Newly Diagnosed Stage III/IV Ovarian Cancer, Neoadjuvant Carbo/Taxol/Pembro, Maintenance Olaparib/Pembro

NCT05952453 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: IRB-300008985 (UAB21117)000539646
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

this is a trial evaluating three chemotherapy agents in patients with newly diagnosed ovarian cancer patients that are Stage III or Stage IV prior to surgery to remove the tumor. After surgery there will be additional chemotherapy given.

Conditions

Ovarian Cancer

Keywords

newly diagnosed; stage III/IV

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  Progression free survival at 36 month according to Response Evaluation Criteria in Solid tumors RECIST 1.1

  36 months

Secondary Outcomes (5)

• Progression free survival at 12 months

  12 months

• Progression free survival at 24 months

  24 months

• pathological complete response (pCR)

  12-20 weeks

• overall survival (OS)

  36 months

• Adverse events (CTCAE v5.0)

  36 months

Study Arms (1)

Carbo/taxol/pembro followed by maintenance of olaparib/pembro post-surgery

EXPERIMENTAL

neoadjuvant carbo/taxol/pembro followed by maintenance olaparib/pembro post- surgery

Drug: Carboplatin; Drug: olaparibp, embro

Interventions

Carboplatin DRUG

neoadjuvant treatment , followed by surgery, then maintenance chemotherapy

Also known as: pembrolizimab, taxol

Carbo/taxol/pembro followed by maintenance of olaparib/pembro post-surgery

olaparibp, embro DRUG

maintenance chemotherapy : olaparib, pembro

Carbo/taxol/pembro followed by maintenance of olaparib/pembro post-surgery

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: females
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants are eligible to be included in the study only if all of the following criteria apply:
• Participant has histologically confirmed FIGO Stage III or Stage IV EOC (high-grade predominantly serous, endometrioid, carcinosarcoma, mixed Mullerian with high grade serous component, clear cell, or low-grade serous OC), primary peritoneal cancer, or fallopian tube cancer.
• Participant is a candidate for carboplatin and paclitaxel chemotherapy, to be administered in the neoadjuvant setting with planned interval debulking surgery.
• Participant that is a candidate for neoadjuvant chemotherapy has a CA-125 (kilounits/L) : carcinoembryonic antigen (CEA; ng/mL) ratio greater than or equal to 25 \[Vergote, I., et al 2010\].
• Note: if the serum CA-125/CEA ratio is less than 25, then a workup should be negative for the presence of a non-ovarian cancer to determine eligibility (e.g., breast or gastrointestinal cancers \[including CRC\]).
• \. Participant is female and at least 18 years of age on the day of signing informed consent.
• \. Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, as assessed within 7 days prior to enrollment.
• \. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
• a.) Not a woman of childbearing potential (WOCBP) OR b.) A WOCBP who agrees to follow contraceptive guidance during the Treatment Period and for at least 120 days following the last dose of pembrolizumab and olaparib and at least 210 days following the last dose of chemotherapy 8. The participant (or legally acceptable representative if applicable) provides written informed consent for the study. The participant may also provide consent for future biomedical research; however, the participant may participate in the main study without participating in future biomedical research.
• \. Participant has adequate organ function as follows; all screening laboratory tests should be performed within 7 days of enrollment:
• Absolute neutrophil count (ANC) ≥1500/μL
• Platelets ≥100 000/μL
• Hemoglobin ≥8.0 g/dL or ≥5.6 mmol/L
• Creatinine OR measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 × ULN OR ≥51 mL/min for participant with creatinine levels \>1.5 × institutional ULN
• Total bilirubin ≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels \>1.5 × ULN

You may not qualify if:

• Participants are excluded from the study if any of the following criteria apply:
• Participant has mucinous, germ cell, or borderline tumor of the ovary.
• Participant has a history of non-infectious pneumonitis that required treatment with steroids or currently has pneumonitis.
• Participant either has myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or has features suggestive of MDS/AML.
• Participant has a known additional malignancy that is progressing or has required active treatment in the last 3 years.
• Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., ductal carcinoma in situ, cervical carcinoma in situ) that has undergone potentially curative therapy are not excluded. Additionally, participants with synchronous primary endometrial cancer or a past history of primary endometrial cancer that met the following conditions are not excluded: Stage not greater than I-A; no more than superficial myometrial invasion, without vascular or lymphatic invasion; no poorly differentiated subtypes, including papillary serous, clear cell or other FIGO Grade 3 lesions.
• Participant has known active central nervous system metastases and/or carcinomatous meningitis. Participants with brain metastases may participate provided they were previously treated (except with chemotherapy) and are radiologically stable, clinically stable, and no steroids were used for the management of symptoms related to brain metastases within 14 days prior to enrollment. Stable brain metastases should be established prior to the first dose of study medication.
• Note: Participants with known untreated, asymptomatic brain metastases (i.e., no neurological symptoms, no requirement for corticosteroids, no or minimal surrounding edema, and no lesion \>1.5 cm) may participate but will require regular imaging of the brain as a site of disease.
• Participant has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (dosing exceeding 10 mg dailyof prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to enrollment.
• Participant has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs).
• Note: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
• Participant has a known history of active tuberculosis (TB; Bacillus Tuberculosis).
• Participant has an active infection requiring systemic therapy.
• Participant is considered to be of poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection.
• Participant has had surgery to treat borderline tumors, early stage EOC, or fallopian tube cancer \<6 months prior to screening.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

O'Neal Comprehensive Cancer Center at UAB

Birmingham, Alabama, 35294, United States

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Carboplatin; Paclitaxel

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

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Rebecca A Arend, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Margaret A Thomas, MPH

CONTACT

2058951802; margaretannthomas@uabmc.edu

Rebecca Arend

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Division Director Gynecology Oncology

Model Details: single- arm phase II trial

Study Record Dates

• First Submitted: May 12, 2023
• First Posted: July 19, 2023
• Study Start: February 17, 2025
• Primary Completion (Estimated): October 30, 2028
• Study Completion (Estimated): December 30, 2030
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)