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Checkpoint Inhibitor

Nivolumab + Urelumab for Bladder Cancer

Phase 2
Waitlist Available
Led By Noah Hahn, MD
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years old at time of consent
Electively refusing cisplatin-based neoadjuvant chemotherapy or ineligible to receive cisplatin-based neoadjuvant chemotherapy based upon specific criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is testing whether adding the drug Urelumab to the drug Nivolumab will help patients with bladder cancer who have had their bladder removed.

Who is the study for?
This trial is for adults over 18 with muscle-invasive bladder cancer who can't or won't take cisplatin-based chemo. They must understand the study and agree to its terms, have certain blood counts (ANC ≥ 1.5 K/mm3, Platelets ≥ 100 K/mm3, Hgb ≥ 9 g/dL), liver function within limits, and a creatinine clearance of at least 30 mL/min. Pregnant women, those not using effective contraception, and patients with recent major surgery or other severe conditions are excluded.Check my eligibility
What is being tested?
The trial tests how well Nivolumab works alone versus combined with Urelumab in shrinking bladder cancer before surgery. Patients are split into two groups: one receives both drugs while the other gets only Nivolumab.See study design
What are the potential side effects?
Nivolumab and Urelumab may cause immune-related side effects like inflammation in various organs including the liver and lungs, skin reactions, hormone gland problems (like thyroid issues), infusion reactions during treatment administration, fatigue, and potential complications from activating the immune system.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am not taking cisplatin-based chemotherapy before surgery by choice or because I'm not eligible.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Immune response to treatment with Nivolumab and Urelumab compared to Nivolumab monotherapy measured by tumor infiltrating CD8+ T cell density at cystectomy
Secondary outcome measures
Cystectomy
Change in expression, assessed by (IHC) analysis, for pathologic CR response, defined by cystectomy staging pT0N0, in cisplatin-ineligible MIBC pts tx w/ Urelumab.
Cisplatin
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Nivolumab in combination with UrelumabExperimental Treatment1 Intervention
Nivolumab and Urelumab combination: Nivolumab 240 mg will be administered by 1 hour intravenous infusion on day 1 and day 15 for two cycles Urelumab 8mg will be administered by 1 hour intravenous infusion on day 1 for two cycles
Group II: Nivolumab monotherapyActive Control1 Intervention
Nivolumab 240 mg will be administered by 1 hour intravenous infusion on day 1 and day 15 for two cycles

Find a Location

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
557 Previous Clinical Trials
32,885 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,499 Total Patients Enrolled
Noah Hahn, MDPrincipal InvestigatorJohns Hopkins University

Media Library

Nivolumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02845323 — Phase 2
Bladder Cancer Research Study Groups: Nivolumab in combination with Urelumab, Nivolumab monotherapy
Bladder Cancer Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT02845323 — Phase 2
Nivolumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02845323 — Phase 2

Frequently Asked Questions

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

Has the FDA acknowledged Nivolumab's efficacy when used concurrently with Urelumab?

"While Nivolumab in combination with Urelumab has not yet been proven effective, there is some data supporting its safety which earned it a 2 on our scale."

Answered by AI

Can new participants still sign up for this experiment?

"This trial is no longer enrolling patients. It was initially posted on May 16th, 2017 and was updated for the last time on July 14th, 2022. There are currently 2873 clinical trials actively enrolling participants with bladder cancer and 747 studies using Nivolumab in combination with Urelumab."

Answered by AI

Are there other similar studies that have used Nivolumab and Urelumab together?

"As of now, there are 747 on-going studies investigating the combination of Nivolumab and Urelumab. Out of these, 82 are in Phase 3. While several clinical trials for this combination therapy are based in Basel, BE, there are 40325 locations worldwide running trials for it."

Answered by AI

What are Nivolumab and Urelumab most often used together to manage?

"Nivolumab in combination with Urelumab is an approved treatment for malignant neoplasms. This medication can also be used to fight unresectable melanoma, squamous cell carcinoma, and metastatic esophageal adenocarcinoma."

Answered by AI

How does this clinical trial compare to similar ones that have been performed in the past?

"Nivolumab in combination with Urelumab has had 747 active clinical trials across the world since 2010. The first study, involving 127 patients and sponsored by Medarex, completed its Phase 1 drug approval stage that year. In the decade since, an additional 252 studies have been conducted."

Answered by AI

How many individuals are being observed in this clinical trial?

"This study is not recruiting patients at this moment. It was originally posted on May 16th, 2017 and was updated on July 14th, 2022. However, if you are still exploring your options, there are 2873 trials for bladder cancer and 747 trials testing Nivolumab in combination with Urelumab that are actively looking for patients."

Answered by AI

In how many different geographic locations is this study being run today?

"At the moment, this clinical trial is taking place at 5 sites. Three of these locations are Aurora, Baltimore and New york; there are also 5 other sites. If you enroll in the trial, try to select a clinic that is close to your residence to limit travel time and costs."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Neoadjuvant Nivolumab With and Without Urelumab in Cisplatin-Ineligible or Chemotherapy-refusing Patients With Muscle-Invasive Urothelial Carcinoma of the Bladder
2017. "Neoadjuvant Nivolumab With and Without Urelumab in Cisplatin-Ineligible or Chemotherapy-refusing Patients With Muscle-Invasive Urothelial Carcinoma of the Bladder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02845323.
~1 spots leftby Jul 2024
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