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MG1-MAGEA3 With Ad-MAGEA3 and Pembrolizumab in Patients With Previously Treated Metastatic Melanoma or Cutaneous Squamous Cell Carcinoma

NCT03773744 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2021-04-06

No results posted yet for this study

Summary

This is a Phase 1b open-label dose escalation trial of Ad/MG1-MAGEA3 and Pembrolizumab in patients with Metastatic Melanoma or Cutaneous Squamous Cell Skin Cancer that has failed prior standard of care treatments. Upon determination of a Maximum Tolerated Dose (MTD) or Maximum Feasible Dose (MFD) the study will be expanded into up to 24 additional Metastatic Melanoma patients.

Conditions

Interventions

DRUG

Ad-MAGEA3

Adenovirus vaccine expressing Melanoma-associated antigen 3 (MAGEA3), a tumor antigen

DRUG

MG1-MAGEA3

MG1 Maraba oncolytic virus expressing Melanoma-associated antigen 3 (MAGEA3), a tumor antigen

DRUG

Pembrolizumab

monoclonal antibody; checkpoint inhibitor of PD1

DRUG

Cyclophosphamide

low-dose chemotherapy

Sponsors & Collaborators

  • Turnstone Biologics, Corp.

    lead INDUSTRY

Principal Investigators

  • Steve Bernstein, MD · Turnstone Biologics

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-15
Primary Completion
2020-10-30
Completion
2021-12-31
FDA Drug
Yes

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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 NCT03773744 on ClinicalTrials.gov