Triple drug cocktail targets tough stomach cancer
NCT ID NCT04209686
First seen Jun 27, 2026 · Last updated Sep 02, 2026 · Updated 2 times
Summary
This phase 2 study is testing a combination of three drugs—paclitaxel (a chemotherapy), pembrolizumab (an immunotherapy), and olaparib (a targeted therapy)—in 36 adults with advanced gastric or gastroesophageal cancer that has worsened after one prior treatment. The goal is to see if the triple therapy is safe and can improve overall survival. Participants receive the drugs intravenously and by mouth over 21-day cycles.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- paclitaxel, pembrolizumab, and olaparib
- What this could lead to
- If successful, this combination could offer a new treatment option for advanced gastric cancer patients who have run out of standard therapies.
- What could go wrong
- This is a small, early-phase trial with only 36 participants, so results may not apply broadly. The three-drug combination may cause significant side effects, and it is not yet known if it improves survival.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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19 people
The number who actually took part.
- Started
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Jul 2020
- Finished
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Nov 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age ≥18 years. * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Must have advanced gastric or gastroesophageal cancer. * Must have received only one prior line of systemic therapy for advanced disease and experienced disease progression on this regimen.. * For Cohort 1: Must have the presence of measurable lesion. * Must agree to have a biopsy. * Life expectancy of greater than 3 months. * Patients must have adequate organ and marrow function defined by study - specified laboratory tests. * Woman of childbearing potential must have a negative pregnancy test. * Must use acceptable form of birth control while on study. * Ability to understand and willingness to sign a written informed consent document. Exclusion Criteria: * Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Require any antineoplastic therapy. * Require any other form of systemic or localized antineoplastic therapy. * Has received prior therapy with paclitaxel or PARP inhibitor. Previous paclitaxel may be allowed if no progression on or within 6 months of receiving this drug. * Hypersensitivity reaction to any paclitaxel, pembrolizumab or related compounds and/or to any of the components. * Allergy to dexamethasone, diphenhydramine and famotidine. * Is taking a moderate or strong CYP3A inhibitor. * Has uncontrolled intercurrent acute or chronic medical illness. * Has a known additional malignancy that is progressing and has required active treatment within the past 1 year. * Has received prior systemic anti-cancer therapy including investigational agents within 2 weeks prior to study treatment. * 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 or has participated in another investigational study within 4 weeks prior to receiving study drug. * Has an active known or suspected autoimmune disease. * Has a diagnosis of immunodeficiency. * Prior tissue or organ allograft or allogeneic bone marrow transplantation. * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. . * Requires daily supplemental oxygen. * History of (non-infectious) pneumonitis that required steroids or has current pneumonitis. * History of encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent. * Infection with HIV or hepatitis B or C at screening. * Has uncontrolled infection requiring systemic therapy.. * Subjects unable to undergo venipuncture and/or tolerate venous access. * Has known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the trial. * Woman who are pregnant or breastfeeding. * A woman of childbearing potential (WOCBP) who has a positive urine pregnancy test within 72 hours prior to study drug initiation.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21231, United States
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Other studies related to the condition(s) this trial covers.
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