What side effects are associated with this type of intervention?

Common treatments for Squamous Cell Carcinoma (SCC) of the head and neck, particularly those targeting HPV 16+, include immunotherapy agents like pembrolizumab and cetuximab. Known side effects of these treatments can include skin reactions, such as severe rash and hypopigmentation, infusion-related reactions, and immune-related adverse events like colitis, hepatitis, and endocrinopathies. Additionally, chemotherapy agents used in combination with these therapies can cause alopecia, fatigue, and gastrointestinal symptoms. It is important to discuss these potential side effects with your healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

FDA-approved treatments for squamous cell carcinoma, particularly those involving immunotherapy, include pembrolizumab and nivolumab, both of which are PD-1 inhibitors. These drugs have shown efficacy in treating recurrent or metastatic squamous cell carcinoma of the head and neck, including HPV-related cases. Pembrolizumab, in particular, has been approved for use in patients with PD-L1 positive tumors. Additionally, cetuximab, an EGFR inhibitor, has been approved for use in combination with chemotherapy for head and neck squamous cell carcinoma. These treatments are relevant as they represent the current landscape of immunotherapy and targeted therapy for squamous cell carcinoma, similar to the investigational HB-201 and HB-202 therapies targeting HPV 16+.

What other types of research exist?

Promising novel alternatives to HB-201 and HB-202 for HPV 16+ Squamous Cell Carcinoma include: <ol> <li>Pembrolizumab (Keytruda) - An anti-PD-1 therapy showing efficacy in recurrent/metastatic SCC.</li> <li></li> </ol> Pembrolizumab plus Cetuximab - Investigated for treatment-refractory metastatic SCC with promising response rates. 3. Imiquimod combined with HPV therapeutic vaccination (TA-CIN) - Studied in vulval intraepithelial neoplasia, potentially applicable to SCC. 4. Farnesyltransferase inhibitors (e.g., Tipifarnib) - Demonstrated objective response rates in HRAS mutant SCC. 5. Metronomic chemotherapy - An investigational approach using frequent, lower doses of chemotherapy to minimize toxicity and target tumor angiogenesis.

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Virus Therapy

Viral Therapy + Pembrolizumab for Head and Neck Cancer

Phase 1 & 2

Waitlist Available

Research Sponsored by Hookipa Biotech GmbH

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Treatment Group E or Group F:

Eligible to receive pembrolizumab, per standard of care and product label.

Must not have

Was discontinued due to a Grade 3 or higher immune-related AE (irAE) after receiving prior therapy with check point inhibitors.

Known history of acquired immunodeficiency syndrome.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 30-months (until progression)

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include immune system reactions leading to inflammation in various organs, infusion-related responses such as fever or chills during administration of therapy, fatigue from treatment burden on the body's resources, digestive issues due to medication affecting gastrointestinal function, blood disorders stemming from bone marrow suppression by chemotherapy agents.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am assigned to either Treatment Group E or F.

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I am approved to receive pembrolizumab treatment.

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I have been diagnosed with head and neck squamous cell carcinoma.

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I have not received any treatment for my cancer since it became metastatic or recurred.

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I am fully active or can carry out light work.

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My cancer is confirmed to be HPV 16 positive.

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My cancer has worsened or returned after standard treatment, including at least one systemic therapy.

Exclusion Criteria

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

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

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I have been diagnosed with AIDS.

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I have an autoimmune or inflammatory disorder that needs treatment to suppress my immune system.

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I have or had lung inflammation not caused by infection that needed treatment.

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My cancer has spread to my brain or its coverings.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 30-months (until progression)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 30-months (until progression)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30-months (until progression) 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 I Dose Escalation: Determine Phase II dose based on incidence of dose-limiting toxicities.

Phase II Dose Expansion: Number of participants with preliminary antitumor activity based on objective response rate.

Secondary study objectives

Phase I Dose Escalation: Number of participants with adverse events (type, frequency, severity).

Phase I Dose Escalation: Number of participants with preliminary antitumor activity based on objective response rate and disease control rate.

Phase II Dose Expansion: Number of participants with adverse events (type, frequency, severity).

+1 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

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.

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Squamous Cell Carcinoma (SCC) include surgery, radiation therapy, and chemotherapy. Surgery involves physically removing the tumor, while radiation therapy uses high-energy rays to kill cancer cells. Chemotherapy employs drugs to target and destroy rapidly dividing cells. Immunotherapy, such as the HB-201 and HB-202 trials, represents a newer approach that leverages the body's immune system to recognize and attack cancer cells. Specifically, these therapies target HPV 16+ related cancers by stimulating an immune response against the virus-infected cells. This is particularly important for SCC patients with HPV 16+ as it offers a targeted treatment option that can potentially improve outcomes and reduce recurrence rates.