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

NCT07815704 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 26-0543
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

high grade serous carcinoma; statin

Outcome Measures

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.

  3 months

Secondary Outcomes (2)

• Progression free survival

  5 years

• Overall Survival

  5 years

Study Arms (2)

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

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

Drug: Standard of Care + atorvastatin

Interventions

Standard of Care + atorvastatin DRUG

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

Atorvastatin with Standard of Care

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

Standard of Care

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Anschutz

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms

Interventions

Standard of Care; Atorvastatin

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Nicole Marjon, MD, PhD

  CU Anschutz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2026
• First Posted: September 11, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2031
• Last Updated: September 11, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)