EUCTR2019-001745-40-ES进行中（未招募）1 期
A Phase 2 Study of Olaparib in Combination with Pembrolizumab in Participants with Previously Treated, Homologous Recombination Repair Mutation (HRRm) and/or Homologous Recombination Deficiency (HRD)-Positive Advanced Cancer - Olaparib in combination with pembrolizumab in HRRm and/or HRD positive
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
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
- All
入选标准
- •1. Has a histologically- or cytologically-confirmed advanced (metastatic
- •and/or unresectable) solid tumor (except breast or ovarian cancers
- •whose tumor has a germline or somatic BRCA mutation) that is not
- •eligible for curative treatment and for which standard of care therapy
- •has failed. Participants must have progressed on or be intolerant to
- •standard of care therapies that are known to provide clinical benefit.
- •There is no limit on the number of prior treatment regimens.
- •2. Has either centrally-confirmed known or suspected deleterious
- •mutations in at least 1 of the specified 15 genes involved in HRR (ie,
- •BRCA1, BRCA2, ATM, BARD1, BRIP1, CDK12, CHEK1, CHEK2, FANCL,
- •PALB2, PPP2R2A, RAD51B, RAD51C, RAD51D, and RAD54L) or centrally confirmed HRD based on the Lynparza HRR-HRD assay.
- •3. Has measurable disease per RECIST 1.1 as assessed by the local site
- •investigator/radiology and confirmed in real time by BICR. BICR must
- •confirm the presence of radiologically measurable disease per RECIST
- •1.1 for the participant to be eligible for the study. Lesions situated in a
- •previously irradiated area are considered measurable if progression has
- •been demonstrated in such lesions.
- •4. Has a life expectancy of at least 3 months.
- •5. Is male or female, who is at least 18 years of age at the time of
- •signing the informed consent.
- •6. Has an Eastern Cooperative Oncology Group (ECOG) performance
- •status of either 0 or 1, as assessed within 3 days of treatment initiation.
- •7. A male participant must agree to use contraception as detailed in the
- •protocol during the treatment period and for at least 120 days (4
- •months), corresponding to time needed to eliminate any study
- •intervention(s) and refrain from donating sperm during this period.
- •8. A female participant is eligible to participate if she is not pregnant,
- •not breastfeeding, and at least 1 of the following conditions applies:
- •- Not a woman of childbearing potential (WOCBP)
- •- A WOCBP who agrees to follow the contraceptive guidance in the
- •Protocol during the treatment period and for at least 180 days (6
- •months) after the last dose of study intervention, corresponding to time
- •needed to eliminate any study intervention(s).
- •9. The participant (or legally acceptable representative if applicable)
- •provides written informed consent for the study. The participant may
- •also provide consent for FBR.
- •However, the participant may participate in the main study without
- •participating in FBR.
- •10. Has adequate organ function; all screening laboratory tests should
- •be performed within 10 days prior to the first dose of study intervention.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •1. Has a known additional malignancy that is progressing or has required
- •active treatment in the last 3 years
- •2. Has a history of non-infectious pneumonitis that required treatment
- •with steroids or currently has pneumonitis
- •3. Has myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML)
- •or with features suggestive of MDS/AML
- •4. Has known central nervous system (CNS) metastases and/or carcinomatous meningitis
- •5. Has an active infection requiring systemic therapy
- •6. Has active tuberculosis
- •7. Has a diagnosis of immunodeficiency or is receiving chronic systemic
- •steroid therapy (dosing in the Protocol) or any other form of
- •immunosuppressive therapy within 7 days prior to the first dose of study
- •intervention
- •8. Has an active autoimmune disease that has required systemic treatment in the past 2 years
- •9. Has a history or current evidence of any condition (please refer to the
- •Protocol), 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
- •10. Received colony-stimulating factors (eg, granulocyte colonystimulating
- •factor [G-CSF], granulocyte-macrophage colony-stimulating
- •factor [GM-CSF] or recombinant erythropoietin) within 28 days prior to
- •the first dose of study intervention
- •11. Is considered a poor medical risk due to a serious, uncontrolled
- •medical disorder, nonmalignant systemic disease or active, uncontrolled
- •12. Has a known psychiatric or substance abuse disorder that would
- •interfere with cooperation with the requirements of the study
- •13. Has a known history of human immunodeficiency virus (HIV)
- •infection. Testing for HIV at screening is only required if mandated by
- •local health authority
- •14. Has known active hepatitis (ie, Hepatitis B or C)
- •15. Is unable to swallow orally administered medication or has agastrointestinal disorder affecting absorption
- •16. A WOCBP who has a positive urine pregnancy test within 72 hours
- •before the first dose of study intervention. If the urine test is positive or
- •cannot be confirmed as negative, a serum pregnancy test will be
- •17. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PDL2
- •agent or with an agent directed to another stimulatory or coinhibitory
- •T-cell receptor (eg, CTLA-4, OX 40, CD137)
- •18. Has received prior therapy with olaparib or with any other PARP
- •19. Were refractory to prior platinum therapy for advanced (metastatic
- •and/or unresectable) solid tumor
- •20. Has received prior systemic anti-cancer therapy including
- •investigational agents within 4 weeks prior to administration of study
- •intervention
- •21. Must have recovered from all AEs due to previous therapies,
- •excluding alopecia, to =Grade 1 or baseline
- •22. Has a known hypersensitivity to the study treatments and/or any of
- •their excipients
- •23. Is currently receiving either strong or moderate inhibitors of
- •cytochrome P450 (CYP)3A4 that cannot be discontinued for the duration
- 另有 7 项未显示
研究者
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