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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Study Summary

This trial is testing a new treatment for head and neck or squamous cell skin cancer that involves using light to kill cancer cells.

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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

Find a Location

Who is running the clinical trial?

Rakuten Medical, Inc.Lead Sponsor
5 Previous Clinical Trials
353 Total Patients Enrolled
Naomi Schechter, MDStudy DirectorRakuten Medical, Inc.
Sarah Arron, MD, PhDStudy DirectorRakuten Medical, Inc.
2 Previous Clinical Trials
31 Total Patients Enrolled

Media Library

ASP-1929 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04305795 — Phase 1 & 2
Head and Neck Squamous Cell Carcinoma Research Study Groups: Cohort 1- 1L HNSCC, Cohort 2- 1L cuSCC, Cohort 3- 2L cuSCC
Head and Neck Squamous Cell Carcinoma Clinical Trial 2023: ASP-1929 Highlights & Side Effects. Trial Name: NCT04305795 — Phase 1 & 2
ASP-1929 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04305795 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has there been further research into this therapeutic intervention?

"The first examination of this treatment was conducted at City of Hope in 2010. Ultimately, there have been 253 trials completed and presently 1013 live studies are occurring with a concentration around Miami, Florida."

Answered by AI

What is the geographic scope of this research endeavor?

"7 hospitals are currently taking part in this clinical trial, these include the University of Miami Hospital and Clinics (Miami), Vanderbilt-Ingram Cancer Center (Nashville) and Mayo Clinic (Rochester). There are 4 additional medical centres that have been approved."

Answered by AI

Are there opportunities for new applicants to join this investigation?

"Affirmative. Clinicaltrials.gov displays that this experiment commenced on December 21st 2020 and is still actively recruiting patients. 74 participants from 7 separate medical centres are sought for the trial's completion."

Answered by AI

What health issues have been alleviated with this intervention?

"This therapeutic intervention is used to treat cancerous tumours. Additionally, it has been proven effective against particularly stubborn cases of melanoma, microsatellite instability high, and chemo-resistant conditions."

Answered by AI

What is the current capacity for participants in this trial?

"The trial sponsor, Rakuten Medical, Inc., necessitates 74 participants that meet their qualifications to conduct the experiment. The study will be held at University of Miami Hospital and Clinics in Miami, Florida as well as Vanderbilt-Ingram Cancer Center in Nashville, Tennessee."

Answered by AI
~4 spots leftby Jun 2024