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Vaccines for Advanced Melanoma (TdVax Trial)
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.
TdVax Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTdVax Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.TdVax Trial Design
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Who is running the clinical trial?
Media Library
- I am 18 years or older and have given my consent.Your hemoglobin level is 9.0 grams per deciliter or higher.I am currently on medication for an infection.I have an active tuberculosis infection.My melanoma is in the eye (uveal) or in mucous membranes.I have had treatment for melanoma that has spread, but surgery is okay.I have a visible or palpable tumor lesion that is at least 8 mm.I have brain metastases or cancer in the lining of my brain that causes symptoms.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.I am scheduled to receive PD-1 or PD-1 plus CTLA-4 therapy.I received a Td vaccine less than 30 days before starting immunotherapy.I have a history of Hepatitis B or active Hepatitis C.I have been diagnosed with HIV.You have had an allergic reaction to the IPOL or Td vaccine in the past.Your absolute neutrophil count is equal to or greater than 1500 per microliter.Your platelet count is at least 100,000 per microliter.I have had pneumonitis that needed steroids.My recent tests show my organs are functioning well.I have stable brain metastases and take no more than 10mg of prednisone daily.My melanoma has spread and is confirmed by tissue analysis.
- Group 1: IPOL Vaccine
- Group 2: Td Vaccine
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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