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Vaccine + Chemotherapy for Head and Neck Cancer
Study Summary
This trial is studying the safety and effectiveness of combining two experimental drugs, HB-201 and HB-202, with chemotherapy using carboplatin and paclitaxel. The study will also look at ways to reduce side effects overall using robotic surgery, chemotherapy and radiotherapy, or radiotherapy alone. Participation in the trial will last about 2 years.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- My cancer is caused by the HPV16 virus.I have another cancer, but it's not getting worse or needing treatment, except for certain skin cancers or early cervical cancer.I haven't taken long-term immune-weakening drugs in the last 6 months.My cancer involves large lymph nodes or is advanced in size.I have not had radiation or chemotherapy for head or neck cancer.I haven't had major surgery for head or neck cancer in the last 8 weeks.I can provide at least 10 tissue slides or am willing to undergo a new biopsy.I am willing and able to sign the consent form for this study.I do not have any severe illnesses that my treatment would worsen.I don't need strong medication for autoimmune or inflammatory conditions, except for minor exceptions like skin issues, thyroid problems, vitiligo, or alopecia.My cancer has spread to distant parts of my body.I am 18 years old or older.My condition is not caused by the HPV16 subtype.My doctor thinks I can be treated with cisplatin.My organ functions are normal as per recent tests.I have active Hepatitis B or C, or it has been eradicated.I have a history of or currently have non-infectious lung inflammation.I haven't had any cancer treatment in the last 8 weeks.I have not received a live vaccine in the last 28 days.My cancer can be measured by scans.I agree to use birth control while on the study drug.My cancer is HPV16-positive and located in my head, neck, or oropharynx.I've had surgery for my cancer that wasn't just a biopsy or to reduce tumor size.I haven't taken any herbal remedies that affect the immune system or major organs in the last 28 days.The origin of my cancer is unknown.I am fully active or can carry out light work.
- Group 1: Phase 1: Dose-Finding Group 2 - Drug Combination 2
- Group 2: Phase 2: Efficacy Arm 1 - HB-201 + Chemotherapy
- Group 3: Phase 1: Dose-Finding Group 1 - Drug Combination 1
- Group 4: Phase 2: Efficacy Arm 2 - HB-201 and HB-202 + Chemotherapy
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What prior investigations have been done on the efficacy of HB-201?
"Currently, 1174 studies pertaining to the efficacy of HB-201 are ongoing with 332 trials in their final stages. Most investigations concerning this drug are conducted in Shanghai; however, 66513 medical sites are investigating its effects worldwide."
Does this investigation currently have any open enrollment?
"Clinicatrials.gov states that this medical experiment is currently accepting applicants, having been posted on August 4th 2022 and revised recently on the 11th of the same month."
What main goals is this research endeavor attempting to accomplish?
"This two-year trial will evaluate the effectiveness of HB-201 and combined chemotherapy's deep response rate. Secondary objectives include assessing pathologic responses in participants who underwent transoral robotic surgery, determining a possible correlation between plasma HPV-DNA and tumor HPV-DNA via next generation sequencing analysis, as well as analyzing changes in plasma HPV DNA during treatment with HB-201 or alternating two vector therapy combined with chemotherapy by way of further NGS assessment."
What is the current enrollment rate of participants for this research?
"Affirmative. Per the information catalogued on clinicaltrials.gov, this medical experiment is actively searching for participants who can join from August 4th 2022 onwards. Currently, 98 individuals need to be recruited from a single site."
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