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Cohort A, Arm II (nivolumab, relatlimab) for Bladder Cancer

Phase 3

Recruiting

Led By Matthew D Galsky

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

New York Heart Association Class III heart failure

(i) Eastern Cooperative Oncology Group (ECOG) performance status = 2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years after completion of study treatment

Awards & highlights

Study Summary

This trial is testing a new blood test called Signatera to see if it can detect bladder cancer DNA in the blood. The test will be used to determine if patients who have had their bladder removed

Who is the study for?

This trial is for adults with bladder cancer who've had their bladders and lymph nodes surgically removed recently. It's not for those who only had part of the bladder taken out or have heart failure, severe hearing loss, bad peripheral neuropathy, or poor overall health. Participants should not have any remaining visible cancer after surgery.Check my eligibility

What is being tested?

The study tests if DNA from tumor cells in blood can guide immunotherapy post-bladder removal surgery. It uses a test called Signatera to detect this DNA and then treats patients with nivolumab alone or combined with relatlimab to prevent cancer recurrence.See study design

What are the potential side effects?

Nivolumab and relatlimab may cause immune-related side effects like inflammation in various organs, potential infusion reactions during treatment administration, fatigue, skin issues, hormonal imbalances, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have moderate heart failure.

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I can walk and take care of myself but cannot do any physical work.

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My bladder cancer is confirmed and mainly urothelial type, but may include other cell types.

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I have moderate to severe numbness, tingling, or pain in my hands or feet.

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I have bladder cancer and haven't had cisplatin before surgery. I can't have cisplatin after surgery either.

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I have moderate to severe hearing loss.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization until confirmed disease recurrence as assessed by the treating physician or death due to any cause, assessed up to 5 years after completion of study treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization until confirmed disease recurrence as assessed by the treating physician or death due to any cause, assessed up to 5 years after completion of study treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization until confirmed disease recurrence as assessed by the treating physician or death due to any cause, assessed up to 5 years after completion of study treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Disease-Free Survival (DFS) (Cohort B)

Overall survival (OS) (Cohort A Phase III)

Proportion of patients who are circulating tumor DNA negative (ctDNA[-]) (Cohort A Phase II)

Secondary outcome measures

Cumulative incidence of ctDNA(+) conversion (Cohort B)

DFS (Cohort A Phase II or III)

Incidence of adverse events (Cohort A)

+5 more

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Cohort B, Arm IV (ctDNA surveillance, nivolumab)Experimental Treatment7 Interventions

Patients in Cohort B, Arm IV undergo ctDNA surveillance consisting of collection of tissue and blood during screening and collection of blood only on study and during follow up. Patients who convert to ctDNA(+) during surveillance then receive nivolumab IV over 30 minutes and relatlimab IV over 30 minutes on day 1 of each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI scans throughout the trial.

Group II: Cohort A, Arm II (nivolumab, relatlimab)Experimental Treatment7 Interventions

Patients in Cohort A, Arm II receive nivolumab IV over 30 minutes and relatlimab IV over 30 minutes on day 1 of each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of tissue during screening and collection of blood throughout the trial. Patients also undergo CT or MRI scans throughout the trial.

Group III: Cohort A, Arm I (nivolumab)Active Control6 Interventions

Patients in Cohort A, Arm I receive nivolumab IV over 30 minutes on day 1 of each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of tissue during screening and collection of blood throughout the trial. Patients also undergo CT or MRI scans throughout the trial.

Group IV: Cohort B, Arm III (nivolumab)Active Control6 Interventions

Patients in Cohort B, Arm III receive nivolumab IV over 30 minutes on day 1 of each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of tissue during screening and collection of blood throughout the trial. Patients also undergo CT or MRI scans throughout the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 2

~1700

Computed Tomography

2017

Completed Phase 2

~2720

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Nivolumab

2014

Completed Phase 3

~4750

Relatlimab

2018

Completed Phase 2

~1120

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,672 Previous Clinical Trials

40,925,612 Total Patients Enrolled

Matthew D GalskyPrincipal InvestigatorAlliance for Clinical Trials in Oncology

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

At how many distinct sites is this research trial currently being conducted?

"A total of 21 patients are being recruited for this clinical trial. Some notable sites include Illinois CancerCare-Bloomington in Bloomington, Illinois CancerCare-Canton in Canton, and Illinois CancerCare-Galesburg in Galesburg. Additionally, there are 18 other locations participating in the recruitment process."

Answered by AI

What is the upper limit for the total number of individuals involved in this medical study?

"Indeed, the information available on clinicaltrials.gov confirms that this trial is actively seeking eligible participants. The study was first posted on October 5th, 2024 and has been recently updated on January 23rd, 2024. A total of 1190 individuals are being recruited across 21 different locations."

Answered by AI

Are there ongoing efforts to actively enroll participants for this clinical trial?

"Indeed, according to the information available on clinicaltrials.gov, this study is actively seeking individuals to participate. The trial was originally posted on October 5th, 2024 and underwent its most recent update on January 23rd, 2024. A total of 1190 participants are being sought across a network of 21 locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder for Bladder Cancer Treatment, MODERN Study

2024. "Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder for Bladder Cancer Treatment, MODERN Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05987241.

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