A Study of Adjuvant NDV-01 (Sustained-release Gemcitabine-docetaxel) for the Treatment of Intermediate Risk NMIBC Following TURBT

NCT ID: NCT07313891

Last Updated: 2026-01-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 302 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-05-01
• Study Completion Date: 2029-11-01

Brief Summary

This is a Phase 3, open-label, randomized trial designed to evaluate the DFS of TURBT followed by NDV-1 (sustained-release gemcitabine-docetaxel) versus TURBT followed by surveillance for the treatment of participants with IR-NMIBC.

Detailed Description

Participants will be randomized 1:1 to NDV-1 (sustained-release gemcitabine-docetaxel) after TURBT (Arm A) vs surveillance after TURBT (Arm B).

Participants in Arm A will receive an induction course and then monthly maintenance courses of NDV-1 (sustained-release gemcitabine-docetaxel) through Month 12, if there is no disease recurrence.

Disease status will be assessed using urine cytology, cystoscopy, and directed TURBT/biopsy (if indicated) every 3 months for the first 2 years after randomization and then every 6 months for an additional year or until disease recurrence.

Participants in Arm B who recur with IR-NMIBC after TURBT and surveillance will be offered treatment with NDV-1 (sustained-release gemcitabine-docetaxel) as per the treatment schedule in Arm A.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A: NDV-01 (sustained-release gemcitabine-docetaxel)

Intervention with NDV-01 (sustained-release gemcitabine-docetaxel)

Group Type: EXPERIMENTAL

NDV-01 (sustained-release gemcitabine-docetaxel)

Intervention Type: DRUG

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

Arm B: surveillance

Surveillance with Cystoscopy, Urine Cytology, Biopsy (if indicated)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

NDV-01 (sustained-release gemcitabine-docetaxel)

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Have a histologically confirmed diagnosis (within 90 days of randomization) of IR NMIBC based on the AUA/SUO criteria of IR NMIBC.

2. Participants must have ≥ 1 IBCG risk factors: multiple tumors, early recurrence (Within 1 year), frequent recurrences (> 1 per year), tumor size (> 3 cm), failure of prior intravesical therapy.

3. 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 assessment method).

4. Patients with LG T1 may be eligible after repeat-TURBT (within 4 weeks of first TURBT) if the repeat pathology shows non-invasive (Ta or less) or no disease. Original and repeat-TURBT must confirm that muscularis propria is present and uninvolved in the specimen. TURBT to occur within 4 months of screening. All pathology specimens must be predominantly urothelial (transitional cell) and have less than 20% variant (e.g., sarcomatoid, squamous component) histology.

Exclusion Criteria

1. Histologically confirmed diagnosis of HR NMIBC (including CIS) or MIBC, locally advanced, nonresectable, or metastatic urothelial carcinoma at any time prior to enrollment.

2. Has had urothelial carcinoma outside of the urinary bladder, (including prostatic 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.

3. Participant has tumor(s) involving the prostatic urethra (ductal or stromal).

4. N+ and/or M+ per CT/MR urography.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Relmada Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Raj S Pruthi, MD MHA

Role: STUDY_DIRECTOR

Relmada Therapeutics

Central Contacts

Scott White, MPH

Role: CONTACT

swhite@relmada.com

+16464285264

Paul Greene

Role: CONTACT

pgreene@relmada.com

+15129691739

References

Tan WS, McElree IM, Davaro F, Steinberg RL, Bree K, Navai N, Dinney CP, O'Donnell MA, Li R, Kamat AM, Packiam VT. Sequential Intravesical Gemcitabine and Docetaxel is an Alternative to Bacillus Calmette-Guerin for the Treatment of Intermediate-risk Non-muscle-invasive Bladder Cancer. Eur Urol Oncol. 2023 Oct;6(5):531-534. doi: 10.1016/j.euo.2023.06.011. Epub 2023 Jul 18.

Reference Type: RESULT

PMID: 37468392 (View on PubMed)

Holzbeierlein JM, Bixler BR, Buckley DI, Chang SS, Holmes R, James AC, Kirkby E, McKiernan JM, Schuckman AK. Diagnosis and Treatment of Non-Muscle Invasive Bladder Cancer: AUA/SUO Guideline: 2024 Amendment. J Urol. 2024 Apr;211(4):533-538. doi: 10.1097/JU.0000000000003846. Epub 2024 Jan 24.

Reference Type: RESULT

PMID: 38265030 (View on PubMed)

Related Links

https://www.auanet.org/guidelines-and-quality/guidelines/bladder-cancer-non-muscle-invasive-guideline

AUA/SUO Guidelines for NMIBC

Other Identifiers

REL-NDV01-301

Identifier Type: -

Identifier Source: org_study_id