A Clinical Study of MK-3120 in People With Bladder Cancer (MK-3120-003)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMerck Sharp & Dohme LLC
About this trial
Researchers are looking for new ways to treat high-risk non-muscle invasive bladder cancer (HR NMIBC). NMIBC is cancer in the tissue that lines the inside of the bladder and has not spread to the bladder muscle or outside of the bladder. In standard treatment for HR NMIBC, doctors first remove the tumor with a procedure called transurethral resection of the bladder tumor (TURBT). Researchers want to learn if using MK-3120, the study medicine, can treat HR NMIBC after TURBT. The goal of this study is to learn about the safety of MK-3120 and if people tolerate it.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Has histologically confirmed carcinoma in situ (CIS) +/- papillary high-risk non-muscle invasive bladder cancer (NMIBC), confirmed locally.
Is an individual whose most recent transurethral resection of bladder tumor (TURBT) was performed within 12 weeks before allocation and showed high-risk NMIBC histology. For individuals with 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).
Is either: a) Bacillus Calmette-Guérin (BCG)-naïve, defined as either having never received BCG or having received BCG more than 2 years before CIS +/- papillary high-risk NMIBC recurrence. Recurrence must be at least 24 months from the last exposure to BCG with evidence of complete response during the 2-year period post-BCG OR; b) BCG-exposed and received adequate BCG therapy and had recurrence of CIS +/- papillary high-risk NMIBC >12 months but ≤24 months after the last BCG dose.
Human immunodeficiency virus (HIV)-infected participants must have well-controlled HIV on antiretroviral therapy.
Disqualifiers
Has history of or current locally advanced (ie, T2, T3, T4) or metastatic urothelial cancer (UC).
Has concurrent extravesical (ie, urethra, ureter, renal pelvis) non-muscle invasive UC or history of extravesical non-muscle invasive UC that recurred within the last 2 years.
Has active total bladder incontinence, active urinary tract infection, neurogenic bladder, or urethral stricture.
Has a condition that would prohibit normal voiding (or holding bladder voiding for 1 to 2 hours).
Trial design
Design model
Single group
Treatments tested in this trial
MK-3120
Biological/VaccineIntravesical administration at one of three doses per protocol
Treatment groups
45 Participants
are divided into 1 treatment groupGroup A: MK-3120Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants Who Experience a Dose-limiting Toxicity (DLT)
Any of the following toxicities will be considered a DLT: Hematuria leading to clot or obstruction; Grade (Gr) 4 thrombocytopenia; Gr 3 thrombocytopenia associated with clinically significant bleeding; Febrile neutropenia for more than 1 hour; Other Gr ≥3 hematologic toxicity lasting \>7 days; Nonhematologic AE ≥Gr 3 (with exceptions); ≥Gr 2 pneumonitis/ interstitial lung disease; Any ≥Gr 3 nonhematologic laboratory value if clinically significant medical intervention is required, leads to hospitalization, persists for \>7 days, results in a drug induced liver injury, or elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) lab value \>8 ×upper limit of normal (ULN) regardless of duration and AST or ALT elevation 5 × to 8 × ULN that persists for greater than 2 weeks; Recurrent Gr 2 AE resulting in \>2 weeks delay in receiving the next treatment dose; Any intervention-related toxicity that results in study intervention discontinuation; Gr 5 toxicity or AE.
Time frame
Up to approximately 5 weeks2
Number of Participants Who Experience One or More Adverse Events (AEs)
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
Time frame
Up to approximately 24 months3
Number of Participants Who Discontinue Study Treatment Due to AEs
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
Time frame
Up to approximately 12 monthsSecondary outcomes
1
Complete Response Rate (CRR)
CR is defined as the absence of all of the following as determined by local assessment using urine cytology, cystoscopy, biopsy and radiology assessments as applicable: * High-risk non-muscle invasive urothelial cancer (UC) (defined as high-grade \[HG\] noninvasive papillary \[Ta\], carcinoma in situ \[CIS\], or any submucosal invasive \[T1\] disease of the bladder, urethra, or upper tract \[ureters, renal pelvis\]) * Any muscle invasive tumor (T2) or greater in the bladder, including transurethral prostate stromal invasion of UC, or in the upper tract (ureters, renal pelvis) * Metastatic UC, defined as: * Regional lymph node metastasis of UC (N1 or greater) * Distant lymph node or visceral metastasis of UC (M1)
Time frame
Up to approximately 3 monthsLocations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
Akershus Universitetssykehus ( Site 0091)Recruiting1478, Lorenskog, Akershus
Norway
NorwaySponsors and contacts
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Source ClinicalTrials.gov