EUCTR2021-003767-10-ES进行中（未招募）1 期
Phase II trial of Pembrolizumab and Olaparib in homologous-recombination deficient (HRD) advanced colorectal cancer (CRC). - PEMBROLA
Grupo Español Multidisciplinar en Cáncer Digestivo (GEMCAD)0 个研究点目标入组 40 人开始时间: 2022年1月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
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. Male/female participants must be at least 18 years of age on the day of signing informed consent and have a histologically confirmed diagnosis of colorectal cancer.
- •2. Have an unresectable locally-advanced or metastatic colorectal cancer and have progressive disease confirmed by radiologic assessment.
- •3. Have provided an archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides.
- •4. Have DNA HRD defined as either having a BRCA known deleterious mutation (somatic or germinal) and/or RAD 51 score < 10%.
- •5. Have received at least 2 and no more than 4 prior lines of systemic therapy (including adjuvant treatment). Patients must have received at least: fluoropyrimidines, oxaliplatin and irinotecan, with or without anti-VEGF or anti-EGFR therapy if RAS wild type.
- •6. Must be oxaliplatin-sensitive defined as having received a minimum of 8 cycles of FOLFOX (fluorouracil, folinic acid and oxaliplatin) or 6 cycles of XELOX (capecitabine and oxaliplatin) as first line therapy, and a progression free survival = 9 months in the first line setting.
- •7. Patients with both MSS or MSI-H advanced colorectal cancer will be suitable to participate in the trial.
- •8. The participant (or legally acceptable representative if applicable) provides written informed consent to participate in the trial.
- •9. Have measurable disease based on RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions after radiotherapy.
- •10. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention.
- •11. Have adequate organ function as defined below. Blood samples must be collected within 7 days prior to the start of study intervention:
- •Hematological
- •Absolute neutrophil count (ANC) =1500/µL
- •Platelets =100 000/µL
- •Hemoglobin =9.0 g/dL or =5.6 mmol/La
- •Creatinine OR Measured or calculatedb creatinine clearance (GFR can also be used in place of creatinine or CrCl) =1.5 × ULN OR =30 mL/min for participants 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 AST (SGOT) and ALT (SGPT) =2.5 × ULN (=5 × ULN for participants with liver metastases)
- •Coagulation
- •International normalized ratio (INR) OR prothrombin time (PT) Activated partial thromboplastin time (aPTT) =1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants
- •12. A male participant must agree to use a contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 28 days prior to any study treatment administration plus an additional 180 days after the last dose of study treatment and refrain from donating sperm during this period.
- •13. A female participant is eligible to participate if she is not pregnant (see Appendix 3), not breastfeeding, and at least one of the following conditions applies:
- •a. Not a woman of childbearing potential (WOCBP) as defined in Appendix 3
- •b. A WOCBP who agrees to follow the contraceptive guidance in Appendix 3 during the treatment period and for at least 180 days after the last dose of study treatment.
排除标准
- •1. 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 (eg, CTLA-4, OX-40, CD137) or with any PARP inhibitor.
- •2. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.
- •3. Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to allocation.
- •4. Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (=2 weeks of radiotherapy) to non-CNS disease.
- •5. A WOCBP who has a positive urine pregnancy test within 72 hours prior to allocation (see Appendix 3). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- •6. Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed.
- •7. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
- •8. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
- •9.Has known CNS metastases and/or carcinomatous meningitis.
- •10. Has severe hypersensitivity (=Grade 3) to pembrolizumab or olaparib and/or any of its excipients.
- •11. Has 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). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.
- •12. Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease of any etiology.
- •13. Has an active infection requiring systemic therapy.
- •14. Has a known history of Human Immunodeficiency Virus (HIV) infection.
- •No HIV testing is required
- •15. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA is detected) infection.
- •16. 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 participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
- •17. Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.
- •18. Current, clinically relevant bowel obstruction, including sub-occlusive disease, related to underlying d
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