NCT06460961Befejeződött1. fázis
A Study of MK-6837 as a Monotherapy and Combination Therapy in Participants With Advanced/Metastatic Solid Tumors (MK-6837-001)
A Phase 1 Open-label, Multicenter Study of MK-6837 as Monotherapy and Combination Therapy in Participants With Advanced/Metastatic Solid Tumors
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. aug. 28.
Rövid összefoglaló (regiszter, angolul)
The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of MK-6837, administered as a monotherapy and in combination with pembrolizumab (MK-3475), in participants with histologically or cytologically confirmed advanced/metastatic solid tumors that have not responded to conventional therapy. There will not be any hypothesis testing in the study. As of Amendment 04 (effective date: 18-Dec-2025), there are no pharmacokinetic (PK) secondary outcome measures in this study.
- Állapot (regiszter)
- Befejeződött
- Fázis (regiszter)
- 1. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 40 (tényleges)
- Első benyújtás
- 2024. jún. 11.
- Kezdés
- 2024. júl. 14.
- Elsődleges befejezés
- 2026. júl. 29.
- Fő szponzor
- Merck Sharp & Dohme LLC
- NCT-szám
- NCT06460961
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 1. fázis
- Bevont résztvevők: 40
- 2024. júl. 14. és az elsődleges befejezés (2026. júl. 29.) között
- 7 helyszín, 4 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
- Received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention
- Has received any prior immunotherapy and was discontinued from that treatment due to a Grade 3 or higher immune-related AE (except endocrine disorders that can be treated with replacement therapy) or was discontinued from that treatment due to Grade 2 myocarditis or recurrent Grade 2 pneumonitis
- Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids
- Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed
- Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of study intervention
- Participants who have not adequately recovered from major surgery or have ongoing surgical complications
Más betegség
- Has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or better from any Adverse Events (AEs) that were due to cancer therapeutics administered more than 4 weeks earlier
- History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years
- Has clinically significant cardiovascular disease
- HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- Known additional malignancy that is progressing or has required active treatment within the past 2 years
- Active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy
- History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- Active infection requiring systemic therapy
- History of allogeneic tissue/solid organ transplant
Egyéb
- The main exclusion criteria include but are not limited to the following:
- Known active Central Nervous System (CNS) metastases and/or carcinomatous meningitis
Kiket keres a vizsgálat
- The main inclusion criteria include but are not limited to the following:
- Histologically or cytologically confirmed solid tumor by pathology report that is advanced or metastatic
- Human Immunodeficiency Virus (HIV)-infected participants must have well controlled HIV on Antiretroviral Therapy (ART)
- Participants who are Hepatitis B Surface Antigen (HBsAg) positive are eligible if they have received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load before allocation
- Participants with history of Hepatitis C Virus (HCV) infection are eligible if HCV viral load is undetectable at screening
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (7)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| The Alfred Hospital (Site 1001) | Melbourne | Ausztrália | Ismeretlen állapot |
| Westmead Hospital (Site 1002) | Westmead | Ausztrália | Ismeretlen állapot |
| Princess Margaret Cancer Centre (Site 2001) | Toronto | Kanada | Ismeretlen állapot |
| Sheba Medical Center-ONCOLOGY (Site 3001) | Ramat Gan | Izrael | Ismeretlen állapot |
| Atlantic Health System Morristown Medical Center (Site 4001) | Morristown | Egyesült Államok | Ismeretlen állapot |
| Providence Portland Medical Center (Site 4002) | Portland | Egyesült Államok | Ismeretlen állapot |
| South Texas Accelerated Research Therapeutics (START) (Site 4003) | San Antonio | Egyesült Államok | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.