問卷
Log In
繁中 EN
TPIDB
TPIDB Outstanding PI
TPIDB > Search Result > Clinical Trials List

Clinical Trials List

Protocol NumberV937-013
NCT Number(ClinicalTrials.gov Identfier)NCT04521621
Completed

2020-08-17 - 2023-12-12

Phase I/II

Recruiting4

Terminated2

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

  • Trial Applicant

    Merck Sharp & Dohme (I.A.) LLC

  • Sponsor

    Merck Sharp & Dohme Corp.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Chen-Yuan Lin Division of Hematology & Oncology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Pin-Nan Cheng Digestive System Department
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 張義芳 Division of Hematology & Oncology
MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 盧勝男 Digestive System Department
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chia-Chi Lin Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Chen-Chun Lin Digestive System Department
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Condition/Disease

Advanced/Metastatic Solid Tumors

Objectives

The purpose of this study is to evaluate the safety, tolerability, and efficacy in participants with advanced/metastatic or recurrent malignancies who receive V937 in Combination with Pembrolizumab (MK-3475). The primary objective for Part 1 is to evaluate the objective response rate, and the primary objective for Part 2 is to determine the safety and tolerability of V937 administered in combination with pembrolizumab.

Test Drug

V937;吉舒達®/Keytruda®

Active Ingredient

Coxsackievirus A21
Pembrolizumab

Dosage Form

IVT
IVT

Dosage

7.5 x 107 TCID50/mL
100 mg/4 mL

Endpoints

Primary Outcome Measures :

Part 1: Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Investigator [ Time Frame: Up to approximately 5 years ]
ORR is defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions and no new lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by investigator. For this study, RECIST 1.1 has been modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, and to specify that intratumoral injection does not render a lesion non-evaluable. Only the Part 1 arms will be analyzed in this outcome measure.

Number of Participants who Experience a Dose-Limiting Toxicity (DLT) [ Time Frame: Up to approximately 4 weeks ]
DLTs are defined as toxicities that: are possibly, probably, or definitely related to study intervention administration; and meet pre-defined study criteria.

Part 2: Number of Participants Who Experienced One or More Adverse Events (AEs) [ Time Frame: Up to approximately 107 weeks ]
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. Only the Part 2 arms will be analyzed in this outcome measure.

Part 2: Number of Participants Who Discontinued Study Intervention Due to an Adverse Event (AE) [ Time Frame: Up to approximately 103 weeks ]
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. Only the Part 2 arms will be analyzed in this outcome measure.

Inclution Criteria

Inclusion Criteria:

Locally-advanced disease that is not amenable to surgery or radiation, or Stage IV advanced/metastatic solid tumor malignancies
Histologically- or cytologically-confirmed diagnosis of an advanced/metastatic solid tumor.
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
Submitted a baseline tumor sample for analysis. Participants enrolling in Part 2 Cohorts D-F may enroll without submitting a tumor sample if all other enrollment criteria are met.
Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale obtained within 72 hours prior to the first dose of study intervention
If participant has known human immunodeficiency virus (HIV)-positive disease, participant must have well-controlled HIV on antiretroviral therapy (ART), per study criteria.
Adequate organ function
Male participants are eligible to participate if they agree to the following during the intervention period and for at least 120 days: Be abstinent from heterosexual intercourse as their preferred and usual lifestyle and agree to remain abstinent, OR must agree to use contraception unless confirmed to be azoospermic.
Female participants are eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:

Is not a woman of childbearing potential (WOCBP)
Is a WOCBP and using a contraceptive method that is highly effective, 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.
Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Part 1, All Cohorts: participants must have at least one injectable lesion amenable to injection and/or biopsy.
Part 1, Cohort A:

Locally recurrent, inoperable OR metastatic breast cancer treated with at least 1 prior line of therapy in the metastatic setting with skin involvement and/or subcutaneous lesions or accessible lymph nodes amenable to local injection. An exception would be allowed for participants who are not eligible to receive chemotherapy.
Diagnosis of triple-negative breast cancer (estrogen receptor, progesterone receptor, and HER2-receptor negative status)
Part 1, Cohort B:

Histologically confirmed advanced or metastatic head and neck squamous cell carcinoma (HNSCC) of the oral cavity, oropharynx, hypopharynx, and/or larynx considered incurable and/or treated with no more than 1 previous line of therapy
Tumors must be PD-L1+
Documentation of HPV status for oropharyngeal cancers. Other HNSCC subtypes may submit HPV testing, but is not required.
Part 1, Cohort C:

Histologically confirmed cutaneous squamous cell carcinoma (cSCC) as the primary site of malignancy
Recurrent/metastatic disease only: Has metastatic disease defined as disseminated disease distant from the initial/primary site of diagnosis and/or with a history of locally-recurrent disease previously treated with surgery and/or radiotherapy, which is now incurable
Locally-advanced disease only: Must be ineligible for surgical resection per study criteria, and must have received prior radiation therapy to the index site or deemed ineligible for radiation therapy
Part 2, Solid Tumors+Liver Metastases Dose Level 1-3 arms:

Histologically-confirmed advanced/metastatic solid tumor that has progressed on all treatment known to confer clinical benefit
Metastatic liver lesion(s) not exceeding one-third of the total liver volume AND a minimum of one injectable liver lesion
Part 2, Cohort D:

Advanced hepatocellular carcinoma (HCC) following progression on, or intolerance to, sorafenib or lenvatinib with no curative options
Diagnosis of HCC confirmed by radiology, histology, or cytology
Child-Pugh Class A score
If a participant has a history of hepatitis C virus (HCV) infection, then he/she must have been successfully treated for this condition
Controlled (treated) hepatitis B participants will be allowed if they meet protocol-specified criteria
Participants who are anti-hepatitis B core (HBc) positive, negative for hepatitis B surface antigen (HBsAg), negative or positive for anti-hepatitis B surface (HBs), and who have an HBV viral load under 100 IU/mL, do not require HBV anti-viral prophylaxis
Part 2, Cohort E:

Histologically- or cytologically-confirmed diagnosis of locally advanced, unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma
Received at least one prior line of therapy that includes a platinum/fluoropyrimidine doublet or triplet regimen
Had proven clinical progression 6 months following (or during) last dose of adjuvant or neo-adjuvant therapy
Human epidermal growth factor receptor 2 (HER2) negative status; or, those with HER2 positive status AND documented disease progression on a prior regimen containing trastuzumab

Exclusion Criteria

Exclusion Criteria:

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 Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or better
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
If participant has had injection or radiation therapy, participant must be recovered from toxicity and/or complications of intervention
History of second malignancy, unless potentially curative treatment has been completed with no further evidence of malignancy
Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with treated brain metastases may participate if lesions are radiologically stable.
Active infection requiring therapy, except HIV criteria as stated above, and HBV and HCV criteria for HCC cohort as stated above
History of interstitial lung disease
History of noninfectious pneumonitis requiring active steroid therapy or ongoing pneumonitis
Active autoimmune disease that required systemic treatment in the past 2 years except vitiligo or resolved childhood asthma/atopy
Known Hepatitis B or C infections or known to be positive for HBsAg/HBV deoxyribonucleic acid (DNA) or Hepatitis C Antibody or ribonucleic acid (RNA)
History of Kaposi's sarcoma and/or Multicentric Castleman's Disease
Known hypersensitivity to V937 and/or pembrolizumab or any of their excipients
Received prior therapy with anti-programmed cell death protein-1 (anti-PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1) agents, Talimogene Laherparepvec (T-VEC), or any other oncolytic virus therapies
Received a live or live-attenuated vaccine within 30 days prior to first dose of study intervention. Administration of killed vaccines is allowed.
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
Part 2, Cohort D:

Has had esophageal or gastric variceal bleeding within the last 6 months
Has had clinically diagnosed hepatic encephalopathy in the 6 months prior to initiation of study intervention
Part 2, Cohort E:

Squamous cell or undifferentiated gastric cancer

The Estimated Number of Participants

  • Taiwan

    26 participants

  • Global

    185 participants

聯絡我們

台灣臨床試驗主持人資料庫 TPIDB

All Contents Copyright 2020 台灣臨床試驗主持人資料庫TPIDB