NCT04592211Toboroz1/2. fázis
Pembrolizumab, Olaparib, Recurrent/Advanced Gastric and Gastro-esophageal Junction(GEJ) Cancer
An Open Label, Single-Arm, Multi-center Phase Ib/II Study to Evaluate the Efficacy of Paclitaxel in Combination With Pembrolizumab and Olaparib as a Second Line Treatment in Immune Checkpoint Inhibitor-experienced Recurrent/Advanced Gastric and Gastro-esophageal Junction(GEJ) Cancer.
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. júl. 11. · Több mint 12 hónapja nem frissült - kérdezd meg a helyszínt, nyitott-e még
Rövid összefoglaló (regiszter, angolul)
Pembrolizumab is a potent humanized immunoglobulin G4 (IgG4) monoclonal antibody (mAb) with high specificity of binding to the programmed cell death 1 (PD 1) receptor, thus inhibiting its interaction with programmed cell death ligand 1 (PD-L1) and programmed cell death ligand 2 (PD-L2). Olaparib is a potent PARP inhibitor (PARP1, 2, and 3) that is being developed as a monotherapy as well as for combination with chemotherapy, ionizing radiation, and other anti-cancer agents including novel agents and immunotherapy. Paclitaxel is widely used in breast, lung and gastric cancer with every 3-week or weekly cycle. Various targeted anticancer agents have been investigated with paclitaxel and combination with ramucirumab, a monoclonal anti-VEGFR2 antibody, was approved as a 2nd line treatment.
- Állapot (regiszter)
- Toboroz
- Fázis (regiszter)
- 1/2. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 71 (tervezett)
- Első benyújtás
- 2020. okt. 15.
- Kezdés
- 2021. okt. 1.
- Elsődleges befejezés
- 2025. dec. 31.
- Fő szponzor
- Yonsei University
- Betegségek
- Gyomor- és nyelőcsőrák
- NCT-szám
- NCT04592211
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 1/2. fázis
- Tervezett résztvevők: 71
- 2021. okt. 1. és az elsődleges befejezés (2025. dec. 31.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- A WOCBP who has a positive urine pregnancy test within 72 hours prior to allocation
- Has received prior systemic anti-cancer therapy including investigational agents within 2 weeks prior to allocation.
- Has received prior radiotherapy within 2 weeks of start of study treatment.
- Has received a live vaccine within 30 days prior to the first dose of study drug.
- Is currently participating in or has participated in a study of an investigational agent including trastuzumab or has used an investigational device within 4 weeks prior to the first dose of study treatment.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
- Participant has received previous allogenic bone-marrow, tissue/solid organ transplant or double umbilical cord transplantation (dUCBT).
Más betegség
- Has a known additional malignancy that is progressing or has required active treatment within the past 5 years.
- Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients, PARP inhibitor and paclitaxel.
- Has active autoimmune disease that has required systemic treatment in the past 2 years
- Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
- Has an active infection requiring systemic therapy.
- Has a known history of Human Immunodeficiency Virus (HIV).
- Has an active of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive and HBV titer >2000 IU/ml) or known active Hepatitis C virus (defined as HCV RNA is detected) infection.
- Has an active TB (Bacillus Tuberculosis) with treatment.
Egyéb
- Has known active CNS metastases and/or carcinomatous meningitis.
Kiket keres a vizsgálat
- Provided written informed consent for treatment.
- Age ≥ 19 years old
- measurable or evaluable disease based on RECIST 1.1. Lesions
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 on time of patient's allocation.
- Adequate organ function as defined by the following criteria:
- A life expectancy of at least 3 months
- Is able to swallow and retain orally administered medications
- Failed first-line trastuzumab treatment for HER2 positive patients
- Highly effective contraception for both male and female subjects if the risk of conception exists.
- Left ventricular ejection fraction (LVEF) ≥50%
Életkor a regiszterben: 19 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Severance hospital | Seoul | Dél-Korea | Toboroz |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.