Ovarian CancerPhase 2NCT07815704
Targeting Immune Modulation in High Grade Serous Carcinoma: Combined Effects of Chemotherapy and Atorvastatin
A Phase 2 study of Ovarian Cancer and Fallopian Tube Cancers, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn how atorvastatin in patients with advanced high grade serous cancer of the ovary, fallopian tube, or peritoneum changes the tumor immune environment. Read more about this study
- Who is it for?
- Ages 18 to 89 years, women only
- Conditions the study is for
- Ovarian Cancer, Fallopian Tube Cancers, Primary Peritoneal Cancer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Aug 2031
- Phase
- Phase 2
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 to 89 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be a patient with ovarian cancer aged 18-89
- Diagnosed via tissue biopsy not ascites
- For persons of reproductive potential, use of highly effective method(s) of contraception.
- Patients with primary Stage III/IV high-grade serous ovarian/fallopian tube/primary peritoneal cancer not amenable to upfront cytoreductive surgery.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2.
- Absolute Neutrophil Count 1500 cells/mL
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- Platelet count > 100,000 mL.
- Hemoglobin 9.0 g/dL
- Serum albumin ³ 2.5 g/dL.
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN).
- aspartate aminotransferase (AST )and alanine aminotransferase (ALT) ≤ 3.0 x ULN.
- Serum creatinine ≤ 1.5x ULN
Who cannot join
- Inability to comply with study and follow-up procedures.
- Significant cardiovascular disease, such as New York Heart Association cardiac disease (class II or greater), myocardial infarction within the past 3 months, unstable arrhythmia, or unstable angina.
- Known clinically significant liver disease defined as AST and ALT > 3.0 x ULN and/or total bilirubin ≥ 1.5 x ULN, or documented history of active viral, alcoholic, or other hepatitis, cirrhosis, and inherited liver disease.
- Participation in investigational clinical trial within last 30 days.
- Medical history of untreated HIV infection. Patients with medical history of HIV infection are eligible provided they meet following criteria
- Are stable on antiretroviral therapy for ≥4 weeks before randomization
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- Agree to adhere to antiretroviral therapy per World Health Organization (WHO) guidelines
- Have no documented multi-drug resistance that would prevent effective antiretroviral therapy
- Have a viral load of <400 copies per mL at screening
- Have CD4+ T cell count at ≥ 350 cells per μL
- Have no history of acquired immunodeficiency syndrome (AIDS) -defining opportunistic infection ≤ 12 months before randomization.
- Inability to provide informed consent.
- Known central nervous system (CNS) malignancy or CNS metastases.
- Patients with previous malignancy within the past 2 years from cycle 1, day 1, except those with negligible risk of metastasis or death, such as adequately controlled basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the breast.
- History of stroke or transient ischemic attack (TIA) within 3 months prior to cycle 1 day 1(C1D1).
- Patients with prognosis for survival less than 6 months.
- Patients deemed otherwise clinically unfit for clinical trial per Investigator's discretion.
- Patients with duodenal stent or other gastrointestinal (GI) disorder/defect that would interfere with absorption of oral medication.
- o Includes patients unable to swallow orally administered medication and patients with GI disorders likely to interfere with absorption of the study medication
- Female patients who maintain fertility potential and refuse to comply to use contraception and be followed for pregnancy by pregnancy testing.
- Patients who are currently pregnant or lactating.
- Prior or current statin use that would prohibit randomization into SOC arm.
- Planned treatment with bevacizumab in the primary treatment setting.
- Diagnosis based on ascites assessment only and not a tissue biopsy.
- Patients deemed otherwise clinically unfit for clinical trial per investigators discretion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Colorado Anschutz
Aurora, Colorado, 80045
About this study
The goal of this clinical trial is to learn how atorvastatin in patients with advanced high grade serous cancer of the ovary, fallopian tube, or peritoneum changes the tumor immune environment. The main question it aims to answer is:
- Does atorvastatin combined with standard of care chemotherapy and surgery changes the number of tumor-promoting macrophages in the tumor microenvironment
- Researchers will compare standard of care chemotherapy and surgery to see if there is a difference in tumor promoting macrophages.
- Participants will take atorvastatin (daily pill) alongside their standard treatment.
- Conditions
- Ovarian Cancer, Fallopian Tube Cancers, Primary Peritoneal Cancer, High Grade Serous Adenocarcinoma of Ovary
- Being tested
- Standard of Care + atorvastatin, Standard of Care (SOC)
- Keywords
- high grade serous carcinoma, statin
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of Care + atorvastatinDrug
Neoadjuvant chemotherapy with carboplatin and paclitaxel in addition to daily atorvastatin, interval debulking surgery, then 2-3 additional cycles of carboplatin and paclitaxel
Standard of Care (SOC)Drug
neoadjuvant chemotherapy with 3-4 cycles of carboplatin/paclitaxel, interval debulking surgery, then 2-3 additional cycles of chemotherapy with carboplatin/paclitaxel
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | neoadjuvant chemotherapy with 3-4 cycles of carboplatin/paclitaxel, interval debulking surgery, then 2-3 additional cycles of chemotherapy with carboplatin/paclitaxel Receives: Drug: Standard of Care (SOC) |
| Atorvastatin with Standard of Care | Experimental | Patients in this arm will take atorvastatin daily alongside neoadjuvant chemotherapy with 3-4 cycles of carboplatin/paclitaxel, interval debulking surgery, then 2-3 additional cycles of chemotherapy with carboplatin/paclitaxel Receives: Drug: Standard of Care + atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of CD163+ tumor associated macrophages in post-treatment specimens.
The primary efficacy endpoint is the change from baseline to the post-treatment surgical specimen in the mean CD163 H-score among CD68-positive tumor-associated macrophages. CD68 and CD163 expression will be assessed by multispectral immunohistochemistry in paired pre-treatment biopsy and post-treatment surgical samples.
Measured: 3 months
Secondary outcomes (2)
Progression free survival
Investigator-assessed progression-free survival will be defined as the time from randomization to the first documented occurrence of objective disease progression or death from any cause, whichever occurs first.
Measured: 5 years
Overall Survival
Overall survival as defined by the time of randomization to time of death from any cause.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionAug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicole Marjon, MD, PhD, Principal investigator, CU Anschutz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07815704
- Sponsor's protocol ID
- 26-0543
- Status last verified
- Sep 2026
- First submitted
- 31 Aug 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: All data will be de-identified prior to sharing with other researchers