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Virus Therapy

Pembrolizumab for Cancer

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 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
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Pneumothorax
5%
Malnutrition, Hypercalcemia and Weakness
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
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

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,937 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,908 Previous Clinical Trials
5,066,612 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,790 Previous Clinical Trials
8,067,574 Total Patients Enrolled
~16 spots leftby Jun 2025
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