-lpuj
The incidence of systemic ARRs of any grade was 13% for subcutaneous amivantamab compared to 66% IRRs for intravenous amivantamab. The ...
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