NCT06540391进行中（未招募）1 期
A Phase 1b, Randomized, Open-Label Trial to Evaluate Safety, Engraftment, and Initial Signs of Clinical Activity of MB097 in Combination With Pembrolizumab in Melanoma Patients With Primary Resistance to an AntiPD1Containing Immunotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 41
- 试验地点
- 19
- 主要终点
- Safety and tolerability of MB097 in combination with pembrolizumab
研究概览
简要总结
A Phase 1b study to evaluate the safety and tolerability of MB097 given in combination with pembrolizumab in patients with melanoma who demonstrate primary resistance to anti-PD1 therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The main inclusion criteria include but are not limited to the following:
- •Must have primary resistant cutaneous melanoma and have experienced disease progression as defined by RECIST v1.1 after receiving at least 6 weeks of exposure to PD-1/PD-L1 inhibitor therapy, generally correlating with 2 complete cycles of PD-1/PD-L1 inhibitor therapy.
- •Must have histological or cytological confirmation of Stage III (unresectable) or Stage IV cutaneous melanoma
- •Must have radiographically measurable disease per RECIST v1.1
- •Must be at least 18 years of age at time of informed consent
- •Must provide written informed consent, according to local guidelines, signed and dated by the patient prior to the performance of any study-specific procedures, sampling, or analysis
- •Must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 at time of informed consent.
- •Must have acceptable organ function, as evidenced by laboratory data prior to first dose of any study drug
- •Female patients must not be lactating or pregnant
- •Male patients, and female patients of childbearing potential who are at risk of pregnancy must agree to use a highly effective method of contraception
- •Must have life expectancy ≥12 weeks after the start of any study drug per Investigator's judgment
- •Must be willing and able to comply with the Protocol, scheduled visits, treatment plan, study restrictions, laboratory tests, contraceptive guidelines, and all other study procedures.
排除标准
- •The main exclusion criteria include but are not limited to the following
- •Any treatment for melanoma following the failure of an aPD-1-containing treatment, i.e., no intervening treatments between aPD-1 failure and enrollment into study;
- •Prior therapy with any of the following:
- •Radiation therapy to target lesions within 6 weeks of the first dose of MB097
- •Major invasive surgery, excluding placement of vascular access, within 28 days of the first dose of any study drug
- •Probiotic supplement use within 7 days of the first dose of any study
- •LBP use, including FMT, within 6 months of start of therapy with MB
- •Active, uncontrolled infection requiring systemic antimicrobial, antiviral, or antifungal therapy.
- •Active, uncontrolled, symptomatic brain metastases or leptomeningeal metastases
- •Ocular, uveal, acral, or mucosal melanoma
- •Prior treatment-related toxicities that have not resolved to Grade 2 or less per NCI CTCAE v5.0;
- •Patients with a history of immune-related colitis may be included if symptoms have resolved to Grade 1 or less for at least 14 days prior to screening
- •Any history of CTCAE v5.0 immune-related toxicity Grade 3 or greater from prior CPI that is recurrent or steroid-refractory
- •Known hypersensitivity to any of the ingredients of the study drug(s) or known hypersensitivity to vancomycin (oral or IV)
- •Significant medical conditions which, in the Investigator's opinion, could compromise or interfere with the patient's safety or integrity of the study outcomes
- •Severe colitis of any etiology (except colitis associated with treatment with an aPD-1 inhibitor)
- •History of another malignancy within 3 years before the first dose of any study drug, or any evidence of residual disease from a previously diagnosed malignancy
- •Clinically significant (i.e., active) cardiovascular disease
- •Any clinically significant safety concern related to prior CPI therapy
- •Active autoimmune disease that required systemic treatment in the past 2 years prior to screening
- •History of investigational agent or device use within 4 weeks prior to the first dose of study treatment or current participation in a study of an investigational agent
- •History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation, or, in the opinion of the Investigator, is considered to not be in the best interest of the patient to participate in the study.
研究组 & 干预措施
MB097 and pembrolizumab
Experimental
MB097 PO (2 capsules once a day) for 6 months Pembrolizumab IV 200mg Q3W for 6 months
干预措施: MB097 (Biological)
MB097 and pembrolizumab
Experimental
MB097 PO (2 capsules once a day) for 6 months Pembrolizumab IV 200mg Q3W for 6 months
干预措施: Pembrolizumab (Biological)
MB097 and pembrolizumab with vancomycin preconditioning
Experimental
Vancomycin 125mg QID for 5 days plus 2 day wash-out prior to receiving MB097 PO (2 capsules once a day) for 6 months Pembrolizumab IV 200mg Q3W for 6 months
干预措施: MB097 (Biological)
MB097 and pembrolizumab with vancomycin preconditioning
Experimental
Vancomycin 125mg QID for 5 days plus 2 day wash-out prior to receiving MB097 PO (2 capsules once a day) for 6 months Pembrolizumab IV 200mg Q3W for 6 months
干预措施: Pembrolizumab (Biological)
MB097 and pembrolizumab with vancomycin preconditioning
Experimental
Vancomycin 125mg QID for 5 days plus 2 day wash-out prior to receiving MB097 PO (2 capsules once a day) for 6 months Pembrolizumab IV 200mg Q3W for 6 months
干预措施: Vancomycin (Drug)
Extended treatment
Experimental
Patients experiencing clinical benefit may continue to receive study intervention (pembrolizumab only IV 200mg Q3W) until such time as a criterion for discontinuation is met or 35 doses of pembrolizumab have been administered.
干预措施: Pembrolizumab (Biological)
结局指标
主要结局
Safety and tolerability of MB097 in combination with pembrolizumab
时间窗: From Visit 1 to 30 days after the last dose of study treatment
Assessed by the following: * The incidence and severity of treatment-emergent AEs (TEAEs) per NCI CTCAE v5.0; * Immune-related AEs (irAEs); * AESIs; and * Any clinically significant abnormalities in laboratory results, physical examination findings, 12-lead ECG findings, and vital signs using the NCI CTCAE v5.0.
次要结局
- Duration of response(Up to Week 24 or Week 105(for patients in extended treatment))
- Progression-free survival,(Up to Week 24 and Week 36, and Week 105(for patients in extended treatment))
- Best objective response rate (b-ORR) by RECIST v1.1 and iRECIST(Up to Week 24 or Week 105(for patients in extended treatment))
- Overall response rate (ORR) by RECIST v1.1 and iRECIST(Up to Week 24 or Week 105(for patients in extended treatment))
- Disease control rate (DCR) by RECIST v1.1 and iRECIST(Up to Week 24 or Week 105(for patients in extended treatment))
- Time to progression(Up to Week 24 or Week 105(for patients in extended treatment))
- Quantification of MB097 strains at baseline and over the intervention period in patients treated with MB097 with and without vancomycin preconditioning and correlation to efficacy measures(Up to Week 24 or Week 105(for patients in extended treatment))
研究者
研究点 (19)
Loading locations...
相似试验
招募中
1 期
Open Label Study to Evaluate BL-M07D1 in HER2 Expressing Malignant Solid TumorsEndometrial CancerBiliary Tract CancerGastroesophageal-junction CancerCervical CancerOvarian CancerBreast CancerEsophageal CancerLung CancerGastric CancerUrothelial CarcinomaNCT06293898SystImmune Inc.280
已完成
1 期
Safety and Efficacy Study of Pembrolizumab (MK-3475) in Combination With Chemotherapy as Neoadjuvant Treatment for Participants With Triple Negative Breast Cancer (TNBC) (MK-3475-173/KEYNOTE-173)Triple Negative Breast NeoplasmsNCT02622074Merck Sharp & Dohme LLC60
招募中
1 期
Phase I Clinical Study of BL-M07D1 in Locally Advanced or Metastatic Digestive Tract Tumors and Other Solid TumorsLocally Advanced or Metastatic Digestive Tract TumorsOther Solid TumorsNCT05631964Sichuan Baili Pharmaceutical Co., Ltd.26
已完成
1 期
A Study To Assess The Tolerability And Clinical Activity Of Gedatolisib In Combination With Palbociclib/Letrozole Or Palbociclib/Fulvestrant In Women With Metastatic Breast CancerBreast CancerNCT02684032Celcuity Inc141
终止
1 期
Live Biotherapeutic Product MRx0518 and Pembrolizumab Combination Study in Solid TumorsOncologySolid TumorNon Small Cell Lung CancerRenal Cell CarcinomaMelanomaBladder CancerNCT036378034D pharma plc63