Nivolumab + Urelumab for Bladder Cancer

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen byNoah Hahn, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This study evaluates the post cystectomy CD8+ tumor response of patients receiving Nivolumab plus Urelumab versus Nivolumab alone. Half the patients will receive Nivolumab plus Urelumab, while the other half will receive Nivolumab alone.

Eligibility Criteria

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.

Inclusion Criteria

I am 18 years old or older.

Patients who give a written informed consent obtained according to local guidelines

I am not taking cisplatin-based chemotherapy before surgery by choice or because I'm not eligible.

See 1 more

Exclusion 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.

See 9 more

Treatment Details

Interventions

Nivolumab (Checkpoint Inhibitor)
Urelumab (Checkpoint Inhibitor)

Trial OverviewThe 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.

Participant Groups

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

Nivolumab is already approved in United States, European Union, Canada, Switzerland for the following indications:

🇺🇸 Approved in United States as Opdivo for: