Study on Cemiplimab, Low-Dose Paclitaxel, and Carboplatin for Treating Recurrent or Metastatic Head and Neck Cancer

Sponsor: Marcelo Bonomi

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04862650

Provider View

This clinical trial is testing a combination of the immunotherapy drug cemiplimab with low-dose chemotherapy drugs paclitaxel and carboplatin to see if it can better treat squamous cell carcinoma of the head and neck that has returned or spread.

Patient Parameters

Program Overview

The purpose of this study is to find out if combining cemiplimab, an immunotherapy drug, with low-dose chemotherapy drugs paclitaxel and carboplatin can effectively treat squamous cell carcinoma of the head and neck that has come back or spread to other parts of the body. Cemiplimab may help the immune system attack cancer cells, while paclitaxel and carboplatin work to stop cancer cells from growing and spreading. This study aims to see if this combination works better than current treatments.

Description

The main goal of this study is to see how well the combination of cemiplimab, paclitaxel, and carboplatin works in shrinking tumors after 12 weeks of treatment. Researchers will also look at how safe and tolerable the treatment is, starting with a small group of ten patients to ensure safety. They will also track how long patients live without the cancer getting worse and their overall survival at one and two years.

The study will also explore how well a tool called a clinical nomogram predicts patient outcomes and compare it to another measure called the combined positive score (CPS). Researchers will perform detailed immune analyses to understand how the treatment affects immune cells and whether certain immune cells become more active in patients who respond well to the treatment.

Participants will receive cemiplimab through an IV every three weeks for up to two years, and paclitaxel and carboplatin through an IV once a week for up to 24 weeks. Treatment will continue unless the cancer progresses or side effects become too severe. After finishing the treatment, patients will have follow-up visits at 14 days and then every 12 weeks.

Eligibility Criteria

Inclusion Criteria

  • Have recurrent or metastatic squamous cell carcinoma of the head and neck, including the oral cavity, oropharynx, larynx, and hypopharynx.
  • Have not received prior systemic therapy for recurrent or metastatic disease.
  • If the primary cancer site is unknown, the tumor must test positive for p-16, and the patient must have received prior treatment for head and neck cancer.
  • At least four weeks must have passed since any prior radiation or surgery.
  • At least four weeks must have passed since any curative intent systemic therapy.
  • Must have at least one measurable tumor as seen on a CT or MRI scan.
  • Be 18 years or older.
  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Meet specific blood count and organ function criteria.
  • Agree to use effective contraception during the study and for four months after the last treatment.
  • Women of childbearing potential must have a negative pregnancy test before starting treatment.
  • Be willing to provide written informed consent and comply with study visits and assessments.

Exclusion Criteria

  • Have cancer that can be treated with curative local therapy.
  • Have nasopharyngeal, salivary gland, lip, or sinonasal carcinoma.
  • Require ongoing treatment with corticosteroids or other immunosuppressive drugs.
  • Have received previous immunotherapy with monoclonal antibodies or PI3K inhibitors.
  • Have known brain metastases unless stable for at least 21 days before joining the study.
  • Have known infections like HIV, hepatitis B, or C.
  • Have significant heart disease within the past six months.
  • Have a history of lung inflammation (pneumonitis) within the past five years.
  • Have received live vaccines within 30 days of starting the study treatment.
  • Be pregnant or breastfeeding.
  • Have any other condition that could interfere with the study or its procedures.

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