Your session is about to expire
← Back to Search
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 belowSelect...
I am 18 years old or older.
Select...
I am not taking cisplatin-based chemotherapy before surgery by choice or because I'm not eligible.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
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 moreTrial 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
561 Previous Clinical Trials
33,084 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,650 Previous Clinical Trials
4,130,817 Total Patients Enrolled
Noah Hahn, MDPrincipal InvestigatorJohns Hopkins University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is advanced and cannot be removed by surgery.I have cancer in the upper part of my urinary system.I have recently received treatment for cancer, including immunotherapy or radiation.I am not using two highly effective birth control methods.I have had a solid organ or bone marrow transplant in the past.I have not had any major surgery, open biopsy, or significant injury recently.I am willing and able to follow the study's requirements.I am a fertile male and do not plan to use contraception.I do not have any severe or uncontrolled health conditions.I am 18 years old or older.I am not taking cisplatin-based chemotherapy before surgery by choice or because I'm not eligible.You must have certain levels of white blood cells, platelets, hemoglobin, bilirubin, and liver enzymes in your blood, and a certain level of kidney function.I have another cancer besides non-melanoma skin cancer or prostate cancer.I have had severe liver inflammation due to alcohol, fat, auto-immune disease, or medication.
Research Study Groups:
This trial has the following groups:- Group 1: Nivolumab in combination with Urelumab
- Group 2: Nivolumab monotherapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger