Durvalumab +/- Tremelimumab for Bladder Cancer

Recruiting in Palo Alto (17 mi)

+188 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?A Phase III, Randomized, Open-Label, Controlled, Multi-Center, Global Study of First-Line MEDI4736 (Durvalumab) Monotherapy and MEDI4736 (Durvalumab) in Combination with Tremelimumab Versus Standard of Care Chemotherapy in Patients with Stage IV Urothelial Cancer

Eligibility Criteria

This trial is for adults with Stage IV bladder cancer who haven't had first-line chemotherapy. They must know their tumor PD-L1 status and can be eligible or ineligible for cisplatin-based chemo due to certain health conditions. People with prior immune therapy, autoimmune/inflammatory disorders, brain metastases not stable off steroids, active infections like TB/HIV, recent live vaccines, or current immunosuppressants (with some exceptions) cannot join.

Inclusion Criteria

My tumor's PD-L1 status has been confirmed by a lab test.

I have Stage IV bladder cancer that hasn't been treated with first-line chemotherapy.

I am either eligible or not for cisplatin chemotherapy based on specific health conditions.

Exclusion Criteria

I have previously received immunotherapy or vaccines for cancer, but not within the last 28 days.

My brain or spinal cord cancer is stable, and I haven't taken steroids for over 2 weeks.

I do not have active infections like TB, hepatitis B, C, or HIV.

+4 more

Participant Groups

The study tests Durvalumab alone or combined with Tremelimumab against standard chemo drugs (Gemcitabine with Cisplatin or Carboplatin). It's a Phase III trial where patients are randomly assigned to one of these treatments to compare effectiveness as a first-line treatment in advanced bladder cancer.

3Treatment groups

Experimental Treatment

Active Control

Group I: MonotherapyExperimental Treatment1 Intervention

MEDI4736 (Durvalumab)

Group II: Combination TherapyExperimental Treatment2 Interventions

MEDI4736 (Durvalumab) + Tremelimumab

Group III: Standard of CareActive Control3 Interventions

Standard of Care Chemotherapy Treatment

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

🇺🇸 Approved in United States as Paraplatin for: