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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT07815704
Phase
PHASE2
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

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
  • 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 Details

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.

Key Dates

First listed
Sep 11, 2026
Start date
Sep 30, 2026
Status verified
Sep 2026
Primary completion
Aug 31, 2028
Completion
Aug 31, 2031

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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
  • 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

Primary Outcome Measure

Change from baseline of CD163+ tumor associated macrophages in post-treatment specimens. [ Time Frame: 3 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado AnschutzAuroraColorado80045-

Find similar trials in Aurora, CO

Nationwide
Ovarian cancer trialsOncology trialsGynecologic oncology trialsWomen's health trials
By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
University of Colorado Anschutz· Aurora, CO

Related Studies