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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.

Must not have

Unequivocal demonstration of distant metastatic disease (M1 disease).

Non-HPV16 subtype.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has spread to distant parts of my body.

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My condition is not caused by the HPV16 subtype.

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I have a history of or currently have non-infectious lung inflammation.

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I've had surgery for my cancer that wasn't just a biopsy or to reduce tumor size.

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The origin of my cancer is unknown.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~6120