Clinical Trial · NCT03208712

Radium-223 and Atezolizumab in Patients With Urothelial Carcinoma With Bone Metastases Who Have Had Disease Progression After Platinum-Based Chemotherapy

Overview

This is a single-arm, single-site pilot of Radium-223 (55 kBq/kg) IV q3 weeks for up to 6 doses in combination with Atezolizumab 1200mg IV once every 3 weeks until investigator determined lack of benefit, unacceptable toxicity, or 17 doses in patients with urothelial carcinoma with bone metastases who have disease progression after platinum-containing chemotherapy.

Sponsor

University of Michigan Rogel Cancer Center

Phase

Early Phase 1

Contacts

Ajjai Alva, M.D. (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT03208712

Drug / Compound

Radium-223 dichloride

Isotope(s):

Target(s):

No Explicit Target

Ligand Class: Small Molecules

Eligibility

Inclusion

Subjects must have at least 1 bone metastasis of any size on imaging.
ECOG performance status of 0- 2 (Eastern Cooperative Oncology Group Performance Status: an attempt to quantify cancer patients' general well-being and activities of daily life. The score ranges from 0 to 5 where 0 is asymptomatic and 5 is death.)
Adequate organ and marrow function Subjects must have measurable disease on physical exam or imaging per RECIST 1.1 criteria.
* Subjects must have a histologic diagnosis of urothelial carcinoma with radiologic, histologic or cytologic evidence of metastatic disease.
Subjects must have progression of disease within 12 months of platinum-containing chemotherapy (chemotherapy could have been given in the neoadjuvant, adjuvant or metastatic settings) for urothelial cancer.

Exclusion

Need for systemic corticosteroids \> 10 mg prednisone daily or equivalent alternative steroid (except physiologic dose for adrenal replacement therapy) or other immunosuppressive agents (such as cyclosporine or methotrexate). Use of topical and inhaled corticosteroids is permitted.
* Prior treatment with anti-PD-1/PD-L1, and anti-CTLA-4 is NOT allowed. Prior intravesical BCG therapy is allowed.
Treatment with any investigational agent or on an interventional clinical trial within 30 days prior to treatment on protocol
No prior or concurrent malignancy is allowed except for: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, localized or locally advanced prostate cancer definitively treated without recurrence or with biochemical recurrence only, or any other cancer fully treated or from which the subject has been disease-free for at least 2 years.
Autoimmune diseases such as rheumatoid arthritis or systemic lupus erythematosus. Note: Vitiligo, mild psoriasis (topical therapy only) or hypothyroidism are allowed.