Using RP1 to treat advanced skin cancers in organ transplant patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1B/2 study is a multicenter, open-label trial investigating the safety and effectiveness of RP1, a genetically modified herpes simplex virus, in treating advanced cutaneous malignancies in organ transplant recipients. The study aims to evaluate the objective response rate and tolerability of RP1 through intra-tumoral injections in patients with confirmed recurrent or metastatic skin cancers. A total of 65 patients will be enrolled, participating for up to three years, which includes a screening period, treatment phase, and follow-up. The trial specifically targets patients who have not responded to previous treatments and have stable organ transplants.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

1. Voluntary agreement to provide written informed consent prior to any study procedures and the willingness and ability to comply with all aspects of the protocol and understand the risk to their organ allograft.
2. Patients with histologically or cytologically confirmed recurrent, locally advanced or metastatic (to skin, soft tissue or lymph nodes) cutaneous malignancies, including CSCC, basal cell carcinoma, Merkel cell carcinoma, and melanoma
3. Patients must have progressed following local resection, prior radiation, topical or systemic therapies.
4. Documentation from the patient's transplant physician confirming that the patient's allograft is stable.
5. Patients for whom surgical or radiation treatment of lesions is contraindicated.
6. At least 1 lesion that is measurable and injectable by study criteria (tumor of ≥1cm in longest diameter or ≥1.5 cm in shortest diameter for lymph nodes).
7. Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
8. Anticipated life expectancy \> 6 months
9. Baseline ECG without evidence of acute ischemia.
10. All patients must consent to provide archived or newly obtained tumor material (either formalin-fixed, paraffin-embedded \[FFPE\] block or 20 unstained slides).

Key Exclusion Criteria:

1. Prior treatment with an oncolytic therapy.
2. Patients with visceral metastases.
3. Patients with active herpetic infections or prior complications of HSV-1 infection (e.g., herpetic keratitis or encephalitis).
4. Patients with a history of organ graft rejection within 12 months.
5. Had systemic infection requiring intravenous (IV) antibiotics or anti-virals, or other serious infection within 60 days prior to dosing.
6. Patients who require intermittent or chronic use of systemic (oral or intravenous) anti-virals with known anti-herpetic activity (e.g., acyclovir) unless for organ allograft preservation.
7. Patients requiring CTLA-4-Ig medications.
8. Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments beyond that required for maintenance allograft rejection prevention. The following are not exclusionary: vitiligo, childhood asthma that has resolved, type 1 diabetes, residual hypothyroidism that requires only hormone replacement, or psoriasis that does not require systemic treatment.
9. Active infection with hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV).
10. Any history of transplant-related viral infections, such as BKV, EBV or CMV, within 3 months of study entry. Patients with a history of hepatitis B or C virus must have undetectable viral load within 3 months of study entry.
11. Patients with a condition requiring an increase in the patient's usual immunosuppressive medications within 60 days of study treatment.
12. Known active CNS metastases and/or carcinomatous meningitis.

Where it's running

• Medical Dermatology Specialists
  Phoenix, Arizona, United States Recruiting
• University of California, San Diego
  La Jolla, California, United States Recruiting
• University of California, Los Angeles
  Los Angeles, California, United States Recruiting
• UCSF, Helen Diller Family Comprehensive Cancer Center
  San Francisco, California, United States Recruiting
• University of Colorado Cancer Center School of Medicine
  Aurora, Colorado, United States Recruiting
• University of Miami Sylvester Comprehensive Cancer Center
  Miami, Florida, United States Recruiting

Study contacts

• Study coordinator: Clinical Trials at Replimune
• Email: Clinicaltrials@replimune.com
• Phone: 1-781-222-9570

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Personalized immunotherapy platform for cancer treatment

  This study is testing a new way to identify melanoma and skin cancer patients who might not respond well to immunotherapy by analyzing their tumor samples.

  Recruiting at 3 sites Melanoma Institute Australia · Sydney, New South Wales and 2 other locations · NCT06536257

• MQ710 with or without pembrolizumab for advanced skin and other solid tumors

  This will test different doses of MQ710, alone or together with pembrolizumab, in adults with advanced or recurrent solid tumors (including skin cancers) to find a safe dose with mild side effects.

  Recruiting at 5 sites Phase 1 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT05859074

• In-home cancer treatment with remote specialist support for patients in the Florida Panhandle

  This program will try giving standard cancer treatments at home to people living in the Florida Panhandle and nearby areas to see if they prefer it and have better treatment satisfaction.

  Recruiting Phase 2 Mayo Clinic · Jacksonville, Florida · NCT07285044

• Oncolytic virus treatment combined with nivolumab for advanced solid tumors

  This study is testing a new virus treatment combined with an existing cancer drug to see if it can help people with advanced solid tumors, like lung cancer, whose cancer has not improved with previous treatments.

  Recruiting Phase 1 Memgen, Inc. · Tampa, Florida and 1 other locations · NCT05076760

• Methionine-Reduced Diet in Solid Tumors (early-phase)

  A small pilot study will test whether a methionine-reduced diet can change blood levels in adults with various solid tumors who are receiving standard cancer therapy.

  Recruiting Early Phase 1 University of California, Irvine · Orange, California · NCT07628634

• Lifileucel (TIL) plus chemotherapy and IL-2 for advanced cutaneous squamous cell and Merkel cell carcinoma

  This trial will try lifileucel (tumor-infiltrating lymphocytes) combined with lymphodepleting chemotherapy and interleukin-2 in adults with unresectable or metastatic cutaneous squamous cell carcinoma or Merkel cell carcinoma who have previously received immunotherapy.

  Recruiting Phase 2 Dana-Farber Cancer Institute · Boston, Massachusetts · NCT07288073

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.