Study of HB-200 alone and with pembrolizumab for patients with Recurrent/ Metastatic HPV 16+ Head and Neck and other Cancers

  • STATUS
    Recruiting
  • sponsor
    Hookipa Biotech
Updated on 27 May 2022
cancer
measurable disease
carcinoma
squamous cell carcinoma
pembrolizumab
head and neck cancer
neck cancer

Summary

HB-201 and HB-202 are study drugs which are designed to train the body to recognize and fight substances found in HPV16+ cancer. This trial studies the safety and anti-cancer effect of HB-201 and HB-202 in people. HPV is a group of more than 200 related viruses, each given a number. HPV 16 is one of the highest risk groups for HPV-related cancers.
 
The trial enrolls patients with metastatic/recurrent HPV 16+ head and neck squamous cell cancer who have not yet received treatment in this setting (1L, first line) and who are eligible to receive pembrolizumab as part of their standard of care.

This trial also enrolls patients who have HPV 16+ head and neck cancers who have received prior therapy in metastatic/recurrent setting (2L+). Patients will receive the study drugs alone or in addition to their pembrolizumab standard of care treatment.

Description


Details
Condition Head and Neck Cancer, Squamous Cell Carcinoma, Metastatic/Recurrent Cancer
Clinical Study IdentifierTX291163
SponsorHookipa Biotech
Last Modified on27 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Documentation of confirmed HPV 16+ head and neck squamous cell carcinoma via genotype testing (HPV16 testing can be initiated at the study center)
Must be ≥18 years old
ECOG performance status of 0 to 1
Screening laboratory values and medication/radiation wash-out windows must meet protocol specified-criteria (the study center will confirm this)
Have ≥ 1 measurable tumor by tumor imaging assessment
For patients who HAVE previously received treatment for metastatic/recurrent cancer (second line +, 2L+): must have had tumor progression or recurrence on standard of care therapy including ≥ 1 prior therapy
For patients who previously have NOT received treatment for metastatic/recurrent cancer (first line, 1L): must have head and neck squamous cell carcinoma and be eligible to receive pembrolizumab per standard of care / product label

Exclusion Criteria

Any serious or uncontrolled medical disorder that, in the opinion of the study doctor, may increase the risk associated with study participation / treatment administration
Another ongoing cancer that requires treatment, unless protocol defined criteria is met
Any side effects to prior anticancer therapy that have not improved to normal unless protocol-defined criteria is met
Known history of acquired immunodeficiency syndrome (AIDS). HIV positive patients with CD4 T cells > 200/mm3 who do not have AIDS are eligible. Testing for HIV is not mandatory
For patients receiving pembrolizumab on trial: any contraindication to receiving pembrolizumab (including history of severe allergic reaction to pembrolizumab or like drugs and history of non-infectious pneumonitis requiring treatment)
Untreated and/or symptomatic metastatic central nervous system disease, unless protocol-defined criteria is met
Active, known or suspected, autoimmune or inflammatory disorders requiring immunosuppressive therapy
Positive hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody, indicating acute or chronic infection
Allogenic tissue/solid organ transplant
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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