Could a daily aspirin boost ovarian cancer treatment?
NCT ID NCT05080946
First seen Jun 25, 2026 · Last updated Sep 16, 2026 · Updated 4 times
Summary
This early-phase study is testing whether taking a daily 325 mg aspirin alongside standard chemotherapy can reduce immune-suppressing cells in ovarian, fallopian tube, or peritoneal tumors. About 100 women will take either aspirin or a placebo for up to 5 cycles of chemo. The goal is to see if aspirin makes the tumor more vulnerable to the immune system, potentially improving treatment outcomes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Aspirin (325 mg daily)
- What this could lead to
- If it works, this could point toward a way to make standard chemotherapy more effective for ovarian cancer by reducing immune suppression in the tumor.
- What could go wrong
- This is a very early, small pilot study (Phase 1) looking at immune markers, not survival. Aspirin may not change tumor immune features, and results may not lead to a new treatment.
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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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2021
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- 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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Female participants only
- 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.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Participants that are greater than or equal to 18 years of age * For U.S. sites, patients can read and understand English or Spanish; for Canadian site, participants can read and understand English or French * Histology confirmed, or clinical suspicion of, invasive epithelial ovarian, fallopian tube, or peritoneal carcinoma. Must be grade 2 or 3 or high (where high is defined as grade 2/3). All histologies including serous, endometrioid, clear cell sarcoma, or carcinosarcoma histology is acceptable. Mixed histology also acceptable. * Treatment naïve for this cancer diagnosis * Planned for neoadjuvant chemotherapy (platinum-based doublet with taxane +/- anti-VEGF antibody) for at least 3 but no more than 5 cycles followed by an interval debulking surgery. \[Note: this study evaluates response while on neoadjuvant treatment. The final collection of specimen and questionnaire is at the time of surgery and immediate post-operative state. Therefore, there are no eligibility criteria related to treatment in the adjuvant setting (e.g., intraperitoneal treatment) and adjuvant therapy should proceed as the physician deems appropriate.\] * Measurable disease as defined by RECIST 1.1, CT scan (with or without contrast) within 12 weeks of study enrollment. * Eastern Cooperative Oncology Group (ECOG) performance status of 0,1, or 2 * Able to provide tissue biopsy (core or excisional) sufficient for diagnosis and biomarker analysis, may use outside archival tissue if available. * If currently using anti-coagulation medication, no contraindication for temporary stoppage of use during the study based on physician judgement * Willing and able to swallow pills without difficulty * Un-transfused platelet count \> 100,000 cells/μL * Willing and able to participate in all required evaluations and procedures in this study protocol (e.g. undergoing treatment, scheduled visits and examinations, serum testing, questionnaires, pill log/diary) * Absolute neutrophil count \> 1.5 x 109 cells/L * Hemoglobin \> 9.0 g/dL, may use transfusions and the value can be post-transfusion * Estimated creatinine clearance of \> 30 mL/min, calculated using the formula Cockcroft-Gault \[(140-age) x Mass (kg)/(72 x creatinine mg/dL)\] x 0.85 for female * No severe hepatic impairment defined as AST or ALT elevation \< 2.5 x institutional ULN, unless liver metastasis is present \< 5 x ULN Exclusion Criteria: * Definite contraindication for either aspirin use or stopping current aspirin use based on physician's clinical judgment * History of vascular event in the last 12 months (e.g., myocardial infarction or unstable angina, stroke, coronary artery angioplasty or stenting, coronary artery bypass graft, relevant \[serious or significant\] arrhythmias, significant vascular disease, congestive heart failure or vascular interventions). * History of hypertensive crisis and/ or uncontrolled HTN, systolic blood pressure \> 150 mmHg; diastolic blood pressure \> 90mmHg. Participants must have blood pressure \< 150/90 mmHg taken in a clinic setting by a medical professional within 2 weeks prior to starting study. * Current or history of ulcers which prohibits aspirin consumption, severe hepatic failure, or acute or chronic renal disease where aspirin use is contraindicated * History of gastrointestinal or genitourinary bleeding or other bleeding diathesis or coagulopathy within 6 months prior to enrollment of study * Uncontrolled erosive esophagitis requiring 2 or more treatments * Other cancer diagnosis in the last 3 years other than non-melanoma skin cancer * Autoimmune disorder requiring systemic therapy * Chronic steroid use defined as 3 weeks in the past year or any length of time in the past 30 days. * Other aspirin or NSAID hypersensitivities or contraindications (e.g. allergy) * History of bariatric surgery * Currently pregnant at the Screening visit or planning on becoming pregnant during the study period * Participant is unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with study medication. * Metabolism CYP2C9, known G6PD deficient patients
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Inova Schar Cancer Institute
Fairfax, Virginia, 22031, United States
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Moffitt Cancer Center
Tampa, Florida, 33612, United States
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Oregon Health and Science University
Portland, Oregon, 97239, United States
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University of Virginia Comprehensive Cancer Center
Charlottesville, Virginia, 22903, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New PET tracer aims to light up hidden cancer targets
- Can inhaled manganese make ovarian cancer immunotherapy hit harder?
- Can a pill shrink Hard-to-Treat ovarian tumors?
- New antibody aims to preserve immune checkpoint while fighting cancer