Advanced Gastric AdenocarcinomaPhase 2NCT04209686
Paclitaxel, Pembrolizumab and Olaparib in Previously Treated Advanced Gastric Adenocarcinoma
A Phase 2 study testing Paclitaxel, Olaparib and Pembrolizumab in people with Advanced Gastric Adenocarcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and clinical activity of paclitaxel plus olaparib and pembrolizumab in patients with previously treated advanced Gastric Cancer (GC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Gastric Adenocarcinoma
- What is being tested?
- Paclitaxel, Olaparib and Pembrolizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2020to 17 Nov 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21231
About this study
Official title: Phase 2 Study of Paclitaxel, Pembrolizumab and Olaparib in Previously Treated Advanced Gastric Adenocarcinoma
The purpose of this study is to evaluate the safety and clinical activity of paclitaxel plus olaparib and pembrolizumab in patients with previously treated advanced Gastric Cancer (GC).
- Conditions
- Advanced Gastric Adenocarcinoma
- Being tested
- Paclitaxel, Olaparib, Pembrolizumab
- Keywords
- Paclitaxel, Olaparib, Pembrolizumab, Immunotherapy, Anti-PD-1, PARP inhibitors, Gastric Cancer
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaclitaxelDrug
Also called Taxol
Paclitaxel (80mg/m^2) will be administered IV on days 1 and 8 starting with Cycle 2. Each Cycle is 21 days.
OlaparibDrug
Also called Lynparza
Olaparib (100mg or 300mg) will be administered orally on Days 1-21 of each Cycle. Each Cycle is 21 days.
PembrolizumabDrug
Also called MK-3475; Keytruda
Pembrolizumab (200mg) will be administered IV on day 1 of each Cycle. Each Cycle is 21 days.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Measurable Disease | Experimental | Not described Receives: Drug: Paclitaxel; Drug: Olaparib; Drug: Pembrolizumab |
| Arm 2: Unmeasurable Disease | Experimental | Not described Receives: Drug: Paclitaxel; Drug: Olaparib; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Overall survival is the time from the start of first dose of study drug to death or end of follow-up (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis). Estimation based on the Kaplan-Meier curve.
Measured: Up to 27 months
Secondary outcomes (2)
Number of Participants Experiencing Grade 3 or Above Study Drug-related Adverse Events (AEs)
When calculating the incidence of AEs, each AE (as defined by NCI CTCAE v5.0) will be counted only once for a given subject. Laboratory abnormalities that were asymptomatic and not clinically significant were excluded.
Measured: 15 months
Number of Participants Experiencing Immune-related Adverse Events (irAEs)
When calculating the incidence of AEs, each AE (as defined by NCI CTCAE v5.0) will be counted only once for a given subject. Laboratory abnormalities that were asymptomatic and not clinically significant were excluded.
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2019
- Study start31 Jul 2020
- Primary completion17 Nov 2025
- Study completion17 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced Gastric AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Katherine Bever, MD, Principal investigator, Johns Hopkins Medical Institution
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04209686
- Sponsor's protocol ID
- J19135
- Other IDs
- IRB00209006
- Status last verified
- Aug 2026
- First submitted
- 20 Dec 2019
- Last updated
- 1 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Paclitaxel, Pembrolizumab and Olaparib in Previously Treated Advanced Gastric Adenocarcinoma
- ClinicalTrials.gov ID
- NCT04209686
- Acronym / sponsor ID
- J19135
- Conditions
- Advanced Gastric Adenocarcinoma
- Keywords
- Paclitaxel, Olaparib, Pembrolizumab, Immunotherapy, Anti-PD-1, PARP inhibitors, Gastric Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 31 Jul 2020 (actual)
- Primary completion
- 17 Nov 2025 (actual)
- Study completion
- 17 Nov 2025 (actual)
- First posted
- 24 Dec 2019 (actual)
- Results
- Posted 1 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and clinical activity of paclitaxel plus olaparib and pembrolizumab in patients with previously treated advanced Gastric Cancer (GC).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Measurable Disease | Experimental | Drug: Paclitaxel, Drug: Olaparib, Drug: Pembrolizumab |
| Arm 2: Unmeasurable Disease | Experimental | Drug: Paclitaxel, Drug: Olaparib, Drug: Pembrolizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (25 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PaclitaxelAlso: TaxolPaclitaxel (80mg/m^2) will be administered IV on days 1 and 8 starting with Cycle 2. Each Cycle is 21 days. | Drug | Arm 1: Measurable Disease, Arm 2: Unmeasurable Disease |
| OlaparibAlso: LynparzaOlaparib (100mg or 300mg) will be administered orally on Days 1-21 of each Cycle. Each Cycle is 21 days. | Drug | Arm 1: Measurable Disease, Arm 2: Unmeasurable Disease |
| PembrolizumabAlso: MK-3475; KeytrudaPembrolizumab (200mg) will be administered IV on day 1 of each Cycle. Each Cycle is 21 days. | Drug | Arm 1: Measurable Disease, Arm 2: Unmeasurable Disease |
Primary outcome
Overall Survival (OS)
Time frame: Up to 27 months
Overall survival is the time from the start of first dose of study drug to death or end of follow-up (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis). Estimation based on the Kaplan-Meier curve.
2 secondary outcomes
Number of Participants Experiencing Grade 3 or Above Study Drug-related Adverse Events (AEs)
Time frame: 15 months
Number of Participants Experiencing Immune-related Adverse Events (irAEs)
Time frame: 15 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine Bever, MD principal investigator
Johns Hopkins Medical Institution
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Paclitaxel, Olaparib and Pembrolizumab in people with Advanced Gastric Adenocarcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: Up to 27 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.