NL-OMON49591已完成2 期
Phase 2 INSPIRE trial: Ipilimumab with Nivolumab in molecular-Selected patients with castration-resistant PRostate cancer - INSPIRE
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 69
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
- •1. Written informed consent.
- •2. Histological diagnosis of adenocarcinoma of the prostate. Patients who have
- •no histological diagnosis must be willing to undergo a biopsy to prove prostate
- •adenocarcinoma.
- •3. Metastatic Castration-Resistant Prostate Cancer (mCRPC), metastatic disease
- •defined either by measurable disease by RECIST1.1 criteria and/or presence of
- •bone-metastatic disease evaluable per PCWG3 criteria. For cohort 1, measurable
- •disease is compulsory.
- •4. An immunogenic phenotype, consisting of one of the next criteria:
- •1, mismatch repair deficiency and/or a high mutational burden of >7 mutations
- •per Mb (cluster A);
- •2, BRCA2 inactivation and/or BRCAness signature (cluster B);
- •3, a tandem duplication signature (cluster C).
- •5. Age >=18 years.
- •6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 - 1.
- •7. PSA >= 2 ng/ml.
- •8. Documented willingness to use an effective means of contraception while
- •participating in the study and for 7 months post last dose of treatment.
- •9. Documented ongoing castrate serum testosterone <50 ng/dL (<2.0 nM).
- •10. Received prior castration by orchiectomy and/or ongoing Luteinizing
- •Hormone-Releasing Hormone (LH-RH) agonist treatment.
- •11. Progression of disease by PSA utilizing PCWG3 criteria and at least another
- •of the following criteria;
- •a. Bone scan: disease progression as defined by at least 2 new lesions on bone
- •b. Soft tissue disease progression defined by modified RECIST 1.1.
- •c. Clinical progression with worsening pain and the need for palliative
- •radiotherapy for bone metastases.
- •12. Having a biopsiable metastatic lesion and willingness to undergo a
- •baseline* and on-treatment tumour biopsy for next-generation sequencing and
- •biomarker analyses. *When sufficient FFPE material is available from a biopsy
- •in castrate-state, one may apply for a waiver for a new baseline biopsy.
排除标准
- •1. Prior treatment with checkpoint immunotherapy (CTLA-4, or PD-1 and PD-L1
- •antagonists) for cohort 1. For cohort 2 patients may have prior treatment with
- •monotherapy CTLA-4 or PD-1 or PD-L1.
- •2. Surgery, chemotherapy within 4 weeks prior to trial entry / randomisation
- •into the study. Any other therapies for prostate cancer, other than GnRH
- •analogue therapy and osteoporosis preventing agents, are not allowed.
- •3. Radiotherapy within 2 weeks prior to trial entry. Radiation-related side
- •effects higher than grade 1, or above baseline.
- •4. Participation in another interventional clinical trial and any concurrent
- •treatment with any investigational drug within 4 weeks prior to trial entry /
- •randomisation.
- •5. History of seizure or any condition that may predispose to seizure
- •including, but not limited to underlying brain injury, stroke, primary brain
- •tumours, brain metastases, or alcoholism.
- •6. Untreated or symptomatic brain or leptomeningeal involvement.
- •7. Inadequate organ and bone marrow function as evidenced by: a. haemoglobin
- •<6.2 mmol/L b. Absolute neutrophil count <1.0 x 109/L c. Platelet count < 75 x
- •109/L d. Albumin <30 g/dL. e. AST / SGOT and/or ALT / SGPT >= 2.5 x ULN (>= 5 x
- •ULN if liver metastases present) f. Total bilirubin >= 1.5 x ULN (except for
- •patient with documented Gilbert*s disease) g. Serum Creatinine > 1.5 x ULN
- •8. Any of the following cardiac criteria; a. Any clinically significant
- •abnormalities in rhythm, conduction, or morphology of a resting ECG (e.g.,
- •complete left bundle branch block, third degree heart block)
- •c. Experience of any of the following procedures or conditions in the preceding
- •six months: coronary artery bypass graft, angioplasty, vascular stent,
- •myocardial infarction, congestive heart failure NYHA >= Grade2
- •d. Uncontrolled hypotension defined as - systolic blood pressure (BP) <90mmHg
- •and/or diastolic BP <50mmHg
- •9. Clinically significant history of liver disease consistent with Child-Pugh
- •Class B or C, including viral or other hepatitis, current alcohol abuse, or
- •10. History of clinically relevant auto-immune disease (including Crohn*s
- •disease or ulcerative colitis). Any other finding giving reasonable suspicion
- •of a disease or condition that contraindicates the use of nivolumab or
- •ipilimumab or that may affect the interpretation of the results or renders the
- •patients at high risk from treatment complications.
- •10. Need for chronic corticosteroid therapy of >10 mg of prednisolone or >0.5mg
- •of dexamethasone per day or an equivalent dose of other anti-inflammatory
- •corticosteroid. Patients in which corticosteroids cannot be stopped prior to
- •entering the trial are allowed a maximum of 10mg of prednisolone per day or
- •equivalent. In the case of corticosteroid discontinuation, a 2-week (14 days)
- •washout is required with a mandatory PSA check prior to starting the trial. If
- •the PSA has declined compared to the value obtained prior to stopping
- •corticosteroids, patients will not be eligible for study. Patients can only
- •enter the study with a confirmed PSA increase.
- •11. Malignancies other than prostate cancer within 3 years prior to trial entry
- •/ randomization, except for adequately treated basal or squamous cell skin
- •cancer and non-muscle invasive bladder cancer.
- •12. Active second malignancy, except basal or squamous cell sk
研究者
相似试验
进行中（未招募）
1 期
A phase II trial to study the effectivity of combination immunotherapy in patients with prostate cancer (INSPIRE)(metastatic) castration-resistant prostate cancerEUCTR2020-001240-25-NLRadboudumc75
进行中（未招募）
1 期
Study of Nivolumab plus Ipilimumab, Ipilimumab or Cabazitaxel in Men with Metastatic Castration-Resistant Prostate CancerEUCTR2016-001928-54-DKBristol-Myers Squibb International Corporation489
进行中（未招募）
1 期
Study of Nivolumab plus Ipilimumab, Ipilimumab or Cabazitaxel in Men with Metastatic Castration-Resistant Prostate CancerMetastatic Castration-Resistant Prostate CancerMedDRA version: 21.1Level: PTClassification code: 10036909Term: Prostate cancer metastatic Class: 100000004864MedDRA version: 21.1Level: LLTClassification code: 10076506Term: Castration-resistant prostate cancer Class: 10029104CTIS2022-502909-15-00477
进行中（未招募）
1 期
Study of Nivolumab plus Ipilimumab, Ipilimumab or Cabazitaxel in Men with Metastatic Castration-Resistant Prostate CancerMetastatic Castration-Resistant Prostate CancerMedDRA version: 21.1Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: LLTClassification code 10076506Term: Castration-resistant prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2016-001928-54-DEBristol-Myers Squibb International Corporation489
进行中（未招募）
1 期
A Study to Evaluate Preliminary Efficacy of Nivolumab Plus Ipilimumab, Ipilimumab Alone, or Cabazitaxel in Men with Metastatic Castration-Resistant Prostate CancerEUCTR2016-001928-54-ESBristol-Myers Squibb International Corporation495