EUCTR2018-003636-79-DKActive, not recruitingPhase 1
A Phase 2, single-arm study of bempegaldesleukin (NKTR-214) incombination with nivolumab in cisplatin ineligible, locally advanced or metastatic urothelial cancer patients
ektar Therapeutics0 sites205 target enrollmentStarted: March 14, 2019Last updated:
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 205
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Each patient will be entered into this study only if he/she meets all of the following criteria:
- •Male or female patients, age 18 years or older at the time of signing the informed consent form (ICF).
- •Patients must have histologically or cytologically documented inoperable, locally advanced (T4b, any N; or any T, N2-3) or metastatic (M1, Stage IV) urothelial cell carcinoma (also termed transitional cell
- •carcinoma) including renal pelvis, ureters, urinary bladder and urethra.
- •Patients with mixed histologies are required to have a dominant transitional cell pattern.
- •Tumor tissue is required to be analyzed by the central laboratory to document PD L1 status. Tissue can be provided in one of 2 ways: 1) A new biopsy taken during screening 2) Archival tissue from either a formalin - fixed, paraffin - embedded (FFPE) tissue block or unstained tumor tissue sections (see Section 7.5). Archival tissue must be within 12 months prior to enrollment and with no intervening treatment. 3) A tracking number confirming shipment of the sample to the central
- •laboratory supplied prior to Cycle 1 Day 1.
- •Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status = 2.
- •Patients must have measurable disease per RECIST 1.1 criteria, and have adequate organ function.
- •Patients must be able and willing to comply with the study visit schedule and study procedures.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 70
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 135
Exclusion Criteria
- •A patient will be excluded from this study if he/she meets any of the following criteria:
- •1. Female patients who are pregnant or lactating, who plan to get pregnant, or who have a positive serum or urine pregnancy test.
- •2. Active brain metastases or leptomeningeal metastases. Patients with brain metastases are eligible if these have been treated and there is no radiographic evidence of progression for at least 4 weeks after
- •treatment is complete (confirmed by the head imaging obtained within 28 days prior to Cycle 1 Day 1). There must also be no requirement for immunosuppressive doses of systemic corticosteroids (> 10 mg/day prednisone equivalents) for at least 2 weeks prior to Cycle 1 Day 1. Stable dose of anticonvulsants is allowed. Treatment for CNS metastases may include whole brain radiation, stereotactic radiosurgery (e.g. GammaKnife, CyberKnife, or equivalent) or neurosurgical resection.
- •Patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 28 days prior to Cycle 1 Day 1 are not eligible.
- •3. Prior active malignancy within the previous 3 years except for locally curable cancers with negligible risk of metastases or death that have been treated with expected curative outcome, such as basal or
- •squamous cell skin cancer, carcinoma in situ of the prostate, cervix, or breast. An incidental finding of prostate cancer (identified upon resection of the prostate) is acceptable, provided that one of the
- •following criteria is met: T2N0M0 or Gleason score = 3+4, or prostate - specific antigen (PSA) below upper limit of normal by local laboratory and not requiring active treatment.
- •4. Patients who have an active, known or suspected autoimmune disease. Patients requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease that requires systemic steroids or immunosuppressive agents. (Exceptions include any patient on 10 mg or less of prednisone or equivalent, patients with vitiligo, hypothyroidism stable on hormone replacement, Type I diabetes, Graves' disease, Hashimoto's disease, alopecia areata, eczema, or psoriasis.)
- •5. Patients with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of Cycle 1 Day 1. Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
- •6. Patients must not have received prior IL-2 therapy.
- •7. Patients who have received any live/ attenuated vaccine within 30 days before Cycle 1 Day 1.
- •8. Prior treatment with an anti PD-1, anti PD-L1,anti-PD-L2, or anti CTLA-4 antibody, agents that target IL-2 pathway, or any other antibody or drug specifically targeting T- cell costimulation or immune checkpoint pathways.
- •9. History of allergy to study drug components.
- •10. History of severe hypersensitivity reaction to any monoclonal antibody.
- •11. History of organ, hematopoetic, or tissue tranasplant that requires the systemic use of immunosuppressive agents.
- •12. Active infection requiring systemic therapy within 14 days prior to Cycle 1 Day 1.
- •13. Any positive test result for hepatitis B virus (HBV) or hepatitis C virus (HCV) indicating presence of virus, e.g. hepatitis B surface antigen (HBsAg) positive, or hepatitis C antibody (anti-HCV) positive (except if HCV-RNA negative ).
- •14. Known history of
Investigators
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