Bladder Clinical Trials
A Phase III, Randomized, Open-Label, Multi-Center, Global Study to Determine the Efficacy and Safety of Durvalumab in Combination with Gemcitabine+Cisplatin for Neoadjuvant Treatment Followed by Durvalumab Alone for Adjuvant Treatment in Patients with Muscle-Invasive Bladder Cancer (NIAGARA).
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.
- 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
- 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
Incyte INCB 54828-201
A Phase 2, Open-label, Single Agent, Multi-Center Study to Evaluate the Efficacy and Safety of INCB054828 in Subjects with Metastatic or Surgically Unresectable Urothelial Carcinoma Harboring FGF/FGFR Alterations
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.
- 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.
- 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