EUCTR2017-002259-26-IE进行中（未招募）1 期
A Randomized, Open-Label, Phase 3 Study to Evaluate Efficacy and Safety of Pembrolizumab (MK-3475) plus Epacadostat vs Standard of Care (Sunitinib or Pazopanib) as First-Line Treatment for Locally Advanced or Metastatic Renal Cell Carcinoma (mRCC) (KEYNOTE-679/ECHO-302) - Pembrolizumab (MK-3475) plus Epacadostat vs SOC in mRCC
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 630
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 histologic confirmation of locally advanced or metastatic RCC (Stage IV per American Joint Committee on Cancer) with a clear cell component with or without sarcomatoid features.
- •2. Must not have received any prior systemic therapy for their mRCC.
- •3. Have measurable disease per RECIST 1.1 as determined by the site. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
- •4. Have provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. The tumor tissue must have been obtained prior to randomization and after the latest systemic treatment for RCC.
- •5. Have a Karnofsky performance status of = 70 within 14 days prior to randomization.
- •6. Male/female participants who are at least 18 years of age on the day of signing the informed consent.
- •7. A male participant must agree to use contraception, during the treatment period and for at least 120 days after the last dose of pembrolizumab and epacadostat and up to 180 days after last dose of SOC agents and refrain from donating sperm during this period.
- •Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the participant.
- •8. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
- •a) Not a woman of childbearing potential (WOCBP)
- •b) A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 120 days after the last dose of pembrolizumab and epacadostat and up to 180 days after last dose of SOC agents. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the participant.
- •9. The participant (or legally acceptable representative if applicable) provides written
- •informed consent for the trial
- •10. Have adequate organ function. Specimens must be collected within 14 days prior to randomization.
- •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 315
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 315
排除标准
- •1. Has a history of severe hypersensitivity reaction (eg, generalized rash/erythema, hypotension, bronchospasm, angioedema or anaphylaxis) to study treatments or their excipients.
- •2. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (doses exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study treatment . Corticosteroid use as premedication for IV contrast prophylaxis is permitted.
- •3. Has an active autoimmune disease that has required systemic treatment in past 2 years (ie, 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 systemic treatment .
- •4. Has a known additional malignancy that has progressed or has required active systemic treatment in the last 3 years. Note: participants with curatively treated basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, curatively resected in situ cervical cancer and curatively resected in situ breast cancer are not excluded.
- •5. Has known active central nervous system metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable (ie, without evidence of progression for at least 4 weeks by repeat imaging ) (note that the repeat imaging should be performed during study screening), clinically stable, and have not required steroids for at least 14 days before first dose of study treatment.
- •6. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
- •7. Has an active infection requiring systemic therapy.
- •8. Has a known history of human immunodeficiency virus (HIV) infection. No HIV testing is required unless mandated by local health authority.
- •9. Has a known history of or is positive for active Hepatitis B (HBsAg reactive) or has active Hepatitis C (HCV RNA). Note: Testing must be performed to determine eligibility.
- •10. Has any history of serotonin syndrome after receiving serotonergic drugs.
- •11. Has a history of a gastrointestinal condition or procedure that in the opinion of the Investigator may affect oral drug absorption.
- •12. Has a history of any of the following cardiovascular conditions within 12 months prior to randomization: myocardial infarction, unstable angina pectoris, cardiac angioplasty or stenting, coronary/peripheral artery bypass graft, Class III or IV congestive heart failure per New York Heart Association (NYHA), cerebrovascular accident or transient ischemic attack, or NYHA Class III or IV congestive heart failure (CHF). Medically controlled arrhythmia stable on medication is permitted.
- •13. Has a history of deep vein thrombosis or pulmonary embolism within 6 months of screening.
- •14. Poorly controlled hypertension (defined as systolic BP = 150 mm Hg or diastolic BP = 90 mm Hg). Initiation or adjustment of antihypertensive medication(s) is permitted prior to randomization.
- •15. Has a history or presence of an abnormal electrocardiogram (ECG) that, in the Investigator's opinion, is clinically meaningful. Screening QTc interval > 480 msec is excluded (corrected by Fridericia or Bazett formula). In the event that a single QTc is > 480 msec, the participant may enroll if the average QTc for 3 ECGs is < 480 msec.
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