Olaparib Monotherapy and Olaparib + Pembrolizumab Combination Therapy for Ovarian Cancer

NCT04417192 | Completed Phase 2

• 1 other identifier: EPOC1903
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief Summary

To evaluate the efficacy and safety of preoperative olaparib monotherapy and preoperative olaparib plus pembrolizumab combination therapy in patients with untreated stage III, IV high-grade serous or Grade 3 endometrioid ovarian cancer with Homologous Recombination Deficiency (HRD) positivity.

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  Objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumours (RECIST) version. 1.1.

  6 weeks

Secondary Outcomes (4)

• The incidence of adverse events

  Up to 30 days after the last dose

• Chemotherapy response score (CRS)

  6 months from the end of registration

• Progression-free survival (PFS)

  6 months from the end of registration

• Overall survival (OS)

  6 months from the end of registration

Other Outcomes (3)

• Biomarkers

  2 years

• The change in tumor-infiltrating lymphocytes

  2 years

• The therapeutic effect

  2 years

Study Arms (1)

Olaparib or Olaparib Plus Pembrolizumab

EXPERIMENTAL

Cohort 1 : Olaparib will be administered for 6 weeks before surgery. Cohort 2 : Olaparib and Pembrolizumab will be administered simultaneously for 2 cycles(6 weeks) before surgery.

Drug: Olaparib; Drug: Pembrolizumab

Interventions

Olaparib DRUG

Olaparib will be administered at a dose of 300mg as oral dose, twice a day.

Olaparib or Olaparib Plus Pembrolizumab

Pembrolizumab DRUG

Pembrolizumab will be administered at a dose of 200mg as a 30-minutes IV infusion, Q3W (25 minutes to 40 minutes are acceptable).

Olaparib or Olaparib Plus Pembrolizumab

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has given signed informed consent to participate in the clinical trial of her own will.
• Is aged 20 years or older on the day of signing the informed consent.
• Has been diagnosed with histologically confirmed, Stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer by the International Federation of Gynecology and Obstetrics (FIGO) staging system (2014), with a histological type of high-grade serous or Grade 3 endometrioid carcinoma.
• Have measurable disease based on RECIST 1.1.
• Is a candidate for debulking surgery.
• Has an HRD-positive tumor.
• Has an ECOG Performance Status of 0 or 1.
• Laboratory test results within 21 days prior to enrollment have met the following organ function criteria. However, measurements within 14 days of blood transfusion or administration of granulocyte-colony stimulating factor (G-CSF) are excluded.
• Neutrophil count ≥ 1,500/mm3
• Platelet count ≥ 100,000/mm3
• Hemoglobin ≥ 9.0 g/dL
• Serum creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 50 mL/min
• T-Bil ≤ 2.0 mg/dL
• ALT and AST ≤ 100 U/L (≤ 200 U/L if liver metastasis is present)
• A woman of childbearing potential must agree to use contraception after signing the informed consent, throughout the study period, and until at least 120 days following the last dose of the study drug

You may not qualify if:

• Has received previous allogeneic bone-marrow transplantation.
• Has concurrent interstitial lung disease/pneumonitis, or a history of (noninfectious) interstitial lung disease/pneumonitis that required treatment with steroids. Interstitial lung disease/pneumonitis includes radiation pneumonitis.
• Has received prior antitumor therapy (e.g., chemotherapy, molecular-targeted therapy, therapeutic antibody, endocrine therapy, immunotherapy, and investigational therapy).
• Has received surgery under general anesthesia within 28 days prior to enrollment. However, surgery to diagnose ovarian/fallopian tube/peritoneal cancer performed under general anesthesia is allowed.
• Has received radiation or radioactive isotope therapy within 28 days prior to enrollment.
• Has uncontrolled pericardial effusion, pleural effusion, or peritoneal effusion.
• Has a history of cerebral infarction, cerebral hemorrhage, or transient cerebral ischemia within 180 days prior to enrollment.
• Has a history of deep vein thrombosis or pulmonary embolism.
• Is receiving systemic glucocorticoid therapy or systemic immunosuppressive therapy.
• Has a history of autoimmune disease.
• Is infected with human immunodeficiency virus (HIV).
• Is infected with active\* hepatitis B or hepatitis C.
• \*: Active hepatitis B is defined as HBs antigen positive.
• Has a symptomatic infection within 14 days prior to enrollment.
• Has received a live vaccine within 28 days prior to enrollment.

Sponsors & Collaborators

• National Cancer Center Hospital East: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (3)

National Cancer Center Hospital East

Kashiwa, Chiba, Japan

Location

National Hospital Organization Shikoku Cancer Center

Matsuyama, Ehime, Japan

Location

Kurume University Hospital

Kurume, Fukuoka, Japan

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

olaparib; pembrolizumab

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

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: Chief of Breast and Medical Oncology Division

Model Details: This study has 2 cohorts. Cohort 1 is Olaparib monotherapy Cohort 2 is Olaparib plus Pembrolizumab combination therapy

Study Record Dates

• First Submitted: June 2, 2020
• First Posted: June 4, 2020
• Study Start: December 1, 2020
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: July 6, 2023

Record last verified: 2023-07

Locations

JP (3)