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Brief Title: Anti-PD(L)1 and SBRT in the Treatment of Advanced, Platinum-Refractory Urothelial Carcinoma

FAST: Feasibility Trial of Anti-PD(L)1 and SBRT in the Treatment of Advanced, Platinum-Refractory Urothelial Carcinoma

INTRODUCTION

  • Org Study ID: UMCC 2017.069
  • Secondary ID: HUM00135161
  • NTC ID: NCT03287050
  • Sponsor: University of Michigan Rogel Cancer Center

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.


  • Overall Status
    Recruiting
  • Start Date
    January 23, 2018
  • Phase
    Early Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: The percentage of subjects who receive 4 doses of pembrolizumab and at least one session of treatment of SBRT

Primary Outcome 1 - Timeframe: 15 weeks

CONDITION

  • Urothelial Carcinoma

ELIGIBILITY


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

Minimum Age: N/A

Maximum Age: 18 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Ajjai Alva, M.D.

Role: Principal Investigator

Affiliation: University of Michigan Rogel Cancer Center

Overall Contact

Name: Ajjai Alva, M.D.

Phone: (734) 936-0091

Email: ajjai@umich.edu

LOCATION

Facility Status Contact
Facility: University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan 48109
United States
Status: Recruiting Contact:
Ajjai Alva, M.D.
734-936-0091
ajjai@umich.edu