Study on Using Blood Tests to Guide Immunotherapy After Bladder Cancer Surgery, MODERN Study

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05987241

Provider View

This clinical trial is exploring whether a blood test can help identify bladder cancer patients who need additional immunotherapy after surgery to prevent the cancer from returning. The study will also evaluate if the immunotherapy drugs nivolumab and relatlimab can improve survival and delay cancer progression.

Patient Parameters

Program Overview

This study aims to determine if a blood test that detects DNA from tumor cells can identify bladder cancer patients who need extra treatment after surgery. The test looks for circulating tumor DNA (ctDNA) in the blood, which may indicate remaining cancer cells. Patients with positive ctDNA results may receive immunotherapy drugs, nivolumab and relatlimab, to help the immune system fight cancer. The study will assess if this approach can improve survival and delay cancer progression in patients who have had their bladder surgically removed.

Description

PRIMARY OBJECTIVES:

  • To compare how well the blood test can clear ctDNA in patients treated with nivolumab alone versus nivolumab with relatlimab.
  • To compare overall survival between patients receiving nivolumab alone and those receiving both nivolumab and relatlimab.
  • To compare disease-free survival in patients receiving immediate nivolumab treatment versus those monitored and treated only if ctDNA becomes positive.

SECONDARY OBJECTIVES:

  • To compare disease-free survival between patients treated with nivolumab alone and those treated with both drugs.
  • To explore the link between ctDNA clearance and survival outcomes.
  • To compare overall survival in patients receiving immediate treatment versus those treated upon ctDNA conversion.
  • To determine the time from ctDNA positivity to cancer recurrence on scans.
  • To estimate how many patients become ctDNA positive and receive nivolumab.
  • To compare the incidence of ctDNA positivity between different treatment arms.
  • To assess the safety of nivolumab plus relatlimab.

EXPLORATORY OBJECTIVES:

  • To study changes in ctDNA levels over time and their impact on outcomes.
  • To estimate the costs and value of care for patients treated with nivolumab alone versus both drugs.
  • To estimate the costs and value of care for patients treated with nivolumab versus those monitored and treated upon ctDNA conversion.

QUALITY OF LIFE OBJECTIVES:

  • To compare quality-adjusted survival using a specific quality of life scale.
  • To compare overall quality of life over time using a cancer-specific questionnaire.
  • To compare bladder cancer-specific quality of life at different time points.
  • To compare patient-reported fatigue at different time points.

OUTLINE: Patients are divided into two groups based on ctDNA results.

COHORT A: Patients with positive ctDNA are randomized to one of two treatments:

  • ARM I: Receive nivolumab every 28 days for up to 12 cycles, with regular blood tests and scans.
  • ARM II: Receive both nivolumab and relatlimab every 28 days for up to 12 cycles, with regular blood tests and scans.

COHORT B: Patients with negative ctDNA are randomized to one of two treatments:

  • ARM III: Receive nivolumab every 28 days for up to 12 cycles, with regular blood tests and scans.
  • ARM IV: Undergo regular ctDNA monitoring and receive treatment if ctDNA becomes positive.

After treatment, patients are followed up at specific intervals to monitor their health and cancer status.

Eligibility Criteria

Inclusion Criteria

  • Must have bladder cancer confirmed by lab tests.
  • Must have had bladder surgery 3 to 12 weeks before joining the study.
  • No visible cancer left after surgery.
  • Must be at high risk of cancer returning based on specific criteria.
  • Must have available tumor tissue for testing.
  • Must be 18 years or older.
  • Must be in good overall health.
  • Must not be pregnant or nursing.
  • Must not have received certain treatments after surgery.
  • Must not have received prior PD-1/PD-L1 or LAG-3 treatments.
  • Must have adequate blood cell counts and organ function.
  • Must not have active autoimmune diseases or certain infections.
  • Must not be on immunosuppressive medications.
  • Must have a negative pregnancy test if applicable.
  • Must not have had major surgery or live vaccines recently.
  • Must have a ctDNA test result from central testing.
  • Must not have evidence of metastatic disease on recent scans.
  • Must not have changes in health that affect treatment safety.
  • Must start treatment within 6 weeks of a positive ctDNA result.

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