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Chemotherapy

Vaccine + Chemotherapy for Head and Neck Cancer

Phase 1 & 2
Recruiting
Led By Ari Rosenberg, MD
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects with American Joint Committee on Cancer (8th edition, 2018) N1 (solitary lymph node >=3cm), N2-N3 nodal disease or T3-T4 primary tumor (with any N).
No previous radiation or chemotherapy for a head and neck cancer.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

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.

Who is the study for?
Adults with HPV16-positive head and neck cancers, specifically oropharyngeal carcinoma, who haven't had prior radiation/chemotherapy or complete surgical resection recently. They must have a certain level of tumor size/spread, be in good health with normal organ function, not pregnant/breastfeeding, and willing to use contraception.Check my eligibility
What is being tested?
The trial tests the safety and effectiveness of TheraT® vectors (HB-201 and HB-202) combined with chemotherapy drugs carboplatin and paclitaxel. It aims to see if this combination can shrink tumors more effectively than standard treatments alone.See study design
What are the potential side effects?
Potential side effects may include typical chemotherapy-related issues like nausea, fatigue, hair loss; immune reactions due to experimental vaccines; plus risks associated with robotic surgery such as infection or bleeding.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer involves large lymph nodes or is advanced in size.
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I have not had radiation or chemotherapy for head or neck cancer.
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I can provide at least 10 tissue slides or am willing to undergo a new biopsy.
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I am 18 years old or older.
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My cancer can be measured by scans.
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I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 1 : Phase 1 Dose of HB-201 and HB-201/202 Combined with Chemotherapy
Phase 2 : Deep Response Rate of Participants Treated with HB-201 or HB-201/202 Combined with Chemotherapy
Secondary outcome measures
Changes in Plasma HPV-DNA During Study Treatment with HB-201 and Alternating HB201/202 Combined with Chemotherapy
Correlation Between Plasma HPV-DNA and Tumor HPV-DNA
Locoregional Control
+3 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Phase 2: Efficacy Arm 2 - HB-201 and HB-202 + ChemotherapyExperimental Treatment5 Interventions
Participants in this group will receive alternating doses of HB-201 and HB-202 combined with chemotherapy using carboplatin and paclitaxel at the dose established in the first phase of the study. After completing treatment at the established phase 2 dose, subjects will receive surgery, radiotherapy alone, or chemotherapy with radiotherapy together based on how their tumor responds to the medications.
Group II: Phase 2: Efficacy Arm 1 - HB-201 + ChemotherapyExperimental Treatment5 Interventions
Participants in this group will receive HB-201 combined with chemotherapy using carboplatin and paclitaxel at the dose established in the first phase of the study. After completing treatment at the established phase 2 dose, subjects will receive surgery, radiotherapy alone, or chemotherapy with radiotherapy together based on how their tumor responds to the medications.
Group III: Phase 1: Dose-Finding Group 2 - Drug Combination 2Experimental Treatment4 Interventions
All participants in this group will receive alternating doses of HB-201 and HB-202 combined with chemotherapy using carboplatin and paclitaxel. Participants will be given 3 doses of HB-201 & HB-202 alternating two vector therapy. Patients will receive 2 doses of HB-202 and 1 dose of HB-201. HB-202 will be administered on cycle 1 day 15 and cycle 3 day 15, and HB-201 will be administered on cycle 2 day 15 with three 21-day cycles of chemotherapy with carboplatin on day 1 and paclitaxel 100mg/m2 on days 1, 8, and 15.
Group IV: Phase 1: Dose-Finding Group 1 - Drug Combination 1Experimental Treatment4 Interventions
All participants in this group will receive HB-201 combined with chemotherapy using carboplatin and paclitaxel. - HB-201 will be administered on cycle 1 day 15, cycle 2 day 15, and cycle 3 day 15 with three 21-day cycles of carboplatin on day 1 and paclitaxel 100mg/m2 on days 1, 8, and 15
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transoral Robotic Surgery
2012
N/A
~110
Carboplatin
2014
Completed Phase 3
~6670
Paclitaxel
2011
Completed Phase 4
~5380

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor
997 Previous Clinical Trials
817,600 Total Patients Enrolled
Ari Rosenberg, MDPrincipal InvestigatorUniversity of Chicago - Comprehensive Cancer Center
4 Previous Clinical Trials
516 Total Patients Enrolled

Media Library

Carboplatin (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT05108870 — Phase 1 & 2
Oropharyngeal Carcinoma Research Study Groups: Phase 2: Efficacy Arm 1 - HB-201 + Chemotherapy, Phase 1: Dose-Finding Group 2 - Drug Combination 2, Phase 1: Dose-Finding Group 1 - Drug Combination 1, Phase 2: Efficacy Arm 2 - HB-201 and HB-202 + Chemotherapy
Oropharyngeal Carcinoma Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT05108870 — Phase 1 & 2
Carboplatin (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05108870 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

What therapeutic effects does HB-201 provide?

"HB-201 is an efficacious treatment for melanoma, neoplasm metastasis, and non-Hodgkin lymphoma."

Answered by AI
~51 spots leftby Jan 2026