Study on Nivolumab Alone or with Relatlimab or Ipilimumab for Advanced Basal Cell Carcinoma

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT03521830

Provider View

This clinical trial is testing the effectiveness of the drug nivolumab, either by itself or combined with other drugs, in treating patients with advanced basal cell carcinoma that cannot be surgically removed or has spread to other parts of the body.

Patient Parameters

Program Overview

This study is exploring how well nivolumab, alone or with other drugs like relatlimab or ipilimumab, works in treating advanced basal cell carcinoma (BCC) that cannot be removed by surgery or has spread. The trial is in Phase 2, which means it is focused on understanding the effectiveness of these treatments.

Description

This study is open-label, meaning both the researchers and participants know which treatment is being given. It is divided into three groups based on the patient's previous treatments:

  • Cohort A: Patients who have not received certain previous treatments will receive nivolumab alone. This involves an IV infusion every 4 weeks for up to 48 weeks.
  • Cohort B: Patients whose cancer has worsened on nivolumab and relatlimab will receive nivolumab with ipilimumab. This involves a series of IV infusions over several weeks.
  • Cohort C: Patients whose cancer has worsened on nivolumab will receive nivolumab with relatlimab. This involves an IV infusion every 4 weeks for up to 48 weeks.

Patients in Cohort A whose cancer progresses may be moved to Cohort B or C if deemed appropriate by the study doctor.

Treatment may be stopped for reasons such as complete response, severe side effects, disease progression, other illnesses, or non-compliance with study requirements.

Eligibility Criteria

Inclusion Criteria

  • Must sign a consent form and be willing to follow study procedures.
  • Must have a performance status of 0-1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Must have advanced basal cell carcinoma that cannot be surgically removed or has spread.
  • Must have at least one measurable tumor.
  • Must be 18 years or older.
  • Must not have received certain previous treatments for BCC.
  • Must meet specific blood test requirements.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception.
  • Men must agree to use contraception if sexually active with women of childbearing potential.

Exclusion Criteria

  • Pregnant or breastfeeding women.
  • Patients with untreated or unstable brain metastases.
  • Patients with autoimmune diseases or on certain medications may need special approval to participate.
  • Patients with certain viral infections like active hepatitis B or C.
  • Patients with another active cancer within the last 2 years may need special approval to participate.
  • Organ transplant recipients.
  • Patients with severe allergies to study drugs.
  • Prisoners or those detained for treatment of psychiatric or physical illnesses may need special approval to participate.

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