A Study of NDV-01 as an Intravesical Administration to Patients With BCG-Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC), Refractory to First-line Therapy

NCT07342517 | Withdrawn Phase 3 DMC FDA Drug

• 1 other identifier: REL-NDV01-302
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a Phase 3, open-label single-arm trial designed to evaluate the safety and efficacy of NDV-01 (sustained-release gemcitabine-docetaxel) in adult participants with NMIBC with CIS who have failed BCG therapy and who have failed first-line therapy for BCG-unresponsive NMIBC (approved or in development) and are recommended for radical cystectomy.

Conditions

Bladder (Urothelial, Transitional Cell) Cancer; Urothelial Carcinoma Bladder; Urothelial Carcinoma Recurrent; Urologic Cancer; Bladder (Urothelial, Transitional Cell) Cancer Superficial (Non-Invasive)

Outcome Measures

Primary Outcomes (1)

• To evaluate the efficacy of NDV-01 (determined by complete response [CR] anytime) administered by intravesical instillation in patients with BCG-unresponsive NMIBC who have recurred after first-line intravesical therapy (approved or in development).

  Percentage of participants with CR at anytime based on cystoscopy, urine cytology, and biopsies. Protocol-driven mapping biopsies (as assessed by central pathology) will be performed at 12 months

  12 months

Study Arms (1)

NDV-01 (sustained-release gemcitabine-docetaxel)

EXPERIMENTAL

Drug: NDV-01 (sustained-release gemcitabine-docetaxel) Description: Intravesical instillation of NDV-01 (sustained-release gemcitabine-docetaxel)

Drug: NDV-01 (sustained-release gemcitabine-docetaxel)

Interventions

NDV-01 (sustained-release gemcitabine-docetaxel) DRUG

Intravesical instillation of NDV-01 (sustained-release gemcitabine-docetaxel)

NDV-01 (sustained-release gemcitabine-docetaxel)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• BCG-unresponsive NMIBC with CIS of the bladder, with or without coexisting papillary Ta/T1 tumor(s) who are ineligible for or have elected not to undergo cystectomy at the time of enrollment and have experienced 1) CIS disease within 12 months of treatment.
• Participants with BCG-unresponsive disease must have received up to two first-line therapies or BCG-unresponsive disease and who are recommended 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, MMC, or valrubicin monotherapy. Participants will have demonstrated recurrence or intolerance after one or two first-line therapy(ies).
• 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. Participants 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.

You may not qualify if:

• \- 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/any T1, CIS of the upper urinary tract is allowable if treated with complete nephroureterectomy more than 24 months prior to initiating study: Participant has tumor(s) involving the prostatic urethra (ductal or stromal); N+ and/or M+ per computerized tomography (CT)/Magnetic Resonance Imagery (MR) urography. History of prior T2/T3 urothelial carcinoma of the bladder.

Sponsors & Collaborators

• Relmada Therapeutics, Inc.: lead

Related Publications (1)

• Steinberg RL,Thomas LJ,O'Donnell MA,Nepple KG

  BACKGROUND

Related Links

• AUA/SUO Guidelines for NMIBC

MeSH Terms

Conditions

Neoplasms; Urologic Neoplasms

Condition Hierarchy (Ancestors)

Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A Phase 3, Open-label Single-arm Study of NDV-01

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: January 15, 2026
• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: March 17, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share