NL-OMON50489已完成不适用
An Open-label, Multicenter, Phase 1b Study of JNJ-63723283, a PD-1 Inhibitor, Administered in Combination with Apalutamide in Subjects with Metastatic Castration- Resistant Prostate Cancer - 56021927PCR2032 / Kronos
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
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 99（—）
入选标准
- •Each potential subject must satisfy all of the following criteria to be
- •enrolled in the study:
- •1. >=18 years of age
- •2. Criterion modified per Amendment 3
- •* Pathologically confirmed adenocarcinoma of the prostate on initial diagnosis
- •* Pathologically confirmed t-SCNC (by screening biopsy of a metastatic site):
- •Cohort 5 only
- •3. Criterion modified per Amendment 1
- •3.1 Metastatic disease as documented by technetium-99m (99mTc) bone scan or
- •metastatic lesions by computed tomography (CT) or magnetic resonance imaging
- •(MRI) scans (visceral or lymph node disease). CT-portion of PET/CT scan may be
- •used for eligibility. If lymph node metastasis is the only evidence of
- •metastatic disease, it must be >= 1.0 cm in the short axis and above the level
- •of the iliac bifurcation.
- •4. Criterion modified per Amendment 1
- •4.1 Criterion modified per Amendment 4
- •4.2 Criterion modified per Amendment 5
- •4.3 Progression (all of the criteria below must be met):
- •* PSA progression confirmed per Prostate Cancer Clinical Trials Working Group
- •(PCWG3): Castration-resistant prostate cancer (CRPC) demonstrated during
- •continuous ADT, defined as 2 rises of PSA, at least 1 week apart with the last
- •PSA >=2 ng/mL.
- •* PSA progression on AR-targeted therapy (abiraterone plus
- •prednisone/prednisolone [AA-P]; apalutamide, darolutamide, or enzalutamide).
- •* Radiographic progression of soft tissues according to Response Evaluation
- •Criteria in Solid Tumors, version 1.1 (RECIST 1.1) modified based on PCWG3, or
- •radiographic progression of bone according to PCWG3.
- •5. Criterion modified per Amendment 2
- •5.1 Criterion modified per Amendment 3
- •5.2 Criterion modified per Amendment 4
- •5.3 Criterion modified per Amendment 5
- •5.4 Progressed while on therapy with AA-P, enzalutamide, darolutamide, or
- •apalutamide. No washout is required, and no additional therapy may have been
- •administered between discontinuation of AR-targeted the agents and study
- •treatment. Subjects will be assigned to cohorts based on the results of the
- •biomarker panel.
- •Cohort 1: Biomarker-negative or biomarker-unknown subjects with adenocarcinoma
- •(and not t-SCNC) who progressed on AA-P
- •Cohort 2: Biomarker-negative or biomarker-unknown subjects with adenocarcinoma
- •(and not t-SCNC) who progressed on apalutamide, darolutamide, or enzalutamide
- •Cohort 3: Biomarker-positive subjects who progressed on AA-P
- •Cohort 4: Biomarker-positive subjects who progressed on apalutamide,
- •darolutamide, or enzalutamide
- •Cohort 5: Biomarker-negative subjects with t-SCNC who progressed on treatment
- •with AA-P, apalutamide, darolutamide, or enzalutamide
- •Note: Prior docetaxel for HSPC is allowed; no washout is required.
- •Note: Subjects who have developed t-SCNC and are biomarker-positive will be
- •assigned to either Cohort 3 or 4, depending on therapy history.
- •6. Surgical or medical castration, with testosterone levels of <50 ng/dL. If
- •the subject is being treated with GnRH analogs (subject who has not undergone
- 另有 7 项未显示
排除标准
- •1. Criterion modified per Amendment 3
- •1.1 Initial diagnosis of primary prostatic neuroendocrine or small cell
- •2. Brain metastases.
- •3. Prior treatment with an anti-PD-1, anti-PD-L1, or anti CTLA-4 antibody.
- •4. Prior chemotherapy, except for docetaxel for HSPC.
- •5. Prior therapy with poly ADP-ribose polymerase (PARP) inhibitors.
- •6. Criterion modified per Amendment 5
- •6.1 Both prior abiraterone acetate plus prednisone/prednisolone (AA-P) and
- •apalutamide, darotulamide or enzalutamide.
- •7. Criterion modified per Amendment 3
- •7.1 Therapies that must be discontinued or substituted at least 4 weeks prior
- •to first dose of
- •study drug include the following:
- •* Medications known to lower the seizure threshold (see Prohibited Medications)
- •* Herbal and non-herbal products that may decrease PSA levels (eg, megestrol,
- •reductase inhibitors).
- •8. Criterion modified per Amendment 3
- •8.1 Any investigational agent for the treatment of castration-resistant
- •prostate cancer
- •9. If a subject has undergone major surgery, they must have recovered
- •adequately from the toxicities or complications from the intervention within 4
- •weeks prior to starting therapy.
- •10.History of any of the following:
- •* Seizure or known condition that may pre-dispose to seizure (including but not
- •to: stroke, transient ischemic attack, or loss of consciousness within 1 year
- •prior to first
- •dose of study drug, brain arteriovenous malformation; or intracranial masses
- •schwannomas and meningiomas that are causing edema or mass effect)
- •* Active malignancies (ie, requiring treatment change in the last 24 months)
- •urothelial cancer (except skin cancers within the last 24 months that are
- •completely cured).
- •* Any of the following within 6 months prior to first dose of study drug:
- •unstable angina, myocardial infarction, symptomatic congestive heart failure,
- •arterial or
- •venous thromboembolic events (eg, pulmonary embolism, cerebrovascular accident
- •including transient ischemic attacks), or clinically significant ventricular
- •arrhythmias or
- •New York Heart Association (NYHA) Class II to IV heart disease; uncomplicated
- •vein thrombosis (DVT) is not considered exclusionary
- •11. Criterion modified per Amendment 3
- •11.1 Criterion modified per Amendment 4
- •11.2 Uncontrolled hypertension (2 or more readings of blood pressure at the
- •clinic that are
- •above: systolic >=160 mmHg or diastolic >=100 mmHg)
- •12. Gastrointestinal disorder affecting absorption.
- •13. Active infection or conditions requiring treatment with antibiotics.
- •14. Has taken immunosuppressive doses of systemic medications, such as
- •corticosteroids (doses >10 mg/day prednisone or equivalent), within 2 weeks
- •before first dose of study drug.
- •15. Active autoimmune disease or a documented history of autoimmune disease
- 另有 7 项未显示
研究者
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