EUCTR2018-001973-25-PL进行中（未招募）1 期
A Randomized Phase 3, Double-Blind Study of Chemotherapy With or Without Pembrolizumab Followed by Maintenance With Olaparib or Placebo for the First- Line Treatment of BRCA non-mutated Advanced Epithelial Ovarian Cancer (EOC) (EOC)(KEYLYNK-001 / ENGOT-ov43 / GOG-3036) - First-line chemotherapy plus pembrolizumab and olaparib for BRCA non-mutated advanced EOC
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,284
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1. Participant has histologically confirmed FIGO Stage III or Stage IV
- •EOC (high-grade predominantly serous, endometrioid, (any grade),carcinosarcoma, mixed mullerian with highgrade serous component,
- •clear cell, or low-grade serous OC), primary peritoneal cancer, or
- •fallopian tube cancer
- •2. Participant has just completed primary debulking surgery or is eligible
- •for primary debulking surgery or is a potential candidate for interval
- •debulking surgery.
- •3. Participant is a candidate for carboplatin and paclitaxel chemotherapy,
- •to be administered in the adjuvant or neoadjuvant setting
- •4. 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
- •5. Participant is able to provide a newly obtained core or excisional
- •biopsy of a tumor lesion for prospective testing of BRCA1/2 and PD-L1
- •status prior to randomization
- •6. Participant is female and at least 18 years of age on the day of signing
- •informed consent
- •7. Participant has an Eastern Cooperative Oncology Group (ECOG)
- •performance status of 0 or 1, as assessed within 7 days prior to initiating
- •chemotherapy in the Lead-in Period and within 3 days prior to Day 1 of
- •8. A female participant is eligible to participate if she is not pregnant or
- •breastfeeding, and at least 1 of the following conditions applies:
- •Is not a woman of childbearing potential (WOCBP)
- •Is a WOCBP and using a contraceptive method that is highly effective
- •(with a failure rate of <1% per year), with low user dependency, or be
- •abstinent from heterosexual intercourse as their preferred and usual
- •lifestyle (abstinent on a long-term and persistent basis), during the
- •Treatment Period and for at least 120 days following the last dose of
- •pembrolizumab (or pembrolizumab placebo) and bevacizumab (if
- •administered), at least 180 days following the last dose of olaparib (or
- •olaparib placebo), and at least 210 days following the last dose of
- •chemotherapy and agrees not to donate eggs (ova, oocytes) to others or
- •freeze/store for her own use for the purpose of reproduction during this
- •period. The investigator should evaluate the potential for contraceptive
- •method failure (ie, noncompliance, recently initiated) in relationship to
- •the first dose of study treatment.
- •A WOCBP must have a negative highly sensitive pregnancy test (urine
- •or serum as required by local regulations) within either 24 hours (urine)
- •or 72 hours (serum) before the first dose of study treatment.
- •If a urine test cannot be confirmed as negative (eg, an ambiguous
- •result), a serum pregnancy test is required. In such cases, the
- •participant must be excluded from participation if the serum pregnancy
- •result is positive.
- •The investigator is responsible for review of medical history, menstrual
- •history, and recent sexual activity to decrease the risk for inclusion of a
- •woman with an early undetected pregnancy.
- •Contraceptive use by women should be consistent with local
- •regulations regarding the methods of contraception for those
- •participating in clinical studies. If the contraception requirements in the
- •local label for any of the study interventions is more stringent than the
- 另有 5 项未显示
排除标准
- •1.Participant has mucinous, germ cell, or borderline tumor of the ovary
- •2.Participant has a known or suspected deleterious mutation (germline or somatic) in either BRCA1 or BRCA2
- •3.Participant has a history of non-infectious pneumonitis that required treatment with steroids or currently has pneumonitis
- •4.Participant either has myelodysplastic syndrome (MSD)/acute myeloid leukemia (AML)or has features suggestive of MDS/AML
- •5.Participant has a known additional malignancy that is progressing or has required active treatment in the last 3 years
- •6.Participant has ongoing Grade 3 or Grade 4 toxicity, excluding alopecia, following chemotherapy administered during the Lead-in Period
- •7.Participant has known active central nervous system metastases and/or carcinomatous meningitis
- •8.Participant has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7days prior to randomization
- •9.Participant has an active autoimmune disease that has required systemic treatment in the past 2years
- •10.Participant has a known history of active tuberculosis
- •11.Participant has an active infection requiring systemic therapy
- •12. Participant has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant’s involvement for the full duration of the study, or is not in the best interest of the participant to be involved, in the opinion of the treating investigator
- •13. Participant has received colony-stimulating factors within 4 weeks (28days) prior to receiving chemotherapy during the Lead-in Period.
- •14. Participant is considered to be of poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection
- •15. Participant has had surgery <6 months prior to screening to treat borderline tumors, early stage EOC, or early stage fallopian tube cancer
- •16. Participant has a known psychiatric or substance abuse disorder that would interfere with the ability to cooperate with the requirements of the study
- •17. Participant has a known history of human immunodeficiency virus (HIV) infection.
- •18. Participant has a known history of hepatitis B (defined as hepatitis B surface antigen [HBsag] reactive) or known active hepatitis C virus infection.
- •19. Participant is either unable to swallow orally administered medication or has a gastrointestinal disorder affecting absorption
- •20. Participant has uncontrolled hypertension.
- •21. Participant has current, clinically relevant bowel obstruction, abdominal fistula or gastrointestinal perforation, related to underlying EOC
- •22.Participant has a history of hemorrhage, hemoptysis or active gastrointestinal bleeding within 6 months prior to randomization
- •23.A WOCBP who has a positive urine pregnancy test within 72 hours before the first dose of chemotherapy in the lead-in period and within 72 hours prior to Day1 od Cycle1, is pregnant or breastfeeding, or is expecting to conceive children within the projected duration of the study.
- •24.Participant has received prior treatment for any stage of OC
- •25.Participant has received prior therapy with an anti-PD-1, anti-PD-L1,or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor
- •26.Participant has received prior therapy with either olaparib or any other PARP inhibitor
- •27.Is a participant for whom intraperitoneal chemot
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