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Virus Therapy

Pembrolizumab for Cancer

Q: What are the proposed results of this medical study?

<p>According to the study's sponsor, Merck Sharp &#x26; Dohme LLC, the primary outcome measurement will be the number of participants who discontinue the study intervention due to an adverse event. This will be measured over a period of up to 4 weeks. Additionally, the trial will assess secondary outcomes including objective response rate and overall survival.</p>

Q: What condition is V937 most often used to treat?

<p>V937 is most commonly used as an anti-<a href="https://www.withpower.com/clinical-trials/cancer">cancer</a> drug, but it has also shown efficacy in treating microsatellite instability high and disease progression after chemotherapy.</p>

Phase 1 & 2

Waitlist Available

Research Sponsored by Merck Sharp & Dohme Corp.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 44 months

Awards & highlights

Study Summary

This trial is testing a new drug, V937, to see if it is safe and effective when used with another drug, pembrolizumab, to treat advanced or recurrent cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 44 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 44 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 44 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants who Experience a Dose-Limiting Toxicity (DLT)

Part 1: Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Investigator

Part 2: Number of Participants Who Discontinued Study Intervention Due to an Adverse Event (AE)

+1 more

Secondary outcome measures

Duration of Response (DOR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Investigator

Duration of Response (DOR) per Response Evaluation Criteria in Solid Tumors 1.1 for Immune-Based Therapeutics (iRECIST) as Assessed by Investigator

Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors 1.1 for Immune-Based Therapeutics (iRECIST) as Assessed by Investigator

+6 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183

21%

Fatigue

13%

Nausea

11%

Back pain

Shortness of Breath

Anemia

Abdominal pain

Diarrhea

Pneumonia

Kidney Injury and/or Infection

Dyspnea

Weight Loss

Malnutrition, Hypercalcemia and Weakness

Pneumothorax

Intractable pain, back pain, hip pain

Activated partial thromboplastin time prolonged

Pleural effusion

Atrial fibrillation with rapid ventricular response

Thrombocytopenia

Respiratory failure

Skin rash

colitis

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm

Trial Design

8Treatment groups

Experimental Treatment

Group I: Part 2, Cohort E: Gastric CarcinomaExperimental Treatment2 Interventions

This arm will enroll participants with gastric carcinoma solid tumors. Participants receive the gebasaxturev recommended phase 2 dose (RP2D) intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 is 28 days, and cycles 2-35 are 21 days.

Group II: Part 2, Cohort D: Hepatocellular Carcinoma (HCC)Experimental Treatment2 Interventions

This arm will enroll participants with hepatocellular carcinoma (HCC) solid tumors. Participants receive the gebasaxturev recommended phase 2 dose (RP2D) intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 is 28 days, and cycles 2-35 are 21 days.

Group III: Part 2 Dose Level 3, Solid Tumors + Liver MetastasesExperimental Treatment2 Interventions

This arm will enroll participants with solid tumors with liver metastases. Participants receive dose level 3 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 is 28 days, and cycles 2-35 are 21 days.

Group IV: Part 2 Dose Level 2, Solid Tumors + Liver MetastasesExperimental Treatment2 Interventions

This arm will enroll participants with solid tumors with liver metastases. Participants receive dose level 2 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 is 28 days, and cycles 2-35 are 21 days.

Group V: Part 2 Dose Level 1, Solid Tumors + Liver MetastasesExperimental Treatment2 Interventions

This arm will enroll participants with solid tumors with liver metastases. Participants receive dose level 1 of gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 is 28 days, and cycles 2-35 are 21 days.

Group VI: Part 1, Cohort C: Cutaneous Squamous Cell CarcinomaExperimental Treatment2 Interventions

This arm will enroll participants with cutaneous squamous cell carcinoma (cSCC) solid tumors. Participants receive gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 is 28 days, and cycles 2-35 are 21 days.

Group VII: Part 1, Cohort B: Head and Neck Squamous Cell CarcinomaExperimental Treatment2 Interventions

This arm will enroll participants with head and neck squamous cell carcinoma (HNSCC) solid tumors. Participants receive gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 is 28 days, and cycles 2-35 are 21 days.

Group VIII: Part 1, Cohort A: Triple-Negative Breast CancerExperimental Treatment2 Interventions

This arm will enroll participants with triple-negative breast cancer (TNBC) solid tumors. Participants receive gebasaxturev intratumorally for 8 cycles, and pembrolizumab intravenously for a maximum of 35 cycles. Cycle 1 is 28 days, and cycles 2-35 are 21 days.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2010

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor

2,286 Previous Clinical Trials

4,581,753 Total Patients Enrolled

Merck Sharp & Dohme LLCLead Sponsor

3,886 Previous Clinical Trials

5,054,478 Total Patients Enrolled

Medical DirectorStudy DirectorMerck Sharp & Dohme LLC

2,777 Previous Clinical Trials

8,063,411 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this study currently looking for more participants?

"The trial has completed recruitment as of November 4th, 2020. 664 other trials are currently recruiting patients with neoplasm metastasis and 1000 V937 trials are still looking for participants."

Answered by AI

What are the proposed results of this medical study?

"According to the study's sponsor, Merck Sharp & Dohme LLC, the primary outcome measurement will be the number of participants who discontinue the study intervention due to an adverse event. This will be measured over a period of up to 4 weeks. Additionally, the trial will assess secondary outcomes including objective response rate and overall survival."

Answered by AI

What is the V937 clinical trial's place in ongoing research?

"V937 was first studied in 2010 at City of Hope. There have been 249 completed trials since then. At the moment, there are 1000 active clinical trials, a significant portion of which are located in Toronto, Canada."

Answered by AI

What condition is V937 most often used to treat?

"V937 is most commonly used as an anti-cancer drug, but it has also shown efficacy in treating microsatellite instability high and disease progression after chemotherapy."

Answered by AI

What is the total amount of people who have signed up for this research project?

"As of now, this study has paused recruitment. The clinical trial was first posted on October 28th 2020 and most recently updated on November 4th 2022. However, there are currently 664 other trials for neoplasm metastasis and 1000 studies for V937 that are actively searching for participants."

Answered by AI

Recent research and studies

Human Gene TherapyJournal

Reverse-phase Ultra-performance Chromatography Method for Oncolytic Coxsackievirus Viral Protein Separation and Empty to Full Capsid Quantification

Deng, James Z., Richard R. Rustandi, Damon Barbacci, Andrew R. Swartz, Amanda Gulasarian, and John W. Loughney. 2022. “Reverse-phase Ultra-performance Chromatography Method for Oncolytic Coxsackievirus Viral Protein Separation and Empty to Full Capsid Quantification”. Human Gene Therapy. Mary Ann Liebert Inc. doi:10.1089/hum.2022.013.

Human Gene TherapyJournal

Reverse-phase Ultra-performance Chromatography Method for Oncolytic Coxsackievirus Viral Protein Separation and Empty to Full Capsid Quantification

clinicaltrials.govStudy

A Study of Gebasaxturev (V937) in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic Solid Tumors (V937-013)

2020. "A Study of Gebasaxturev (V937) in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic Solid Tumors (V937-013)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04521621.