Urinary Bladder CancerPhase 2NCT06822010
SeqUential GeMcitabine and MITomycin Treatment for Favorable High-Risk Upper Urinary Tract Urothelial Carcinoma
A Phase 2 study testing Sequential Gemcitabine and Jelmyto Treatment (Gem/Jel) in people with Urinary Bladder Cancer and Upper Tract Urothelial Cancer, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
This Phase II clinical trial, titled "A Phase II Trial of Sequential Gemcitabine and Mitomycin Treatment for Favorable High-Risk Upper Urinary Tract Urothelial Carcinoma (SUMMIT)," aims to evaluate the safety and effectiveness of a combination chemotherapy treatment for patients with favorable papillary high-grade… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Urinary Bladder Cancer, Upper Tract Urothelial Cancer, Urothelial Cancer
- What is being tested?
- Sequential Gemcitabine and Jelmyto Treatment (Gem/Jel)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2026to 1 Apr 2029
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet all of the following applicable inclusion criteria to participate in the study:
- Patient has signed Informed Consent Form and is willing and able to comply with all requirements of the protocol.
- Patient is at least 18 years of age.
- Naive or recurrent patients with High Grade Ta +/- CIS, non-invasive UTUC in the upper tract (pyelocalyceal system or ureter).
- Histologic confirmation with biopsy is necessary.
- All patients must undergo ureteroscopy with biopsy.
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- Non-Invasive Papillary Carcinoma (HGTa) lesions must be maximally ablated with ≤ 15 mm residual papillary disease in total.
- 4. Favorable high-grade upper tract urothelial carcinoma (UTUC) as per American Urological Association (AUA) risk stratification below (except that multifocality, obstruction, ureteral involvement, bladder involvement will be allowed).
- If the bladder is involved with NMIBC it should be treated prior to or during Gem/Jel treatments.
- 5. Patients with ECOG (Eastern Cooperative Oncology Group) performance status <3 (with Karnofsky >40).
- 6. Patients with life expectancy greater than 24 months at time of screening. 7. Patient has no active urinary tract infection (UTI) as confirmed by urine culture or urinalysis.
- 8. Female Patients of childbearing potential, must have a negative serum pregnancy test at screening and must agree to use two acceptable \& effective methods of contraception, until 6 months post treatment 9. All sexually active male patients must agree to use a condom during intercourse, for at least 48 hours post each instillation.
- 10. Male patients who have a partner that is a female of childbearing potential must agree to use two acceptable \& effective methods of contraception until 6 months post treatment.
- 11. Patients must not have any other medical condition(s) that make(s) their participation in the study unadvisable in the opinion of the investigator.
Who cannot join
- Invasive upper tract urothelial carcinoma (suspected cT2-4 on imaging) or lymphadenopathy (cN1-3) Bilateral disease Patient is actively being treated or intends to be treated with systemic chemotherapy during the duration of the trial.
- 4. Any other malignancy diagnosed within 2 years of trial entry with the exception of:
- Basal or squamous cell skin cancers, or b. Noninvasive cancer of the cervix, or c. Any other cancer deemed to be of low-risk for progression or patient morbidity during trial period (basal or squamous cell skin cancers, noninvasive cancer of the cervix, prostate cancer under active surveillance, renal cancer under active surveillance).
- 4. Administration not feasible via nephrostomy tube. 5. Inability to deliver the investigational drug to the pyelocalyceal system. 6. Patient has any other medical or mental condition(s) that make(s) his/her participation in the trial unadvisable in the opinion of the treating urologist.
- 7. Patient has contraindication to mitomycin C (MMC )treatment, or known sensitivity to MMC.
- 8. Patient has an intractable bleeding disorder (e.g., coagulation factors deficiencies, Von Willebrand Disease).
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- 9. Patient is currently receiving any other investigational agents or has participated in a research protocol involving administration of an investigational product within the past 30 days prior to Visit 1.
- 10. Pregnant (positive serum pregnancy test), planning to become pregnant during the trial period, breast-feeding, or of childbearing potential and not practicing reliable contraception.
- In case of a symptomatic UTI the patient will be treated with a full course of antibiotics, and the instillation will be postponed until resolution. In the case of asymptomatic bacteriuria, the use of prophylactic antibiotics and postponement of the treatment is left to the discretion of the PI.
- Women of non-childbearing potential:
- At least 12 months since the last menses, or
- Without uterus and/or both ovaries, or
- Has been surgically sterile for at least 6 months prior to trial drug administration.
- Acceptable methods of birth control which are considered to have a low failure rate (i.e., less than 1% per year) when used consistently and correctly, such as implants, injectable, combined (estrogen/progesterone) oral contraceptives, intrauterine devices (IUDs-only hormonal), condoms with spermicide, sexual abstinence or vasectomized partner.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Rutgers Cancer Institute
New Brunswick, New Jersey, 08901
Vignesh Packiam, MD, 732-235-2465, vp624@cinj.rutgers.edu
About this study
Official title: A Phase II Trial of SeqUential GeMcitabine and MITomycin Treatment for Favorable High-Risk Upper Urinary Tract Urothelial Carcinoma (SUMMIT)
This Phase II clinical trial, titled "A Phase II Trial of Sequential Gemcitabine and Mitomycin Treatment for Favorable High-Risk Upper Urinary Tract Urothelial Carcinoma (SUMMIT)," aims to evaluate the safety and effectiveness of a combination chemotherapy treatment for patients with favorable papillary high-grade upper tract urothelial carcinoma (UTUC). The study focuses on sequential administration of two drugs, gemcitabine and Jelmyto (a gel-based form of mitomycin), to potentially preserve kidney function and avoid nephroureterectomy (kidney removal), which is the current standard of care for participants with non-endoscopically resectable tumors.
Read the detailed description
Participants enrolled in the study will receive six weekly doses of gemcitabine and Jelmyto delivered directly into the affected kidney through a nephrostomy tube. Based on the tumor's response, patients may receive an additional six doses or transition to a standard maintenance regimen. The primary goal is to assess the complete response rate of this treatment and determine its effectiveness in preserving kidney function while managing cancer recurrence. Secondary objectives include evaluating safety, recurrence-free survival at 12 and 24 months, and patient-reported outcomes over time.
The study is expected to last approximately 3 years, with participants undergoing regular follow-up evaluations. If the treatment is ineffective, standard procedures such as nephroureterectomy may still be performed.
- Being tested
- Sequential Gemcitabine and Jelmyto Treatment (Gem/Jel)
- Keywords
- upper tract urothelial cancer, urothelial cancer, gemcitabine, jelmyto, mitomycin
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sequential Gemcitabine and Jelmyto Treatment (Gem/Jel)Drug
Also called Gemcitabine (endoluminal administration), Jelmyto (gel-based mitomycin, endoluminal administration)
Drug: Gemcitabine (endoluminal administration)
Drug: Jelmyto (gel-based mitomycin, endoluminal administration)
| Study group | Role | What they receive |
|---|---|---|
| Sequential Gemcitabine and Jelmyto Treatment (Gem/Jel) | Experimental | Participants in this arm will receive six weekly doses of sequential gemcitabine and Jelmyto (mitomycin) directly administered into the affected kidney through a nephrostomy tube. Depending on the tumor's response, participants may receive an additional six weekly doses or transition to a standard of care maintenance regimen. The primary goal of this arm is to evaluate the complete response rate, safety, and long-term outcomes such as recurrence-free survival and kidney preservation.
Interventions:
Drug: Gemcitabine (endoluminal administration)
Drug: Jelmyto (gel-based mitomycin, endoluminal administration) Receives: Drug: Sequential Gemcitabine and Jelmyto Treatment (Gem/Jel) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response (CR) Rate
The proportion of participants who achieve a complete response, defined as the absence of detectable high-grade disease via ureteroscopy, imaging (CTU/MRU), and urine cytology following the completion of the initial Gem/Jel treatment regimen. A complete response indicates no visible tumor during endoscopic evaluation and no evidence of cancer cells in collected samples
Measured: At the end of the initial 6-week induction phase (up to 12 weeks if re-induction is necessary)
Secondary outcomes (1)
Safety and Incidence of Adverse Events
Frequency and severity of adverse events associated with the sequential Gem/Jel treatment, including drug-related toxicities and complications related to the nephrostomy tube, evaluated using Common Terminology Criteria for Adverse Events (CTCAE) criteria CTCAE) guidelines, which categorize the severity of side effects on a scale from mild (grade 1) to severe (grade 5).
Measured: Throughout the study period (up to 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start6 Mar 2026
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Bladder CancerStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- 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
- Model description
- The study uses a Single Group Assignment model, where all participants enrolled in the trial will receive the same experimental intervention: sequential administration of gemcitabine and Jelmyto (mitomycin). The intervention is delivered directly into the kidney through a nephrostomy tube over six weekly treatments, with possible additional cycles based on the tumor's response. The objective of this model is to evaluate how this combination treatment affects tumor response, recurrence rates, and kidney preservation outcomes in participants with favorable high-grade upper tract urothelial carcinoma (UTUC). No control group or randomization is used, as the primary purpose is to determine the safety and efficacy of the sequential chemotherapy treatment in a focused patient population.
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vignesh Packiam, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06822010
- Sponsor's protocol ID
- 082411
- Other IDs
- Pro2024002505
- Status last verified
- May 2026
- First submitted
- 6 Feb 2025
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of SeqUential GeMcitabine and MITomycin Treatment for Favorable High-Risk Upper Urinary Tract Urothelial Carcinoma (SUMMIT)
- ClinicalTrials.gov ID
- NCT06822010
- Acronym / sponsor ID
- 082411
- Keywords
- upper tract urothelial cancer, urothelial cancer, gemcitabine, jelmyto, mitomycin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 6 Mar 2026 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Apr 2029 (estimated)
- First posted
- 12 Feb 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.
This Phase II clinical trial, titled "A Phase II Trial of Sequential Gemcitabine and Mitomycin Treatment for Favorable High-Risk Upper Urinary Tract Urothelial Carcinoma (SUMMIT)," aims to evaluate the safety and effectiveness of a combination chemotherapy treatment for patients with favorable papillary high-grade upper tract urothelial carcinoma (UTUC). The study focuses on sequential administration of two drugs, gemcitabine and Jelmyto (a gel-based form of mitomycin), to potentially preserve kidney function and avoid nephroureterectomy (kidney removal), which is the current standard of care for participants with non-endoscopically resectable tumors.
Detailed description
Participants enrolled in the study will receive six weekly doses of gemcitabine and Jelmyto delivered directly into the affected kidney through a nephrostomy tube. Based on the tumor's response, patients may receive an additional six doses or transition to a standard maintenance regimen. The primary goal is to assess the complete response rate of this treatment and determine its effectiveness in preserving kidney function while managing cancer recurrence. Secondary objectives include evaluating safety, recurrence-free survival at 12 and 24 months, and patient-reported outcomes over time.
The study is expected to last approximately 3 years, with participants undergoing regular follow-up evaluations. If the treatment is ineffective, standard procedures such as nephroureterectomy may still be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study uses a Single Group Assignment model, where all participants enrolled in the trial will receive the same experimental intervention: sequential administration of gemcitabine and Jelmyto (mitomycin). The intervention is delivered directly into the kidney through a nephrostomy tube over six weekly treatments, with possible additional cycles based on the tumor's response. The objective of this model is to evaluate how this combination treatment affects tumor response, recurrence rates, and kidney preservation outcomes in participants with favorable high-grade upper tract urothelial carcinoma (UTUC). No control group or randomization is used, as the primary purpose is to determine the safety and efficacy of the sequential chemotherapy treatment in a focused patient population.
| Arm | Type | Receives |
|---|---|---|
| Sequential Gemcitabine and Jelmyto Treatment (Gem/Jel) | Experimental | Drug: Sequential Gemcitabine and Jelmyto Treatment (Gem/Jel)Participants in this arm will receive six weekly doses of sequential gemcitabine and Jelmyto (mitomycin) directly administered into the affected kidney through a nephrostomy tube. Depending on the tumor's response, participants may receive an additional six weekly doses or transition to a standard of care maintenance regimen. The primary goal of this arm is to evaluate the complete response rate, safety, and long-term outcomes such as recurrence-free survival and kidney preservation. Interventions: Drug: Gemcitabine (endoluminal administration) Drug: Jelmyto (gel-based mitomycin, endoluminal administration) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Subjects must meet all of the following applicable inclusion criteria to participate in the study:
- Histologic confirmation with biopsy is necessary.
- All patients must undergo ureteroscopy with biopsy.
- Non-Invasive Papillary Carcinoma (HGTa) lesions must be maximally ablated with ≤ 15 mm residual papillary disease in total.
- 4. Favorable high-grade upper tract urothelial carcinoma (UTUC) as per American Urological Association (AUA) risk stratification below (except that multifocality, obstruction, ureteral involvement, bladder involvement will be allowed).
Key exclusion criteria (14 listed)
- Invasive upper tract urothelial carcinoma (suspected cT2-4 on imaging) or lymphadenopathy (cN1-3) Bilateral disease Patient is actively being treated or intends to be treated with systemic chemotherapy during the duration of the trial.
- 4. Administration not feasible via nephrostomy tube. 5. Inability to deliver the investigational drug to the pyelocalyceal system. 6. Patient has any other medical or mental condition(s) that make(s) his/her participation in the trial unadvisable in the opinion of the treating urologist.
- 7. Patient has contraindication to mitomycin C (MMC )treatment, or known sensitivity to MMC.
- 8. Patient has an intractable bleeding disorder (e.g., coagulation factors deficiencies, Von Willebrand Disease).
- 9. Patient is currently receiving any other investigational agents or has participated in a research protocol involving administration of an investigational product within the past 30 days prior to Visit 1.
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 |
|---|---|---|
| Sequential Gemcitabine and Jelmyto Treatment (Gem/Jel)Also: Gemcitabine (endoluminal administration), Jelmyto (gel-based mitomycin, endoluminal administration)Drug: Gemcitabine (endoluminal administration) Drug: Jelmyto (gel-based mitomycin, endoluminal administration) | Drug | Sequential Gemcitabine and Jelmyto Treatment (Gem/Jel) |
Primary outcome
Complete Response (CR) Rate
Time frame: At the end of the initial 6-week induction phase (up to 12 weeks if re-induction is necessary)
The proportion of participants who achieve a complete response, defined as the absence of detectable high-grade disease via ureteroscopy, imaging (CTU/MRU), and urine cytology following the completion of the initial Gem/Jel treatment regimen. A complete response indicates no visible tumor during endoscopic evaluation and no evidence of cancer cells in collected samples
1 secondary outcome
Safety and Incidence of Adverse Events
Time frame: Throughout the study period (up to 3 years)
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 6 May 2026.
- Individual participant dataSharing planned: No
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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 Sequential Gemcitabine and Jelmyto Treatment (Gem/Jel) in people with Urinary Bladder Cancer and Upper Tract Urothelial Cancer, run by Rutgers, The State University of New Jersey at 1 site in United States.
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 14 inclusion and 14 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 6 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 United States. 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 Vignesh Packiam, MD (732-235-2465, VP624@cinj.rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Response (CR) Rate (time frame: At the end of the initial 6-week induction phase (up to 12 weeks if re-induction is necessary)). 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 6 May 2026.