Chemotherapy + Immunotherapy for Head and Neck Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether adding chemotherapy or chemo-immunotherapy to the usual surgery and radiation can better treat head and neck cancer that has recurred and spread locally. The trial uses a combination of drugs, including carboplatin and paclitaxel, which stop cancer cells from growing, and cemiplimab, an immunotherapy that enhances the body's ability to fight cancer. It seeks participants with head and neck squamous cell carcinoma (a type of cancer in the mouth, throat, or voice box) that has returned or persists after initial treatment. Participants should have cancer that tests positive for PD-L1 (a protein that helps tumors evade immune detection) and be candidates for surgery to remove the tumor. As a Phase 2 trial, this 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. However, it does mention that you cannot have received investigational anti-cancer agents within 4 weeks prior to registration and that prior systemic therapy for recurrent or metastatic cancer is not allowed. It's best to discuss your current medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Past research has shown promise in using the combination of paclitaxel, carboplatin, and cemiplimab for treating certain head and neck cancers. Studies have found this combination to be generally well-tolerated, with some reporting mild side effects and only a few cases of more serious reactions. This suggests the treatment might be manageable for many patients.
Carboplatin and paclitaxel have been effective and relatively safe in other head and neck cancer treatments. Adding cemiplimab may enhance the immune system's ability to fight cancer cells. While individual reactions may vary, current data indicates these treatments are reasonably safe for most people.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the chemo-immunotherapy combination for head and neck cancer because it brings a fresh approach to treatment. Unlike traditional methods that primarily focus on chemotherapy and surgery, this new combination includes cemiplimab, an immunotherapy drug. Cemiplimab works by boosting the body's immune system to better recognize and attack cancer cells, which is different from the typical chemotherapy approach of directly targeting and killing cancer cells. This dual action of chemotherapy and immunotherapy could offer a more robust and comprehensive attack on the cancer, potentially leading to better outcomes for patients.
What evidence suggests that this trial's treatments could be effective for head and neck cancer?
Research shows that using paclitaxel and carboplatin together effectively treats head and neck squamous cell carcinoma. Studies found that 80% of patients responded well, with more than half experiencing a complete disappearance of their cancer. In this trial, some participants will receive only paclitaxel and carboplatin, while others will receive these drugs combined with cemiplimab, which helps the immune system fight cancer. This combined approach aims to improve outcomes for patients whose cancer has returned or persisted.678910
Who Is on the Research Team?
Nabil F Saba
Principal Investigator
NRG Oncology
Are You a Good Fit for This Trial?
This trial is for patients with PD-L1 positive head and neck squamous cell carcinoma that's locally recurrent or persistent. They must have measurable disease, be eligible for salvage surgery without gross residual disease, and have insurance coverage for chemotherapy. Specific criteria apply based on the cancer location (oral cavity, oropharynx, larynx). Major vascular involvement disqualifies participation.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Neoadjuvant Chemotherapy or Chemo-Immunotherapy
Patients receive paclitaxel and carboplatin, with or without cemiplimab, every 21 days for 2 cycles before salvage surgery
Salvage Surgery
Patients undergo standard of care salvage surgery
Post-operative Radiation Therapy
Patients with high risk features undergo radiation therapy and receive cisplatin weekly for 6 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Carboplatin
- Cemiplimab
- Paclitaxel
Trial Overview
The study tests adding chemotherapy (carboplatin and paclitaxel) or chemo-immunotherapy (with cemiplimab added) to standard salvage surgery followed by radiation therapy and cisplatin in high-risk patients. The goal is to see if these additions improve outcomes compared to surgery alone in treating advanced head and neck cancer.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
Patients receive paclitaxel IV, carboplatin IV and cemiplimab IV, over 30 minutes, on day 1 of each cycle. Cycles repeat every 21 days for 2 cycles in the absence of disease progression or unacceptable toxicity. 6-10 weeks after cycle 1 day 1 patients undergo standard of care salvage surgery. Starting within 8 weeks of surgery, patients with high risk features also undergo radiation therapy daily for 5 treatments per week for 6 weeks and receive cisplatin IV once per week for 6 weeks during radiation treatment, in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, PET scan and optionally undergo blood sample collection throughout the study.
Patients receive paclitaxel IV and carboplatin IV on day 1 of each cycle. Cycles repeat every 21 days for 2 cycles in the absence of disease progression or unacceptable toxicity. 6-10 weeks after cycle 1 day 1 patients undergo standard of care salvage surgery. Starting within 8 weeks of surgery, patients with high risk features also undergo radiation therapy daily for 5 treatments per week for 6 weeks and receive cisplatin IV once per week for 6 weeks during radiation treatment, in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, PET scan and optionally undergo blood sample collection throughout the study.
Patients undergo standard of care salvage surgery. Starting within 8 weeks of surgery, patients with high risk features also undergo radiation therapy daily for 5 treatments per week for 6 weeks and receive cisplatin IV once per week for 6 weeks during radiation treatment, in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, PET scan and optionally undergo blood sample collection throughout the study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor
Citations
Effectiveness of paclitaxel and carboplatin combination in ...
The combination of paclitaxel and carboplatin was effective in heavily pretreated patients with squamous cell carcinoma of the head and neck.
Long-term outcomes with concurrent carboplatin, paclitaxel ...
Treatment with concurrent carboplatin, paclitaxel and radiation is safe and offers curative potential for poor prognosis patients with locally advanced SCCHN.
Long-term outcomes with concurrent carboplatin, paclitaxel ...
Forty of 50 evaluable patients (80%) had an objective response, with a complete response rate of 52%. With a median follow-up of 69 months years ...
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journals.lww.com
journals.lww.com/ojji/fulltext/2021/05020/carboplatin_in_combination_with_3_weekly.6.aspxCarboplatin in Combination with 3-Weekly Paclitaxel as First
The results showed that this combination has significant activity, with the DCR of 40.7% in first-line treatment of R/M SCCHN. Toxicities were manageable and ...
Long-term outcomes with concurrent carboplatin, paclitaxel ...
Forty of 50 assessable patients (80%) had an objective response, with a complete response rate of 52%. With a median follow-up of 69 months for surviving ...
NCT04862650 | Cemiplimab, Low-Dose Paclitaxel and ...
Giving cemiplimab in combination with paclitaxel and carboplatin may work better in treating recurrent or metastatic squamous cell carcinoma of the head and ...
Safety and efficacy of the combination carboplatin ...
Stable disease was seen in 2 patients (13.3%) and progressive disease was observed in 5 pts (33.3%). Toxicity was mild: we recorded 1 case of G3 toxicity ( ...
Carboplatin in combination with weekly Paclitaxel as first-line ...
Our study shows Carboplatin and Paclitaxel in first-line in recurrent/metastatic head and neck squamous cell carcinoma appear efficient for patients ineligible ...
Cemiplimab, Low-Dose Paclitaxel and Carboplatin for the ...
This phase II trial studies the effect of cemiplimab in combination with low-dose paclitaxel and carboplatin in treating patients with squamous cell carcinoma ...
Effectiveness of paclitaxel and carboplatin combination in ...
A phase II study was conducted to evaluate the activity of paclitaxel and carboplatin in advanced head and neck cancer. Twenty-four patients with measurable ...
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