← Back to Search

Vaccines for Advanced Melanoma (TdVax Trial)

Phase 1
Recruiting
Led By Georgia Beasley, MD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female participants who are at least 18 years of age on the day of signing informed consent
Participant must have at least 1 lesion that is at least 8 mm in size and is cutaneous, subcutaneous, palpable, or amenable to ultrasound guided core biopsy. The lesion chosen for biopsy can also be a target lesion but does not have to be a target lesion
Timeline
Screening 3 weeks
Treatment Varies
Follow Up informed consent through date of vaccine (est apx 4-5 months)
Awards & highlights

TdVax Trial Summary

This trial will study the safety of giving the Tetanus Diptheria Vaccine or Polio Boost Immunization to patients with metastatic melanoma who are already receiving immune checkpoint inhibitor therapy.

Who is the study for?
This trial is for adults with advanced metastatic melanoma who are about to start or are already on PD-1 therapy or combined PD-1 and anti CTLA-4 therapy. They must have at least one lesion suitable for biopsy, good organ function, and no history of certain conditions like uveal/mucosal melanoma, active pneumonitis requiring steroids, known HIV infection, recent Td vaccine receipt within 30 days before IO therapy, immunodeficiency states or systemic steroid use.Check my eligibility
What is being tested?
The study tests the safety and feasibility of giving a Tetanus Diptheria Vaccine (Td) or Polio Boost Immunization (IPOL) alongside standard immune checkpoint inhibitor therapies in patients with metastatic melanoma. It aims to see if these vaccines can boost the body's immune response when given during cycle 4 of IO therapy.See study design
What are the potential side effects?
Potential side effects from the vaccines may include local reactions at the injection site such as pain and swelling, fever, fatigue, headache and gastrointestinal symptoms. The study will also monitor any additional side effects that might occur due to combining vaccines with IO therapies.

TdVax Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years or older and have given my consent.
Select...
I have a visible or palpable tumor lesion that is at least 8 mm.
Select...
I am scheduled to receive PD-1 or PD-1 plus CTLA-4 therapy.
Select...
My melanoma has spread and is confirmed by tissue analysis.

TdVax Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~informed consent through date of vaccine (est apx 4-5 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and informed consent through date of vaccine (est apx 4-5 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 subjects out of the proposed 25 that successfully receive the vaccine after 4 cycles of IO therapy
Safety, as measured by the change in the number and severity of adverse events deemed related to the vaccine or study procedures (blood draw and biopsies)
Secondary outcome measures
Preliminary efficacy, as measured by objective response rate

TdVax Trial Design

2Treatment groups
Experimental Treatment
Group I: Td VaccineExperimental Treatment1 Intervention
The first 15 subjects enrolled will receive the Td (tetanus diphtheria) vaccine at cycle 4 of IO therapy. The Td vaccine is administered as 0.5 mL intramuscular injection in the extremity (thigh or upper arm) in closest proximity to the largest tumor.
Group II: IPOL VaccineExperimental Treatment1 Intervention
Subjects 16 through 25 will receive the IPOL (polio booster) vaccine at cycle 4 of IO therapy. The IPOL vaccine is administered as 0.5 mL intramuscular or subcutaneous injection in the extremity (thigh or upper arm) in closest proximity to the largest tumor

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,363 Previous Clinical Trials
3,420,481 Total Patients Enrolled
16 Trials studying Melanoma
401 Patients Enrolled for Melanoma
Georgia Beasley, MDPrincipal InvestigatorDuke University
1 Previous Clinical Trials
12 Total Patients Enrolled
1 Trials studying Melanoma
12 Patients Enrolled for Melanoma

Media Library

Tetanus Diptheria Vaccine Clinical Trial Eligibility Overview. Trial Name: NCT05077137 — Phase 1
Melanoma Research Study Groups: IPOL Vaccine, Td Vaccine
Melanoma Clinical Trial 2023: Tetanus Diptheria Vaccine Highlights & Side Effects. Trial Name: NCT05077137 — Phase 1
Tetanus Diptheria Vaccine 2023 Treatment Timeline for Medical Study. Trial Name: NCT05077137 — Phase 1

Frequently Asked Questions

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

What medical conditions does the Tetanus Diptheria Vaccine typically address?

"TD Vaccine is a useful tool for providing immunity to diphtheria, pertussis, and active booster immunization."

Answered by AI

Is this experiment the inaugural one of its kind?

"Presently, 25 ongoing clinical trials related to the Tetanus Diptheria Vaccine are taking place in 315 cities and 44 countries. This research was first initiated by Pharmacyclics LLC back in 2016 with a relatively small-scale Phase 2 trial involving 42 people. Over the past five years, 325 other studies have concluded as well."

Answered by AI

Are there any slots still available for volunteers in this research study?

"Correct. Records on clinicaltrials.gov demonstrate that this research endeavour, first posted on September 7th 2021, is currently looking for volunteers. The team's aim is to enrol 25 participants from a single site."

Answered by AI

Is the inoculation of Tetanus Diptheria Vaccine risk-free for subjects?

"The safety of Tetanus Diptheria Vaccine is anticipated to receive a score of 1, as this trial consists mostly in the initial stages of data collection and evaluation."

Answered by AI

What is the aggregate figure of participants in this trial?

"Yes, according to clinicaltrials.gov this study is still actively enrolling patients and has been since September 7th 2021. The last updated date was on the 8th of September 2022; 25 participants are needed from 1 medical site."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
2021. "A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05077137.
~3 spots leftby Sep 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top