TCTR20160606004尚未招募1 期
Phase II, Randomized Non-Inferiority Study Comparing an Individualized Cancer Vaccine (AlloVaxTM) to Chemotherapy in Subjects with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (R/M SCCHN)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 99
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 Years 至 0 Years（—）
- 性别
- All
入选标准
- •Inclusion Criteria:
- •Each subject must meet the following criteria to be enrolled in this study:
- •1.Adult males and female subjects aged 18 years or older at screening visit.
- •2.Histopatholologically or cytologically confirmed diagnosis of locoregionally recurrent unresectable or previously untreated metastatic squamous cell carcinoma of the head and neck (R/M SCCHN).
- •3.Tumor lesion safely accessible for biopsy or surgical excision resulting in a minimum of 0.2 g of tumor sample for CRCL processing.
- •4.Subjects must have measurable disease according to revised RECIST v.1.1 guidelines.
- •5.ECOG ≤1.
- •6.Subjects must be screened to be negative for HIV1, HBsAg, HCV and RPR (syphilis). After confirmation that subject is negative for these agents, the tumor can be processed into CRCL. The tests results ideally should be obtained prior to conducting a tumor harvest procedure, but in any case prior to CRCL manufacture.
- •7.Subjects must have adequate organ function including:
- •7.1. Marrow:
- •oWBC >3000/mm3
- •oPlatelets >100,000/mm3
- •oAbsolute neutrophil count ≥ 1,500/mm³
- •oHemoglobin ≥ 10.0 g/dL (transfusion allowed)
- •7.2. Hepatic:
- •oSerum Total bilirubin < 2 x ULN mg/dL,
- •oALT (SGPT) / AST (SGOT) ≤3 x upper limit of normal (ULN).
- •7.3. Renal:
- •oSerum creatinine (SCR) <2.0 x ULN, or
- •oCreatinine clearance (CCR) >30 mL/min.
- •8.Pre-study EKG without significant abnormalities.
- •9.Women of child-bearing potential must have a negative urine or serum pregnancy test result within 72 hours prior to the start of study drug administration.
- •10.If child producing potential age, must agree to use contraception or avoidance of pregnancy measures while enrolled on study and receiving the experimental product.
- •11.Ability to understand the study, its inherent risks, side effects and potential benefits and be able to give written informed consent to participate.
排除标准
- •Exclusion Criteria:
- •Subjects with any of the following will be excluded from the participation in the study:
- •1.Clinical evidence or radiological evidence of brain metastasis.
- •2.Treated for another primary cancer within 2 years prior to signing inform consent form.
- •3.Any concomitant anticancer therapies.
- •4.History of severe hypersensitivity to monoclonal antibody drugs or any contraindication to any of the study drugs.
- •5.Concomitant active autoimmune disease (e.g., rheumatoid arthritis, multiple sclerosis, autoimmune thyroid disease, uveitis).
- •6.Prior experimental therapy or cancer vaccine treatment (e.g., dendritic cell therapy, heat shock vaccine).
- •7.Clinical requirement for systemic steroids or immunosuppressive therapy, including: cyclosporine, antithymocyte globulin, or tacrolimus within 1 month prior to signing inform consent form.
- •8.Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, requiring parenteral antibiotics, symptomatic congestive heart failure, severe myocardial insufficiency, cardiac arrhythmia.
- •All infections must be resolved and the subject must remain a febrile for seven days prior to being placed in the study.
- •9.History of blood transfusion reactions.
- •10.Psychiatric or addictive disorders or other condition that, in the opinion of the investigator, would preclude study participation.
- •11.Female subject is pregnant or breast-feeding.
研究者
相似试验
招募中
2 期
“NALPAC” A NON-COMPARATIVE RANDOMIZED PHASE 2 STUDY, EVALUATING THE EFFICACY OF 5-FU + NALIRI AND 5-FU + NALIRINOX FOR METASTATIC PANCREATIC DUCTAL ADENOCARCINOMA (PDAC), PROGRESSIVE AFTER GEMCITABINE-ABRAXANE OR GEMCITABINE MONOTHERAPY.2024-516336-97-00Groupe Belge D'Oncologie Digestive134
招募中
2 期
“A phase II randomized non-comparative study, with NEOadjuvant plus adjuvant Therapy with combination or sequence of vemurafenib, cobImetinib, and atezolizuMab in patients with high-risk, surgically resectable BRAF mutated and wild-type Melanoma”2024-516659-41-00Fondazione Melanoma Onlus94
进行中（未招募）
1 期
A randomized, non-comparative, phase II study investigating the best epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) sequence in advanced or metastatic non-small-cell lung cancer (NSCLC) harboring EGFR mutationsAdvanced or metastatic untreated EGFR mutation positive NSCLCMedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2019-002869-35-ITFONDAZIONE RICERCA TRASLAZIONALE (FORT)189
进行中（未招募）
1 期
A randomized, non-comparative, phase II study investigating the best epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) sequence in advanced or metastatic non-small-cell lung cancer (NSCLC) harboring EGFR mutationsEUCTR2019-002869-35-ESFONDAZIONE RICERCA TRASLAZIONALE (FORT)189
已完成
2 期
Oral drug therapy as palliative chemotherapy in Head and Neck cancersCTRI/2014/07/004791Tata Memorial Hospital110