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New treatment option for Gastric Cancer Stage IV
Official title Pembrolizumab, Olaparib, Recurrent/Advanced Gastric and Gastro-esophageal Junction(GEJ) Cancer
ClinicalTrials.gov ID: NCT04592211
What this study is testing
What is olaparib+pembrolizumab+paclitaxel?
olaparib+pembrolizumab+paclitaxel is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for gastric cancer stage iv.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join if
- 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:
You likely can't join if
- 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...
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or...
See the full eligibility criteria
- 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 people if the risk of conception exists.
- Left ventricular ejection fraction (LVEF) ≥50%
- 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...
- Has a known additional malignancy that is progressing or has required active treatment within the past 5 years.
- Has known active CNS metastases and/or carcinomatous meningitis.
- 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.
- Participant has received previous allogenic bone-marrow, tissue/solid organ transplant or double umbilical cord transplantation (dUCBT).
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.