NL-OMON54181招募中2 期
Phase 2b Clinical Study Evaluating Efficacy and Safety of TAR-200 in Combination with Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants with High-Risk Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guerin (BCG) who are Ineligible for or Elected Not to Undergo Radical Cystectomy - SunRISe-1
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 9
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. Age >=18 years male or female (or the legal age of consent in the
- •jurisdiction in which the study is taking place) at the time of informed
- •consent 2. Histologically confirmed diagnosis of persistent or recurrent CIS
- •(or Tis), with or without papillary disease (T1, high-grade Ta) or papillary
- •disease only (high-grade Ta or any T1 and absence of CIS), within 12 months of
- •completion (last dose) of adequate BCG therapy, in patients who have received
- •adequate BCG 3. All visible papillary disease must be fully resected (absent)
- •prior to randomization (residual CIS acceptable for participants eligible for
- •Cohorts 1, 2, and 3 only) and documented in the eCRF at Screening cystoscopy.
- •For patients with papillary disease only (Cohort 4), local urine cytology at
- •screening must be negative or atypical (for HGUC). 4. Participants must be
- •willing to undergo all study procedures (e.g., multiple cystoscopies from
- •Screening through the end of study and TURBT/bladder biopsy for assessment of
- •recurrence/progression) 5. Participants must be ineligible for or have elected
- •not to undergo radical cystectomy 6. BCG-unresponsive high-risk NMIBC after
- •treatment with adequate BCG therapy defined as a minimum of 5 of 6 full doses
- •of an induction course (adequate induction) plus 2 of 3 doses of a maintenance
- •course, or at least 2 of 6 doses of a second induction course 7. All AEs
- •adverse events associated with any prior surgery and/or intravesical therapy
- •must have resolved to CTCAE version 5.0 Grade <2 prior to screening 8.
- •Participants must sign the informed consent form ICF indicating that he or she
- •understands the purpose of, and procedures required for, the study and is
- •willing to participate in the study and agree to store samples when applicable
- •9. Eastern Cooperative Oncology Group ECOG performance status Grade 0, 1, or 2
- •10. Adequate bone marrow, liver, and renal function (creatinine clearance >30
- •mL/min) 11. Contraceptive use by participants should be consistent with local
- •regulations regarding the use of contraceptive methods for participants
- •participating in clinical studies. Investigators will advise both male and
- •female participants on the options for banking of sperm and ova, respectively
- •for reproductive conservation a. A female participant must be either of the
- •following: i. Not of childbearing potential ii. Of childbearing potential and
- •practicing true abstinence, or have a sole partner who is vasectomized, or
- •practicing at least 1 highly effective user independent method of contraception
- •Participant must agree to continue the above throughout the study and for 6
- •months after the last dose of study treatment. Note: If a women becomes of
- •childbearing potential after start of the study, the woman must comply with
- •point ii, as described above. A female participant must also agree to not
- •donate eggs (ova, oocytes) or freeze for future use for the purposes of
- •assisted reproduction during the study and for at least 6 months after the last
- •dose of study drug, and not be breastfeeding (including participants
- •temporarily withholding breastfeeding) and not planning to become pregnant
- •during the study and for at least 6 months after the last dose of study drug.
- •Female participants should consider preservation of eggs prior to study
- •treatment as anti-cancer treatments may impair fertil
排除标准
- •1. Presence or history of histologically confirmed, muscle-invasive, locally
- •advanced, nonresectable, or metastatic urothelial carcinoma (ie,T2,T3,T4,
- •and/or Stage IV).
- •2. Must not have had urothelial carcinoma or histological variant at any site
- •outside of the urinary bladder. Ta/T1/CIS of the upper urinary tract (including
- •renal pelvis and ureter) is allowable if treated with complete
- •nephrouretrectomy more than 24 months prior to randomization.
- •3. Active malignancies (ie progressing or requiring treatment change in the
- •last 24 months prior to randomization) other than the disease being treated
- •under study:
- •a. skin cancer (non-melanoma or melanoma) that is considered completely cured
- •b. non-invasive cervical cancer that is considered completely cured
- •c. adequately treated lobular carcinoma in situ (LCIS) and ductal CIS
- •d. history of localized breast cancer and receiving antihormonal agents
- •e. history of localized prostate cancer (N0M0) and receiving androgen
- •deprivation therapy
- •f. Localized prostate cancer (N0M0)
- •4. Presence of any bladder or urethral anatomic feature (eg. urethral
- •stricture) that may prevent the safe insertion, indwelling use, or removal of
- •TAR-200, or passage of a urethral catheter for intravesical chemotherapy, or
- •administration of intravesical BCG. Participants with tumors involving the
- •prostatic urethra in men will be excluded.
- •5. Evidence of bladder perforation during diagnostic cystoscopy.
- •6. Bladder post-void residual (PVR) volume >350mL at Screening after second
- •voided urine.
- •7. No history of acute ischemic heart disease within 30 days of cohort
- •assignment, or history of uncontrolled cardiovascular disease.
- •8. A history of clinically significant polyuria with recorded 24-hour urine
- •volumes greater than 4000 mL.
- •9. Received a live virus vaccine within 30 days of planned start of study
- •treatment. Inactivated (non-live or non-replicating) vaccines approved or
- •authorized for emergency use (eg, COVID-19) by local health authorities are
- •10. Active infection requiring systemic IV therapy within 14 days prior to
- •randomization.
- •11. Currently participating or has participated in a study of an
- •investigational agent and received study therapy or investigational device
- •within 4 weeks prior to screening.
- •12. Indwelling catheters are not permitted; however, intermittent
- •catheterization is acceptable.
- •13. Received serial intervening intravesical chemotherapy or immunotherapy from
- •the time of pre-screening or screening cystoscopy/TURBT to starting study
- •treatment. Peri-operative intravesical chemotherapy prior to study is allowed
- •per institutional guidelines.
- •14. Prior therapy with an anti-programmed -cell death 1, anti-PD-ligand 2
- •agent, or with an agent directed to another co-inhibitory T-cell receptor.
- •15. Not recovered from toxicity of prior anticancer therapy (except toxicities
- •which are not clinically significant such as alopecia, skin discoloration).
- •16. No clinically significant liver disease that precludes participant
- •treatment regimens prescribed on the study.
- •17. Human immunodeficiency virus (HIV) infection, unless the participant has
- 另有 3 项未显示
研究者
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