Study Comparing Opdualag and Nivolumab Before Surgery for High-Risk Basal Cell Carcinoma

Sponsor: University of California, San Diego

Sponsor score: 40

ClinicalTrials ID:NCT06624475

Provider View

This clinical trial is testing two different treatments, Opdualag and Nivolumab, given before surgery to see which is more effective for patients with high-risk basal cell carcinoma that can be surgically removed.

Patient Parameters

Program Overview

This Phase 2 study is comparing two treatments, Opdualag (a combination of Nivolumab and Relatlimab) and Nivolumab alone, given before surgery to patients with high-risk basal cell carcinoma (BCC) that can be removed by surgery. The study aims to find out which treatment is more effective in reducing the cancer before surgery.

Description

Participants in this study will receive either Opdualag or Nivolumab for four treatment cycles, each lasting four weeks, before undergoing surgery to remove the cancer. If the cancer progresses significantly after two cycles, surgery may be performed earlier. If the treatment is working well, it may continue beyond four cycles. In some cases, if the cancer appears to be completely gone, surgery might be skipped. The main goal is to see how well the cancer responds to the treatment before surgery. After surgery, participants will be monitored for any return of the cancer and other health outcomes.

Eligibility Criteria

Inclusion Criteria

  • Must understand and agree to sign a consent form.
  • Must have a confirmed diagnosis of basal cell carcinoma.
  • Must have high-risk BCC, defined as a tumor 20 mm or larger on the head/neck or 40 mm or larger on the body/limbs.
  • The cancer must be removable by surgery and at risk of causing cosmetic or functional issues.
  • Must not have received prior treatment for BCC.
  • Must be 18 years or older.
  • Must be in good general health with an ECOG score of 0 or 1.
  • Must have adequate blood, liver, and kidney function based on specific medical tests.
  • HIV-positive individuals on effective treatment with undetectable viral load are eligible.
  • Individuals with controlled hepatitis B or cured hepatitis C are eligible.
  • Must not have had another active cancer within the last 2 years, except for certain skin cancers or non-invasive cancers.
  • Women of childbearing potential must use effective birth control during and after treatment and must not donate eggs during this time.

Exclusion Criteria

  • Currently receiving other experimental treatments.
  • Participated in another study with an experimental treatment within 4 weeks.
  • Allergic to Opdualag, Nivolumab, or their ingredients.
  • Have untreated or symptomatic brain metastases.
  • Have cancer spread to the brain's lining.
  • Received a live vaccine within 30 days before starting the study.
  • Had radiation therapy within 2 weeks before starting the study.
  • Require high doses of steroids or other immune-suppressing drugs.
  • Have an active autoimmune disease, except for certain stable conditions.
  • Have had a tissue or organ transplant.
  • Have severe heart disease or recent heart issues.
  • Have a history of heart inflammation (myocarditis).
  • Have high levels of certain heart enzymes unless cleared by a cardiologist.
  • Have any other serious medical or psychiatric conditions that could interfere with the study.
  • Pregnant or breastfeeding women are not eligible due to potential risks to the baby.

Locations

FACILITYZIPCITYSTATE
University of California, San Diego Moores Cancer Center92093La JollaCalifornia

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