An Open-label, Randomized, Phase 2/3 Study of Olaparib Plus Pembrolizumab Versus Chemotherapy Plus Pembrolizumab After Induction of Clinical Benefit With First-line Chemotherapy Plus Pembrolizumab in Participants With Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer (TNBC) (KEYLYNK 009) - MK-7339-009

Merck Sharp & Dohme Corp.0 个研究点目标入组 276 人开始时间: 2022年11月17日最近更新: 2024年8月21日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Merck Sharp & Dohme Corp.
入组人数: 276

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 18 至 65+（—）
性别: All

入选标准

•Has locally recurrent inoperable Triple Negative Breast Cancer (TNBC) that has not previously been treated with chemotherapy and that cannot be treated with curative intent OR has metastatic TNBC that has not been previously treated with chemotherapy, A female participant must not be pregnant or breastfeeding and must agree to the following if is a woman of childbearing potential (WOCBP): have a negative pregnancy test within 24 hours before the start of study treatment and agree to be abstinent or use contraception and refrain from donating eggs (ova, oocytes) during the intervention period and for at least the time needed to eliminate each study intervention (180 days for olaparib and chemotherapy; 120 days for pembrolizumab), Has received up to 6 cycles but not less than 4 cycles of induction therapy without permanently discontinuing from pembrolizumab or both carboplatin and gemcitabine, Has achieved complete response (CR), partial response (PR), or stable disease (SD) based on RECIST 1.1 by Blinded Independent Central Review (BICR) at the Week 18 evaluation, Is able to complete during post-induction at least the Cycle 1, Day 1 doses of olaparib and pembrolizumab or the Cycle 1, Day 1 doses of at least one of the chemotherapy agents being administered at the end of induction (carboplatin and/or gemcitabine) in addition to pembrolizumab, Has ECOG performance status of 0 or 1, as assessed within 7 days prior to the start of post-induction study treatment, Has no higher than Grade 1 toxicities related to induction therapy (excluding alopecia) prior to randomization, Has been treated with anthracycline and/or a taxane in the neoadjuvant/adjuvant setting, if they received systemic treatment in the neoadjuvant/adjuvant setting, unless anthracycline and/or taxane was contraindicated or not considered the best treatment option for the participant in the opinion of the treating physician, Has measurable disease based on RECIST 1.1, Has provided a recently obtained or archival (no more than 3 years old) core or excisional biopsy of a tumor lesion not previously irradiated, Be a male or female at least 18 years of age, Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 as assessed within 7 days prior to the start of induction study treatment, Has a life expectancy =27 weeks from the day of first study treatment, Demonstrate adequate organ function within 10 days prior to the start of study treatment, A male participant must agree to be abstinent or use contraception and refrain from donating sperm during the intervention period and for at least the time needed to eliminate each study intervention (95 days for olaparib and chemotherapy; no requirement for pembrolizumab)

排除标准

•Has a known additional malignancy that is progressing or has required active treatment within the past 5 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (eg, cervical cancer in situ) that have undergone potentially curative therapy, Has a known history of human immunodeficiency virus (HIV) infection, 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 [qualitative] is detected) infection, Has a history of class II-IV congestive heart failure or myocardial infarction within 6 months of first study treatment, Has neuropathy =Grade 2, Has not recovered (eg, to =Grade 1 or to baseline) from AEs due to a previously administered therapy, Has a known history of hypersensitivity or allergy to pembrolizumab, olaparib and any of its components, and/or to any of the study chemotherapies (eg, carboplatin or gemcitabine) and any of their components, Has severe hypersensitivity (=Grade 3) to the study treatments and/or any of their excipients, Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study, Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the Screening Visit through 180 days after the last dose of study treatment, Is a WOCBP who has a positive urine pregnancy test within 24 hours prior to randomization or treatment allocation, 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 the first dose of study treatment, Has received prior therapy with either olaparib or any other poly adenosine diphosphate ribose polymerase (PARP) inhibitor, Has received prior radiotherapy within 2 weeks of start of study treatment, Has received colony-stimulating factors (eg, granulocyte colony stimulating factor [G-CSF], granulocyte macrophage colony stimulating factor [GM-CSF] or recombinant erythropoietin) within 2 weeks prior to the first dose of study treatment, Has had an allogenic tissue/solid organ transplant, Has received previous allogenic bone marrow transplant or double umbilical cord transplantation (dUCBT), Has had major surgery within 2 weeks of starting study treatment or has not recovered from any effects of any major surgery, Has received a live or live-attenuated vaccine within 30 days prior to first study treatment, Is receiving any medication prohibited in combination with study chemotherapies unless medication was stopped within 7 days prior to first study treatment, Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another co-inhibitory T cell receptor (such as cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX-40, CD137) or has previously participated in a study evaluating pembrolizumab regardless of treatment received, 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 treatment, Has an active autoimmune disease that has required systemic treatment in the past 2 years, Has presence of uncontrolled, potentially reversible cardiac conditions, as judged by the inve

研究者

发起方

Merck Sharp & Dohme Corp.

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