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APX005M + Pembrolizumab for Melanoma
Study Summary
This trial is for patients with metastatic melanoma who have not previously been treated with immunotherapy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 1 & 2 trial • 140 Patients • NCT03123783Trial Design
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Who is running the clinical trial?
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- I have not had a blood clot in an artery in the last 3 months.I've only had certain skin cancers, in-situ cervical cancer, non-anaplastic thyroid cancer, or have been cancer-free for 2 years.I agree to use effective birth control during and for 4 months after the study.You have a condition that weakens your immune system.I have at least two melanoma lesions that can be injected, each larger than 10 mm.I am 18 years old or older.I am fully active or can carry out light work.Your hemoglobin level is higher than 9 grams per deciliter.I have received experimental vaccines or immune therapies.My melanoma diagnosis comes from skin or mucosal areas, not the eye.Your white blood cell count is higher than 3000 per cubic millimeter.I am on medication for an active autoimmune disease.My cancer is at an advanced stage and cannot be removed by surgery.I haven't had cancer treatment or surgery in the last 28 days, except for certain palliative care.I have had pembrolizumab or PD-1/L1 therapy, but it's been 6 months since my last dose.I have previously received treatments like anti-PD-1 or anti-PD-L1.Your platelet count is at least 100,000 per cubic millimeter.I am a woman who can become pregnant, am pregnant, or am nursing.Your liver enzymes (ALT and AST) are within a certain range, and if your liver is affected by the tumor, they are within a slightly higher range.Your absolute neutrophil count (ANC) is at least 1500 per cubic millimeter.My brain metastases are treated, stable, and I have no symptoms.I am taking more than 7.5 mg/day of prednisone or its equivalent.You do not have HIV antibodies in your blood.Your total bilirubin level should be less than 2.0 mg/dl, unless you have Gilbert's Syndrome, in which case it should be less than 3.0 mg/dl.I do not have any serious infections.You have a blood clotting problem that is currently active.I have severe heart failure or had a heart attack in the last 6 months.Your blood creatinine level is less than or equal to 2.0 mg/dl.I have a history of blood cancer.
- Group 1: APX005M + Pembrolizumab
- 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
Could you provide a synopsis of other research done involving APX005M?
"Presently, there are 967 ongoing clinical trials exploring APX005M with 122 of them in the late phase. Houston has a notable presence among the 35761 locations running studies for this drug, but it is not limited to that city alone."
Are any medical facilities currently enrolling participants for this clinical research?
"Affirmative. Information hosted on clinicaltrials.gov verifies that this medical study is actively looking for subjects to enrol in the trial. The initial posting date was June 2nd 2017 and the last edit was made September 22nd 2022, with a need of 41 participants from one site being advertised."
What is the current enrollment figure for this research study?
"Affirmative. According to the records from clinicaltrials.gov, this investigation is still actively recruiting patients and was first made available on June 2nd 2017. The trial seeks a total of 41 participants across one medical centre for enrollment."
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