Brief Title
Anti-PD(L)1 and SBRT in the Treatment of Advanced, Platinum-Refractory Urothelial Carcinoma
Official Title
FAST: Feasibility Trial of Anti-PD(L)1 and SBRT in the Treatment of Advanced, Platinum-Refractory Urothelial Carcinoma
Brief Summary
This is a feasibility trial of anti-PDL1/PD1 (pembrolizumab) and stereotactic body radiation therapy (SBRT) in patients with advanced, platinum-refractory urothelial carcinoma.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
The Percentage of Subjects Who Receive 4 Doses of Pembrolizumab and at Least One Session of Treatment of SBRT
Secondary Outcome
The Number of Grades 3-5 Drug Related Adverse Events (AEs)
Condition
Urothelial Carcinoma
Intervention
Pembrolizumab
Study Arms / Comparison Groups
Pembrolizumab + SBRT
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
6
Start Date
January 24, 2018
Completion Date
November 10, 2020
Primary Completion Date
March 13, 2019
Eligibility Criteria
Inclusion Criteria: - Subjects must have a histologic diagnosis of urothelial carcinoma - Subjects must have radiologic evidence of metastatic disease with measurable disease by RECIST 1.1 criteria other than the target lesion(s) for SBRT - Subjects must have at least 1 metastatic lesion previously not radiated that is amenable to SBRT per treating radiation oncologist. - Subjects must have had progression of disease within 12 months of platinum-containing chemotherapy (chemotherapy could have been given in the neoadjuvant, adjuvant or metastatic setting) for urothelial cancer - ECOG performance status of 0 to 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.) - Absolute neutrophil count of ≥ 1000/mm3, platelet count ≥ 100,000/mm3, hemoglobin ≥ 8.0 g/dl; total bilirubin/ALT/AST < 2.5 x upper limit of normal (patients with known gilbert disease who have serum bilirubin ≤3x ULN may be enrolled); serum creatinine <3.0mg/dl or if elevated, a calculated estimated glomerular filtration rate (eGFR) of ≥30 mL/min/1.73 m2 - Subjects must have recovered to baseline or ≤ grade 1 CTCAE v 4.03 from toxicities related to any prior treatments unless AE(s) are clinically non-significant and/or stable on supportive therapy - Subjects must be ≥ 2 weeks from most recent systemic therapy or most recent radiation therapy - Women of childbearing potential must have a negative serum or urine pregnancy test within 28 days prior to registration. - Age ≥ 18 years Exclusion Criteria: - Prior treatment with anti-PD-1/PD-L1 and anti-CTLA-4 is NOT allowed. Prior intravesical BCG (Bacillus Calmette-Guerin) therapy is allowed - Treatment with any investigational agent or on an interventional clinical trial within 30 days prior to registration. - 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 are NOT allowed. Vitiligo, mild psoriasis (topical therapy only) or hypothyroidism are allowed - Need for systemic corticosteroids >10mg prednisone daily or equivalent alternative steroid - Any history of organ allografts - Any history of HIV or hepatitis B infection - Known brain metastases
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Zachery Reichert, MD, PhD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03287050
Organization ID
UMCC 2017.069
Secondary IDs
HUM00135161
Responsible Party
Sponsor
Study Sponsor
University of Michigan Rogel Cancer Center
Study Sponsor
Zachery Reichert, MD, PhD, Principal Investigator, University of Michigan Rogel Cancer Center
Verification Date
December 2021