[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Relmada Therapeutics, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":74},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":4},"100628630","phase-3-a-study-of-ndv-01-sustained-release-gemcitabine-docetaxel-in-participants-with-non-muscle-invasive-bladder-cancer-100628630",false,"NCT07464145","A Study of NDV-01 (Sustained-release Gemcitabine-docetaxel) in Participants With Non-muscle Invasive Bladder Cancer","A Phase 3 Study Evaluating the Efficacy and Safety of NDV-01 in Participants With Non-muscle Invasive Bladder Cancer (RESCUE)","RESCUE","Cohort 1 Inclusion Criteria:\n\n1. Be ≥18 years of age (or the legal age of majority in the jurisdiction in which the study is taking place) at the time of informed consent.\n2. Have a histologically confirmed diagnosis (within 90 days of randomization) of IR NMIBC based on the AUA\u002FSUO criteria of IR NMIBC (excluding LGT1 tumors).\n3. Participant must be willing to undergo all study procedures (e.g., multiple cystoscopies from Screening through the end of study and TURBT for assessment of recurrence\u002Fprogression) and receive the assigned treatment, including intravesical chemotherapy if randomized into that arm.\n4. Participant must have ≥ 1 IBCG risk factors: 1) multiple tumors, 2) early recurrence (within 1 year), 3) frequent recurrences (\\> 1 per year), 4) tumor size (\\> 3 cm), 5) failure of prior induction intravesical therapy.\n5. Visible papillary disease must be fully resected prior to randomization, and absence of disease must be documented at Screening cystoscopy. The same method for visualizing disease at Screening cystoscopy should be used throughout for the participant (white light versus enhanced cystoscopic method \\[e.g., blue light cystoscopy, narrow-band imaging\\]).\n\n   All pathology specimens must be predominantly urothelial (transitional cell) and have less than 20% variant (e.g., sarcomatoid, squamous component) histology.\n6. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.\n\nCohort 1 Exclusion Criteria:\n\n1. Histologically confirmed stage T1 tumors.\n2. Histologically confirmed diagnosis of HR NMIBC (including CIS) or muscle-invasive bladder cancer (MIBC), locally advanced, nonresectable, or metastatic urothelial carcinoma at any time prior to enrollment.\n3. Has had urothelial carcinoma outside of the urinary bladder (including prostatic urethra, ureter, or renal pelvis) or has a predominant histological variant of urothelial carcinoma (UC). Ta\u002Fany T1, CIS of the upper urinary tract is allowable if treated with complete nephroureterectomy more than 24 months prior to initiating study.\n4. Participant has tumor(s) involving the prostatic urethra (ductal or stromal).\n5. N+ and\u002For M+ per computed tomography (CT)\u002Fmagnetic resonance (MR) urography.\n6. Received an investigational treatment for bladder cancer within 6 months prior to randomization, before the planned first dose of study treatment, or is currently enrolled in an investigational study.\n7. Received adjuvant induction intravesical chemotherapy within 3 months of current diagnosis. Peri-operative instillation of a single dose of intravesical chemotherapy is allowed per institutional guidelines.\n8. Received prior intravesical treatment with immunotherapy, including BCG, within 3 months prior to randomization.\n\nCohort 2 Inclusion Criteria:\n\n1. Cohort 2a: BCG-unresponsive NMIBC with CIS of the bladder, with or without coexisting papillary Ta\u002FT1 tumor(s) who are ineligible for or have elected not to undergo cystectomy at the time of enrollment and have received 1 or 2 lines of therapy after meeting criteria for BCG unresponsiveness and experienced biopsy confirmed CIS disease within 12 months of last treatment, where:\n\n   * Adequate BCG regimen consists of at least 2 courses of BCG, where the first course (induction) must have included at least 5 of 6 doses and the second course may have included a re-induction (at least 2 of 6 treatments) or maintenance (at least 2 of 3 doses). Adequacy of the BCG regimen will be determined by the Investigator in conjunction with the Sponsor.\n   * Treatment after BCG unresponsiveness includes either approved or in development therapy\n   * Post-treatment presence of CIS must be documented or indicated by pathology at screening or within 4 months of screening (provided no therapy for CIS disease was given after the most recent biopsy).\n   * For inclusion, a participant with BCG-unresponsive disease (as defined above) must have received up to two lines of therapy for BCG-unresponsive disease and who are being considered for radical cystectomy. Such therapies may include agents approved or in development (e.g., pembrolizumab, nadofaragene firodenovec, nogapendekin alfa inbakicept-pmln, cretostimogene grenadenorepvec, detalimogene voraplasmid, TARA-002, gemcitabine intravesical system (INLEXZO®), gemcitabine-docetaxel, gemcitabine, MMC, or valrubicin monotherapy. Participant will have demonstrated biopsy-proven recurrence with HG papillary disease (without CIS) after one or two first-line therapy(ies).\n2. Cohort 2b: BCG-unresponsive NMIBC of the bladder, with papillary Ta\u002FT1 tumor(s) and without co-existing CIS, who are ineligible for or have elected not to undergo cystectomy at the time of enrollment and have experienced recurrent Ta\u002FT1 disease within 12 months of treatment with 1 or 2 lines of therapy after BCG-unresponsive status.\n\n   * For inclusion, a participant with BCG-unresponsive disease (as defined above) must have received up to two lines of therapy for BCG-unresponsive disease and who are being considered for radical cystectomy. Such therapies may include agents approved or in development (e.g., pembrolizumab, nadofaragene firodenovec, nogapendekin alfa inbakicept-pmln, cretostimogene grenadenorepvec, detalimogene voraplasmid, TARA-002, gemcitabine intravesical system (INLEXZO®), gemcitabine-docetaxel, gemcitabine, MMC, or valrubicin monotherapy. Participant will have demonstrated biopsy-proven recurrence with HG papillary disease (without CIS) after one or two first-line therapy(ies).\n\nAll Cohort 2\n\n1. A participant with HG T1 may be eligible after repeat-TURBT showing non-invasive (Ta or less) or no disease. Either original or repeat-TURBT must confirm that muscularis propria is present and uninvolved in the specimen.\n2. All specimens must be predominantly urothelial (transitional cell) carcinoma with or without squamous or glandular differentiation. Pure squamous or glandular tumors will not be included. A participant with less than 10% micropapillary histology will be included. All other variant histology (e.g., plasmacytoid, small cell, nested, trophoblastic variants) will not be included.\n\nCohort 2 Exclusion Criteria:\n\n1. Has had urothelial carcinoma outside of the urinary bladder (i.e., urethra, ureter, or renal pelvis) or has a predominant histological variant of UC. Ta\u002Fany T1, CIS of the upper urinary tract is allowable if treated with complete nephroureterectomy more than 24 months prior to initiating study and is considered to be without evidence of recurrent disease.\n\n   * Participants have tumor(s) involving the prostatic urethra (ductal or stromal).\n   * N+ and\u002For M+ per computerized tomography (CT)\u002FMagnetic Resonance Imagery (MR) urography.\n2. History of prior T2\u002FT3 urothelial carcinoma of the bladder.\n3. Concurrent treatment with any chemotherapeutic agent.\n4. Intravesical chemotherapy within 3 months of enrollment (including INLEXZO®, gemcitabine-docetaxel)","ALL","18 Years",{"count":20,"type":21},393,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","Study REL-NDV01-303 is a Phase 3, open-label, multi-center study to determine the safety and efficacy of NDV-01 in adult participants with NMIBC. The study will include two cohorts:\n\n* Cohort 1: a randomized, open-label, parallel group, multi-center, Phase 3 study evaluating the efficacy and safety of the NDV-01 versus observation in participants with histologically confirmed IR-NMIBC.\n* Cohort 2: an open-label, multi-center, single-arm Phase 3 study evaluating the efficacy and safety of the NDV-01 in two populations of high-risk NMIBC:\n\n  * Cohort 2a: will include participants with HR-NMIBC who have a biopsy-proven recurrence with CIS ± papillary disease after receiving one or 2 lines of therapy for BCG-unresponsive NMIBC (approved or in development).\n  * Cohort 2b: will include participants with high-risk papillary-only disease (without CIS) NMIBC who have a biopsy-proven recurrence with HG papillary disease after receiving one or 2 lines of therapy for BCG-unresponsive NMIBC (approved or in development).\n\nThis study will evaluate the safety and efficacy of intravesical administration of NDV-01, and its effect on disease recurrence and progression in patients with NMIBC who have IR disease and have recently undergone a TURBT (Cohort 1) and in patients who have HR BCG-unresponsive disease and who have recurred after first-line therapy for BCG-unresponsive patients - both approved and in development - and are unwilling or unable to undergo radical cystectomy (Cohort 2). Both GEM and DOCE have established safety and efficacy across a range of tumor types, including IR and BCG-unresponsive NMIBC. By combining both GEM and DOCE in an intravesical extended-release formulation, Relmada believes that NDV-01 has the potential to be an agent for second-line therapy in patients who have recurred after first-line therapy in BCG-unresponsive disease, thereby avoiding radical cystectomy. This study will serve as a master protocol for all cohorts included in the study.",[27,28,29,30,31],"Bladder (Urothelial, Transitional Cell) Cancer","Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive)","Urothelial Carcinoma Bladder","Urothelial Carcinoma Recurrent","Urologic Cancer",[33,34,35],"NMIBC","non-muscle-invasive bladder cancer","bladder cancer","NOT_YET_RECRUITING","2026-03-05",{"date":39,"type":40},"2026-03-11","ACTUAL",{"date":42,"type":21},"2026-06",{"date":44,"type":21},"2032-09",{"name":46,"class":47},"Relmada Therapeutics, Inc.","INDUSTRY",{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},"100567050","phase-2-open-label-study-to-evaluate-the-safety-and-efficacy-of-ndv01-kit-in-high-grade-nmibc-100567050","NCT06663137","Open Label Study to Evaluate the Safety and Efficacy of NDV01 KIT in High Grade NMIBC","An Open Label, Single Arm Study, to Evaluate the Safety and Efficacy of NDV01 KIT in Patients With High Grade Non Muscle Invasive Bladder Cancer (NMIBC)","HGNMIBC","Subjects may participate in the study if they meet all the following criteria:\n\nInclusion criteria:\n\n* Aged 18 - 80 years old\n* Able to give informed consent\n* Histologically confirmed diagnosis of high grade non-muscle invasive bladder cancer (NMIBC) - patients having high-grade disease at first evaluation after induction BCG alone (at least 5 of 6 doses) may qualify in the absence of disease progression.\n* Participants must be ineligible for or have elected not to undergo radical cystectomy.\n* Available for the whole duration of the study.\n* Life expectancy \\>2 years, in the opinion of the investigator.\n* Eastern Cooperative Oncology Group (ECOG) status 2 or less.\n* Absence of concomitant upper tract urothelial carcinoma or urothelial carcinoma within the prostatic urethra. Freedom from upper tract disease (if clinically indicated) as indicated by no evidence of upper tract tumor by either intravenous pyelogram, retrograde pyelogram, computed tomography (CT) scan with or without urogram, or MRI with or without urogram performed within 6 months of enrolment.\n* Patients with prostate cancer on active surveillance at low risk for progression, defined as Prostate-Specific Antigen (PSA) \\\u003C 10 ng\u002FdL, Gleason score 6 and clinical stage tumor-1 (cT1) are permitted to be in the study at the discretion of the investigator (see exclusion criterion 10).\n* Female patients of childbearing potential must use maximally effective birth control during the period of therapy, must be willing to use contraception for 1 month following the last study drug infusion and must have a negative urine or serum pregnancy test upon entry into this study. Otherwise, female patients must be postmenopausal (no menstrual period for a minimum of 12 months) or surgically sterile. 'Maximally effective birth control' means that the patient, if sexually active, should be using a combination of two methods of birth control that are approved and recognized to be effective by Regulatory Agencies.\n\nExclusion criteria:\n\n* Current or previous evidence of muscle invasive (muscularis propria) or metastatic disease presented. Examples that increase the risk of metastatic disease are (but not limited to):\n* Presence of lymphovascular invasion and\u002Fmicropapillary disease as shown in the histology of the biopsy sample.\n* Patients with T1 disease accompanied by the presence of hydronephrosis secondary to the primary tumor - Unless scheduled for treatment like nephrostomy or JJ stent insertion..\n* Current systemic therapy for bladder cancer.\n* Symptomatic urinary tract infection or bacterial cystitis (once satisfactorily treated, patients can enter the study).\n* Clinically significant and unexplained elevated liver or renal function tests.\n* Women who are pregnant or lactating or refuse to commit to using contraception anytime during the study.\n* Any other significant disease or other clinical findings which in the investigator's opinion would prevent study entry.\n* History of malignancy of other organ system within past 5 years, except treated basal cell carcinoma or squamous cell carcinoma of the skin and ≤ pathological tumor-2 (pT2) upper tract urothelial carcinoma at least 24 months after nephroureterectomy.","80 Years",{"count":58,"type":21},70,[60],"PHASE2","This is a prospective, single-arm study evaluating the safety and efficacy of NDV01 KIT, a fixed-dose combination of gemcitabine HCl and docetaxel, administered via intravesical instillation in patients with high-grade Non-Muscle Invasive Bladder Cancer (NMIBC). NDV01 KIT includes 60 mL Carbopol Gel followed by 15 g NDV01 solution (gemcitabine HCl 1000 mg and docetaxel 40 mg), administered biweekly for six treatments, followed by monthly maintenance therapy for up to 12 months. The study includes a pharmacokinetic (PK) sub-study assessing systemic exposure to NDV01's active ingredients.",[63],"Non Muscle Invasive Bladder Cancer","RECRUITING","2025-06-10",{"date":67,"type":40},"2025-06-13",{"date":69,"type":40},"2024-08-01",{"date":71,"type":21},"2026-08",{"name":46,"class":47},1,""]