Physician

Yacoub Faroun, MD

Study Coordinator

Megan Gavinski, BS

484-503-4157

 

Megan.Gavinski@sluhn.org

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Treatment Agent: Durvalumab

Synopsis: AstraZeneca is doing this research to find out if the medication called Durvalumab combined with the standard of treatment will work and be safe for the treatment of Muscle Invasive Bladder Cancer. Durvalumab has been approved by the FDA as therapy for the treatment of locally advanced or metastatic urothelial carcinoma (bladder cancer), for patients whose cancers progressed during or after platinum-based chemotherapy. Durvalumab is still in the development stage for the treatment of Muscle Invasive Bladder Cancer and is not approved for treatment of Muscle Invasive Bladder Cancer except for use in research studies like this.

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• Patient resectable muscle-invasive bladder cancer with clinical stage T2N0M0-T4aN0M0 with transitional cell histology
• Patients must be planning to undergo a radical cystectomy at the time of randomization
• Patients who have not received prior systemic chemotherapy or immunotherapy for treatment of MIBC
• ECOG performance status of 0 or 1
• Must have a life expectancy of at least 12 weeks at randomization

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• Evidence of lymph node or metastatic disease at time of screening.
• Prior pelvic radiotherapy treatment
• Prior exposure to immune-mediated therapy (with exclusion of Bacillus-Calmette Guerin [BCG]), including but not limited to other anti-CTLA-4, anti-PD-1, anti PD-L1, or anti-PD-L2 antibodies.
• Current or prior use of immunosuppressive medication within 14 days before the first dose of investigational product (IP). The following are exceptions to this criterion: Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra articular injection); Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent; Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication)
• Receipt of live attenuated vaccine within 30 days prior to the first dose of IP.
• Uncontrolled intercurrent illness
• Active infection including Tuberculosis, Hepatitis B, Hepatitis C, and Human Immunodeficiency

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Physician

Yacoub Faroun, MD

Study Coordinator

Megan Gavinski, BS

484-503-4157

 

Megan.Gavinski@sluhn.org

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Treatment Agent: IMMU-132

Synopsis: You are being asked to take part in this research study because you have urothelial cancer that has progressed or returned. Your doctor is researching a potential new therapy product called sacituzumab govitecan. This is an experimental therapy, which means that sacituzumab govitecan is not approved by the FDA for use by the general public. Sacituzumab govitecan is composed of a drug attached to an antibody. The antibody in this study is a protein able to bind to the cells of your cancer and thereby facilitates the action of chemotherapy. This drug has been given to a small group of patients with your disease and this study is being conducted to further evaluate its effectiveness and how it is tolerated.

Sacituzumab govitecan is an investigational medication which means the FDA allows its use only in research.

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• Patients with histologically confirmed urothelial cancer.
• ECOG Performance status score of 0 or 1.
• Cohort 1: Have had progression or recurrence of urothelial cancer following receipt of platinum-containing regimen (cisplatin or carboplatin):
  1. Received a first-line platinum-containing regimen in the metastatic setting or for inoperable locally advanced disease;
  2. Or received neo/adjuvant platinum-containing therapy for localized muscle-invasive urothelial cancer, with recurrence/progression ≤12 months following completion of therapy.
• Cohort 1: In addition to above criterion, have had progression or recurrence of urothelial cancer following receipt of an anti-PD-1 /PD-L1 therapy.
• Cohort 2: Were ineligible for platinum-based therapy for first line metastatic disease and have had progression or recurrence of urothelial cancer after a first-line therapy for metastatic disease with anti-PD-1/PD-L1 therapy. Subject may not have received any platinum for treatment of recurrent, metastatic or advanced disease.
• Adequate renal and hepatic function.
• Adequate hematologic parameters without transfusional support.
• Creatinine clearance ≥30mL/min as calculated by the Cockroft-Gault formula.
• Subjects must have a 3-month life expectancy.
• Have measurable disease by CT or MRI as per RECIST 1.1 criteria.

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• Women who are pregnant or lactating.
• Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
• Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
• Requires concomitant medication interfering with ABCA1 transporter or UGT1A1
• Has an active second malignancy.
• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
• Has known active Hepatitis B or Hepatitis C
• Has other concurrent medical or psychiatric conditions

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Treatment Agent: INCB054828

Synopsis: The primary purpose of this research study is to assess how metastatic or surgically unresectable Urothelial Carcinoma with FGF/FGFR alterations responds to treatment with INCB054828. The other goals of the study are to determine how safe and well tolerated the study drug, INCB054828, is, and to obtain data to try and identify patients who would benefit most from INCB054828.

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• Histologically documented metastatic or surgically unresectable urothelial carcinoma; may include primary site from ureters, upper tract, renal pelvis, and bladder.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
• Life expectancy ≥ 12 weeks.
• Radiographically measurable or evaluable disease per RECIST v1.1.
• Known FGF/FGFR alteration from the sponsor's central laboratory and have either 1) failed at least 1 previous treatment for their metastatic or surgically unresectable urothelial carcinoma (ie, chemotherapy, immunotherapy) or 2) are platinum ineligible.

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• Patients on supportive care only and not receiving anti-cancer therapy are not eligible to enroll
• Patients with unknown date of diagnosis of cHL
• Patients whose prior cHL therapy, and dates of therapy (eg, surgery, radiation, or drug therapy) are unknown
• Any other non-HL (non-Hodgkin Lymphoma) active malignancy for which the patient is receiving treatment
• Patients participating in a clinical study that does not allow enrollment into a non-interventional study
• Patients enrolled who go on to receive only supportive, palliative, hospice, or end-of-life care remain on study and should not be discontinued from follow-up.

Other protocol defined inclusion/exclusion criteria could apply

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