Protocol: ECOG – EA8192
Please Note: Below is partial eligibility, for full eligible requirement’s, please contact GHCI Research Department at (810) 762-8181, (810) 762-8079 and/or (810) 762-8038. Thank you!
- ≥18 years of age.
- Patient must have a diagnosis of high grade upper tract urothelial carcinoma proven by biopsy within 60 days prior to registration.
- Patients must not have any component of small cell carcinoma. Other variant histologic types are permitted provided the predominant (≥ 50%) subtype is urothelial carcinoma.
- Patient must have no evidence of metastatic disease or clinically enlarged lymph nodes (≥1.0 cm short axis) on imaging required within 28 days prior to registration (solitary slightly enlarged lymph node with negative biopsy is allowed).
- Patient must not have another active (or within 2 years) second malignancy other than resected non-melanoma skin cancers, resected in situ breast, cervical or other in situ carcinoma, and either clinically insignificant per the investigator (e.g. ≤Gleason 3+4) on surveillance or previously treated prostate cancer with no rising PSA
and no plan to treat.
- Patient must not have received prior radiation therapy to ≥ 25% of the bone marrow for other diseases.
- Patient must not have received prior systemic anthracycline therapy. NOTE: Patients who have received prior intravesical chemotherapy at any time for non-muscle invasive urothelial carcinoma of the bladder are eligible.
- Patient must not be on or have used immunosuppressive medication within 14 days prior to the first dose of MEDI4736 (MEDI4736 (durvalumab)). The following are exceptions to this criterion: Intranasal, inhaled, intra-auricular, topical steroids, or local steroid injections (e.g. intra-articular injection). Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent at the time of enrollment. Steroids as premedications for hypersensitivity reactions (e.g. CT
- Patient must not have a concomitant primary urothelial carcinoma of the bladder and/or urethra. NOTE: Patients in whom concomitant or prior bladder/urethra
predominant (≥50%) urothelial carcinoma have been surgically resected and demonstrated to be only noninvasive cancer (<cT1N0) are eligible regardless of time
- Patient must not have prior history of muscle-invasive urothelial carcinoma with or without systemic chemotherapy (T2-4a and/or N1) within 2 years prior to registration. NOTE: Patients who have no evidence of disease (NED) for more than 2 years from the latest therapy (surgery, radiation, chemotherapy, or clinical trial) are eligible.
- Patient must have a body weight of > 30 kg.
- Patient must have a life expectancy of ≥ 12 weeks.