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Nivolumab + Ipilimumab for Cancer
Study Summary
This trial is testing a combination of two immunotherapy drugs to see if they're more effective than either drug alone in treating HIV-associated classical Hodgkin lymphoma or solid tumors.
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 do not have pancreatitis.You have tested positive for HIV-1 infection using an approved test or have medical records confirming the presence of HIV.Your hemoglobin level must be 9 grams per deciliter or higher within 2 weeks before joining the study, if you are not in the Hodgkin lymphoma expansion group.I am mostly active and can care for myself.My hemoglobin level is at least 9 g/dL, or it's lower due to Hodgkin lymphoma in my bone marrow.My bilirubin levels are within the required range for the study.My blood tests for lipase and amylase are below 1.5 times the upper limit.My kidney function is within the required range for the Hodgkin Lymphoma study.My HIV viral load is undetectable or very low.My bilirubin levels are within the normal range, or slightly higher if I have Gilbert's disease.My white blood cell count is within the required range for the Hodgkin Lymphoma study.My white blood cell count is at least 1,000, unless it's low because of my lymphoma.I haven't taken experimental drugs in the last 4 weeks and haven't had full-body radiation, but limited radiation might be okay if certain conditions are met. My brain cancer has been treated, with no signs of worsening in the last month.I am not on high-dose steroids or other strong immune system drugs.My cancer has spread, cannot be surgically removed, and standard treatments have failed.I have HIV-related Hodgkin lymphoma that has not improved after at least one treatment.I have a tumor or lesion that can be measured and was scanned within the last 4 weeks.I had treatment for metastatic disease, but it's been over 4 weeks since my last session.Your platelet count is at least 75,000 per cubic millimeter within 2 weeks before joining the study.Your neutrophil count is at least 1,000 per cubic millimeter of blood within 2 weeks before joining the study.Your white blood cell count is at least 2,000 cells per cubic millimeter within 2 weeks before joining the study.I am older than 18 years.Your kidney function is good, with a creatinine level below 1.5 times the upper limit of normal, or a creatinine clearance above 50 ml/min, as measured within 2 weeks before joining the study.I have not been treated with drugs targeting immune checkpoints and have no active autoimmune diseases.My platelet count is at least 75,000/mm^3 or low due to my lymphoma.Your blood test showed that you have enough protein called albumin in your blood.Your blood tests for lipase and amylase levels must be within a certain range before you can join the study.My cancer type is not excluded from the trial based on its response to nivolumab.My liver function tests are within the required range for the Hodgkin Lymphoma study.I am allergic to certain medications similar to ipilimumab or nivolumab.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.Your liver function tests should be within a certain range before you can participate in the study.
- Group 1: Treatment (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
What is the geographic distribution of medical institutions currently conducting this trial?
"Currently, this clinical trial is being conducted across 24 sites. Notably, the cities of Columbus, La Jolla and Bronx are all hosting study locations; other locations are available as well. If a participant chooses to enroll in the trial they should select the closest location to minimize travel requirements."
What medical conditions is Ipilimumab typically employed to address?
"Typically, ipilimumab is given to patients after they have not responded well to anti-angiogenic therapy. It can also be used for conditions such as malignant neoplasms and cancerous melanomas or squamous cell carcinoma."
How many participants are currently enrolled in this experiment?
"Affirmative. Details hosted on clinicaltrials.gov demonstrate that this trial is actively searching for recruits, having been posted on August 27th 2015 and most recently updated November 29th 2022. 96 individuals are required at 24 different medical sites."
Are there any additional research projects that have been conducted regarding Ipilimumab?
"In 2009, ipilimumab was first studied at Texas Children's Hospital. This drug has since been employed in 365 completed trials and is currently being tested through 764 active clinical studies; many of these experiments are located in Columbus, Ohio."
To what degree can Ipilimumab be relied upon to protect patients?
"The safety of Ipilimumab was scored 1 out of 3 due to the fact that this is a Phase 1 clinical trial, indicating that there are limited data points confirming both its efficacy and safety."
May individuals still apply to participate in the experiment?
"The clinical trial in question is open to applicants, as indicated by data hosted on the clinicaltrials.gov website. This research project was posted online initially on August 27th 2015 and has seen its most recent update occur November 29th 2022."
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