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Ipilimumab + Nivolumab for Melanoma
Study Summary
This trial will help determine if two doses of the combination of ipilimumab and nivolumab is sufficient for patients with early benefit, compared to the usual way of trying to give four doses.
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 2021 Phase 3 trial • 1844 Patients • NCT03068455Trial Design
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Who is running the clinical trial?
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- I don't have another cancer that needs treatment or affects melanoma tests.My melanoma cannot be removed by surgery and is stage III or IV.I haven't received CTLA-4 or PD-1/PD-L1 therapy for my metastatic disease.My blood tests meet the required levels, and I am 18 or older.I use two birth control methods and will continue for 23 weeks after my last treatment dose.I am able to understand and follow the study's requirements.You are expected to live for at least 4 months.I do not have any serious illnesses like infections needing antibiotics or bleeding disorders.I am fully active or can carry out light work.I am not on high-dose steroids or immunosuppressants due to an autoimmune disease.I do not have active HIV, Hepatitis B, or C infections.I have a history of autoimmune motor neuropathy.Women who are pregnant or breastfeeding cannot participate in the study.I have at least one tumor outside the brain that can't be removed surgically and can be measured on scans.
- Group 1: ipilimumab and 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
Are there any analogous trials with ipilimumab previously conducted?
"As of now, 765 studies are currently investigating ipilimumab with 86 trials in their final stage. Although many medical centres based in Pittsburgh, Pennsylvania have conducted research on this drug, there exist 42707 other locations devoted to its clinical trial."
To what extent is this medical research being conducted in North America?
"This medical trial is actively enrolling patients at Lehigh Valley Health Network in Allentown, Pennsylvania, Hartford Healthcare Cancer Institute @ Hartford Hospital in Hartford, Connecticut and Memoral Sloan Kettering Basking Ridge in Basking Ridge, New york. An additional 12 sites are also available for data collection."
For what health concerns is ipilimumab usually prescribed?
"Ipilimumab can be employed to ameliorate the effects of previous angiogenic therapy, malignant growths, and inoperable melanoma."
What is the current scale of this medical trial’s cohort?
"This trial is not presently seeking new participants. It was initially listed on April 17th 2017, and last updated on March 10th 2022. Should you wish to explore alternative studies, there are 765 trials that accept metastatic melanoma patients and an additional 765 clinical trials involving ipilimumab currently recruiting individuals."
Are new participants being recruited for this investigation?
"This trial is not actively accepting patients at this point in time. The posting date was April 17th, 2017 and it has been revised as recently as March 10th 2022. Other relevant studies include 765 trails for metastatic melanoma and an additional 765 trials recruiting participants who wish to utilize ipilimumab treatment."
Is ipilimumab deemed a secure treatment option for individuals?
"The safety of ipilimumab is rated 2 on our team's rating scale as it has progressed to Phase 2 clinical trials, showcasing some evidence for its safety but none pertaining to efficacy."
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