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NCT06524544Toboroz3. fázis

A Study Comparing the Combination of Pembrolizumab and Sacituzumab Govitecan-hziy Versus Standard of Care in the Treatment of Advanced Urothelial Cancer

A Phase III Randomized Trial of Pembrolizumab in Combination With Sacituzumab Govitecan-hziy vs Standard of Care in Anti-PD(L)1-Resistant Advanced Urothelial Cancer

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. nov. 4.

Következő lépések

Rövid összefoglaló (regiszter, angolul)

This phase III trial compares the effectiveness of pembrolizumab and sacituzumab govitecan-hziy to standard of care in treating patients with urothelial cancer that has spread to nearby tissue or lymph nodes (locally advanced) or that has spread to other places in the body (metastatic). 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. Sacituzumab govitecan-hziy is a monoclonal antibody, called sacituzumab, linked to a chemotherapy drug called govitecan-hziy. Sacituzumab attaches to TROP2 positive tumor cells in a targeted way and delivers govitecan-hziy to kill them. The usual treatment approach is treatment with chemotherapy such as cisplatin, carboplatin, gemcitabine, docetaxel or paclitaxel. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid 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. Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Giving pembrolizumab and sacituzumab govitecan-hziy may be more effective than usual care of carboplatin or cisplatin with gemcitabine, docetaxel or paclitaxel in treating patients with locally advanced or metastatic urothelial cancer.

Állapot (regiszter)
Toboroz
Fázis (regiszter)
3. fázis
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
320 (tervezett)
Első benyújtás
2024. júl. 26.
Kezdés
2025. dec. 2.
Elsődleges befejezés
2030. dec. 31.
Fő szponzor
National Cancer Institute (NCI)
Betegségek
Hólyagrák
NCT-szám
NCT06524544

Mit vállalsz

  • Vizsgálat típusa: Beavatkozással járó · 3. fázis
  • Tervezett résztvevők: 320
  • 2025. dec. 2. és az elsődleges befejezés (2030. dec. 31.) között
  • 163 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.

Ki nem vehet részt

Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.

Kiket keres a vizsgálat

  • Patient must be ≥ 18 years of age
  • Patient must have Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
  • Patient must have locally advanced (unresectable and/or not amenable to curative intent therapy) or metastatic urothelial cancer
  • Patient must have histologically (or based on urine cytology) proven conventional urothelial carcinoma (UC) of any urinary tract origin [any histologic subtype except neuroendocrine (small or large cell)] are permitted so long as tumors include ≥ 1% conventional urothelial histology). NOTE: Pure non-urothelial histology is excluded
  • Patient must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Baseline imaging must be obtained ≤ 35 days prior to randomization
  • Patient must have the following prior treatment(s). Patient must have had progression on or after the immediate prior anti-cancer therapy
  • Patient must have had prior exposure to anti-PD(L)1 therapy [anti -PD(L)1 monotherapy or as a combination regimen in any disease/therapy setting for UC]. Patients must have received at least 1 dose of anti-PD(L)1 therapy
    • NOTE: Anti-PD(L)1 therapy does not need to be the most recent therapy received prior to enrollment on this protocol
    • NOTE: Patient must not have had progression within 12 weeks of starting their first anti-PD(L) 1 therapy, even if anti-PD-(L)1 treatment was given in more than one lines of therapy
  • Patient must have had ≥ 1 line of systemic therapy given in the advanced/metastatic disease setting, except for patients who had received anti-PD(L)1 + enfortumab vedotin in the localized disease setting (e.g., neoadjuvant and/or adjuvant) and had cancer progression within 12 months from the last systemic therapy dose
  • For tumors with known FGFR3+ susceptible alteration (for FGFR inhibitor), patients must have received a prior FGFR inhibitor unless contraindicated per physician discretion
  • Patient must have received prior enfortumab vedotin or any other Nectin-4 directed therapy or other MMAE-containing therapy in any disease/therapy setting unless contraindicated per physician
  • Patient must have had no prior exposure to Sacituzumab govitecan-hziy or other TROP-2 directed therapies or antibody-drug conjugate that contains topo-isomerase I inhibitor, e.g. trastuzumab deruxtecan
  • Patient must have Bellmunt score of 0-2. The Bellmunt score assesses a patient's risk and is calculated based on ECOG PS, hemoglobin level and presence of liver metastases
  • Patient must not have history of grade 3-4 immune-related adverse events on prior anti-PD1/L1, except for endocrinopathies on adequate hormone therapy repletion and/or clinically insignificant laboratory abnormalities
  • Patient must have recovered (i.e., ≤ grade 1) from clinically significant AEs due to previously administered systemic therapy agent, except for endocrinopathies on adequate hormone therapy repletion
    • NOTE: Patients with ≤ grade 2 neuropathy, any grade of alopecia, or any grade of non-clinically significant laboratory abnormality are exceptions to this criterion and are allowed in this trial.
    • Examples of non-clinically significant laboratory abnormalities include, but are not limited to:
    • Lymphopenia or monopenia
    • Lymphocytosis or monocytosis
    • Increase in amylase or lipase with no clinical correlation
    • Any other abnormal laboratory findings that have no clinical relevance per the treating investigator.
    • NOTE: If patient has undergone major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to randomization
  • Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy. A patient of childbearing potential is defined as anyone, regardless of whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months). Patient must not nurse infants while on protocol treatment and for 4 months after the last dose of protocol treatment
  • Patient must not expect to conceive or father children by using an accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study. Patients of childbearing potential must continue contraceptive method(s) or abstain for 6 months after the last dose of protocol treatment. Patients with partners who could become pregnant should use effective contraception during therapy and for 3 months after the last dose of protocol treatment
  • Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible
  • Absolute neutrophil count (ANC) ≥ 1,500/uL (obtained ≤ 14 days prior to randomization)
  • Platelets ≥ 100,000/uL (obtained ≤ 14 days prior to randomization)
  • Albumin ≥ 3 g/dL (obtained ≤ 14 days prior to randomization)
  • Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (obtained ≤ 14 days prior to randomization)
  • Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase [SGPT]) ≤ 3 × institutional ULN or ≤ 5.0 x institutional ULN if known liver metastases (obtained ≤ 14 days prior to randomization)
  • Creatinine clearance (CrCl) ≥ 30 mL/min (obtained ≤ 14 days prior to randomization) NOTE: CrCl is estimated using the Cockcroft-Gault formula (or can be measured by 24-hour urine collection if needed)
  • Hemoglobin (Hb) ≥ 8.5 g/dl (obtained ≤ 14 days prior to randomization)
  • Patient must not have a known genetic UGT1A1 *28/*28 or *6/*6 homozygous variant genotype. Patients with homozygous variant types are considered poor metabolizers and are at higher risk for severe adverse events when compared to wild-type. Patients with heterozygous UGT1A1 variants (i.e. *1/*28 or *1/*6) are eligible and should be counseled accordingly and be very closely monitored if randomized to the sacituzumab govitecan arm
    • NOTE: If a patient's UGT1A1 status is unknown, they are eligible to enroll (the study does not require this test as part of screening)
  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible
  • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
  • Patients with history of hepatitis C virus (HCV) infection must have been treated and considered cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
  • Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression and are not using steroids > 10 mg of prednisone (or equivalent) daily for brain metastases for at least 7 days prior to randomization
  • Patients with prior or concurrent malignancy that is not considered clinically significant and whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen (at the discretion of the treating physician) are eligible
  • Patient must not be on systemic immunosuppressive medication, including steroids (if doses exceed the equivalent of prednisone 10 mg daily). Short courses of steroids, e.g. "burst", which are discontinued prior to randomization are acceptable. Patients on inhaled, intranasal, intra-articular and/or topical steroids are eligible
  • Patient must be English or Spanish speaking to be eligible for the HRQOL component of the study.
    • NOTE: Sites cannot translate the associated HRQOL forms

Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (163)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

HelyszínVárosOrszágHelyszín állapota
Avera Cancer Institute-AberdeenAberdeenEgyesült ÁllamokToboroz
McFarland Clinic - AmesAmesEgyesült ÁllamokToboroz
Mary Greeley Medical CenterAmesEgyesült ÁllamokToboroz
Community Hospital of AnacondaAnacondaEgyesült ÁllamokToboroz
ThedaCare Regional Cancer CenterAppletonEgyesült ÁllamokToboroz
Duluth Clinic AshlandAshlandEgyesült ÁllamokToboroz
Emory Saint Joseph's HospitalAtlantaEgyesült ÁllamokToboroz
Emory University Hospital MidtownAtlantaEgyesült ÁllamokToboroz
Emory University Hospital/Winship Cancer InstituteAtlantaEgyesült ÁllamokToboroz
Louisiana Hematology Oncology Associates LLCBaton RougeEgyesült ÁllamokToboroz
Houston Methodist San Jacinto HospitalBaytownEgyesült ÁllamokToboroz
FHCC OverlakeBellevueEgyesült ÁllamokToboroz
Central Vermont Medical Center/National Life Cancer TreatmentBerlin CornersEgyesült ÁllamokToboroz
Billings Clinic Cancer CenterBillingsEgyesült ÁllamokToboroz
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Trinity Health IHA Medical Group Hematology Oncology - BrightonBrightonEgyesült ÁllamokToboroz
Roswell Park Cancer InstituteBuffaloEgyesült ÁllamokToboroz
University of Vermont and State Agricultural CollegeBurlingtonEgyesült ÁllamokToboroz
University of Vermont Medical CenterBurlingtonEgyesült ÁllamokToboroz
Trinity Health IHA Medical Group Hematology Oncology - CantonCantonEgyesült ÁllamokToboroz
Saint Francis Medical CenterCape GirardeauEgyesült ÁllamokToboroz
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UT Southwestern Simmons Cancer Center - RedBirdDallasEgyesült ÁllamokToboroz
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Geisinger Cancer Center Dickson CityDickson CityEgyesült ÁllamokToboroz
Essentia Health Cancer CenterDuluthEgyesült ÁllamokToboroz
Minnesota Oncology - EdinaEdinaEgyesült ÁllamokToboroz
Fairview Southdale HospitalEdinaEgyesült ÁllamokToboroz
Crossroads Cancer CenterEffinghamEgyesült ÁllamokToboroz
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Saint Vincent HospitalErieEgyesült ÁllamokToboroz
Essentia Health Cancer Center-South University ClinicFargoEgyesült ÁllamokToboroz
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The University of Kansas Cancer Center - OlatheOlatheEgyesült ÁllamokToboroz
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Allegheny General HospitalPittsburghEgyesült ÁllamokToboroz
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FHCC at Northwest HospitalSeattleEgyesült ÁllamokToboroz
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Springfield Memorial HospitalSpringfieldEgyesült ÁllamokToboroz
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Siteman Cancer Center at Christian HospitalSt LouisEgyesült ÁllamokToboroz
Missouri Baptist Medical CenterSt LouisEgyesült ÁllamokToboroz
Stony Brook University Medical CenterStony BrookEgyesült ÁllamokToboroz
Houston Methodist Sugar Land HospitalSugar LandEgyesült ÁllamokToboroz
Missouri Baptist Sullivan HospitalSullivanEgyesült ÁllamokToboroz
Houston Methodist The Woodlands HospitalThe WoodlandsEgyesült ÁllamokToboroz
Community Medical CenterToms RiverEgyesült ÁllamokToboroz
University of Kansas Health System Saint Francis CampusTopekaEgyesült ÁllamokToboroz
UPMC Cancer Center-UniontownUniontownEgyesült ÁllamokToboroz
Carle Cancer CenterUrbanaEgyesült ÁllamokToboroz
Essentia Health Virginia ClinicVirginiaEgyesült ÁllamokToboroz
UPMC Cancer Center-WashingtonWashingtonEgyesült ÁllamokToboroz
Reading HospitalWest ReadingEgyesült ÁllamokToboroz
University of Kansas Hospital-Westwood Cancer CenterWestwoodEgyesült ÁllamokToboroz
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Geisinger Wyoming Valley/Henry Cancer CenterWilkes-BarreEgyesült ÁllamokToboroz
Roswell Park Amherst CenterWilliamsvilleEgyesült ÁllamokToboroz
UMass Memorial Medical Center - University CampusWorcesterEgyesült ÁllamokToboroz
Avera Cancer Institute at YanktonYanktonEgyesült ÁllamokToboroz
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor CampusYpsilantiEgyesült ÁllamokToboroz

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