Pembrolizumab + Radiation vs Chemotherapy + Radiation for Head and Neck Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This phase II trial studies the effect of pembrolizumab alone compared to the usual approach (chemotherapy \[cisplatin and carboplatin\] plus radiation therapy) after surgery in treating patients with head and neck squamous cell carcinoma that has come back (recurrent) or patients with a second head and neck cancer that is not from metastasis (primary). Radiation therapy uses high energy radiation or protons to kill tumor cells and shrink tumors. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. Carboplatin is also in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. Giving pembrolizumab alone after surgery may work better than the usual approach in shrinking recurrent or primary head and neck squamous cell carcinoma.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you must not be on immunosuppressive medication within 7 days before starting the trial, except for certain types like low-dose steroids or specific premedications.
Is the combination of pembrolizumab and radiation safe for head and neck cancer patients?
Pembrolizumab, when used with radiation or chemotherapy, has been generally considered safe for head and neck cancer patients, though it can cause serious side effects like pneumonia, liver inflammation, and thyroid issues. In studies, most patients experienced mild side effects, but some had more severe reactions like anemia and high blood pressure.12345
What makes the drug pembrolizumab unique for head and neck cancer treatment?
Pembrolizumab is unique because it is an immune checkpoint inhibitor that helps the body's immune system attack cancer cells by blocking the PD-1 pathway, and it is being studied in combination with radiation and chemotherapy for locally advanced head and neck cancer, offering a potential alternative for patients who cannot tolerate cisplatin.15678
What data supports the effectiveness of the drug pembrolizumab when used with radiation for head and neck cancer?
Research shows that pembrolizumab, when combined with radiation, can stimulate the immune system to fight head and neck cancer. It has been effective in treating recurrent or metastatic head and neck cancer and is being studied for use in locally advanced cases, showing promise in early trials.15679
Who Is on the Research Team?
Dan P Zandberg
Principal Investigator
ECOG-ACRIN Cancer Research Group
Are You a Good Fit for This Trial?
Adults aged 18-79 with recurrent or second primary head and neck squamous cell carcinoma, who've had surgery and prior radiation, can join this trial. They must have no distant disease spread, a specific protein (PD-L1) score >=1, and proper organ function. Those with severe allergies to pembrolizumab, active infections requiring systemic treatment, recent live vaccines, certain heart conditions or transplants are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive either pembrolizumab or chemotherapy with radiation therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Carboplatin
- Cisplatin
- Pembrolizumab
- Proton Beam Radiation Therapy
Carboplatin is already approved in United States, European Union, Canada for the following indications:
- Ovarian cancer
- Testicular cancer
- Lung cancer
- Head and neck cancer
- Brain cancer
- Ovarian cancer
- Small cell lung cancer
- Ovarian cancer
- Small cell lung cancer
- Testicular cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor