What side effects are associated with this type of intervention?

The most common treatments for Squamous Cell Carcinoma (SCC) include photoimmunotherapy and anti-PD1 therapy. Photoimmunotherapy can cause localized side effects such as skin reactions, pain at the treatment site, and swelling. Anti-PD1 therapy can lead to immune-related side effects including fatigue, rash, diarrhea, and more severe conditions like pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis. Combining these therapies may increase the risk of both localized and systemic immune-related adverse effects.

What prior FDA approvals exist?

The FDA has approved several treatments for squamous cell carcinoma that involve immune checkpoint inhibitors and targeted therapies. Pembrolizumab (Keytruda) and nivolumab (Opdivo) are anti-PD1 therapies approved for recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). These drugs work by blocking the PD-1 receptor, thereby enhancing the immune system's ability to fight cancer cells. Additionally, cetuximab (Erbitux), an anti-EGFR monoclonal antibody, has been approved for HNSCC. For advanced cutaneous squamous cell carcinoma (cSCC), cemiplimab (Libtayo), another anti-PD1 therapy, has been approved. These treatments are similar to the ASP-1929 photoimmunotherapy being studied, which combines a photosensitizer-antibody conjugate activated by light with anti-PD1 therapy to target and kill cancer cells.

What other types of research exist?

Promising alternatives to ASP-1929 photoimmunotherapy combined with anti-PD1 therapy for Squamous Cell Carcinoma patients include: 1) Enfortumab Vedotin, an antibody-drug conjugate targeting Nectin-4, which has shown efficacy in urothelial carcinoma and is being explored in other cancers. 2) Pembrolizumab combined with chemotherapy, which has shown significant benefits in various cancers, including head and neck squamous cell carcinoma. 3) Atezolizumab combined with chemotherapy, particularly for patients with high PD-L1 expression, as it has shown improved progression-free survival in clinical trials. 4) Novel combinations of immune checkpoint inhibitors, such as nivolumab with ipilimumab, which are being investigated for enhanced efficacy in solid tumors.

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Virus Therapy

Photoimmunotherapy + Anti-PD1 for Head and Neck Cancer

Phase 1 & 2

Waitlist Available

Research Sponsored by Rakuten Medical, Inc.

Eligibility Criteria Checklist

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

Must have

Histologically or cytologically confirmed locally advanced or metastatic cutaneous squamous cell carcinoma not amenable to definitive surgery or radiation. (Cohort 2)

Patients must be actively receiving single-agent, systemic anti-PD1 therapy at the time of screening (Cohort 3)

Must not have

Radiation therapy (or other non-systemic therapy) within 4 weeks prior to study Day 1 or not fully recovered from adverse events due to a previously administered treatment

Active infection requiring systemic therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Summary

This trial tests a new treatment combining a light-sensitive drug and an immune booster for patients with hard-to-treat head and neck or skin cancers. The goal is to see if this combination is safe and effective in shrinking tumors.

Who is the study for?

This trial is for adults with certain advanced squamous cell cancers in the head, neck, or skin. Participants must have at least one tumor accessible to light treatment and measurable disease. They should be relatively healthy (ECOG 0-1), not have had recent systemic cancer therapy (except if over 6 months ago as part of multimodal treatment), and agree to use effective contraception methods.

What is being tested?

The study tests ASP-1929 photoimmunotherapy combined with anti-PD1 drugs Pembrolizumab or Cemiplimab in patients with recurrent/metastatic head & neck squamous cell carcinoma or cutaneous squamous cell carcinoma that can't be treated by surgery/radiation.

What are the potential side effects?

Possible side effects include reactions related to the immune system affecting organs, infusion-related reactions, fatigue, issues like infections due to lowered immunity from anti-PD1 drugs. Specific side effects of ASP-1929 photoimmunotherapy are not detailed but may involve local tissue damage.

Eligibility Criteria

Inclusion Criteria

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

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My skin cancer is advanced, cannot be removed by surgery or treated with radiation.

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I am currently on a single-agent anti-PD1 therapy.

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My head and neck cancer has returned or spread, with a CPS score of 1 or more.

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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

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

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I haven't had radiation or similar treatments in the last 4 weeks, or I've recovered from their side effects.

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I am currently on medication for an infection.

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I have had treatments like chemotherapy before my main cancer treatment.

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I have not received a live vaccine in the last 30 days.

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I have tested positive for HIV/AIDS.

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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

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I have lung scarring or inflammation not caused by an infection.

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I do not have any active infections like TB, Hepatitis B, or Hepatitis C.

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I have cancer that has spread to my brain or surrounding membranes.

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I have previously been treated with anti-PD1 or anti-PD-L1 therapy.

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I haven't taken high-dose steroids or immunosuppressants in the last 14 days.

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I have received anti-PD-1 therapy before my current treatment plan.

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I haven't had major surgery or significant injury in the last 28 days and don't expect to need major surgery during the study.

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I have not been in a study for a new treatment or used a new device within the last 4 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Characterize the safety and tolerability of ASP-1929 PIT treatment in combination with anti-PD1 therapy

HNSCC: Assess the effect of ASP-1929 PIT treatment with anti-PD1 therapy on tumor response

Neoplasms

Secondary study objectives

Duration of Response (DOR)

Overall Survival (OS)

Progression-free survival (PFS)

+1 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Cohort 3- 2L cuSCCExperimental Treatment2 Interventions

Locally advanced or metastatic cutaneous squamous cell carcinoma

Group II: Cohort 2- 1L cuSCCExperimental Treatment2 Interventions

Locally advanced or metastatic cutaneous squamous cell carcinoma

Group III: Cohort 1- 1L HNSCCExperimental Treatment2 Interventions

Recurrent locally advanced and/or metastatic head and neck squamous cell carcinoma

0 / 18Eligibility 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 photoimmunotherapy and immune checkpoint inhibitors like anti-PD1 therapy. Photoimmunotherapy uses a photosensitizer-antibody conjugate that specifically targets cancer cells. When activated by light, this conjugate induces cell death, directly attacking the tumor. Anti-PD1 therapy, on the other hand, blocks the PD-1 receptor on immune cells, preventing cancer cells from evading the immune response. This enhances the body's ability to recognize and destroy cancer cells. These treatments are crucial for SCC patients as they offer targeted and effective ways to combat the cancer, potentially improving outcomes and reducing side effects compared to traditional therapies.