ClinicalTrials.gg
Not yet recruitingNCT07815704Updated Sep 11, 2026

Targeting Immune Modulation in High Grade Serous Carcinoma: Combined Effects of Chemotherapy and Atorvastatin

A Phase 2 interventional study of Standard of Care + atorvastatin and Standard of Care (SOC) in Ovarian Cancer, Fallopian Tube Cancers and Primary Peritoneal Cancer, sponsored by University of Colorado, Denver. Not yet recruiting at 1 site in United States. Open to female participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2026-09-11.

Sponsored by University of Colorado, Denver · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 89 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 1,778 studies in Ovarian Neoplasms with a site in United States — 280 open to participants now, 455 under way, 46 of them phase 3. Ovarian Neoplasms · United States.

Planned enrollment
802nd of 1,497
40 · median 47
Started
2026
with 63 others
Phase 2
485 of 1,778
53 open now
Primary completion
2028-08
later than 328 of 453 live
Registered
1,767th of 1,778
by date

Among the 1,778 studies in Ovarian Neoplasms with a site in United States, this one is the 802nd largest by planned enrollment of the 1,497 interventional ones that give a count, is one of 64 that started in 2026, is one of 485 in phase 2, reaches primary completion later than 328 of the 453 other live ones, and was the 1,767th registered.

Ovarian Neoplasms

3,385 studies on the registry are indexed under Ovarian Neoplasms; 792 are open to participants now.

Browse Ovarian Neoplasms studies →

Open to participants now

280 of the 1,778 studies in Ovarian Neoplasms with a site in United States are open now. Recruiting first, the newest first:

275 more — sign in →

All 280 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 604 Ovarian Neoplasms studies recruiting now, 441 (73%) set no upper age limit and 107 (18%) stop at 75 or younger; 39 take children under 18; 45 take healthy volunteers.

This study: 18 Years to 89 Years · female · no healthy volunteers.

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02

Study 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. 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.
03

Conditions studied

  • Ovarian Cancer
  • Fallopian Tube Cancers
  • Primary Peritoneal Cancer
  • High Grade Serous Adenocarcinoma of Ovary

Keywords

  • high grade serous carcinoma
  • statin
04

Who can participate

Ages eligible
18 Years to 89 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Be a patient with ovarian cancer aged 18-89
  • Diagnosed via tissue not ascites
  • For persons of , use of highly effective method(s) of .
  • Patients with primary Stage III/IV high-grade serous ovarian/fallopian tube/primary peritoneal cancer not amenable to upfront cytoreductive surgery.
  • (ECOG) Performance Status of 0, 1 or 2.
  • 1500 cells/mL
  • count > 100,000 mL.
  • 9.0 g/dL
  • Serum albumin ³ 2.5 g/dL.
  • Total ≤ 1.5 x (ULN).
  • (AST )and alanine aminotransferase (ALT) ≤ 3.0 x ULN.
  • Serum creatinine ≤ 1.5x ULN

Exclusion criteria

Exclusion Criteria:

  • Inability to comply with study and follow-up procedures.
  • Significant cardiovascular disease, such as cardiac disease (class II or greater), myocardial infarction within the past 3 months, unstable arrhythmia, or unstable angina.
  • Known liver disease defined as and ALT > 3.0 x and/or total ≥ 1.5 x ULN, or documented history of active viral, alcoholic, or other hepatitis, cirrhosis, and inherited liver disease.
  • Participation in clinical trial within last 30 days.
  • Medical history of untreated 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
    • 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 at ≥ 350 cells per μL
    • Have no history of acquired immunodeficiency syndrome (AIDS) -defining opportunistic infection ≤ 12 months before randomization.
  • Inability to provide .
  • Known central nervous system (CNS) or .
  • Patients with previous malignancy within the past 2 years from cycle 1, day 1, except those with negligible risk of 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 (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 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 .
  • Patients deemed otherwise clinically unfit for clinical trial per investigators discretion
Terms in these criteria, in plain language(20)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Reproductive potential

Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.

Criteria about it usually ask for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

CD4 count

The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Active comparator
    Standard of Care

    neoadjuvant chemotherapy with 3-4 cycles of carboplatin/paclitaxel, interval debulking surgery, then 2-3 additional cycles of chemotherapy with carboplatin/paclitaxel

    Drug: Standard of Care (SOC)

  • Experimental
    Atorvastatin with Standard of Care

    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

    Drug: Standard of Care + atorvastatin

Interventions

  • DrugStandard of Care + atorvastatin

    Neoadjuvant chemotherapy with carboplatin and paclitaxel in addition to daily atorvastatin, interval debulking surgery, then 2-3 additional cycles of carboplatin and paclitaxel

  • DrugStandard of Care (SOC)

    neoadjuvant chemotherapy with 3-4 cycles of carboplatin/paclitaxel, interval debulking surgery, then 2-3 additional cycles of chemotherapy with carboplatin/paclitaxel

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 months

Secondary outcomes

  1. 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.

    Time frame: 5 years

  2. Overall Survival

    Overall survival as defined by the time of randomization to time of death from any cause.

    Time frame: 5 years

07

Study locations

1 site
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No — All data will be de-identified prior to sharing with other researchers

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Aug 2028, 23 months later.

Of 228 non-industry phase 2 interventional studies under Ovarian Neoplasms, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 40 and three quarters within 80. This study's planned 23 months is below that.

Counting every sponsor, half of 344 studies reached it within 47 months; a quarter within 33 and three quarters within 72.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 31, 2026
First posted
Sep 11, 2026
StartEst.
Sep 2026
Primary completionEst.
Aug 2028
CompletionEst.
Aug 2031
Last update
Sep 11, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07815704
Responsible party
Sponsor
First posted
Sep 11, 2026
Start date
Sep 2026 (estimated)
Primary completion
Aug 2028 (estimated)
Completion
Aug 2031 (estimated)
Last update
Sep 11, 2026

Study contacts

Nicole Marjon, MD, PhD
principal investigator · CU Anschutz

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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