Non-Muscle Invasive Bladder CancerPhase 1/2TroFuse-027NCT06637423
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Patients With Bladder Cancer (MK-2870-027)
A Phase 1/2 study testing Sacituzumab tirumotecan, Rescue medication and Supportive care measures in people with Non-Muscle Invasive Bladder Cancer, run by Merck Sharp & Dohme LLC at 13 sites in 6 countries.
Trial 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. 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?
- Sacituzumab tirumotecan, Rescue medication and Supportive care measures
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 13 sitesin 6 countries
- Study dates
- 20 Dec 2024to 14 Mar 2029
- Phase
- Phase 1/2
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
- 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
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- 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
Who cannot join
- The key exclusion criteria include but are not limited to the following:
- Newly diagnosed low-grade non-muscle invasive bladder cancer (Ta NMIBC) in the bladder
- Past or current history of high-grade (Ta or T1 or CIS) NMIBC, muscle invasive bladder cancer (MIBC) or metastatic urothelial carcinoma (UC)
- Has a condition that would prohibit normal voiding (or hold bladder voiding for 1 to 2 hours)
- Has history of documented severe dry eye syndrome, severe Meibomian gland disease, and/or blepharitis, or severe corneal disease that prevents and/or delays corneal healing
- Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Chron's disease, ulcerative colitis, or chronic diarrhea)
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- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
- Known additional malignancy that is progressing or has required active treatment within the past 3 years
- History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
Trial locations and contacts
13 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
13 sites in 6 countries
United States4 sites
- Active, not recruiting
Michael G Oefelein Clinical Trials ( Site 0053)
Bakersfield, California, 93301
- Active, not recruiting
Johns Hopkins University ( Site 0055)
Baltimore, Maryland, 21287
- Active, not recruiting
Northwestern University ( Site 0051)
Chicago, Illinois, 60611
- Active, not recruiting
Moffitt Cancer Center ( Site 0057)
Tampa, Florida, 33612
France3 sites
- Active, not recruiting
HENRI MONDOR HOSPITAL ( Site 0011)
Créteil, Val-de-Marne, 94010
- Active, not recruiting
Hôpital Claude Huriez ( Site 0012)
Lille, Nord, 59037
- Active, not recruiting
Gustave Roussy ( Site 0013)
Villejuif, Val-de-Marne, 94805
Canada2 sites
- Active, not recruiting
Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer ( Site 0002)
Sherbrooke, Quebec, J1H 5N4
- Active, not recruiting
Princess Margaret Cancer Centre ( Site 0003)
Toronto, Ontario, M5G 1Z5
Spain2 sites
- Active, not recruiting
Hospital Universitario 12 de Octubre ( Site 0042)
Madrid, 28041
- Active, not recruiting
Hospital Universitario Virgen de la Victoria ( Site 0043)
Málaga, Andalusia, 29010
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus Medisch Centrum ( Site 0032)
Rotterdam, South Holland, 3015 GD
Study Coordinator, +31107041566
United Kingdom1 site, 1 recruiting
- Recruiting
St Bartholomew s Hospital ( Site 0061)
London, London, City of, EC1A 7BE
Study Coordinator, +4407535510363
About this study
Official title: A Phase 1/2 Open-label Clinical Study to Evaluate the Safety and Efficacy of Intravesical Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in Participants With Intermediate-risk Non-muscle Invasive Bladder Cancer (NMIBC)
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.
- Conditions
- Non-Muscle Invasive Bladder Cancer
- Being tested
- Sacituzumab tirumotecan, Rescue medication, Supportive care measures
- Keywords
- Non-Muscle Invasive Bladder Cancer, Low Grade, Intermediate Risk, Recurrent Low-Grade
- 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.
Sacituzumab tirumotecanDrug
Also called SKB264, sac-TMT, MK-2870
Intravesical administration
Rescue medicationDrug
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.
Supportive care measuresDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Sacituzumab tirumotecan | Experimental | Participants receive intravesical Sacituzumab Tirumotecan for 6 weeks Receives: Drug: Sacituzumab tirumotecan; Drug: Rescue medication; Drug: Supportive care measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Dose Limiting Toxicity (DLT)
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.
Measured: Up to approximately 7 weeks
Number of Participants Experiencing an Adverse Event (AE)
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.
Measured: Up to approximately 10 weeks
Number of Participants Discontinuing Study Treatment due to an Adverse Event (AE)
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.
Measured: Up to approximately 6 weeks
Secondary outcomes (14)
Area Under the Serum Concentration-Time Curve (AUC) of sacituzumab tirumotecan (sac-TMT) Antibody-Drug Conjugate (ADC)
Blood samples will be collected to determine the AUC of sac-TIMT ADC
Measured: Up to approximately 6 weeks
Maximum Serum Concentration (Cmax) of sac-TMT ADC
Blood samples will be collected to determine the Cmax of sac-TMT ADC
Measured: Up to approximately 6 weeks
Minimum Serum Concentration (Cmin) of sac-TMT ADC
Blood samples will be collected to determine the Cmin of sac-TMT ADC
Measured: Up to approximately 6 weeks
Serum Apparent terminal half-life (t½) of sac-TMT ADC
Blood samples will be collected to determine the t1/2 of sac-TMT ADC
Measured: Up to approximately 6 weeks
Serum AUC of sac-TMT Total Antibody (TAb)
Blood samples will be collected to determine the AUC of sac-TMT Tab
Measured: Up to approximately 6 weeks
Serum Cmax of sac-TMT Tab
Blood samples will be collected to determine the Cmax of sac-TMT Tab
Measured: Up to approximately 6 weeks
Serum Cmin of sac-TMT Tab
Blood samples will be collected to determine the Cmin of sac-TMT Tab
Measured: Up to approximately 6 weeks
Serum t½ of sac-TMT Tab
Blood samples will be collected to determine the t1/2 of sac-TMT Tab
Measured: Up to approximately 6 weeks
Plasma AUC of sac-TMT payload
Blood samples will be collected to determine the AUC of sac-TMT payload
Measured: Up to approximately 6 weeks
Plasma Cmax of sac-TMT payload
Blood samples will be collected to determine the Cmax of sac-TMT payload
Measured: Up to approximately 6 weeks
Plasma Cmin of sac-TMT payload
Blood samples will be collected to determine the Cmin of sac-TMT payload
Measured: Up to approximately 6 weeks
Plasma t½ of sac-TMT payload
Blood samples will be collected to determine the t1/2 of sac-TMT payload
Measured: Up to approximately 6 weeks
Complete Response Rate (CRR)
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.
Measured: Up to approximately 6 months
Duration of Complete Response (DCR)
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.
Measured: Up to approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start20 Dec 2024
- Primary completion14 Mar 2029 (estimated)
- Study completion14 Mar 2029 (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.
- More trials run by Merck Sharp & Dohme LLCThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06637423
- Sponsor's protocol ID
- 2870-027
- Other IDs
- 2024-514983-23-00, U1111-1308-6998, MK-2870-027
- Acronym
- TroFuse-027
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2024
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf