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Focused Ultrasound + PD-1 Blockade for Advanced Cancers (AM-003 Trial)
AM-003 Trial Summary
This trial is testing whether Focused Ultrasound Ablation (FUSA) is safe to use with and without PD-1 blockade and with and without intratumoral poly-ICLC.
AM-003 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowAM-003 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.AM-003 Trial Design
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Who is running the clinical trial?
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- You have tried other treatments that didn't work, or you can't use standard treatments because they are not safe for you.You are 18 years old or older.You have a type of cancer that has spread and can be measured.You have tried standard treatments and they didn't work, or you can't use them because of other health reasons.You have advanced solid tumors with skin, tissue, or lymph node spread that can be reached for ultrasound and biopsy.You have HIV, or currently have Hepatitis B or C, unless there are some special circumstances.You have an ongoing infection that needs treatment with medication throughout your body.You have severe heart disease categorized as Class III or IV by the New York Heart Association.You have a history of autoimmune disorders that needed strong medication to treat, or your autoimmune disorder affected your internal organs.You have had another type of cancer in the past, with some exceptions.For Cohort 2, if you have tried all the approved treatments that are known to work for your condition and they didn't help or you couldn't tolerate them, then you can participate in the primary treatment for Cohort 2.You are able to perform daily activities without any major issues.You have received a specific treatment called polyICLC within the past 4 weeks, unless there are special circumstances.For the first group of patients, you have an advanced solid cancer that can be treated with a specific type of medication and have tumors that can be treated with focused ultrasound. If you have uveal melanoma, you cannot participate in this group.You have a type of cancer that can be treated with a specific type of medication, and your tumor can be treated with focused ultrasound.If you have cancer that has gotten worse while on a specific type of treatment, but your doctor thinks it's best for you to continue with that treatment, then you may still be able to join this study. This could apply if you have some new small areas of cancer growth, or if your cancer has only slightly grown in multiple areas and there are no other treatment options available for you. If you have cancer that has gotten worse after a certain type of treatment, you may still be able to join this study if you have some areas of cancer that can't be removed and can be treated with a specific type of therapy.The area we want to study must be visible and meet certain requirements when seen using ultrasound.You have a type of cancer that has spread and can be measured.You are 18 years old or older.If your condition has not worsened after 12 weeks of treatment with PD1/PDL1 therapy, you may still be eligible for this trial. Your doctor may recommend continuing PD1/PDL1 therapy even if you are not on this trial.
- Group 1: Cohort 1, primary regimen (Regimen 1a)
- Group 2: Cohort 1, secondary regimen (Regimen 2a)
- Group 3: Cohort 2, primary regimen (Regimen 1b)
- Group 4: Cohort 2, secondary regimen (Regimen 2b)
- 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 openings still available for this clinical experimentation?
"Affirmative. According to clinicaltrials.gov, this research endeavour was initially posted on November 21st 2019 and most recently revised on June 23rd 2022. The study is currently in search of 32 participants from a single site."
What potential risks do patients face when using Echopulse?
"The safety of Echopulse has been assessed as a 1, due to the minimal clinical data demonstrating its efficacy and security in this Phase One trial."
What maladies does Echopulse typically address?
"Echopulse is often used to address scalp structure issues, but it can also be utilized to treat condylomata acuminata, facial features and superficial basal cell carcinoma."
What is the current number of participants in this research project?
"Affirmative, the information located on ClinicalTrials.gov points to this trial actively seeking participants since first posted in November 2019 and last updated June 2022; with an aim of enrolling 32 individuals from one site."
Is there previous research that has utilized Echopulse technology?
"Currently, 21 trials are being conducted on Echopulse, 5 of which are in the third and final stage. Most locations for such studies can be found in Houston, Texas; however, 84 sites worldwide have been approved to run these experiments."
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