Study on Adjuvant Treatment Based on Response to Pre-Surgery Nivolumab for Melanoma

Sponsor: Abramson Cancer Center at Penn Medicine

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04013854

Provider View

This clinical trial is exploring a treatment plan for patients with melanoma that can be surgically removed. Participants will receive nivolumab before surgery and then continue with additional treatment after surgery, which will be determined by how well the cancer responds to the initial treatment.

Patient Parameters

Program Overview

The study aims to find out if giving nivolumab before surgery, followed by additional treatment after surgery, can help control melanoma that can be surgically removed. After surgery, patients will receive either nivolumab alone or a combination of ipilimumab and nivolumab, depending on how the cancer responds to the initial treatment.

Description

In this study, patients with Stage III melanoma that can be surgically removed will first receive a dose of nivolumab, a type of immunotherapy, through an IV. About four weeks later, they will have surgery to remove the cancer. After surgery, patients will continue treatment for up to one year. If the cancer responds well to the initial nivolumab treatment, patients will receive nivolumab alone. If the response is less complete, patients will be randomly assigned to receive either nivolumab alone or a combination of ipilimumab and nivolumab for a year. The goal is to see if this approach can help control the cancer more effectively.

Eligibility Criteria

Inclusion Criteria

  • Must have Stage III melanoma that can be surgically removed, as determined by a doctor.
  • Must be 18 years or older.
  • Must be able to provide written consent to participate.
  • Must have a good performance status, meaning they are fully active or have some restrictions but can still do light work.
  • Must have adequate organ function based on specific blood tests.
  • Women must not be pregnant or breastfeeding and must agree to use effective birth control during the study and for a specified time after.
  • Men must agree to use birth control during the study and for a specified time after.

Exclusion Criteria

  • Cannot have melanoma that cannot be completely removed by surgery.
  • Cannot have received certain types of cancer treatments before, such as anti-PD-1 or anti-CTLA-4 therapies.
  • Cannot have had other cancer treatments within four weeks before starting the study.
  • Cannot have received blood transfusions or certain growth factors within four weeks before starting the study.
  • Cannot have received a live vaccine within 30 days before starting the study.
  • Cannot be participating in another clinical trial or have used an investigational device recently.
  • Cannot have certain immune system disorders or be on high doses of steroids.
  • Cannot have another active cancer that requires treatment.
  • Cannot have active autoimmune diseases that required treatment recently.
  • Cannot have lung diseases like pneumonitis that required steroids.
  • Cannot have active infections that need treatment.
  • Cannot have uncontrolled HIV or active hepatitis B or C infections.
  • Cannot have any condition that might interfere with the study or is not in their best interest to participate.
  • Cannot have psychiatric or substance abuse issues that would interfere with the study.
  • Cannot be pregnant or planning to become pregnant or father a child during the study and for a specified time after.
  • Cannot be prisoners or involuntarily incarcerated individuals.

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