Non Muscle Invasive Bladder CancerPhase 2NCT06972615
Intravesical Chemotherapy in Combination With Systemic Pembrolizumab in NMIBC Unresponsive or Exposed to BCG Therapy
A Phase 2 study testing intravesical Chemotherapy docetaxel/gemcitabine in people with Non Muscle Invasive Bladder Cancer, run by BLATAM at 1 site in Argentina.
Trial summary
interventional study of intravesical chemotherapy and sistemic immunotherapy in NMIBC Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Muscle Invasive Bladder Cancer
- What is being tested?
- intravesical Chemotherapy docetaxel/gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteArgentina
- Study dates
- 21 May 2026to 15 Jun 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 in 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. Subjects with tumors of mixed transitional/non-transitional cell histology are allowed, but transitional cell carcinoma must be the predominant histology. Subjects with predominant or exclusively non-transitional cell histology are not allowed. Confirmation of histology, grade and stage will be performed by central review and must be completed during the screening period and prior to enrollment.
- In subjects 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 adequate BCG therapy and have developed high risk NMIBC that is unresponsive or exposed to BCG therapy.
- Adequate BCG therapy must include:
- An induction course with at least 5 out of 6 BCG instillations (adequate induction); and
Show all 13Show fewer
- 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 of the last BCG dose but not meeting the definition of BCG-unresponsive
Who cannot join
- 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 treatment.
- 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 intravesical treatment given as part of the most recent cystoscopy/ transurethral resection of bladder tumor, during the screening period, such as with chemotherapy as per local/regional practices, is acceptable.)
- 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 previously administered agent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Argentina1 site, 1 recruiting
- Recruiting
BLATAM
CABA, 1123
Federico Losco, MD, +541164978075, flosco@blatam.com
About this study
Official title: A Phase II, Single Arm Study, Evaluating Intravesical Gemcitabine/Docetaxel in Combination With Systemic Pembrolizumab in Subjects With High Risk NMIBC Unresponsive or Exposed to Bacillus Calmet-Guerin (BCG) Therapy
interventional study of intravesical chemotherapy and sistemic immunotherapy in NMIBC
Read the detailed description
patients will receive intrravesical chemotherapy every 3 weeks and systemic pembrolizumb every 6 week. for a total of 1 year of treatment
- Conditions
- Non Muscle Invasive Bladder Cancer
- Being tested
- intravesical Chemotherapy docetaxel/gemcitabine
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravesical Chemotherapy docetaxel/gemcitabineDrug
Also called pembrolizumb
intravesical quimiotherapy plus intravenous immunotherapy
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | intrravesical docetaxel plus gemcitabine and intravenous pembrolizumab Receives: Drug: intravesical Chemotherapy docetaxel/gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
eficacy
Complete Response rate
Measured: 3 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
To evaluate safety and tolerability of systemic pembrolizumab in combination with intravesical gemcitabine/docetaxel
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start21 May 2026
- Primary completion31 Dec 2029 (estimated)
- Study completion15 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Muscle Invasive Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BLATAM
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06972615
- Sponsor's protocol ID
- MK-3475-G14
- Status last verified
- May 2026
- First submitted
- 18 Apr 2025
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: de-identified demographic information (age, sex), baseline disease characteristics, treatment received, key efficacy outcomes (e.g., response rates, progression-free survival, overall survival), and safety data (adverse events). Data will be shared in aggregate or de-identified format to ensure patient confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Single Arm Study, Evaluating Intravesical Gemcitabine/Docetaxel in Combination With Systemic Pembrolizumab in Subjects With High Risk NMIBC Unresponsive or Exposed to Bacillus Calmet-Guerin (BCG) Therapy
- ClinicalTrials.gov ID
- NCT06972615
- Acronym / sponsor ID
- MK-3475-G14
- Conditions
- Non Muscle Invasive Bladder Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- BLATAMResearch network
- Study start
- 21 May 2026 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 15 Jun 2030 (estimated)
- First posted
- 15 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
interventional study of intravesical chemotherapy and sistemic immunotherapy in NMIBC
Detailed description
patients will receive intrravesical chemotherapy every 3 weeks and systemic pembrolizumb every 6 week. for a total of 1 year of treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment | Experimental | Drug: intravesical Chemotherapy docetaxel/gemcitabineintrravesical docetaxel plus gemcitabine and intravenous pembrolizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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 in 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. Subjects with tumors of mixed transitional/non-transitional cell histology are allowed, but transitional cell carcinoma must be the predominant histology. Subjects with predominant or exclusively non-transitional cell histology are not allowed. Confirmation of histology, grade and stage will be performed by central review and must be completed during the screening period and prior to enrollment.
- In subjects 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 adequate BCG therapy and have developed high risk NMIBC that is unresponsive or exposed to BCG therapy.
- An induction course with at least 5 out of 6 BCG instillations (adequate induction); and
Key exclusion criteria (5 listed)
- 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 treatment.
- 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 intravesical treatment given as part of the most recent cystoscopy/ transurethral resection of bladder tumor, during the screening period, such as with chemotherapy as per local/regional practices, is acceptable.)
- 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 previously administered agent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intravesical Chemotherapy docetaxel/gemcitabineAlso: pembrolizumbintravesical quimiotherapy plus intravenous immunotherapy | Drug | treatment |
Primary outcome
eficacy
Time frame: 3 months
Complete Response rate
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 1 year
To evaluate safety and tolerability of systemic pembrolizumab in combination with intravesical gemcitabine/docetaxel
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. de-identified demographic information (age, sex), baseline disease characteristics, treatment received, key efficacy outcomes (e.g., response rates, progression-free survival, overall survival), and safety data (adverse events). Data will be shared in aggregate or de-identified format to ensure patient confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing intravesical Chemotherapy docetaxel/gemcitabine in people with Non Muscle Invasive Bladder Cancer, run by BLATAM at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gustavo M Villoldo, MD (+541156164207, gvilloldo@blatam.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
eficacy (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.