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Eftilagimod Alpha + Pembrolizumab for Head and Neck Cancer (TACTI-003 Trial)
TACTI-003 Trial Summary
This trial is testing a new drug combination to see if it is more effective than just one of the drugs alone, for people with a certain type of cancer.
TACTI-003 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTACTI-003 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.TACTI-003 Trial Design
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Who is running the clinical trial?
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- My cancer has been tested for PD-L1 using an FDA-approved method.My head or neck cancer has returned or spread and cannot be cured with treatment.I have previously been treated with specific immune system targeting drugs.I can carry out all my daily activities without help.I have stable brain metastases and haven't needed steroids for 14 days.I have had at least one treatment for my cancer after it came back or spread, but not within the last 6 months if it was part of a combined treatment approach for advanced but not spread cancer.I can provide a tissue sample for HPV testing for my throat cancer.My condition can be treated with the goal of curing it.My cancer is in the head or neck but not in areas the study specifies.I am not on high doses of steroids or other immune-weakening medicines.I can provide a tissue sample for PD-L1 testing.I haven't had cancer treatment or been in a trial for new treatments in the last 4 weeks.My head or neck cancer worsened within 6 months after treatment meant to cure it.
- Group 1: (CPS ≥1): Pembro + Efti
- Group 2: (CPS <1): Pembro + Efti
- Group 3: (CPS ≥1): Pembro
- 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
Are there any patients who can still participate in this research?
"Yes, according to the latest information from clinicaltrials.gov, this trial is still looking for patients. The original posting was on 8/27/2021, and it has been updated as recently as 9/15/2022. They are hoping to enroll 154 participants at 3 locations."
Pembrolizumab has caused serious side effects in some people, correct?
"Pembrolizumab's efficacy has not been clinically proven, but it did receive a score of 2 due to data supporting its safety profile."
What other scientific papers involving Pembrolizumab have been published?
"City of Hope first studied pembrolizumab in 2010 and, since then, 253 similar trials have completed. As of now, there are 1002 ongoing clinical trials--a majority of which are based in Birmingham, Alabama."
How many people fit the criteria to participate in this clinical trial?
"The listing on clinicaltrials.gov does show that this research is looking for participants. According to the site, the trial was first posted on 8/27/2021 and updated on 9/15/2022. They need 154 individuals from 3 different locations."
For what sorts of medical conditions is Pembrolizumab generally prescribed?
"Pembrolizumab is most often administered to patients with malignant neoplasms. It can also help those suffering from unresectable melanoma, microsatellite instability high, and disease progression after chemotherapy."
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