A Phase III Randomized, Open-Label, Multicenter Study to Determine the Efficacy and Safety of Durvalumab in Combination With Tremelimumab and Enfortumab Vedotin or Durvalumab in Combination With Enfortumab Vedotin for Perioperative Treatment in Patients Ineligible for Cisplatin or Who Refuse Cisplatin Undergoing Radical Cystectomy for Muscle Invasive Bladder Cancer (VOLGA) - VOLGA

Astra Zeneca0 个研究点目标入组 32 人开始时间: 待定最近更新: 2024年4月15日

试验速览

阶段: 3 期
状态: 招募中
发起方
入组人数: 32

研究概览入排标准研究者记录与标识符相似试验

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 Participant must be >= 18 years
•2 Histologically or cytologically documented muscle-invasive TCC of the bladder
•with clinical stage of T2-4aN0-N1M0
•3 Medically fit for cystectomy and able to receive neoadjuvant therapy
•4 ECOG performance status of 0 to 2 with no deterioration over the previous 2
•weeks prior to baseline or day of first dosing.
•5 Provision of the most recent tissue sample from MIBC to assess the PD L1
•status/expression prior to randomization.
•6 Cisplatin-ineligible, determined by protocol OR Refuse cisplatin-based
•chemotherapy
•7 Adequate organ and marrow function, determined by protocol
•8 Minimum life expectancy of 12 weeks at randomization per the opinion of the
•investigator.
•9 Body weight > 30 kg.
•10 Negative pregnancy test (serum) for women of childbearing potential.
•11 Female participants must be 1 year post-menopausal, surgically sterile, or
•using one highly effective form of birth control (a highly effective method of
•contraception is defined as one that can achieve a failure rate of less than 1%
•per year when used consistently and correctly.) Women of childbearing potential
•must agree to use one highly effective method of birth control. They should
•have been stable on their chosen method of birth control for a minimum of 3
•months before entering the study to 90 days after the last dose of durvalumab,
•180 days after the last dose of durvalumab + tremelimumab, or 2 months after
•the last dose of EV, whichever is longer. Non sterilized male partners of a
•woman of childbearing potential must use a male condom plus spermicide (condom
•alone in countries where spermicides are not approved) throughout this period.
•12 Non-sterilized male participants who intend to be sexually active with a
•female partner of childbearing potential must be surgically sterile or using an
•acceptable method of contraception (per protocol) from the time of screening
•throughout the total duration of the study and the drug washout period (90 days
•after the last dose of durvalumab, 180 days after the last dose of durvalumab +
•tremelimumab, or 4 months after the last dose of EV, whichever is longer) to
•prevent pregnancy in a partner. Male participants must not donate or bank sperm
•during this same time period.
•13 Capable of giving signed informed consent as described in protocol Appendix
•A 3, which includes compliance with the requirements and restrictions listed in
•the ICF and in the protocol.
•14 Provision of signed and dated written Optional Genetic Research Information
•informed consent prior to collection of sample for optional genetic research
•that supports Genomic Initiative.

排除标准

•1 Evidence of multiple lymph node (N2+) or metastatic TCC/UC, extravesical
•TCC/UC that invades the pelvic and/or abdominal wall for bladder cancer (T4b),
•or primary non bladder (ie, ureter, urethral, or renal pelvis) TCC/UC of the
•urothelium.
•2 Nephroureterectomy required per investigator at the time of randomization for
•tumor of the mid ureter, renal pelvis, or collecting system.
•3 Ureterectomy required if a ureteral tumor is present proximal to common
•iliacs in addition to planned cystectomy.
•4 History of allogeneic organ transplantation that requires use of
•immunosuppressive agents. Participants with a history of allogenic stem cell
•transplantation are also excluded.
•5 Active or prior documented autoimmune or inflammatory disorders (eg. Given
•per protocol). The following are exceptions to this criterion:
•* Participants with vitiligo or alopecia
•* Participants with hypothyroidism (eg, following Hashimoto syndrome) stable on
•hormone replacement
•* Any chronic skin condition that does not require systemic therapy
•* Participants without active disease in the last 5 years may be included but
•only after consultation with the Study Physician
•* Participants with celiac disease controlled by diet alone may be included but
•only after consultation with the Study Physician
•6 Uncontrolled intercurrent illness, including but not limited to, ongoing or
•active infection, symptomatic congestive heart failure, uncontrolled
•hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, active
•interstitial lung disease, serious chronic gastrointestinal conditions
•associated with diarrhea, or psychiatric illness/social situations that would
•limit compliance with study requirement, substantially increase risk of
•incurring AEs or compromise the ability of the participant to give written
•informed consent
•7 Ongoing sensor or motor neuropathy of CTCAE Grade 2 or higher
•8 Active keratitis or corneal ulcerations. Participants with superficial
•punctate keratitis are allowed if the disorder is being adequately treated in
•the opinion of the investigator.
•9 History of another primary malignancy except for
•* Prostate cancer of pathologic stage <= T2cN0M0 that has been previously
•treated without evidence of biochemical recurrence at time of study entry and
•who in the opinion of the investigator are not deemed to require active
•intervention at the present time, or participants with incidental histologic
•findings of prostate cancer that has not been treated prior to the study and
•who do not require specific therapy for prostate cancer beyond the surgery
•described in the protocol and also are considered to be at low risk for
•recurrence per the investigator
•* Malignancy treated with curative intent and with no known active disease >= 5
•years before the first dose of IP and of low potential risk for recurrence
•* Adequately treated non-melanoma skin cancer or lentigo maligna without
•evidence of disease
•* Adequately treated carcinoma in situ without evidence of disease
•10 History of active primary immunodeficiency
•11 Active infection including tuberculosis , hepatitis B, hepatitis C, or human
•immunodeficiency virus. Participants with a past or resolved hepatitis B
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研究者

发起方

Astra Zeneca

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