EUCTR2021-003712-27-ES进行中（未招募）1 期
A Phase 2b, Open-label, Multicenter, Randomized Parallel-Group, Two-Stage, Study of an Immunotherapeutic Treatment DPX-Survivac and Pembrolizumab, with and without Intermittent LowDose Cyclophosphamide, in Subjects with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (VITALIZE). - VITALIZE
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- IMV Inc.
- 入组人数
- 102
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. Adults = 18 years of age who are willing and able to provide written informed consent
- •2. Have an ECOG performance status of = 1. Subjects with an ECOG performance status of 2 may be enrolled with Medical Monitor approval. The number of subjects with an ECOG performance status of 2 will be capped at approximately 20% of any treatment arm and must be reserved prior to consenting the subject.
- •3. Pathologically confirmed diagnosis of DLBCL, as defined by the 2016 World Health Organization classification including DLBCL NOS high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, Epstein-barr virus (EBV) positive DLBCL, and T cell rich B cell lymphoma (TCRBCL). Subjects with DLBCL transformed from indolent lymphoma (except for Richter’s transformation) are eligible.
- •4. Subjects must have progressive disease following at least two (2) lines of prior systemic therapy for DLBCL; prior treatment must have included an anthracycline and rituximab (or another CD20-targeted agent).
- •5. Subjects must be ASCT or CAR-T ineligible according to the Investigator as defined by at least one of the following:
- •a. One or more co-morbidities, poor performance status and/or advanced age that in the opinion of the Investigator makes the subject medically unfit to receive ASCT or CAR-T therapy
- •b. Active disease following induction and salvage chemotherapy or inadequate stem cell/CAR-T mobilization and/or apheresis
- •c. Failure of prior ASCT or CAR-T
- •d. Unable to receive CAR-T therapy due to financial, geographic, or insurance issues
- •e. Unwilling to undergo ASCT or CAR-T treatment
- •6. Have at least one bi-dimensionally measurable lesion per Lugano (2014)1 as assessed by local imaging. For subjects staged with PET-CT, focal uptake in nodal and extranodal sites that is in keeping with lymphoma, according to the distribution and/or CT characteristics, is considered involvement with lymphoma, including but not limited to, spleen, liver, bone, and thyroid.
- •7. Willing to provide pre-treatment and on-treatment tumor biopsy tissue.
- •a. Pre-treatment: fresh biopsy preferred but archival may be submitted if there has been no exposure to systemic anti-cancer or localized radiation at site of biopsy between date of biopsy and analysis.
- •i. Confirmation of availability of the pre-treatment tumor biopsy or eligible archival
- •tissue and request to obtain material must be made during screening period.
- •b. On-treatment at study D70, unless deemed unsafe by the Investigator.
- •8. Demonstrate adequate organ function
- •9. Life expectancy > 3 months.
- •10. A subject is eligible to participate if they are not pregnant, not breastfeeding, and at least one of the following conditions applies:
- •a. For females:
- •i. Not a woman of childbearing potential (WOCBP), or
- •ii. A WOCBP who agrees to follow contraceptive guidance during the treatment period and for at least 120 days after the last dose of study treatment.
- •b. Males who agree to follow contraceptive guidance during the treatment period and for at least 210 days after the last dose of study treatment
- •11. Ability to comply with protocol requirements
- •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 38
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 68
排除标准
- •1. Primary CNS lymphoma or active secondary CNS involvement and/or lymphomatous meningitis. CNS imaging and cerebrospinal fluid sampling are not mandatory in the absence of a clinical suspicion of lymphomatous involvement of the CNS.Chemotherapy, immunotherapy, major surgery, or investigational agent treatment within 28 days of D0 or 5 half-lives whichever is shorter, except as noted:
- •a. Radiotherapy within 14 days of day 0. Subjects must have recovered from all radiation related toxicities, not require corticosteroids, and not have had radiation pneumonitis.
- •b. Autologous stem cell transplant (ASCT) within <100 days prior to D0.
- •c. Chimeric antigen receptor T cell (CAR-T) therapy within <28 days prior to D0
- •All treatment related toxicities related to prior therapies must be recovered to < Grade 1 or baseline, except for organ function criteria mandated by the inclusion criteria. Subjects with Grade 2 alopecia, peripheral neuropathy endocrine-related AEs requiring treatment or hormone replacement are eligible.
- •2. The following prior medications/procedures are exclusionary.
- •a. Allogeneic stem cell transplant or allogeneic CAR-T therapy or solid organ transplant
- •b. Prior therapy with anti-survivin therapy
- •c. Anti-PD-1, anti-PD-L1, anti-PD-L2, or CTLA-4 agent
- •d. Chronic systemic steroid therapy (doses exceeding 10 mg daily prednisone equivalent) or other immunosuppressive therapy within 7 days of D0. Single doses, topical applications (e.g., for rash), inhaled sprays (e.g., for obstructive airways diseases), eye drops or local injections (e.g., intra-articular) are permitted.
- •e. Prescribed or over-the-counter probiotic treatments
- •f. Live-attenuated vaccine within 30 days of planned start of study therapy
- •3. Disorders that might interfere with study treatment including:
- •a. History of (non-infectious) pneumonitis that required steroids or current pneumonitis
- •b. Unable to swallow tablets, malabsorption syndrome, short-gut syndrome, gastroparesis or any other gastrointestinal disease or dysfunction (e.g., nausea/vomiting/diarrhea that is CTCAE = Grade 2) that could interfere with absorption of study treatment
- •c. Acute or chronic skin, microvascular disorders, and/or edema or lymphedema that could interfere with subcutaneous injection of DPX-Survivac or subsequent assessment of potential skin reactions.
- •4. Diagnosis of immunodeficiency disorder or history of active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is permitted.
- •5. Clinically severe cardiovascular disease (e.g., NYHA Class III or IV CHF, uncontrolled angina; history of myocardial infarction within 6 months or unstable angina or stroke within 30 days of study entry; uncontrolled hypertension; or clinically significant arrhythmias not controlled by medication).
- •6. Uncontrolled significant active infections.
- •a. Subjects who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization. Note: Subjects should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention.
- •b. Subjects with HCV are eligible if HCV viral load is undetectable at scre
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