NCT07829783Toboroz3. fázis
A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) and Pembrolizumab (MK-3475A) in Participants With Bladder Cancer (MK-2870-055)
A Phase 3 Study Evaluating Sacituzumab Tirumotecan Plus Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) as Induction Therapy, Followed by Local Therapy With Chemoradiation and MK-3475A Consolidation Versus Local Therapy With Chemoradiation in Participants With MIBC Who Elect Bladder Preservation
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. nov. 6.
Rövid összefoglaló (regiszter, angolul)
Researchers are looking for new ways to treat muscle-invasive bladder cancer (MIBC). MIBC is a type of bladder cancer that has spread into the muscle layer of the bladder but has not spread to other distant parts of the body. The usual treatment for MIBC is surgery to remove the bladder but some people choose to have other treatments, such as chemoradiotherapy (CRT), instead of surgery so they can keep their bladder. Researchers want to know if giving 2 trial treatments with CRT can treat MIBC. One trial treatment is called sacituzumab tirumotecan (sac-TMT) and the other trial treatment is called subcutaneous (SC) pembrolizumab (or pembrolizumab and berahyaluronidase alfa). The main goal of this trial is to learn if participants who receive sac-TMT, SC pembrolizumab, and CRT live longer without their cancer growing, spreading, or coming back compared to those who receive CRT alone.
- Állapot (regiszter)
- Toboroz
- Fázis (regiszter)
- 3. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 400 (tervezett)
- Első benyújtás
- 2026. szept. 15.
- Kezdés
- 2026. okt. 23.
- Elsődleges befejezés
- 2031. nov. 17.
- Fő szponzor
- Merck Sharp & Dohme LLC
- Betegségek
- Hólyagrák
- NCT-szám
- NCT07829783
- EU CT-szám
- 2026-526407-30-00
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 3. fázis
- Tervezett résztvevők: 400
- 2026. okt. 23. és az elsődleges befejezés (2031. nov. 17.) között
- 10 helyszín, 2 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.
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Korábbi kezelés
- Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease
- Has received prior pelvic/local radiation therapy for any reason or any systemic antineoplastic treatment for MIBC
- Has not recovered to Grade ≤1 or baseline from AE associated with anticancer therapy before randomization
Más betegség
- Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing
- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
- Has a known additional malignancy that is progressing or has required active treatment within the past 2 years
- Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids, has current pneumonitis/interstitial lung disease, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments
Egyéb
- The main exclusion criteria include but are not limited to the following:
- Has known presence of diffuse carcinoma in situ (CIS) throughout the bladder
Kiket keres a vizsgálat
- The main inclusion criteria include but are not limited to the following:
- Has a diagnosis of muscle-invasive bladder cancer (MIBC) (cT2-T4aN0-N1)
- Has clinically nonmetastatic bladder cancer (N0-N1M0)
- Is either ineligible for radical cystectomy or has opted for bladder preservation and is planned to receive chemoradiotherapy (CRT)
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (10)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Chang Gung Memorial Hospital at Kaohsiung (Site 2702) | Kaohsiung City | Tajvan | Toboroz |
| MNPE ClinCenter of Oncology,Hematology,Transplantology and Palliative Care of CherkasyRegCouncil (Site 3004) | Cherkasy | Ukrajna | Toboroz |
| Communal non-profit enterprise "Regional clinical hospital of Ivano-Frankivsk Regional Council" (Site 3000) | Ivano-Frankivsk | Ukrajna | Toboroz |
| Limited Liability Company Ukrainian Center of Tomotherapy (Site 3008) | Kropyvnytskyi | Ukrajna | Toboroz |
| Municipal non-profit enterprise "Kyiv City Clinical Oncology Center" of executive body of Kyiv City (Site 3006) | Kyiv | Ukrajna | Toboroz |
| Shalimov Institute of Surgery and Transplantation (Site 3009) | Kyiv | Ukrajna | Toboroz |
| Municipal Enterprise "Volyn Regional Medical Oncology Centre" of the Volyn Regional Council (Site 3007) | Lutsk | Ukrajna | Toboroz |
| University Hospital of the State Nonprofit Company "Danylo Halytsky Lviv National Medical University (Site 3002) | Lviv | Ukrajna | Toboroz |
| MNPE Lviv Oncology Regional Treatment and Diagnostic Center of Lviv Regional Council (Site 3005) | Lviv | Ukrajna | Toboroz |
| ME RIVNE REGIONAL ANTITUMOR CENTER (Site 3010) | Rivne | Ukrajna | Toboroz |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.