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 Unresponsive to Intravesical Bacillus Calmette-Guérin who are Ineligible for or Elected Not to Undergo Radical Cystectomy
- Conditions
- on-Muscle-Invasive Urothelial Carcinoma (NMIBC) of the BladderMedDRA version: 20.0Level: LLTClassification code: 10046714Term: Urothelial carcinoma bladder Class: 10029104Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-506146-23-00
- Lead Sponsor
- Janssen - Cilag International
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 210
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
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), Concurrent urinary tract infection, defined as a symptomatic infection with a positive urine culture with a bacterial count of =10^5 colony forming units (CFU)/mL in urine voided from women, or >10^4 CFU/mL in urine voided from men, or in straight-catheter urine from women, No 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 nephroureterectomy more than 24 months prior to randomization, Known hypersensitivity to gemcitabine (or other drug excipients) or chemically-related drugs, Known hypersensitivity to the TAR-200 device constituent or the (TAR-200) UPC materials, Evidence of radiographic features associated with pulmonary fibrosis/advanced interstitial lung disease or active non-infectious pneumonitis, Participants must not have active tuberculosis, Major surgery within 4 weeks before screening (TURBT is not considered major surgery), Any condition for which participation would not be in the best interest of the participants or that could prevent, limit, or confound the protocol-specified assessments, 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 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), Presence of any bladder or urethral
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method