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Virus Therapy

Pembrolizumab for Melanoma

Phase 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 3 years

Awards & highlights

Study Summary

This trial is testing a new drug, V937, to see if it is more effective than the current standard of care for treating people with advanced melanoma who have not yet been treated with anti-PD-L1 therapies.

Eligible Conditions

Advanced/Metastatic Melanoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

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

Treatment Details

Study Objectives

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

Primary outcome measures

Objective Response Rate (ORR) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)

Secondary outcome measures

DOR per RECIST 1.1 as Assessed by the Investigator

Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR

Number of Participants who Discontinue Study Drug Due to an AE

+5 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

3Treatment groups

Experimental Treatment

Group I: PembrolizumabExperimental Treatment1 Intervention

Participants receive pembrolizumab 200 mg by IV infusion on Day 8 of Cycle 1 (28-day cycle) and Day 1 of each subsequent 21-day cycle. Pembrolizumab will be administered for up to 35 cycles (up to 2 years).

Group II: IV Gebasaxturev + PembrolizumabExperimental Treatment2 Interventions

Participants receive gebasaxturev at a dose of 1 X 10^9 TCID50 by IV infusion on Days 1, 3, 5, and 8 of Cycle 1 (28-day cycle) and Day 1 of Cycles 2-8 (21-day cycles) plus pembrolizumab 200 mg by IV infusion on Day 8 of Cycle 1 (28-day cycle) and Day 1 of each subsequent 21-day cycle. Gebasaxturev will be administered for up to 8 cycles (up to 6 months). Pembrolizumab will be administered for up to 35 cycles (up to 2 years).

Group III: ITu Gebasaxturev + PembrolizumabExperimental Treatment2 Interventions

Participants receive gebasaxturev at a dose of 3 X 10^8 TCID50 by ITu injection on Days 1, 3, 5, and 8 of Cycle 1 (28-day cycle) and Day 1 of Cycles 2-8 (21-day cycles) plus pembrolizumab 200 mg by IV infusion on Day 8 of Cycle 1 (28-day cycle) and Day 1 of each subsequent 21-day cycle. Gebasaxturev will be administered for up to 8 cycles (up to 6 months). Pembrolizumab will be administered for up to 35 cycles (up to 2 years).

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

4,582,198 Total Patients Enrolled

31 Trials studying Melanoma

9,377 Patients Enrolled for Melanoma

Merck Sharp & Dohme LLCLead Sponsor

3,888 Previous Clinical Trials

5,054,972 Total Patients Enrolled

120 Trials studying Melanoma

21,598 Patients Enrolled for Melanoma

Medical DirectorStudy DirectorMerck Sharp & Dohme LLC

2,777 Previous Clinical Trials

8,063,779 Total Patients Enrolled

35 Trials studying Melanoma

11,219 Patients Enrolled for Melanoma

Frequently Asked Questions

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

What is the official government stance on Pembrolizumab?

"While there is some data supporting its safety, pembrolizumab has not yet been proven effective and thus receives a score of 2."

Answered by AI

Do you have any data on Pembrolizumab's previous use in human trials?

"Pembrolizumab is the focus of 1000 active clinical trials, 122 of which are in Phase 3. Although most studies for Pembrolizumab originate from Houston, Texas, there are 36034 total locations running trials for this medication."

Answered by AI

Does this research currently have any available openings for participants?

"The clinicaltrials.gov website shows that this study is no longer recruiting patients, as the last update to the posting was on November 4th, 2020. However, there are 1,784 other studies that are still open for enrollment."

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

Efficacy, Safety, and Tolerability of Gebasaxturev (V937) Administered Intravenously or Intratumorally With Pembrolizumab (MK-3475) Versus Pembrolizumab Alone in Participants With Advanced/Metastatic Melanoma (V937-011)

2020. "Efficacy, Safety, and Tolerability of Gebasaxturev (V937) Administered Intravenously or Intratumorally With Pembrolizumab (MK-3475) Versus Pembrolizumab Alone in Participants With Advanced/Metastatic Melanoma (V937-011)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04152863.