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Triple Drug Therapy for Melanoma
Study Summary
This trial is testing a new combination of drugs to treat metastatic melanoma that has stopped responding to other treatments.
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 2017 Phase 3 trial • 1289 Patients • NCT01285609Trial Design
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Who is running the clinical trial?
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- I am 18 years old or older.If you can have children, you need to have a negative pregnancy test before starting the study medication and every 4 weeks while on treatment.I have lung lesions or disease in my airways.I have had a solid organ or stem cell transplant.I have a muscle disorder that could increase my CK levels.My cancer spread while on or after anti-PD-1/PD-L1 therapy.I haven't had any major abdominal issues like fistulas or obstructions in the last 6 months.I have been treated with drugs targeting PD-1 or PD-L1.I have a serious wound, ulcer, or bone fracture that is not healing.I have a tumor affecting my digestive system or have had recent serious digestive issues.I don't have brain metastases or leptomeningeal carcinomatosis, or if I do, they meet certain conditions.My cancer progressed after anti-PD-1/PD-L1 therapy, confirmed 4 weeks post first signs.I am fully active and can carry on all my pre-disease activities without restriction.My melanoma has spread to the lining of my brain and spinal cord.I have recovered from previous treatment side effects, or they are minor and stable.My recent tests show my organs and bone marrow are functioning well.I have not had significant bleeding in the last 3 months.You have a current or suspected autoimmune disease.I haven't taken steroids or immunosuppressants in the last 14 days.My liver is not working well.You have HIV, hepatitis B, or hepatitis C infection.I have not received a live vaccine in the last 30 days.I have been treated with a VEGF(R) inhibitor, with or without immune checkpoint inhibitors.I haven't had any cancer treatment in the last 2 weeks.I haven't had cancer within the last 3 years, except for certain types.I have not had a stroke or blood clot in the last 6 months.My skin cancer has been confirmed to have spread.Your heart's electrical system shows a specific abnormality on a recent test.I have been treated with an anti-CTLA-4 antibody before.I have heart problems or diseases.I require dialysis.I have a history of specific lung conditions or signs of lung inflammation on a CT scan.You have a disease that can be measured according to specific criteria.I have not had major surgery in the last 3 weeks or minor surgery in the last 10 days.My heart is healthy according to specific tests.I am currently taking blood thinners.I do not have stomach or bowel problems that affect how I absorb medication.I haven't had radiation for bone metastases in 2 weeks, other radiation in 4 weeks, or radionuclide treatment in 6 weeks.I may or may not have been treated with BRAF/MEK inhibitors before.My cancer is affecting major blood vessels.
- Group 1: Cabozantinib + Ipilimumab + Nivolumab
- 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
Is this experiment currently enrolling participants?
"Affirmative. Per the information stored on clinicaltrials.gov, this research endeavour is actively recruiting participants. Beginning June 8th 2022, it has been in search of 41 volunteers from a single site."
How many participants can join this trial at its fullest capacity?
"Affirmative, clinicaltrials.gov supports the active recruitment for this trial which was published on June 8th 2022 and most recently updated on that same day. Across a solitary medical centre, 41 patients are sought to participate in this study."
Has the FDA certified Ipilimumab for therapeutic use?
"Due to the lack of clinical data confirming its efficacy, Ipilimumab was assigned a safety score 2 on Power's scale. It has been tested in Phase 2 trials, which have provided some evidence for its security."
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