Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 5:58 AM
Study NCT ID:
NCT07419295
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-19
First Post:
2026-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) to Treat Urothelial Cancer (MK-2870-031)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C111217', 'term': 'vinflunine'}, {'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D004358', 'term': 'Drug Therapy'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 590}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-17', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2030-04-23', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-10', 'studyFirstSubmitDate': '2026-02-10', 'studyFirstSubmitQcDate': '2026-02-10', 'lastUpdatePostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-07-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to approximately 40 months', 'description': 'OS is defined as time from randomization to death due to any cause.'}], 'secondaryOutcomes': [{'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'Up to approximately 32 months', 'description': 'PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1). PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by investigator will be presented.'}, {'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'Up to approximately 32 months', 'description': 'ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience CR or PR as assessed by the investigator will be presented.'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'Up to approximately 49 months', 'description': 'For participants who demonstrate a confirmed CR or PR per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until PD or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by the investigator will be presented.'}, {'measure': 'Number of Participants Who Experience an Adverse Event (AE)', 'timeFrame': 'Up to approximately 49 months', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants that experience AEs will be reported.'}, {'measure': 'Number of Participants Who Discontinue Study Treatment Due to an AE', 'timeFrame': 'Up to approximately 48 months', 'description': 'An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants that discontinue study intervention due to an AE will be reported.'}, {'measure': 'Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Combined Score', 'timeFrame': 'Baseline, up to approximately 49 months', 'description': 'EORTC QLQ-C30 is a questionnaire to assess the overall quality of life (QoL) of cancer patients. Participant responses to questions regarding Global Health Status (GHS; "How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) is computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. Per protocol, the change from baseline in GHS and QoL combined score will be presented.'}, {'measure': 'Change From Baseline in EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score', 'timeFrame': 'Baseline, up to approximately 49 months', 'description': 'EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 is computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score will be presented.'}, {'measure': 'Change From Baseline in EORTC QLQ-C30 Role Functioning (Items 6 and 7) Combined Score', 'timeFrame': 'Baseline, up to approximately 49 months', 'description': 'EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 2 questions about their role functioning (Items 6 and 7) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 6 and 7 is computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined score ranges from 0 to 100. A higher score indicates a better outcome. Per protocol, the change from baseline in the EORTC QLQ-C30 role functioning (items 6 and 7) combined score will be presented.'}, {'measure': 'Change From Baseline in EORTC QLQ-C30 Fatigue (Items 10, 12, and 18) Combined Score', 'timeFrame': 'Baseline, up to approximately 49 months', 'description': 'EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 3 questions about their fatigue (Items 10, 12, and 18) are scored on a 4-point scale (1 = Not at All to 4 = Very Much). The combined score of items 10, 12, and 18 is computed by averaging the raw scores of the 3 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A lower score indicates a better outcome. Per protocol, the change from baseline in the EORTC QLQ-C30 fatigue (items 10, 12, and 18) combined score will be presented.'}, {'measure': 'Change From Baseline in EORTC QLQ-C30 Nausea/Vomiting (Items 14 and 15) Combined Score', 'timeFrame': 'Baseline, up to approximately 49 months', 'description': 'EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 2 questions about their nausea and vomiting symptoms (Items 14 and 15) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 14 and 15 is computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A lower score indicates a better outcome. Per protocol, the change from baseline in the EORTC QLQ-C30 nausea/vomiting (Items 14 and 15) combined score will be presented.'}, {'measure': 'Change From Baseline in EORTC QLQ-C30 Diarrhea (Item 17) Score', 'timeFrame': 'Baseline, up to approximately 49 months', 'description': 'EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to the question: "Have you had diarrhea?" (Item 17) are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better outcome. Per protocol, the change from baseline in the EORTC QLQ-C30 diarrhea (Item 17) score will be presented.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bladder Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.merckclinicaltrials.com/', 'label': 'Merck Clinical Trials Information'}]}, 'descriptionModule': {'briefSummary': 'Researchers are looking for new ways to treat locally advanced or metastatic urothelial cancer (UC). Current treatments for locally advanced or metastatic UC include chemotherapy, immunotherapy, and targeted therapy.\n\nResearchers want to know if giving sacituzumab tirumotecan (sac-TMT), the trial medicine, can treat locally advanced or metastatic UC that got worse after certain treatments. The goal of this trial is to learn if people who receive sac-TMT live longer than those who receive certain non-platinum chemotherapies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has histologically documented locally advanced/metastatic urothelial cancer. Locally advanced disease must not be amenable to resection or radiation with curative intent per investigator assessment\n* Has measurable disease per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as assessed by the investigator\n* Has received treatment with anti-programmed cell death \\[ligand\\] 1 (anti-PD-\\[L\\]1) therapy, platinum-based chemotherapy, and enfortumab vedotin (EV)\n* Prior therapy with disitamab vedotin (DV) is allowed but will not meet the requirement for prior treatment with EV, except in China, where participants may have received DV instead of EV before study entry\n* Has received a maximum of 3 prior lines of therapy\n* Has experienced radiographic disease progression on or after the immediate prior line of therapy before study entry\n* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days of randomization\n* Is eligible to receive at least one of the control arm nonplatinum chemotherapy options (paclitaxel, docetaxel, or vinflunine)\n* Is able to provide archival tumor tissue sample or newly obtained biopsy of a tumor lesion not previously irradiated\n* If human immunodeficiency virus (HIV) positive, has well-controlled HIV on antiretroviral therapy (ART)\n* If hepatitis B surface antigen (HBsAg) positive, has received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and has undetectable HBV viral load\n* If history of hepatitis C virus (HCV) infection, has undetectable HCV viral load\n* Has adequate organ function\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing\n* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease\n* Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease\n* HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease\n* Has received prior systemic anticancer therapy within 4 weeks or 5 half-lives (whichever is shorter) and has not recovered to grade ≤ 1 or baseline from adverse event (AE) associated with anticancer therapy\n* Has received prior therapy with trophoblast cell-surface antigen 2 (TROP2)-targeted antibody drug conjugate (ADC)\n* Has received prior therapy with a topoisomerase 1 inhibitor-containing ADC\n* Has completed prior external radiotherapy within 6 weeks or stereotactic radiotherapy within 4 weeks of start of study intervention, or has radiation related toxicities, requiring corticosteroids\n* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed\n* Has received prior chemotherapy for urothelial cancer with any of the study therapies in the control arm (paclitaxel, docetaxel, and vinflunine)\n* Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention\n* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years\n* Has a current or past history of central nervous system (CNS) metastases and/or carcinomatous meningitis\n* Has an active infection requiring systemic therapy other than those permitted per protocol\n* Has a history of stem cell/solid organ transplant\n* Has not adequately recovered from major surgery, or has ongoing surgical complications"}, 'identificationModule': {'nctId': 'NCT07419295', 'acronym': 'TroFuse-031', 'briefTitle': 'A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) to Treat Urothelial Cancer (MK-2870-031)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': "A Phase 3, Randomized, Open-label Study of Sacituzumab Tirumotecan (MK-2870) Versus Investigator's Choice of Non-platinum Chemotherapy in Participants With Pretreated Locally Advanced/Metastatic Urothelial Carcinoma", 'orgStudyIdInfo': {'id': '2870-031'}, 'secondaryIdInfos': [{'id': 'U1111-1316-4390', 'type': 'REGISTRY', 'domain': 'UTN'}, {'id': '2024-520014-22-00', 'type': 'REGISTRY', 'domain': 'EU CT'}, {'id': 'MK-2870-031', 'type': 'OTHER', 'domain': 'MSD'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sacituzumab tirumotecan', 'description': 'Participants receive 4 mg/kg of sacituzumab tirumotecan every 2 weeks (Q2W) via intravenous (IV) infusion until disease progression or unacceptable toxicity.', 'interventionNames': ['Biological: Sacituzumab tirumotecan', 'Drug: Rescue medications for sacituzumab tirumotecan']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Chemotherapy', 'description': "Participants receive paclitaxel 175 mg/m\\^2, docetaxel 75 mg/m\\^2, or vinflunine 320 mg/m\\^2 IV every 3 weeks (Q3W), at the investigator's discretion, until disease progression or unacceptable toxicity.", 'interventionNames': ['Drug: Vinflunine', 'Drug: Docetaxel', 'Drug: Paclitaxel', 'Drug: Rescue medications for chemotherapy']}], 'interventions': [{'name': 'Sacituzumab tirumotecan', 'type': 'BIOLOGICAL', 'otherNames': ['MK-2870', 'SKB264', 'sac-TMT'], 'description': 'IV infusion', 'armGroupLabels': ['Sacituzumab tirumotecan']}, {'name': 'Vinflunine', 'type': 'DRUG', 'description': 'IV infusion', 'armGroupLabels': ['Chemotherapy']}, {'name': 'Docetaxel', 'type': 'DRUG', 'description': 'IV infusion', 'armGroupLabels': ['Chemotherapy']}, {'name': 'Paclitaxel', 'type': 'DRUG', 'description': 'IV infusion', 'armGroupLabels': ['Chemotherapy']}, {'name': 'Rescue medications for sacituzumab tirumotecan', 'type': 'DRUG', 'description': "Participants receive rescue medication at the investigator's discretion, per approved product label. Recommended rescue medications are pegfilgrastim or equivalent, histamine-1 (H1) receptor antagonist, histamine-2 (H2) receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent, and steroid mouthwash (dexamethasone or equivalent).", 'armGroupLabels': ['Sacituzumab tirumotecan']}, {'name': 'Rescue medications for chemotherapy', 'type': 'DRUG', 'description': "Participants receive rescue medication at the investigator's discretion, per approved product label. Recommended rescue medications are dexamethasone or equivalent, H1 receptor antagonist, H2 receptor antagonist, and laxative.", 'armGroupLabels': ['Chemotherapy']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'url': 'https://externaldatasharing-msd.com/', 'ipdSharing': 'YES', 'description': 'https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}