Intravesical GEM/DOCE for HR BCG-Unresponsive NMIBC

NCT07322263 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 202508227
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn whether a combination of two chemotherapy drugs, Gemcitabine and Docetaxel, can treat high-grade non-muscle-invasive bladder cancer (HG-NMIBC) in adults whose cancer failed conventional BCG therapy. The drugs are given directly into the bladder (intravesically), one immediately after the other. The study will also assess the safety of this treatment. The main questions it aims to answer are: Can this drug combination effectively treat HG-NMIBC that did not respond to BCG and help prevent the cancer from coming back, offering long-term protection? What side effects or medical issues do participants experience during treatment? Researchers will evaluate this non-surgical approach as a potential alternative to bladder removal surgery (radical cystectomy), with the goal of validating it as a bladder-sparing option in this setting. Participants will:

• Go through a screening process, including tumor removal and imaging tests
• Receive weekly bladder treatments with Gemcitabine followed by Docetaxel for 6 weeks
• If the cancer responds, continue with similar once monthly treatments (maintenance therapy) for up to 2 years
• Attend regular check-ups, including bladder exams, urine tests, biopsies, and optional quality-of-life surveys
• Possibly receive a second 6-week treatment cycle if the cancer returns early
• Be followed for up to 5 years to monitor long-term outcomes

Conditions

High-Grade Papillary Bladder Tumors; BCG-Unresponsive Bladder Cancer; Ta Stage Bladder Cancer; T1 Stage Bladder Cancer; BCG-Refractory Bladder Cancer; High-Risk NMIBC; Bladder Cancer; Non-Muscle Invasive Bladder Cancer (NMIBC); Urothelial Carcinoma; Carcinoma in Situ (CIS); Micropapillary Variant Urothelial Carcinoma (Favorable Subtype)

Keywords

Non-Muscle Invasive Bladder Cancer (NMIBC); Urothelial Carcinoma; Carcinoma in Situ (CIS); High-Grade Papillary Bladder Tumors; BCG-Unresponsive Bladder Cancer; Intravesical Chemotherapy; Gemcitabine; Docetaxel; Sequential Gemcitabine and Docetaxel; Bladder-Sparing Therapy; Radical Cystectomy Alternative; Prospective Cohort Study; Recurrence-Free Survival; Progression-Free Survival; Cystectomy-Free Survival; Cancer-Specific Survival; Quality of Life (QoL); FDA-Defined BCG Unresponsive Criteria; ECOG Performance Status; Multicenter International Trial; Bladder Preservation

Outcome Measures

Primary Outcomes (2)

• Efficacy of Intravesical Gemcitabine/Docetaxel in BCG-Unresponsive Carcinoma In Situ NMIBC

  To determine the efficacy of intravesical Gemcitabine/Docetaxel in patients with BCG-unresponsive carcinoma in situ (CIS) urothelial bladder carcinoma, as measured by the complete response (CR) rate (%) at approximately 3 months. CR will be determined through mandatory cystoscopy, urine cytology, and biopsy for those with CIS.

  3 months

• Efficacy of Intravesical Gemcitabine/Docetaxel in BCG-Unresponsive Papillary NMIBC

  To determine the efficacy of intravesical Gemcitabine/Docetaxel in patients with BCG-unresponsive papillary urothelial bladder carcinoma, as measured by high-grade recurrence-free survival (HG RFS) rate (%) at approximately 3 months. Non-positive cytology and non-suspicious visual cystoscopic findings will determine lack of HG disease for subjects entering this study with papillary tumors (HG Ta T1).

  3 months

Secondary Outcomes (7)

• Long-Term Efficacy of Intravesical Sequential Gemcitabine/Docetaxel in BCG-Unresponsive NMIBC

  Up to 60 months (5 years) from initiation of treatment, with key evaluations at 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, and 60 months

• Long-Term Efficacy of Intravesical Sequential Gemcitabine/Docetaxel in BCG-Unresponsive NMIBC

  Up to 60 months (5 years) from initiation of treatment, with key evaluations at 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, and 60 months

• Long-Term Efficacy of Intravesical Sequential Gemcitabine/Docetaxel in BCG-Unresponsive NMIBC

  Up to 60 months (5 years) from initiation of treatment, with key evaluations at 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, and 60 months

• Long Term Efficacy of Intravesical Sequential Gemcitabine/Docetaxel in BCG-Unresponsive NMIBC

  Up to 60 months (5 years) from initiation of treatment, with key evaluations at 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, and 60 months

• Long-Term Efficacy of Intravesical Sequential Gemcitabine/Docetaxel in BCG-Unresponsive NMIBC

  Up to 60 months (5 years) from initiation of treatment, with key evaluations at 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, and 60 months

Other Outcomes (6)

• Safety of Intravesical Sequential Gemcitabine/Docetaxel in BCG-Unresponsive NMIBC: Adverse Event Analysis

  Up to 60 months (5 years) from initiation of treatment, with key evaluations at 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, and 60 months

• Safety of Intravesical Sequential Gemcitabine/Docetaxel in BCG-Unresponsive NMIBC: Adverse Event Analysis

  Up to 60 months (5 years) from initiation of treatment, with key evaluations at 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, and 60 months

• Change in Health-Related Quality of Life Measured by FACT-Bladder (FACT-Bl)

  Up to 60 months (5 years), with assessments at baseline, Week 6 of induction, and at key evaluation points: 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, and 60 months.

Study Arms (2)

Arm A

EXPERIMENTAL

High-grade non-muscle-invasive bladder cancer (HG NMIBC) with carcinoma in situ (CIS), either as pure CIS or concurrent with papillary tumors.

Drug: Intravesical Gemcitabine and Docetaxel

Arm B

EXPERIMENTAL

High-grade non-muscle-invasive bladder cancer (HG NMIBC) with high-grade papillary tumors (stages Ta and/or T1) without carcinoma in situ (CIS).

Drug: Intravesical Gemcitabine and Docetaxel

Interventions

Intravesical Gemcitabine and Docetaxel DRUG

Sequential intravesical administration of Gemcitabine (1000mg) followed by Docetaxel (37 mg), delivered via sterile urethral catheter. Each drug is retained in the bladder for 60 minutes per instillation. The treatment consists of a 6-week induction phase (weekly instillations), followed by a 24-month maintenance phase (monthly instillations). This regimen is designed for patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC), including carcinoma in situ (CIS) and high-grade papillary tumors (Ta/T1). The study evaluates efficacy, tolerability, and bladder preservation outcomes.

Arm A; Arm B

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed diagnosis of urothelial carcinoma of the bladder without synchronous or metachronous upper tract involvement or prostatic urethral involvement. Subjects with negative upper tract imaging within 6 months of the study start and visually normal prostates are potentially eligible. Those with a history of suspicious upper tract cytology or suspicious prostatic urethra visually will require additional upper tract washes and/or biopsies to rule out concurrent extravesical disease.
• Eligible bladder cancer presentations include:
• Carcinoma in situ (CIS), with or without non-muscle-invasive stage Ta or T1 tumors of any grade.
• High-Grade Papillary tumors (stages Ta and/or T1) without CIS.
• All visible bladder tumors must be completely resected within 8 weeks prior to initiating intravesical Gem/Doce therapy.
• If more than 8 weeks have passed since diagnosis or resection of index bladder CIS ± non-invasive tumor (pTa or T1 tumors), an office cystoscopy must be performed within 8 weeks of Gem/Doce initiation to confirm no visible tumor regrowth.
• BCG-Unresponsive Disease as defined by any of the following FDA-accepted criteria:
• Occurrence of high-grade, stage T1 cancer after at least 5/6 weekly BCG induction treatments.
• Occurrence of CIS within 12 months, or high-grade papillary disease, stage Ta/T1, within 6 months after an "adequate" course of BCG therapy.
• An "adequate" course of BCG includes at least 5/6 weekly BCG induction treatments and at least 2/3 weekly BCG maintenance or 2/6 weekly BCG re-induction treatments.
• N.B: Physician may have some flexibility (+/- 1 month) in the use of 6 and 12 months to define BCG-unresponsive NMIBC.
• N.B: Once a patient has been correctly defined as having BCG-unresponsive disease, they will be considered to always be BCG-unresponsive for the purpose of this study. In other words, there is no restriction as to when the BCG-unresponsive term was assigned.
• The occurrence of low-grade (LG) Ta disease will not be considered a HG relapse event given its prognosis is much more favorable that HG disease. However, all LG tumor must be completely resected before continuing with Gemcitabine/Docetaxel therapy.
• Subjects must be eligible for radical cystectomy and decline this standard of care treatment or not be a surgical candidate for radical cystectomy (as appropriate) based on other comorbidities.
• All grossly visible disease in the bladder must be fully resected with pathologic stage and grade assessed at the local study institution. Local pathologists are strongly encouraged to use the current LG and HG AJCC criteria.

You may not qualify if:

• History or concurrent Stage T2 or greater urothelial cancer.
• History or concurrent upper tract or prostatic urethral cancer (no suspicious or positive upper tract cytology and negative upper tract imaging within 6 months of study entry; visually normal or absent prostatic urethra by cystoscopy).
• History or concurrent variant bladder cancer histology including squamous cell carcinoma, adenocarcinoma, small cell carcinoma, plasmacytoid carcinoma, nested urothelial carcinoma, sarcomatoid carcinoma, squamous, glandular, metastatic carcinoma and others. Select urothelial carcinoma with favorable micropapillary differentiation is permitted (see above).
• Active other malignancies excluding indolent or well-controlled prostate cancer, basal or squamous cell skin cancers or non-invasive cancer of the cervix are permitted so long as they are not expected to impact 3-year survival outcomes.
• History of severe hypersensitivity reaction (\>= grade 3) to Gemcitabine and/or Docetaxel.
• History of severe hypersensitivity reaction (\>= grade 3) to Polysorbate 80 containing drugs (Docetaxel is formulated with Polysorbate 80)
• Concurrent treatment with any intravesical or systemic chemotherapeutic agent (8-week washout required).
• Treatment with a checkpoint inhibitor within 2 treatment cycles of enrollment.
• Major surgery within 3 months of enrollment.
• Inadequate organ and bone marrow function as evidenced by:
• Hemoglobin ≤8.0 g/dL.
• Absolute neutrophil count ≤1.5 x 109/L.
• Platelet count ≤80 x 109/L.
• AST/SGOT and/or ALT/SGPT ≥3.0 x ULN.
• Total bilirubin \>1.5 x ULN excepting known benign Gilbert's Disease.

Sponsors & Collaborators

• Michael A. O'Donnell: lead

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

RECRUITING

Related Publications (26)

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Related Links

• Center for Biologics Evaluation and Research. (n.d.). Adstiladrin. U.S. Food and Drug Administration
• Center for Drug Evaluation and Research. (n.d.). Drug trials snapshots: Anktiva. U.S. Food and Drug Administration.

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Non-Muscle Invasive Bladder Neoplasms; Carcinoma, Transitional Cell; Carcinoma in Situ

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Michael A O'Donnell, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Denise Juhr, BS

CONTACT

(319) 467-6313; denise-juhr@uiowa.edu

Mohamad Abou Chakra, MD

CONTACT

319-467-7053; mohamad-abouchakra@uiowa.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: January 7, 2026
• Study Start: April 10, 2026
• Primary Completion (Estimated): January 1, 2033
• Study Completion (Estimated): January 1, 2033
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)