NL-OMON52586招募中不适用
AN OPEN-LABEL, PHASE I STUDY OF NEO-PTC-01 IN PATIENTS WITH ADVANCED OR METASTATIC MELANOMA - NEO-PTC-01 in advanced or metastatic melanoma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 32
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
- •In order to be eligible to participate in this study, a patient must meet all
- •of the following criteria:
- •1. Adult (age 18 to 75) men and women willing and able to give written informed
- •2. Histologically confirmed unresectable or metastatic melanoma.
- •3. Part 1:
- •a. Have previously received a PD-1/PD-L1 inhibitor (either as single agent or
- •in combination) and a CTLA-4 inhibitor-containing regimen (single agent or
- •combination) prior to NEO-PTC-01, with disease progression following these
- •therapies or otherwise lack of clinical benefit as determined by the study
- •investigator.
- •Note: Patients who have received a PD-1/PD-L1 inhibitor and ipilimumab (CTLA-4
- •inhibitor) are eligible. Patients who have discontinued a PD-1/PD-L1 or a
- •CTLA-4 inhibitor due to toxicity and those who are deemed not appropriate to
- •receive a CTLA-4 inhibitor are eligible (except for Part 1 cohort patients to
- •receive additional aPD-1 therapy).
- •4. Part 2:
- •a. Have received/are currently receiving a PD-1/PD-L1 inhibitor (as a single
- •agent or in combination with CTLA-4) for at least 3 months.
- •b. Have documented SD by RECIST 1.1 or clinically asymptomatic progressive
- •disease on the most recent imaging assessment, which must have occurred within
- •3 months of enrollment.
- •c. In the opinion of the investigator, are medically eligible and able to
- •continue with PD-1/PD-L1 inhibitor therapy.
- •d. In the opinion of the investigator, would benefit from the addition of a
- •T-cell-based therapy.
- •5. For known BRAF mutant patients: Patients must have also received targeted
- •therapy (B-raf inhibitor or B-raf/MEK combination therapy) prior to NEO-PTC-01,
- •unless deemed not appropriate to receive these treatments by the investigator.
- •6. Have at least 1 site of measurable disease by RECIST 1.1.
- •7. At least 1 site of disease must be accessible to biopsy for tumor tissue for
- •sequence and immunological analysis. The biopsy site may be the same as the
- •measurable site so long as it remains measurable. Surgical resection of the
- •measurable site may not be performed if that site is the only measurable
- •lesion. An archival biopsy may be used in place if the biopsy was taken within
- •6 months of informed consent.
- •8. Have ECOG PS of 0 or 1.
- •9. Recovered from all toxicities associated with prior treatment to acceptable
- •baseline status (for laboratory toxicities see below limits for inclusion) or
- •an NCI CTCAE version 5.0, Grade of 0 or 1, except for toxicities not considered
- •by the treating physician to be a safety risk (eg, alopecia).
- •10. Screening laboratory values must meet the following criteria and should be
- •obtained prior to any production phase assessments:
- •a. White blood cell (WBC) count >= 3 × 103/µL.
- •b. Absolute neutrophil count (ANC) >= 1.5 × 103/µL.
- •c. Platelet count >= 100 × 103/µL.
- •d. Hemoglobin > 9 g/dL or 6 mmol/L.
- •e. Serum creatinine <= 1.5 × upper limit of normal (ULN) or creatinine clearance
- •>= 50 mL/min by Cockcroft-Gault.
- •f. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 3 ×
- •g. Total bilirubin <= 1.5 × ULN (except in patients with Gilbert Syndrome, who
- 另有 4 项未显示
排除标准
- •A potential patient who meets any of the following criteria will be excluded
- •from participation in this study:
- •1. Age greater than 75 years or less than 18 years.
- •2. Received more than 3 prior lines of therapy for metastatic disease.
- •3. Have an active or history of autoimmune disease (known or suspected).
- •Exceptions are permitted for vitiligo, type I diabetes mellitus, residual
- •hypothyroidism due to autoimmune condition requiring only hormone replacement,
- •psoriasis not requiring systemic treatment, or conditions not expected to recur
- •in the absence of an external trigger.
- •4. Have known active central nervous system metastases and/or carcinomatous
- •meningitis. Patients with previously treated brain metastases may participate
- •provided they are stable (without evidence of progression by imaging [using the
- •identical imaging modality for each assessment, either MRI or CT scan] for at
- •least 4 weeks prior to enrollment and any neurologic symptoms have returned to
- •baseline), have no evidence of new or enlarging brain metastases, and are not
- •using steroids for at least 7 days prior to enrollment. This exception does not
- •include carcinomatous meningitis, which is excluded regardless of clinical
- •and/or radiographic stability.
- •5. Active systemic infections requiring IV antimicrobial therapy, coagulation
- •disorders or other active major medical illnesses of the cardiovascular,
- •respiratory, or immune system, as evidenced by a positive stress thallium or
- •comparable test, myocardial infarction, clinically significant cardiac
- •arrhythmias such as uncontrolled atrial fibrillation, ventricular tachycardia,
- •or second- or third-degree heart block, and obstructive or restrictive
- •pulmonary disease.
- •6. Active major medical illnesses of the immune system including conditions
- •requiring systemic treatment with either corticosteroids (> 10 mg daily
- •prednisone equivalents) or other immunosuppressive medications within 14 days
- •prior to NEO PTC 01 infusion. Inhaled or topical steroids and adrenal
- •replacement doses (<= 10 mg daily prednisone equivalents) are permitted in the
- •absence of active autoimmune disease.
- •7. Known HIV infection, active chronic hepatitis B or C, and/or
- •life-threatening illnesses unrelated to cancer that could, in the
- •investigator*s opinion, interfere with participation in this study.
- •8. Have any underlying medical condition, psychiatric condition, or social
- •situation that, in the investigator*s opinion, would interfere with
- •participation in the study.
- •9. Have a planned major surgery that is expected to interfere with study
- •participation or confound the ability to analyze study data.
- •10. Are pregnant or breastfeeding, or expecting to conceive or father children
- •within the projected duration of the study, starting with the Screening visit
- •through 120 days after the EOT visit. Nursing women are excluded from this
- •study because there is an unknown but potential risk of AEs in nursing infants
- •secondary to treatment of the mother with treatments to be administered in this
- •11. Have a history of another invasive malignancy aside from melanoma, except
- •for the following circumstances:
- •a. Patient has been disease-free for at least 2 years and is deemed by the
- •investigator to be at low risk for recurrence of that malignancy.
- •Patient was not treated with systemic chemoth
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