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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ovarian Cancer; Primary Peritoneal Cancer; High Grade Serous Adenocarcinoma of Ovary; Fallopian Tube Cancers
• Intervention / Treatment: Drug: Standard of Care (SOC); Drug: Standard of Care + atorvastatin

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Anschutz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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
• 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

Exclusion Criteria:

• 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
  • 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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); neoadjuvant chemotherapy with 3-4 cycles of carboplatin/paclitaxel, interval debulking surgery, then 2-3 additional cycles of chemotherapy with carboplatin/paclitaxel
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; Neoadjuvant chemotherapy with carboplatin and paclitaxel in addition to daily atorvastatin, interval debulking surgery, then 2-3 additional cycles of carboplatin and paclitaxel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	5 years
Overall Survival	Overall survival as defined by the time of randomization to time of death from any cause.	5 years

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Nicole Marjon, MD, PhD, CU Anschutz

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2031

Study Registration Dates

• First Submitted: August 31, 2026
• First Submitted That Met QC Criteria: September 8, 2026
• First Posted (Actual): September 11, 2026

Study Record Updates

• Last Update Posted (Actual): September 11, 2026
• Last Update Submitted That Met QC Criteria: September 8, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: statin; high grade serous carcinoma
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Gonadal Disorders; Fallopian Tube Diseases; Ovarian Neoplasms; Fallopian Tube Neoplasms; Health Services Administration; Health Care Quality, Access, and Evaluation; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fatty Acids; Lipids; Azoles; Quality of Health Care; Quality Indicators, Health Care; Pyrroles; Heptanoic Acids; Atorvastatin; Standard of Care
• Other Study ID Numbers: 26-0543

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All data will be de-identified prior to sharing with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No