Viral Therapy + Pembrolizumab for Head and Neck Cancer

Recruiting in Palo Alto (17 mi)

+34 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Hookipa Biotech GmbH

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This trial is testing two new drugs, HB-201 and HB-202, which aim to help the immune system fight HPV 16-related cancers. It focuses on patients with advanced head and neck cancer who are also receiving a standard treatment called pembrolizumab. The goal is to see if these new drugs can improve the body's ability to combat cancer.

Eligibility Criteria

This trial is for patients with HPV16+ recurrent or metastatic head and neck squamous cell carcinoma and other cancers. Participants must have an ECOG performance status of 0 to 1, at least one measurable lesion, meet specific lab value criteria, and be eligible for pembrolizumab treatment. They cannot join if they have autoimmune disorders requiring immunosuppression, a life expectancy under three months, certain infections like hepatitis B/C or AIDS, severe allergies to the drugs used in the study or prior severe reactions to similar treatments.

Inclusion Criteria

I have at least one tumor that can be measured on scans.

Screening laboratory values must meet protocol-specified criteria.

I am assigned to either Treatment Group E or F.

+12 more

Exclusion Criteria

Has a life expectancy of less than 3 months.

I stopped my previous cancer treatment due to a severe immune system side effect.

I have been diagnosed with AIDS.

+14 more

Participant Groups

The trial tests HB-201 alone or alternating with HB-202 intravenous therapies in combination with pembrolizumab against standard care regimens including pembrolizumab. It's a Phase I/II study that includes dose escalation (finding the right drug amount) and expansion (testing it on more people). Some participants may also use a CD8 PET Tracer for imaging studies.

6Treatment groups

Experimental Treatment

Group I: Ph II, Group FExperimental Treatment1 Intervention

Patients with HPV 16+ cancers who had tumor progression or recurrence on standard of care therapy and who are eligible to receive pembrolizumab as part of 2L+ standard of care..

Group II: Ph II, Group EExperimental Treatment1 Intervention

Patients with HPV 16+ HNSCC who are eligible to receive pembrolizumab as part of 1L standard of care.

Group III: Ph II, Group BExperimental Treatment1 Intervention

Patients with HPV 16+ HNSCC who are eligible to receive immune checkpoint inhibitor as part of standard of care.

Group IV: Ph I, sub-studyExperimental Treatment1 Intervention

Patients with HPV 16+ HNSCC who had tumor progression or recurrence on standard of care therapy

Group V: Ph I, Group 3 and Group 4Experimental Treatment1 Intervention

Patients with HPV 16+ HNSCC or Non-HNSCC who had tumor progression or recurrence on standard of care therapy.

Group VI: Ph I, Group 1 and Group 2Experimental Treatment1 Intervention

Patients with HPV 16+ HNSCC or Non-HNSCC who had tumor progression or recurrence on standard of care therapy.