Study on IT-hu14.18-IL2 with Radiation, Nivolumab, and Ipilimumab for Advanced Melanoma

Sponsor: University of Wisconsin, Madison

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03958383

Provider View

This clinical trial is testing a new treatment approach for advanced melanoma using a combination of a special protein (IT-hu14.18-IL2), radiation therapy, and two immunotherapy drugs, nivolumab and ipilimumab. The study aims to find the best dose and evaluate the safety and effectiveness of this combination in shrinking tumors.

Patient Parameters

Program Overview

The purpose of this study is to determine the best dose and evaluate the safety of a new treatment for advanced melanoma. This treatment involves injecting a special protein called IT-hu14.18-IL2 directly into the tumor, along with radiation therapy and two immunotherapy drugs, nivolumab and ipilimumab. These treatments work together to help the immune system attack cancer cells. The study will also look at how well this combination can shrink tumors in patients with advanced melanoma that cannot be removed by surgery.

Description

This study is divided into several phases to find the best dose and evaluate the safety of the treatment combination for advanced melanoma.

  • Phase IA: Participants receive the IT-hu14.18-IL2 protein injected directly into the tumor for several cycles to find the best dose.
  • Phase IB: Participants receive radiation therapy before the IT-hu14.18-IL2 injections to see if this combination is safe and effective.
  • Phase IC: Participants receive radiation therapy and the IT-hu14.18-IL2 injections, along with the immunotherapy drug nivolumab, to evaluate safety and effectiveness.
  • Phase ID: Participants receive radiation therapy, IT-hu14.18-IL2 injections, and both immunotherapy drugs, nivolumab and ipilimumab, to determine the best dose and evaluate safety.

The study will monitor participants for side effects and how well the treatment works in shrinking tumors. Participants will be followed up regularly after completing the treatment to assess their health and the treatment's impact.

Eligibility Criteria

Inclusion Criteria

  • Have advanced melanoma that cannot be removed by surgery.
  • Have measurable disease that can be assessed by scans or clinical exams.
  • Have at least one tumor that can be injected with the study drug and biopsied.
  • Be in good overall health with an ECOG performance status of 0 or 1.
  • Have received or declined at least one approved immunotherapy treatment.
  • If there are brain metastases, they must be stable and not require steroids.
  • Have adequate blood counts and organ function.
  • Be willing to provide informed consent and comply with study requirements.
  • Have a washout period of at least 28 days from any prior cancer treatment.

Exclusion Criteria

  • Have an autoimmune disease requiring treatment, except for certain conditions like controlled diabetes or thyroid disease.
  • Have a genetic condition that increases sensitivity to radiation.
  • Be unable to provide informed consent.
  • Be pregnant, nursing, or not using effective contraception if of childbearing potential.
  • Have recent heart problems or uncontrolled heart rhythm issues.
  • Have significant psychiatric or seizure disorders.
  • Have symptomatic fluid buildup in the chest or abdomen.
  • Have had an organ transplant.
  • Require systemic steroids or immunosuppressive drugs.
  • Have active infections or other serious illnesses.
  • Have another cancer unless disease-free for over 5 years.
  • Have HIV, hepatitis B, or hepatitis C infections.
  • Have significant nerve damage or hypersensitivity to study drugs.

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