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Checkpoint Inhibitor

Tavo + Pembrolizumab for Melanoma (Keynote-695 Trial)

Phase 2

Waitlist Available

Research Sponsored by OncoSec Medical Incorporated

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects must be refractory to anti-PD-1 monoclonal antibodies (mAb)

Received treatment of FDA-approved anti-PD1 mAb for at least 12 weeks

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 2 years

Awards & highlights

Keynote-695 Trial Summary

This trial will study the effects of a new treatment for melanoma that has progressed after treatment with pembrolizumab or nivolumab. The new treatment, tavo, will be given intratumorally (into the tumor) and intravenously (into the vein), and will be delivered using a process called electroporation.

Who is the study for?

This trial is for adults over 18 with Stage III/IV melanoma that's not removable by surgery and has worsened despite treatment with pembrolizumab or nivolumab. Participants must have tried FDA-approved anti-PD1 mAb for at least 12 weeks, have good organ function, agree to use contraception if necessary, and cannot be pregnant or breastfeeding.Check my eligibility

What is being tested?

The study tests a combination of intratumoral tavokinogene telseplasmid (tavo; pIL-12) Electroporation (EP) plus IV Pembrolizumab in patients whose melanoma progressed on prior treatments. It aims to see how well this new approach works in those who didn't respond to previous therapies.See study design

What are the potential side effects?

Possible side effects include reactions at the injection site, flu-like symptoms such as fever and fatigue, nausea, changes in blood pressure or heart rate during electroporation procedure. As with all immunotherapies, there may also be risks of immune-related adverse events.

Keynote-695 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My condition did not improve after anti-PD-1 treatment.

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I have been treated with an FDA-approved anti-PD1 medication for at least 12 weeks.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My cancer worsened within 3 months after my last anti-PD-1 treatment.

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I am a man who is either surgically sterile or willing to use contraception.

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My melanoma cannot be removed by surgery and is classified as Stage III or IV.

Keynote-695 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 2 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)

Secondary outcome measures

Duration of Response (DOR)

Immune Overall Response Rate (iORR)

Immune Progression Free Survival (iPFS)

+3 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

Pneumothorax

Malnutrition, Hypercalcemia and Weakness

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

Keynote-695 Trial Design

1Treatment groups

Experimental Treatment

Group I: tavo-EP plus IV pembrolizumabExperimental Treatment3 Interventions

Intratumoral Tavokinogene Telseplasmid (tavo, pIL 12) plus Electroporation (ImmunoPulse) in Combination with Intravenous Pembrolizumab

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2010

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

OncoSec Medical IncorporatedLead Sponsor

10 Previous Clinical Trials

218 Total Patients Enrolled

3 Trials studying Melanoma

92 Patients Enrolled for Melanoma

Merck Sharp & Dohme LLCIndustry Sponsor

3,896 Previous Clinical Trials

5,062,575 Total Patients Enrolled

120 Trials studying Melanoma

21,540 Patients Enrolled for Melanoma

Jendy SellStudy DirectorOncoSec Medical Incorporated

1 Previous Clinical Trials

65 Total Patients Enrolled

Media Library

Pembrolizumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03132675 — Phase 2

Melanoma Research Study Groups: tavo-EP plus IV pembrolizumab

Pembrolizumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03132675 — Phase 2

Melanoma Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT03132675 — Phase 2

Frequently Asked Questions

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

What are some of the most popular conditions that Pembrolizumab is used to treat?

"Pembrolizumab is a medication used to treat various conditions, such as unresectable melanoma and microsatellite instability high. It can also be prescribed after chemotherapy to help with disease progression."

Answered by AI

What are the dangers that come with taking Pembrolizumab?

"Pembrolizumab was given a score of 2 for safety. Although there is some evidence that suggests it is safe, none of the data collected supports its efficacy."

Answered by AI

Is this clinical trial taking place at multiple locations across North America?

"There are a total of 16 hospitals and medical research institutes conducting this trial. Some locations include Roswell Park Cancer Institute in Buffalo, The University of Arizona Cancer Center in Tucson, Yuma Regional Medical Center, and the Yuma Cancer Center in Yuma."

Answered by AI

Are there precedents for this type of treatment?

"There are currently 1000 trials studying the efficacy of pembrolizumab with 122 of them being phase 3 clinical trials. Pembrolizumab is being tested in many different locations, with Houston, Texas having a concentration of studies but 36034 total sites running pembrolizumab trials."

Answered by AI

Can this clinical trial still enroll new participants?

"The study, which was originally posted on October 3rd 2017 and updated February 14th of this year, is currently looking for patients to participate."

Answered by AI

How many individuals are being monitored for this research project?

"The sponsor, OncoSec Medical Incorporated, needs to enroll 152 patients that meet the study's inclusion criteria in order to begin. The trial will be conducted at multiple sites, with some located at Roswell Park Cancer Institute and The University of Arizona Cancer Center."

Answered by AI

Recent research and studies

Cancer Gene TherapyJournal

Intratumoral Dna-based Delivery of Checkpoint-inhibiting Antibodies and Interleukin 12 Triggers T Cell Infiltration and Anti-tumor Response

Jacobs, Liesl, Lidia Yshii, Steffie Junius, Nick Geukens, Adrian Liston, Kevin Hollevoet, and Paul Declerck. 2021. “Intratumoral Dna-based Delivery of Checkpoint-inhibiting Antibodies and Interleukin 12 Triggers T Cell Infiltration and Anti-tumor Response”. Cancer Gene Therapy. Springer Science and Business Media LLC. doi:10.1038/s41417-021-00403-8.

clinicaltrials.govStudy

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

2017. "Tavo and Pembrolizumab in Patients With Stage III/IV Melanoma Progressing on Either Pembrolizumab or Nivolumab Treatment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03132675.

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