NL-OMON50165已完成不适用
A Phase Ib Trial to Evaluate the Efficacy and Safety of Bintrafusp Alfa Monotherapy in Metastatic or Locally Advanced/Unresectable Urothelial Cancer with Disease Progression or Recurrence Following Treatment with a Platinum Agent - GSK213152
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Can give signed informed consent/assent which includes compliance with the
- •requirements and restrictions listed in the ICF and in this protocol
- •2. Eighteen (18) years at the time of signing the informed consent.
- •3. Histologically confirmed locally advanced or metastatic or locally
- •advanced/unresectable urothelial carcinoma (including renal, pelvis, uterus,
- •urinary bladder, urethra). Mixed histologies are acceptable provided
- •transitional cell carcinoma is the predominant histology. a) Measurable disease
- •per RECIST v1.1 criteria. b) Experienced disease progression or recurrence
- •either (1) following platinum containing chemotherapy for metastatic or locally
- •advanced/unresectable urothelial cancer or (2) within 12 months from completion
- •of neo-adjuvant or adjuvant platinum-containing chemotherapy for localized
- •muscle-invasive urothelial cancer.
- •4. Able to provide, a tumor tissue sample collected during screening and prior
- •to administration of bintrafusp alfa (see SRM for details).
- •5. Able to provide an archival tumor sample (preferably from the most recent
- •biopsy). Archival material is formalin fixed tumor tissue sample from a biopsy
- •of a tumor lesion.
- •6. All prior treatment-related toxicities (defined by National Cancer Institute
- •Common Toxicity Criteria for Adverse Events [NCI-CTCAE] v5.0) must be * Grade 1
- •at the time of enrollment, except alopecia, grade 2 neuropathy, or asymptomatic
- •toxicities that are clinically stable with medical management (e.g. electrolyte
- •abnormalities, etc.). ECOG PS 0 or 1.
- •7. Adequate organ system functions as defined by the laboratory assessments
- •8. Life expectancy of at least 12 weeks.
- •9. A female is eligible if she is not pregnant or breastfeeding, and at least
- •one of the following conditions applies:
- •* Not a woman of childbearing potential (WOCBP). OR
- •* If a WOCBP, use a highly effective contraceptive method (i.e., with a failure
- •rate of <1% per year), preferably with low user dependency, as described in the
- •following time periods:
- •o Before the first dose of the study intervention(s), if using hormonal
- •contraception:
- •* -Has completed at least one 4-week cycle of an oral contraception pill and
- •either had or has begun her menses.
- •-Has used a depot contraceptive or extended-cycle oral contraceptive for least
- •28 days and has a documented negative pregnancy test using a highly sensitive
- •o During the intervention period
- •o After the study intervention period (i.e., after the last dose of study
- •intervention is administered) for at least 2 months. The Investigator evaluates
- •the effectiveness of the contraceptive method in relationship to the first dose
- •of study intervention.
- •Has a negative serum or highly sensitive urine pregnancy test, as required by
- •local regulations, within 24 hours before the first dose of study intervention.
- •If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a
- •serum pregnancy test is required.
- •Male participants:
- •* Contraceptive use by men should be consistent with local regulations
- •regarding the methods of contraception for those participating in clinical
- •* Male participants are eligible to participate if they agree to the following
- •from the time of first dose of study until 125 days after the last dose of
- 另有 1 项未显示
排除标准
- •1. Active brain and/or leptomeningeal disease that is symptomatic or requires
- •therapeutic intervention. Participants with asymptomatic CNS metastases who are
- •clinically stable as demonstrated by serial brain images and have no
- •requirement for corticosteroids for at least 14 days prior to enrollment are
- •eligible. 2. History of malignancy other than urothelial cancer within the last
- •3 years except for localized tumors that have been treated with curative intent
- •or have not required therapy in the past 2 years. (e.g., resected non-melanoma
- •skin cancer, etc.).
- •3. No more than 2 lines of systemic therapy for the treatment of meatastastic
- •disease. If the most recent therapy was not a platinumbased regimen, the
- •participant must have progressed on or after that therapy. 4. Cirrhosis or
- •current unstable liver or bilary disease per investigator assessment defined by
- •the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia,
- •oesophageal or gastric varices, or persistent jaundice. NOTE: Stable
- •non-cirrhotic chronic liver disease (including Gilbert's syndrome or
- •asymptomatic gallstones) is acceptable if participant otherwise meets entry
- •5. Current pneumonitis or history of non-infectious pneumonitis that required
- •systemic immunosuppressive treatment.
- •6. Active autoimmune disease that required systemic immunosuppressive treatment
- •within the past 2 years.
- •7. Received prior allogeneic/autologous bone marrow or solid organ transplant.
- •8. Receiving systemic corticosteroids (10 mg daily oral prednisone or
- •equivalent) or other immunosuppressive agent within 7 days prior to study
- •treatment. Inhaled or topical steroids are permitted. Note: a) Physiologic
- •doses of corticosteroids for treatment of endocrinopathies or steroids with
- •minimal systemic absorption, including (e.g., topical, inhaled,
- •intra-articular, ophthalmic, intranasal); corticosteroids may be continued if
- •the participant is on a stable dose b) Steroids as premedication for
- •hypersensitivity reactions (e.g., CT scan premedication) are permitted.
- •9. Known severe hypersensitivity reactions to monoclonal antibodies or any
- •ingredient used in the study treatment formulation (Grade 3 NCICTCAE v5).
- •10. Active infection requiring systemic therapy.
- •11. Received any live vaccine within 30 days prior first dose of intervention.
- •12. Known history of positive test for human immunodeficiency virus (HIV) with
- •the exception of participants with CD4+ T-cell (CD4+) counts greater than or
- •equal to 350 cells/uL and no history of AIDS-defining opportunistic infections.
- •13. Active hepatitis B virus (HBV) (HBV surface antigen-positive).
- •14. Active hepatitis C virus (HCV) infection, or positive HCV antibody, with
- •the exception of participants that (1) have HCV viral load below the limits of
- •quantitation and (2) completed curative antiviral therapy or are receiving and
- •compliant with antiviral therapy
- •15. History or evidence of cardiac abnormalities within the 6 months prior to
- •first dose of intervention which include: a. Serious, uncontrolled cardiac
- •arrhythmia or clinically significant electrocardiogram abnormalities including
- •second degree (Type II) or third-degree atrioventricular block or QTc interval
- •> 450 msec (or QTc > 480 msec for participants with bundle branch block). b.
- •Cardiomyopathy, myocardial in
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