Immunotherapy for HPV-Positive Throat Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a treatment for individuals with HPV-positive throat cancer that has spread to nearby areas. It aims to determine if adding nivolumab, a drug that helps the immune system attack cancer, after standard chemotherapy and radiation can extend survival and prevent cancer recurrence. Participants will receive either the standard treatment with or without nivolumab, or just nivolumab if their cancer progresses. This trial suits those with HPV-positive throat cancer that has spread and who have not yet undergone chemotherapy or radiation. As a Phase 3 trial, it represents the final step before FDA approval, offering access to potentially groundbreaking treatment.
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, you cannot be on systemic corticosteroids or other immunosuppressive medications during the trial, unless they are inhaled or topical.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Earlier studies have shown that nivolumab is generally safe for people with HPV-related throat cancers. One study found that some patients responded well to it without major safety issues. Another study tested nivolumab with other treatments and found it safe for those with head and neck cancers.
Research supports the use of cisplatin, a chemotherapy drug, for treating HPV-positive throat cancers, though it can have long-term side effects. Intensity-Modulated Radiation Therapy (IMRT), a precise type of radiation treatment, has been shown to be effective and generally well-tolerated, though it may cause some side effects.
Overall, research supports the safety of these treatments, but they can have side effects. Participants should be aware and discuss any concerns with their healthcare team.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for HPV-positive throat cancer because they incorporate immunotherapy, a promising addition to traditional methods. While standard treatments often involve chemotherapy and radiation, this trial introduces nivolumab, an immunotherapy drug that helps the body’s own immune system target and destroy cancer cells. Nivolumab, used in Arm A and Arm C, works by blocking a protein called PD-1, which can prevent the immune system from attacking cancer cells. This approach is different because it aims to harness the immune system for a more targeted attack, potentially leading to better outcomes and fewer side effects compared to conventional therapies alone.
What evidence suggests that this trial's treatments could be effective for HPV-positive throat cancer?
This trial will compare different treatment approaches for HPV-positive throat cancer. One arm involves nivolumab, which studies have shown can improve response rates in patients with this cancer compared to standard chemotherapy. Research indicates that patients taking nivolumab live for a median of 9.1 months, more than twice as long as some standard treatments. Specifically, previous patients found that nivolumab not only helped them maintain their abilities but also improved their symptoms. Another arm involves the combination of cisplatin and radiation therapy, a well-known effective treatment for HPV-positive throat cancer. These treatments work together to help the immune system fight cancer cells while using traditional methods to stop the cancer from growing and spreading.678910
Who Is on the Research Team?
Nabil F Saba
Principal Investigator
ECOG-ACRIN Cancer Research Group
Are You a Good Fit for This Trial?
Adults with intermediate-risk HPV-positive oropharyngeal cancer that has spread locally but not to distant sites. Participants must have adequate organ function, no prior treatments for this cancer, and cannot be pregnant or breastfeeding. They should not have a history of severe allergic reactions to chemotherapy agents like cisplatin or immune conditions that require steroids.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Concurrent Therapy
Patients receive cisplatin and intensity modulated radiation therapy (IMRT) for 7 weeks
Maintenance Therapy
Patients in Arm A receive nivolumab IV every 4 weeks for 12 months
Observation
Patients in Arm B undergo observation after concurrent therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cisplatin
- Intensity-Modulated Radiation Therapy
- Nivolumab
Trial Overview
The trial is testing if adding maintenance immunotherapy (nivolumab) after standard treatment with radiation and chemotherapy (cisplatin) improves survival in patients compared to just the standard treatment alone. It's looking at overall survival and progression-free survival as key outcomes.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
Patients receive nivolumab IV over 30 minutes every 4 weeks for 12 months in the absence of disease progression or unacceptable toxicity. Patients undergo CT or FDG PET/CT scans throughout the trial. Patients may undergo ECHO as clinically indicated. Additionally, patients undergo blood sample collection during screening.
Patients receive cisplatin IV over 60 minutes weekly and IMRT 5 days a week for 7 weeks for a total of 35 fractions. Within 4 weeks after completion of concurrent therapy, patients receive nivolumab IV once weekly over 30 minutes every 4 weeks for 12 months in the absence of disease progression or unacceptable toxicity. Patients undergo CT or FDG PET/CT scans throughout the trial. Patients may undergo ECHO as clinically indicated. Additionally, patients undergo blood sample collection during screening.
Patients receive cisplatin IV over 60 minutes weekly and IMRT 5 days a week for 7 weeks for a total of 35 fractions, and then go on observation. Patients will be offered the option to cross-over to Arm C if they have clearly documented progression within 12 months from the end of cisplatin/radiation therapy. Patients undergo CT or FDG PET/CT scans throughout the trial. Patients may undergo ECHO as clinically indicated. Additionally, patients undergo blood sample collection during screening.
Cisplatin is already approved in European Union, United States, Canada, Japan for the following indications:
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor
Citations
NCT03952585 | De-intensified Radiation Therapy With ...
This phase II/III trial studies how well a reduced dose of radiation therapy works with nivolumab compared to cisplatin in treating patients with human ...
De-intensified Radiation Therapy with Chemotherapy ...
This phase II/III trial studies how well a reduced dose of radiation therapy works with nivolumab compared to cisplatin in treating patients with human ...
Study Finds Standard Chemoradiation Therapy Superior to ...
Current standard chemoradiation therapy remains the most effective treatment for selected patients with human papillomavirus (HPV)-positive oropharyngeal ...
Reduced-Dose Radiation Therapy for HPV-Associated ...
Reducing radiation treatment dose could improve the quality of life (QOL) of patients with good-risk human papillomavirus–associated oropharyngeal squamous ...
Trial Spotlight: Nabil Saba on Study EA3161 for HPV ...
Recent evidence indicated that nivolumab maintained function and improved symptoms in heavily pre-treated patients with SCCHN, making its use in ...
Retrospective study of cisplatin plus radiotherapy toxicities ...
HPV-positive cancers are typically associated with better outcomes compared to HPV-negative tumors (14). Hence, the clinical benefit of ...
The important role of cisplatin in the treatment of HPV ...
This study using causal inference of retrospective patient data confirms the important role of cisplatin in the treatment of HPV-positive OPSCC.
Radiation Therapy for HPV-Positive Oropharyngeal ...
Concurrent cisplatin is recommended for patients receiving definitive RT with T3-4 disease and/or 1 node >3 cm, or multiple nodes. For similar ...
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dailynews.ascopubs.org
dailynews.ascopubs.org/do/therapeutic-de-escalation-hpv-positive-head-and-neck-cancerTherapeutic De-escalation in HPV-Positive Head and Neck ...
Cisplatin-based chemoradiation for locally advanced HPV-positive head and neck cancer has substantial long-term toxicity. To combat this, ...
Radiotherapy plus cisplatin or cetuximab in low-risk human ...
Concomitant cisplatin and radiotherapy should remain the standard of care for patients with low-risk HPV-positive oropharyngeal cancer. Our ...
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