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Tavo and Pembrolizumab in Patients With Stage III/IV Melanoma Progressing on Either Pembrolizumab or Nivolumab Treatment

NCT03132675 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 143

Last updated 2023-03-27

No results posted yet for this study

Summary

Keynote 695 is Phase 2 study of intratumoral tavokinogene telseplasmid (tavo; pIL-12) Electroporation (EP) plus IV Pembrolizumab. Eligible patients will be those with pathological diagnosis of unresectable or metastatic melanoma who are progressing or have progressed on either pembrolizumab or nivolumab.

Conditions

  • Stage III/IV Melanoma

Interventions

BIOLOGICAL

tavokinogene telseplasmid

Intratumoral tavokinogene telseplasmid (tavo, pIL-12) delivered by electroporation every 6 weeks

BIOLOGICAL

Pembrolizumab

Intravenous 3 weekly treatments

DEVICE

ImmunoPulse

Device that electroporates the tavokinogene telseplasmid

Sponsors & Collaborators

Principal Investigators

  • Bridget O'Keeffe, PhD · OncoSec Medical Incorporated

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-03
Primary Completion
2023-03-31
Completion
2024-07-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States
  • Australia
  • Canada
  • Italy
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs
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 NCT03132675 on ClinicalTrials.gov