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New treatment option for Non Muscle Invasive Bladder Cancer
Official title Intravesical Chemotherapy in Combination With Systemic Pembrolizumab in NMIBC Unresponsive or Exposed to BCG Therapy
ClinicalTrials.gov ID: NCT06972615
What this study is testing
What is intravesical Chemotherapy docetaxel/gemcitabine?
intravesical Chemotherapy docetaxel/gemcitabine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for non muscle invasive bladder cancer.
Also referred to as pembrolizumb.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- interventional study of intravesical chemotherapy and sistemic immunotherapy in NMIBC
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Be willing and able to provide documented informed consent for the trial. The subject may also provide consent for Future Biomedical Research...
- Be ≥18 years of age on the day of signing informed consent.
- Have a histologically confirmed diagnosis of high-risk non-muscle invasive (T1, High Grade Ta and/or CIS) transitional cell carcinoma of the bladder...
- In people who have papillary tumors (Ta and T1), a complete TURBT must have been performed, as characterized by:Attainment of a visually complete...
- An induction course with at least 5 out of 6 BCG instillations (adequate induction); and
You likely can't join if
- 1\. Has muscle-invasive (i.e. T2, T3, T4) locally advanced non-resectable or metastatic urothelial carcinoma.
- 2\. Has concurrent extra-vesical (i.e. urethra, ureter or renal pelvis) non-muscle-invasive transitional cell carcinoma of the urothelium.
- 3\. Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or...
- 4\. Has undergone any intervening intravesical chemotherapy or immunotherapy from the time of most recent cystoscopy/ transurethral resection of...
- 5\. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to Cycle 1, Day 1 or who has not recovered...
See the full eligibility criteria
- Be willing and able to provide documented informed consent for the trial. The subject may also provide consent for Future Biomedical Research. However, the subject may participate in the main trial without participating...
- Be ≥18 years of age on the day of signing informed consent.
- Have a histologically confirmed diagnosis of high-risk non-muscle invasive (T1, High Grade Ta and/or CIS) transitional cell carcinoma of the bladder. people with tumors of mixed transitional/non-transitional cell...
- In people who have papillary tumors (Ta and T1), a complete TURBT must have been performed, as characterized by:Attainment of a visually complete resection of all papillary tumors (Ta and T1) 5- Have been treated with...
- An induction course with at least 5 out of 6 BCG instillations (adequate induction); and
- At least 7 out of 9 BCG instillations within 9 months of the first instillation of adequate induction therapy BCG unresponsive high risk NMIBC is defined as:
- Stage progression at 3 months (±4 weeks) despite adequate induction therapy (e.g., Ta to T1, or CIS to T1; note: adequate induction therapy only, defined above, is required in this case); or
- High grade T1 disease at the first evaluation after adequate BCG induction or
- Persistent high risk NMIBC at 6 months (±4 weeks) after adequate BCG; or
- Recurrent high risk NMIBC within 12 months of the last BCG instillation despite having received adequate BCG. BCG Exposed is defined as: having high-grade persistent (BCG resistant) or recurrent NMIBC within 24 months...
- 1\. Has muscle-invasive (i.e. T2, T3, T4) locally advanced non-resectable or metastatic urothelial carcinoma.
- 2\. Has concurrent extra-vesical (i.e. urethra, ureter or renal pelvis) non-muscle-invasive transitional cell carcinoma of the urothelium.
- 3\. Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of...
- 4\. Has undergone any intervening intravesical chemotherapy or immunotherapy from the time of most recent cystoscopy/ transurethral resection of bladder tumor to starting trial treatment. (Note: A single dose of...
- 5\. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to Cycle 1, Day 1 or who has not recovered (ie, ≤ Grade 1 or at baseline) from adverse events due to a...
The study team makes the final eligibility decision.
Where it's taking place
- CABA, Argentina
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include CABA, Argentina. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.