2023-506146-23-00
尚未招募
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- Guérin (BCG) who are Ineligible for or Elected Not to Undergo Radical Cystectomy
概览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 130
- 试验地点
- 46
- 主要终点
- Overall CR rate will be measured by determining the proportion of participants without presence of high-grade disease using results from cystoscopy and centrally read urine cytology at any timepoint
概览
简要总结
To evaluate the overall Complete Response (CR) rate in participants treated with TAR-200 in combination with IV cetrelimab (Cohort 1), or TAR-200 alone (Cohort 2), or IV cetrelimab alone (Cohort 3) with Carcinoma in Situ (CIS) with or without concomitant high-grade Ta or T1 papillary disease. To evaluate DFS in participants treated with TAR-200 alone with papillary disease only (Cohort 4 only).
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •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
- •Adequate bone marrow, liver, and renal function (creatinine clearance >30 mL/min)
- •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 fertility. Investigators will advise female participants on the options of banking of ova for reproductive conservation. b. A male participant must wear a condom (with or without spermicidal foam/gel/film/cream/suppository) when engaging in any activity that allows for passage of ejaculate to another person during the study and for a minimum of 6 months after receiving the last dose of study treatment. His female partner, if of childbearing potential, must also be practicing a highly effective method of contraception. If the male participant is vasectomized, he still must wear a condom (with or without spermicidal foam/gel/film/cream/suppository), but his female partner is not required to use contraception. Male participants should consider preservation of sperm prior to study treatment as anticancer treatments may impair fertility. Investigators will advise male participants on the options for banking of sperm for reproductive conservation. A male participant must also agree to not donate sperm for the purpose of reproduction during the study and for at least 6 months after the last dose of study drug, and not plan to father a child while enrolled in this study or within 6 months after the last dose of study drug.
- •A female participant of childbearing potential must have a negative serum test at screening and a negative urine test within 72hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study, that may exceed those listed in the Schedule of Activities
- •Participants must be willing and able to adhere to the lifestyle restrictions specified in this protocol
- •Histologically confirmed diagnosis of persistent or recurrent HRNMIBC, CIS (OR Tis) [AJCC, 2017], 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 of the last dose of BCG therapy, in patients who have received adequate BCG
- •All visible papillary disease must be fully resected (absent) prior to randomization (residual CIS is 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)
- •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)
- •Participants must be ineligible for or have elected not to undergo radical cystectomy
- •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
排除标准
- •Presence or history of histologically confirmed, muscle-invasive, locally advanced, nonresectable, or metastatic urothelial carcinoma (i.e., T2, T3, T4, and/or Stage IV)
- •Active infection requiring systemic IV therapy within 14 days prior to randomization
- •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
- •Indwelling catheters are not permitted; however, intermittent catheterization is acceptable
- •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
- •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
- •Not recovered from toxicity of prior anticancer therapy (except toxicities which are not clinically significant such as alopecia, skin discoloration)
- •No clinically significant liver disease that precludes participant treatment regimens prescribed on the study
- •Human immunodeficiency virus (HIV) infection, unless the participant has been on a stable anti-retroviral therapy regimen for the last 6 months or more prior to randomization and has had no opportunistic infections and a CD4 count of >350 in the last 6 months
- •Active hepatitis B or C infection (for example, participants with history of hepatitis C infection but undetectable hepatitis C virus PCR test and participants with history of hepatitis B infection with positive HBsAg antibody and undetectable PCR are allowed)
结局指标
主要结局
Overall CR rate will be measured by determining the proportion of participants without presence of high-grade disease using results from cystoscopy and centrally read urine cytology at any timepoint
Overall CR rate will be measured by determining the proportion of participants without presence of high-grade disease using results from cystoscopy and centrally read urine cytology at any timepoint
Cohort 4 only: DFS will be measured as the time from the date of first dose of study treatment to either the time of the first recurrence of highrisk disease, progression, or death due to any cause, whichever occurs first.
Cohort 4 only: DFS will be measured as the time from the date of first dose of study treatment to either the time of the first recurrence of highrisk disease, progression, or death due to any cause, whichever occurs first.
次要结局
- DOR is defined as the date of first CR achieved to the date of first evidence of recurrence or progression or death, using cystoscopy, centrally read bladder biopsy and urine cytology, and imaging, if available. Twelve month DOR will be determined
- OS, defined as the time from the date of first dose of study treatment to death; if a participant has not died at the time of analysis, the participant will be censored at the date last known alive
- Gemcitabine and dFdU concentrations in urine and plasma
- Serum concentration and incidence of anti-cetrelimab antibodies
- Change from baseline and time to symptom deterioration in EORTC QLQ-C30 and EORTC QLQ-NMIBC24
- Frequency and grade of adverse events (AEs) (according to Common Terminology Criteria for Adverse Events [CTCAE] version 5)
- Laboratory abnormalities: CTCAE grades comparing baseline to the worst post-baseline value; other safety data, such as vital signs, will be considered as appropriate
研究者
CTIS point of Contact
Scientific
Janssen - Cilag International
研究点 (46)
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