A Phase 1b/2 Clinical Study of Intratumoral Administration of V937 in Combination with Pembrolizumab (MK-3475) in Participants with Advanced/Metastatic Solid Tumors - Phase 1b/2 Study of ITu V937 in Combination with Pembrolizumab

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc0 个研究点目标入组 185 人开始时间: 2020年10月20日最近更新: 2024年4月15日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 185

研究概览入排标准研究者记录与标识符相似试验

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. Has locally-advanced disease that is not amenable to surgery or radiation, or Stage IV advanced/metastatic solid tumor malignancies
•2. Has histologically- or cytologically-confirmed diagnosis of an advanced/metastatic solid tumor
•3. Has measurable disease by RECIST 1.1 criteria as assessed by investigator. Target lesions in a previously irradiated area will be considered measurable if progression has been demonstrated in such lesions
•4. Has submitted a baseline tumor sample for analysis (either de novo biopsy or an archival tumor block)
•5. Has a performance status of 0 or 1 on the ECOG Performance Scale obtained within 72 hours prior to the first dose of study intervention
•6. If participants have known HIV-positive disease, participants must have well-controlled HIV on ART defined as:
•a. CD4+ T-cell count >350 cells/mm3 at the time of screening
•b. Must have achieved and maintained virologic suppression, defined as HIV RNA levels below 50, or LLOQ (below limits of detection), using a locally available assay at the time of screening
•c. Must be on a stable regimen without any changes in drugs or dose modifications for a minimum of 4 weeks prior to study entry (Day 1)
•7. Demonstrate adequate organ function
•8. Is male or female, from =18 years of age inclusive, at the time of signing the informed consent
•9. Male participants are eligible to participate if they agree to the following during the intervention period for and for at least 120 days after the last dose of study intervention:
•PLUS either:
•- Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent
•- Must agree to use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause) as detailed below:
•Agree to use a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a WOCBP who is not currently pregnant
•10. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
•- Is not a WOCBP
•- Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis), during the intervention period and for at least 120 days after the last dose of study intervention. The investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recently initiated) in relationship to the first dose of study intervention
•- A WOCBP must have a negative highly sensitive pregnancy test ([urine or serum] as required by local regulations) within 72 hours before the first dose of study intervention
•- If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive
•11. The participant (or legally acceptable representative) provides written informed consent for the study. The participant may also provide consent for future biomedical research. However, the participant may participate in the main study without participating in future biomedical research
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes

排除标准

•1. Has had chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks (2 weeks for palliative radiation) prior to first dose of study intervention, or has not recovered to CTCAE Grade 1 or better
•2. If major or minor surgery was performed at/near the area being considered for injection, participant must be recovered from toxicity and/or complications of intervention
•3. Has had injection, or radiation therapy of >30 Gy, participant must be recovered from toxicity and/or complications of intervention
•4. Has a history of second malignancy, unless potentially curative treatment has been completed with no further evidence of malignancy
•5. Has known active CNS metastases and/or carcinomatous meningitis. Participants with treated brain metastases may participate if lesions are radiologically stable
•6. Has an active infection requiring therapy
•7. Has a history of interstitial lung disease
•8. Has a history of noninfectious pneumonitis requiring active steroid therapy or ongoing pneumonitis
•9. Has an active autoimmune disease that required systemic treatment in the past 2 years (ie, necessitating use of disease modifying agents, corticosteroids, or immunosuppressive drugs) except vitiligo or resolved childhood asthma/atopy. Replacement therapy such as thyroxine, insulin, or physiologic corticosteroid replacement therapy (steroid use =10 mg prednisone, or its equivalent, daily) is not considered a form of systemic treatment and is allowed. The use of non-systemic steroids is permitted
•10. Participants with known Hepatitis B or C infections or known to be positive for HBsAg/HBV DNA or Hepatitis C Antibody or RNA. Active Hepatitis C is defined by a known positive Hep C Ab result and known quantitative HCV RNA results greater than the lower limits of detection of the assay
•11. Participants with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease
•12. Has known hypersensitivity to V937 and/or pembrolizumab or any of their excipients
•13.Has known psychiatric or substance abuse disorder that significantly interferes with cooperation with requirements of the trial
•14. Has received prior therapy with anti-PD-1/PD-L1 agents, T-VEC or any other oncolytic virus therapies
•15. Has received a live vaccine within 30 days prior to first dose of study drug. Examples of live vaccines include, but are not limited to: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, BCG, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are permitted. However, intranasal influenza (eg, FluMist®) and OPV vaccines are live attenuated vaccines and not permitted
•16. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention
•17. Is 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 last dose of study intervention

研究者

发起方

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc

相似试验

进行中（未招募）

1 期

Phase 1b/2 Study of V937 Injected into Tumors in Combination with Intravenous (IV) PembrolizumabAdvanced/metastatic solid tumorsMedDRA version: 21.1Level: LLTClassification code 10065252Term: Solid tumorSystem Organ Class: 100000004864

EUCTR2020-001908-42-PLMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc185

进行中（未招募）

1 期

Phase 1b/2 Study of V937 Injected into Tumors in Combination with Intravenous (IV) Pembrolizumab

EUCTR2020-001908-42-PTMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc185

进行中（未招募）

1 期

Phase 1b/2 Study of V937 Injected into Tumors in Combination with Intravenous (IV) Pembrolizumab

EUCTR2020-001908-42-ITMERCK SHARP & DOHME CORP. UNA SUSSIDIARIA DI MERCK & CO. INC.185

已完成

1 期

Phase 1b/2 Study of ITu V937 in Combination with Pembrolizumab

JPRN-jRCT2033200191ohata Nijiro185

进行中（未招募）

1 期

EUCTR2020-001908-42-HUMerck Sharp & Dohme LLC185