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Photoimmunotherapy

RM-1995 Photoimmunotherapy, as Monotherapy or Combined With Pembrolizumab, in Patients With Advanced CuSCC and HNSCC

Phase 1
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
No Placebo-Only Group
All Individual Drugs Already Approved

Summary

This trial tests a new treatment for advanced skin and head and neck cancers that haven't responded to other treatments. The treatment uses a special drug activated by red light to target and kill cancer cells. It can be used alone or with another cancer drug called pembrolizumab, which helps the immune system fight cancer.

Eligible Conditions
  • Head and Neck Squamous Cell Carcinoma
  • Skin Cancer

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Phase 1a Monotherapy: Evaluate the safety and tolerability of RM-1995 PIT treatment, and determine the Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD).
Phase 1b Combination Therapy: Evaluate the safety and tolerability of RM-1995 PIT treatment in combination with pembrolizumab and determine the MTD or MAD.
Secondary study objectives
Assess antitumor activity of RM-1995.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups
Experimental Treatment
Group I: RM-1995 Photoimmunotherapy + Pembrolizumab (Phased 1b Combination Therapy)Experimental Treatment2 Interventions
Patients with locally advanced cuSCC or HNSCC or metastatic disease that has recurred or progressed, despite all available standard therapies.
Group II: RM-1995 Photoimmunotherapy (Phase 1a Monotherapy)Experimental Treatment1 Intervention
Patients with locally advanced cuSCC or HNSCC or metastatic disease that has recurred or progressed, despite all available standard therapies.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved

Find a Location

Who is running the clinical trial?

Rakuten Medical, Inc.Lead Sponsor
6 Previous Clinical Trials
822 Total Patients Enrolled
Naomi SchechterStudy ChairRakuten Medical, Inc.
1 Previous Clinical Trials
275 Total Patients Enrolled
Bogdan VereshStudy ChairRakuten Medical, Inc.
~0 spots leftby Dec 2025
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