What side effects are associated with this type of intervention?

The combination of immunotherapy with monoclonal antibodies (such as cemiplimab) and chemotherapy agents (such as paclitaxel and carboplatin) for laryngeal cancer can lead to a range of side effects. Common side effects of cemiplimab include fatigue, rash, diarrhea, and immune-related adverse events like pneumonitis, colitis, and hepatitis. Paclitaxel and carboplatin, as chemotherapy agents, often cause side effects such as nausea, vomiting, hair loss, decreased blood cell counts (leading to increased risk of infection, anemia, and bleeding), neuropathy, and fatigue. These treatments can also lead to more severe side effects, and patients should be closely monitored by their healthcare team.

What prior FDA approvals exist?

The FDA has approved several treatments for laryngeal cancer, particularly focusing on combinations of immunotherapy and chemotherapy. Pembrolizumab, an immunotherapy drug, has been approved for use in combination with platinum-based chemotherapy (such as cisplatin or carboplatin) for recurrent or metastatic head and neck squamous cell carcinoma, which includes laryngeal cancer. Additionally, cetuximab, another monoclonal antibody, has been approved for use with platinum-based chemotherapy and 5-fluorouracil for similar indications. These treatments are similar to the combination of cemiplimab with paclitaxel and carboplatin being studied in clinical trials.

What other types of research exist?

Promising alternatives to cemiplimab in combination with paclitaxel and carboplatin for laryngeal cancer include: 1) Pembrolizumab, either as monotherapy or in combination with platinum and 5-fluorouracil (5-FU), which has shown efficacy in the KEYNOTE-048 trial. 2) Cetuximab combined with a PD-1 inhibitor, particularly for HPV-negative HNSCC, as suggested by meta-analysis findings. 3) Afatinib, which has been evaluated as a second-line treatment in patients progressing after platinum-based therapy. These alternatives offer different mechanisms of action and have demonstrated potential in clinical settings.

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Alkylating agents

Cemiplimab + Chemotherapy for Head and Neck Cancer

Phase 2

Recruiting

Led By Marcelo R Bonomi, MD

Research Sponsored by Marcelo Bonomi

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status 0-1

At least one measurable lesion as defined by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 on screening computed tomography (CT) or magnetic resonance imaging (MRI)

Must not have

Known infection human immunodeficiency virus (HIV), hepatitis B or C

Clinically significant cardiac disease (e.g., congestive heart failure, unstable or uncontrolled angina, myocardial infarction) within the past six months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the date of enrollment until documented disease progression, assessed up to 2 years

Awards & highlights

Summary

This trial is testing a new treatment that helps the immune system fight cancer while also using drugs to kill cancer cells.

Who is the study for?

Adults with recurrent or metastatic squamous cell carcinoma of the head and neck, who haven't had systemic therapy for this condition before. Participants must have proper kidney function, no recent vaccines, not be on immunosuppressants, and agree to use contraception. Excluded are those with certain heart conditions, active infections like HIV or hepatitis B/C, known brain metastases unless stable, or a history of pneumonitis.

What is being tested?

The trial is testing cemiplimab (an immune system-boosting monoclonal antibody) combined with low-dose paclitaxel and carboplatin (chemotherapy drugs). The goal is to see if this combination is more effective in stopping cancer growth compared to other treatments for head and neck cancers that have spread or returned after treatment.

What are the potential side effects?

Possible side effects include immune-related reactions due to cemiplimab such as inflammation in organs; chemotherapy-related issues like nausea, hair loss from paclitaxel; fatigue; blood cell count changes leading to increased infection risk; and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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I have at least one tumor that can be measured on a CT or MRI scan.

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I am 18 years old or older.

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My cancer has returned or spread and is located in my mouth, throat, voice box, or the area below my pharynx.

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It has been at least 4 weeks since my last cancer treatment or surgery.

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I haven't received any systemic therapy for my recurrent/metastatic disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have HIV, hepatitis B, or hepatitis C.

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I haven't had serious heart problems like heart failure or a heart attack in the last 6 months.

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I am not pregnant or breastfeeding.

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I have been treated with antibody-based immunotherapy before.

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I have been treated with PI3K inhibitors before.

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I have had pneumonitis in the last 5 years.

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My condition can be treated with the aim of curing it.

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My cancer is in the nasopharynx, salivary glands, lip, or sinonasal area.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the date of enrollment until documented disease progression, assessed up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the date of enrollment until documented disease progression, assessed up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of enrollment until documented disease progression, assessed up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Heart rate

Secondary study objectives

Incidence of adverse events

Progression-free survival (PFS)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (cemiplimab, paclitaxel, carboplatin)Experimental Treatment3 Interventions

Patients will be treated with a combination of cemiplimab 350 mg every three weeks, with weekly combination of paclitaxel 25 mg/m2 and carboplatin AUC 1. Treatment will continue for a total of 24 months or until disease progression or unacceptable toxicity. Weekly chemotherapy will stop after six months of treatment (24 weeks). A ten patient safety run-in phase will be initially performed.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Paclitaxel

2011

Completed Phase 4

~5810

Cemiplimab

2015

Completed Phase 3

~1340

Carboplatin

2014

Completed Phase 3

~6120

0 / 14Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Laryngeal Cancer treatments often involve a combination of immunotherapy and chemotherapy. Immunotherapy, such as Cemiplimab, uses monoclonal antibodies to help the body's immune system recognize and attack cancer cells by targeting specific proteins like PD-1 on the surface of these cells. Chemotherapy drugs like Paclitaxel and Carboplatin work by disrupting the growth and division of cancer cells. Paclitaxel stabilizes microtubules, preventing cell division, while Carboplatin forms DNA crosslinks, inhibiting DNA synthesis. These mechanisms are crucial for Laryngeal Cancer patients as they offer a multi-faceted approach to targeting and eliminating cancer cells, potentially improving treatment efficacy and patient outcomes.

Efficacy and safety of postoperative bio-chemoradiotherapy using cetuximab and docetaxel for high-risk head and neck cancer patients in Japan.A pyriform sinus cancer organ preservation strategy comprising induction chemotherapy with docetaxel, cisplatin, and 5-fluorouracil, followed by potentiated radiotherapy: a multicenter, retrospective study.