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A Study Comparing Standard Treatments in People With Non-muscle Invasive Bladder Cancer (NMIBC), COMPARE IT Trial
Trial Status: active
This phase III trial studies whether different standard treatments for non-muscle invasive bladder cancer (NMIBC) influence outcomes, such as cancer coming back after a period of improvement (recurrence), in patients that did not respond to treatment with bacillus Calmette-Guerin (BCG). For patients with NMIBC that has returned after BCG who do not want surgery to remove their bladder, the standard treatments include nadofaragene firadenovec, gemcitabine with or without docetaxel, mitomycin, retreatment with BCG, or pembrolizumab. Nadofaragene firadenovec may kill tumor cells by blocking a gene that helps cancer form and grow. Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid (DNA) and may kill tumor cells. Docetaxel is in a class of medications called taxanes. It stops tumor cells from growing and dividing and may kill them. Mitomycin is a type of antibiotic that is only used in cancer chemotherapy (antineoplastic antibiotic). It works by damaging the cell's DNA and may kill tumor cells. It is given with sodium bicarbonate which helps lower the acidity of the urine and increase the effectiveness of the mitomycin. BCG a weakened form of the bacterium Mycobacterium bovis that does not cause disease. It is used in a solution to stimulate the immune system in the treatment of bladder cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Comparing different standard treatments for NMIBC may help to determine which treatment regimen is most effective in treating patients that did not response to BCG treatment.
Inclusion Criteria
21 years of age or older
Being treated for high-grade NMIBC (Tis, Ta, or T1) under the care of one of the participating treating urologists
One or more prior induction course of BCG at any point in time and judgment by the treating urologist that BCG has failed
* Any amount of maintenance BCG is allowed
In the previous 12 months, receipt of at least one instillation of any intravesical agent (induction or maintenance) or one administration of systemic therapy for NMIBC treatment
* An intravesical agent can include BCG or any other NMIBC treatment
* Up to 15 months from the last instillation is allowed for the treating physician to perform a transurethral resection of bladder tumor (TURBT) so long as there is evidence/suspicion of recurrent disease (by positive cytology, imaging, or cystoscopy) within 12 months of last exposure to an intravesical agent
In the opinion of the treating urologist, there is no contraindication to treatment with nadofaragene firadenovec (i.e. hypersensitivity to interferon alpha [IFNa], severe immunosuppression) and there is uncertainty over whether nadofaragene is better than “best usual care”
Exclusion Criteria
Opting for treatment with radical cystectomy
Currently receiving treatment on a clinical trial of an experimental therapy for NMIBC
Prior exposure to nadofaragene firadenovec
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06929286.
Locations matching your search criteria
United States
New Jersey
Basking Ridge
Memorial Sloan Kettering Basking Ridge
Status: Active
Contact: Eugene J Pietzak
Phone: 646-422-4781
Middletown
Memorial Sloan Kettering Monmouth
Status: Active
Contact: Eugene J Pietzak
Phone: 646-422-4781
Montvale
Memorial Sloan Kettering Bergen
Status: Active
Contact: Eugene J Pietzak
Phone: 646-422-4781
New York
Commack
Memorial Sloan Kettering Commack
Status: Active
Contact: Eugene J Pietzak
Phone: 646-422-4781
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Contact: Eugene J Pietzak
Phone: 646-422-4781
Uniondale
Memorial Sloan Kettering Nassau
Status: Active
Contact: Eugene J Pietzak
Phone: 646-422-4781
West Harrison
Memorial Sloan Kettering Westchester
Status: Active
Contact: Eugene J Pietzak
Phone: 646-422-4781
PRIMARY OBJECTIVE:
I. To determine whether nadofaragene firadenovec improves high-grade recurrence-free-survival, compared with best usual care.
SECONDARY OBJECTIVES:
I. To determine whether nadofaragene firadenovec improves progression-free survival, compared with best usual care.
II. To determine whether nadofaragene firadenovec improves cystectomy-free survival, compared with best usual care.
III. To determine whether nadofaragene firadenovec improves the proportion of patients with carcinoma in situ (CIS) who have a complete response and the duration of complete response, compared with best usual care.
IV. To determine whether nadofaragene firadenovec improves any grade (low- and high-grade) recurrence-free survival, compared with best usual care.
V. To determine the safety and toxicity associated with nadofaragene firadenovec, compared with best usual care.
OUTLINE: Treating urologists are randomized to 1 of 2 arms and patients are assigned to the arm to which their treating urologist was randomized.
ARM I: Patients receive nadofaragene firadenovec intravesically every 3 months for up to 12 months in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive one of the best usual care treatment regimens as per Memorial Sloan Kettering (MSK) Bladder Cancer Working Group consensus treatment algorithm and treating urologist clinical judgement.
GEMCITABINE/DOCETAXEL (GEMDOCE): Patients receive gemcitabine intravesically over 1 hour followed by docetaxel intravesically over 1 hour once a week for up to 6 weeks of induction therapy in the absence of disease progression or unacceptable toxicity. Patients who have a complete response then receive GemDoce intravesical installations once a month for up to 24 months of maintenance therapy in the absence of disease progression or unacceptable toxicity.
BCG RETREATMENT: Patients with previous GemDoce treatment whose last treatment with BCG was > 12 months ago receive retreatment with BCG on study in the absence of disease progression or unacceptable toxicity.
MITOMYCIN: Patients with previous GemDoce treatment whose last treatment with BCG was =< 12 months receive mitomycin intravesically and sodium bicarbonate orally on study in the absence of disease progression or unacceptable toxicity.
GEMCITABINE: Patients receive gemcitabine intravesically twice a week for three weeks followed by one week of rest for a total of twelve installations in the absence of disease progression or unacceptable toxicity.
PEMBROLIZUMAB: Patients receive pembrolizumab intravenously as per Food and Drug Administration label for BCG-unresponsive NMIBC on study in the absence of disease progression or unacceptable toxicity.
GEMDOCE RETREATMENT: Patients receive retreatment with GemDoce on study in the absence of disease progression or unacceptable toxicity.
Additionally, all patients may undergo cystoscopy, bladder biopsy, transurethral resection of bladder tumor (TURBT), urine sample collection, computed tomography (CT), and/or magnetic resonance imaging (MRI) on study.
After completion of study treatment, patients are followed up as per standard clinical care.
Trial PhasePhase III
Trial Typetreatment
Lead OrganizationMemorial Sloan Kettering Cancer Center
