Non-Muscle Invasive Bladder Cancer
Conditions
Keywords
Non-Muscle Invasive Bladder Cancer, Low Grade, Intermediate Risk, Recurrent Low-Grade
Brief summary
The goal of the study is to learn about the safety of Sacituzumab Tirumotecan and if people can tolerate it when given in the bladder and find the highest dose that people can take without having certain problems. Researchers will then choose a dose level of Sacituzumab Tirumotecan to use in future studies to learn how well the drug works.
Interventions
DRUGSacituzumab tirumotecan
Intravesical administration
DRUGRescue medication
Participants are allowed to take rescue medication for stomatitis or oral mucositis. At the discretion of the investigator, participants are provided with a prescription for rescue medications. Recommended rescue medications are antihistamine, histamine-2 (H2) receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent infusion or steroid mouthwash (dexamethasone or equivalent), antiemetic medications, oral nystatin suspension or antifungal medications, antidiarrheal agents, antiemetic agents, opiate and non-opiate analgesic agents, appetite stimulants, and granulocyte and erythroid growth factors.
Participants are allowed to take supportive care measures for the management of adverse events associated with study intervention at the discretion of the investigator. Artificial tear drops or gel may be given as a supportive care for Ocular Surface Toxicity.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The key inclusion criteria include but are not limited to the following: * Has recurrent low-grade (Ta) Non-Muscle Invasive Bladder Cancer (NMIBC) in the bladder * Must have visible tumor by cystoscopy within 12 weeks prior to first dose * Has intermediate-risk NMIBC defined as 1 or more of the following risk factors: * Multiple tumors * \>1 occurrence of low-grade NMIBC within 1 year of the current diagnosis at Screening * Early recurrence (\<1 year) of the initial diagnosis of low-grade disease * Solitary tumor \>3 cm * Failure of prior intravesical treatment * An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 assessed within 14 days prior to first dose
Exclusion criteria
The key
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Dose Limiting Toxicity (DLT) | Up to approximately 7 weeks | DLT will be defined as any drug-related adverse event (AE) observed during the DLT evaluation period (7 weeks). All toxicities will be graded using National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE) version 5.0. |
| Number of Participants Experiencing an Adverse Event (AE) | Up to approximately 10 weeks | An AE is defined as any untoward medical occurrence in a participant administered a study treatment which did not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of study treatment, is also an AE. The number of participants who experience an AE will be reported. |
| Number of Participants Discontinuing Study Treatment due to an Adverse Event (AE) | Up to approximately 6 weeks | An AE is defined as any untoward medical occurrence in a participant administered a study treatment which did not necessarily have to have a causal relationship with this treatment. An AE could be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of study treatment, is also an AE. The number of participants who discontinue study treatment due to an AE will be reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Serum Concentration-Time Curve (AUC) of sacituzumab tirumotecan (sac-TMT) Antibody-Drug Conjugate (ADC) | Up to approximately 6 weeks | Blood samples will be collected to determine the AUC of sac-TIMT ADC |
| Maximum Serum Concentration (Cmax) of sac-TMT ADC | Up to approximately 6 weeks | Blood samples will be collected to determine the Cmax of sac-TMT ADC |
| Minimum Serum Concentration (Cmin) of sac-TMT ADC | Up to approximately 6 weeks | Blood samples will be collected to determine the Cmin of sac-TMT ADC |
| Serum Apparent terminal half-life (t½) of sac-TMT ADC | Up to approximately 6 weeks | Blood samples will be collected to determine the t1/2 of sac-TMT ADC |
| Serum AUC of sac-TMT Total Antibody (TAb) | Up to approximately 6 weeks | Blood samples will be collected to determine the AUC of sac-TMT Tab |
| Serum Cmax of sac-TMT Tab | Up to approximately 6 weeks | Blood samples will be collected to determine the Cmax of sac-TMT Tab |
| Serum Cmin of sac-TMT Tab | Up to approximately 6 weeks | Blood samples will be collected to determine the Cmin of sac-TMT Tab |
| Serum t½ of sac-TMT Tab | Up to approximately 6 weeks | Blood samples will be collected to determine the t1/2 of sac-TMT Tab |
| Plasma AUC of sac-TMT payload | Up to approximately 6 weeks | Blood samples will be collected to determine the AUC of sac-TMT payload |
| Plasma Cmax of sac-TMT payload | Up to approximately 6 weeks | Blood samples will be collected to determine the Cmax of sac-TMT payload |
| Plasma Cmin of sac-TMT payload | Up to approximately 6 weeks | Blood samples will be collected to determine the Cmin of sac-TMT payload |
| Plasma t½ of sac-TMT payload | Up to approximately 6 weeks | Blood samples will be collected to determine the t1/2 of sac-TMT payload |
| Complete Response Rate (CRR) | Up to approximately 6 months | CRR is defined as the percentage of participants who will be absent of residual tumor in the bladder assessed locally by cystoscopy evaluation and negative urine cytology and/or biopsy and imaging if applicable. |
| Duration of Complete Response (DCR) | Up to approximately 24 months | Duration of CR for participants who demonstrate CR is defined as the time from the first documented evidence of CR (absence of residual tumor in the bladder assessed locally by cystoscopy evaluation and negative urine cytology and/or biopsy and imaging if applicable) until the occurrence of histologically confirmed nonmuscle invasive urothelial carcinoma (UC) by local pathology review or locally advanced or metastatic UC, or death due to any cause, whichever occurs first. |
Countries
Canada, France, Netherlands, Spain, United Kingdom, United States
Contacts
CONTACTToll Free Number
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Outcome results
None listed