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Photoimmunotherapy + Anti-PD1 for Head and Neck Cancer
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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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.I am currently on medication for an infection.I have upcoming procedures that involve significant light exposure within 4 weeks after my ASP-1929 PIT treatment.I have an autoimmune disease treated with strong medication in the last 2 years.I have had treatments like chemotherapy before my main cancer treatment.I have not received a live vaccine in the last 30 days.I have tested positive for HIV/AIDS.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.My skin cancer is advanced, cannot be removed by surgery or treated with radiation.I am currently on a single-agent anti-PD1 therapy.My organs are working well.I have lung scarring or inflammation not caused by an infection.I do not have any active infections like TB, Hepatitis B, or Hepatitis C.My head and neck cancer has returned or spread, with a CPS score of 1 or more.I am fully active or restricted in physically strenuous activity but can do light work.I have cancer that has spread to my brain or surrounding membranes.I have previously been treated with anti-PD1 or anti-PD-L1 therapy.My cancer has worsened after 2 months of anti-PD1 therapy, confirmed by two scans.I haven't had cancer, except for certain skin cancers or treated early-stage cervical/breast cancer, in the last 2 years.I am not pregnant, can use 2 effective birth control methods, or will not have sex during the study.I have had chemotherapy or EGFR inhibitor treatment before.I haven't taken high-dose steroids or immunosuppressants in the last 14 days.I have received anti-PD-1 therapy before my current treatment plan.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.I agree to use effective birth control during and up to 120 days after my treatment.I haven't had systemic therapy for recurrent/metastatic disease, except as part of earlier treatment over 6 months ago.I have not been in a study for a new treatment or used a new device within the last 4 weeks.
- Group 1: Cohort 1- 1L HNSCC
- Group 2: Cohort 2- 1L cuSCC
- Group 3: Cohort 3- 2L cuSCC
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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