Immunotherapy + Chemotherapy for Bladder Cancer
(NILE Trial)

Recruiting in Palo Alto (17 mi)

+181 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: AstraZeneca

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This is a randomized, open-label, controlled, multi-center, global Phase III study to determine the efficacy and safety of combining durvalumab ± tremelimumab with standard of care (SoC) chemotherapy (cisplatin + gemcitabine or carboplatin + gemcitabine doublet) followed by durvalumab monotherapy versus SoC alone as first-line chemotherapy in patients with histologically or cytologically documented, unresectable, locally advanced or metastatic transitional cell carcinoma of the urothelium (including renal pelvis, ureters, urinary bladder, and urethra).

Eligibility Criteria

This trial is for adults with advanced urothelial cancer that can't be surgically removed. They should not have had first-line chemotherapy but may have had other treatments if their disease worsened after a year. Participants need to be relatively healthy, able to perform daily activities with ease or some limitation, and women must not be pregnant.

Inclusion Criteria

I have not received first-line chemotherapy.

I am fully active or restricted in physically strenuous activity but can do light work.

I have at least one cancer lesion that has not been treated with radiation.

+4 more

Exclusion Criteria

I am not on strong medication to suppress my immune system.

I may undergo or am considering major surgery as part of my treatment plan.

I have been treated with immune therapy before, but not Bacillus Calmette-Guerin.

+2 more

Participant Groups

The study tests the effectiveness of Durvalumab alone or combined with Tremelimumab alongside standard chemotherapy (Cisplatin + Gemcitabine or Carboplatin + Gemcitabine) versus just the chemotherapy. It's randomized and open-label, meaning patients are assigned treatment by chance and everyone knows which treatment they're getting.

3Treatment groups

Experimental Treatment

Active Control

Group I: Durvalumab in Combination with Tremelimumab+SoC ChemotherapyExperimental Treatment4 Interventions

Durvalumab and Tremelimumab every 3 weeks in concurrence with chemotherapy, followed by durvalumab monotherapy every 4 weeks Tremelimumab will be provided for 4 cycles. All patients will receive one of the following standard of care chemotherapy regimens every 3 weeks for 6 cycles: * cisplatin+ gemcitabine * If the patient is cisplatin-ineligible, carboplatin + gemcitabine

Group II: Durvalumab in Combination with SoC ChemotherapyExperimental Treatment3 Interventions

Durvalumab every 3 weeks in concurrence with chemotherapy, followed by durvalumab monotherapy every 4 weeks. All patients will receive one of the following standard of care chemotherapy regimens every 3 weeks for 6 cycles: * cisplatin+ gemcitabine * If the patient is cisplatin-ineligible, carboplatin + gemcitabine

Group III: SoC ChemotherapyActive Control2 Interventions

Patients will receive one of the following standard of care chemotherapy regimens every 3 weeks for 6 cycles: * cisplatin+ gemcitabine * If the patient is cisplatin-ineligible, carboplatin + gemcitabine

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

🇺🇸 Approved in United States as Paraplatin for: