Radiation Therapy Combined With Experimental Drugs for Bladder Cancer Which Has Spread

Clinical Trial: Bladder Cancer

A Study To Discover if Radiation Therapy with One or Two Experimental Medications Will be Effective in the Treatment of People With Bladder Cancer Which Has Spread to Other Parts of the Body

Technical Title:  Multi-Institutional Phase II Study of Radiation Therapy and Anti-PD-L1 Checkpoint Inhibition (Durvalumab) With or Without Anti-CTLA-4 Inhibition (Tremelimumab) in Patients with Unresectable, Locally Advanced or Metastatic Urothelial Bladder Cancer that are Ineligible or Refusing Chemotherapy

Basic Information:

Bladder cancer which has metastasized (spread) to other parts of the body is commonly treated with a combination of therapies, including chemotherapy. However, many patients are either unable to tolerate or refuse chemotherapy, and are looking for alternatives.

This is designed to test a combination of routine radiation therapy and two experimental drugs, immune therapies known as durvalumab and tremelimumab. Immune therapies are designed to elicit an immune response from the patient’s body. We hope to learn identify the highest dose of these drugs which can be safely tolerated, and to answer some basic scientific questions about how they work in the body. While it is hoped that subjects with metastatic bladder cancer will benefit, no benefit can be guaranteed.

Procedures

Research Procedures:

Patients who enroll will receive either 12 infusions of durvalumab alone, or 11 – 12 infusions of durvalumb and tremelimumab, given over about 12 months, as well as five separate treatments of routine radiation therapy.  There is a significant number of blood draws taken both for routine safety purposes as well as to answer scientific questions, and patients can expect to receive regular routine scans such as CT scans and MRIs.  

Follow-up visits:

Subjects will be asked to return to UCLA for regular follow-up visits for up to five years.  Most of the procedures which occur during these visits are considered routine, but will also contribute to further knowledge about this study.  

Eligibility Criteria (Not a complete list):

Inclusion Criteria

• Must have bladder cancer which has grown or spread to other parts of the body
• Age 18 years or older
• Must be ineligible for or refuse cisplatin-based chemotherapy
• Must be able to care for self, but may be unable to carry on normal activity or to do active work
• Negative serum pregnancy test must be documented
• Ability to understand and the willing ness to sign a written consent form

Exclusion Criteria

• History of or active autoimmune or inflammatory diseases
• Known immune deficiency
• Currently taking chemotherapy
• Prior radiation therapy to the abdomen or pelvis including radiation therapy to the bladder, prostate, or rectum
• Other primary cancer, with some exceptions

Other Inclusion/Exclusion criteria exist. 

For More Detailed Information Contact:

• Albert Chang, MD, PhD., Principal Investigator (310) 825-9771
• Jackie Hernandez, Study Coordinator (310) 267-8991
• Clinical Research Team (310) 825-6577