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A Study of Intratumoral/Intralesional Administration of V938 in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic or Recurrent Malignancies (V938-001)

NCT04135352 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2024-11-12

Study results available
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Summary

The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics, and V938 shedding in participants with advanced/metastatic or recurrent malignancies who receive V938 in combination with pembrolizumab (MK-3475). The primary objective is to determine the safety and tolerability and to identify a recommended Phase 2 dose (RP2D) of V938 administered in combination with pembrolizumab.

Conditions

  • Neoplasm Metastasis

Interventions

DRUG

200 mg of pembrolizumab

Participants receive 200 mg of pembrolizumab intravenously Q3W for a maximum of 35 21-day cycles.

BIOLOGICAL

V938

Participants receive V938 intratumorally in cycles 1-7. Each cycle is 21 days.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-04
Primary Completion
2022-08-24
Completion
2022-08-24
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Israel

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04135352 on ClinicalTrials.gov