Study on MC1R-targeted Alpha-particle Therapy and Combination with Nivolumab for Advanced Melanoma

Sponsor: Perspective Therapeutics

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05655312

Provider View

This clinical trial is testing a new treatment using an alpha-particle therapy targeting MC1R, a receptor on melanoma cells, alone and in combination with Nivolumab, to see if it is safe and effective for adults with advanced melanoma that cannot be surgically removed or has spread.

Patient Parameters

Program Overview

This study is exploring a new treatment for advanced melanoma, a type of skin cancer, using a therapy called [212Pb]VMT01. This therapy targets a specific receptor on melanoma cells and delivers a form of radiation directly to the cancer. The study will test this treatment both on its own and in combination with another drug called Nivolumab. The main goals are to determine if the treatment is safe and if it can help shrink tumors in patients whose melanoma cannot be removed by surgery or has spread to other parts of the body.

Description

The trial is divided into three parts:

  1. Monotherapy Dose-Escalation: Patients will receive increasing doses of [212Pb]VMT01 alone to find the safest and most effective dose.

  2. Combination-Therapy Dose-Escalation: Patients will receive increasing doses of [212Pb]VMT01 along with Nivolumab to determine the best dose for both drugs together.

  3. Dose Expansion: More patients will be treated with the doses found to be most effective in the first two parts, to further study the treatment's effects.

Participants in the monotherapy part may receive up to three doses of [212Pb]VMT01, spaced about eight weeks apart. Those in the combination therapy part may receive Nivolumab every four weeks for up to two years.

The study also includes a sub-study to understand how the treatment spreads in the body and how much of it reaches the tumors. This will help researchers understand the treatment's safety and effectiveness better.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Diagnosed with advanced melanoma that cannot be surgically removed or has spread.
  • Must have tried at least one other approved treatment for melanoma that did not work.
  • Must show uptake of specific imaging agents in at least one tumor site.
  • Must have measurable disease by standard criteria.
  • Must be able to lie still for imaging scans, with sedation if needed.
  • Women must agree to use effective birth control and not donate eggs during and for six months after treatment.
  • Men must agree to use condoms or other birth control methods and not donate sperm during and for six months after treatment.
  • Must have a performance status score of less than 2, indicating good overall health.
  • Must have a life expectancy of at least three months.
  • Must have satisfactory organ function based on lab tests.

Exclusion Criteria

  • Have another active cancer.
  • Have had treatment with radioactive substances before.
  • Are pregnant or breastfeeding.
  • Have a serious infection requiring antibiotics within two weeks before starting treatment.
  • Have a fever within 48 hours before receiving the study treatment.
  • Have taken another investigational drug within 45 days before starting treatment.
  • Have a history of alcohol or drug abuse.
  • Have any medical or social issues that could interfere with the study.

Additional criteria for those receiving combination therapy with Nivolumab:

  • Have untreated or active brain metastases.
  • Have another cancer requiring treatment within the last two years.
  • Have an active autoimmune disease.
  • Require treatment with steroids or other immunosuppressive drugs.
  • Have active hepatitis B, hepatitis C, or HIV.
  • Are taking complementary medications like herbal supplements.
  • Have abnormal blood test results.
  • Have received a live vaccine within 30 days before starting treatment.
  • Have had severe side effects from previous immune therapy.
  • Have an allergy to Nivolumab or its components.

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