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Nivolumab +/- Ipilimumab for Anal Cancer
Study Summary
This trial is testing nivolumab with or without ipilimumab to see if it can treat anal canal cancer that has not responded to other treatments and has spread to other parts of the body.
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 2022 Phase 3 trial • 541 Patients • NCT02041533Trial Design
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Who is running the clinical trial?
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- My cancer can be measured by scans and was checked within the last 28 days.I haven't taken high-dose steroids or immunosuppressants in the last 14 days.I am fully active or have some restrictions but can still care for myself.I have had at least one treatment for advanced anal cancer that cannot be cured.My brain metastases have been treated and stable for over 3 months.I have previously been treated with specific immunotherapy drugs.My cancer is a type of anal cancer that has spread and was previously treated.My cancer can be measured by scans and I've had these scans within the last 28 days.I have an autoimmune disease that could come back or affects my organs.I have no cancer history except for certain skin cancers, early-stage cancers in remission, or any cancer I've been free from for 3+ years.I am 18 years old or older.I am fully active or able to carry out light work.I am HIV positive with a good immune status, undetectable virus, and on HAART.I am 18 years old or older.I agree to heart function tests due to my heart condition or past strong medication use.I've had at least one treatment for advanced anal cancer and waited the required time before starting a new treatment.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.You are currently taking any experimental drugs for other studies.I have had treatment for metastatic anal canal cancer before.My kidney function, measured by creatinine levels or clearance, is within the required range.You have enough infection-fighting white blood cells (neutrophils) in your body (at least 1,500/mcL).You have a healthy amount of white blood cells, which should be at least 2,000 per microliter.I haven't had chemotherapy or radiotherapy in the last 4 weeks and have recovered from any side effects.Your hemoglobin level is at least 9.0 grams per deciliter.Your bilirubin levels should not be higher than 1.5 times the normal limit, but if you have Gilbert syndrome, it can be up to 3.0 mg/dL.I agree to use birth control for 5 months (if woman) or 7 months (if man) after the last treatment dose.Your platelet count should be at least 100,000 per microliter.
- Group 1: Part A (nivolumab)
- Group 2: Part B Arm I (nivolumab)
- Group 3: Part B Arm II (nivolumab, ipilimumab)
- 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 accepting participants?
"Contrary to popular belief, this experiment is not seeking out subjects as of now. The initial posting was on May 1st 2015 and the latest update occurred October 18th 2022. Although recruitment for this medical trial has been suspended, there are 3349 other trials actively looking for volunteers."
Has the Food and Drug Administration sanctioned Nivolumab for therapeutic use?
"Our internal research team at Power assigned nivolumab a score of 2, as this is only in its second phase of testing and there are indications that the treatment may be safe but no evidence yet to confirm efficacy."
Are there numerous venues executing this investigation in Canada?
"For this medical trial, potential participants can register at Wayne State University/Karmanos Cancer Institute in Detroit (MI), M D Anderson Cancer Center in Houston (TX), Smilow Cancer Hospital Care Center - Guiford in Guilford (CT) and 46 other locations."
What other research endeavors have been conducted regarding Nivolumab?
"Currently, there are 765 ongoing studies of Nivolumab with 86 in the most advanced Phase 3. Conveniently for those living nearby, Pittsburgh is a hub for this research; however, trials can be found at 42708 sites around the globe."
What is the central goal of this clinical experiment?
"The primary endpoint of this clinical trial, which will be monitored over a two year period, is Progression-free survival (PFS). Secondary objectives measure the number and severity of adverse events by observing patients' responses to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0., Grade 3/4/5 adverse event incidences according to CTCAE v.5.0, and overall response rates based on CT scans or magnetic resonance imaging in accordance with RECIST 1.1 criteria; complete remission requires disappearance all target lesions and any pathological lymph nodes reduction under 10 mm (< 1 cm), partial remission demands a"
What is the current size of the population enrolled in this experiment?
"This trial is no longer soliciting patients. Initially posted on May 1st 2015 and last revised October 18th 2022, it has since been supplanted by other research initiatives. As of now, there are 2584 clinical studies actively enrolling participants with carcinoma and 765 trials for Nivolumab recruiting volunteers."
To what illnesses is Nivolumab typically prescribed?
"Nivolumab, a popular drug for cancer treatments and countering the effects of anti-angiogenic therapy, is frequently prescribed to combat malignant neoplasms, irresectable melanomas and squamous cell carcinoma."
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