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Nivolumab + Ipilimumab for Uterine Leiomyosarcoma
This trial studies nivolumab and ipilimumab as possible treatments for uterine cancer. Nivolumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Ipilimumab is also a monoclonal antibody. The combination of nivolumab and ipilimumab may work better than nivolumab alone in treating patients with uterine cancer.
- Metastatic Leiomyosarcoma
- Uterine Leiomyosarcoma
Inclusion CriteriaYou will be eligible if you check “Yes” for the criteria below
Study ObjectivesOutcome measures can provide a clearer picture of what you can expect from a treatment.
Side effects dataFrom 2022 Phase 3 trial • 541 Patients • NCT02041533
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- Your AST and ALT levels in your blood are not more than 2.5 times the upper limit of normal. If you have liver metastases, your AST and ALT levels should not be more than 5 times the upper limit of normal.You are expected to live for at least 9 more months.Your kidneys are working well enough, with normal levels of creatinine in your blood or a high enough creatinine clearance rate.You have been diagnosed with advanced leiomyosarcoma of the uterus (ULMS), which means it has spread to other parts of your body or cannot be surgically removed.You cannot have had chemotherapy or radiation treatment within the past month (or 6 weeks for certain types of chemotherapy). You must also have fully recovered from any side effects caused by medication given more than 3 weeks ago. If you have had radiation treatment in the pelvic area, you must show that there is no inflammation or toxicity in your bowels. You may have limited radiation therapy if certain criteria are met.You have had recent digestive problems such as diverticulitis, abscess, blockage, or abnormal tissue growth in your abdomen. Your doctor will check if you need more treatment before joining the study.The study is only for people who are expected to live longer than 9 months.You may still participate in the study if you have vitiligo, type 1 diabetes mellitus, mild hypothyroidism that is managed with hormone replacement, or psoriasis that does not require systemic treatment. However, if you have a medical condition that is not expected to come back unless triggered by an external event, you may not be able to enroll in the study.Your platelet count is greater than or equal to 100,000 per microliter.You have a tumor that can be measured and is at least 2 centimeters using standard techniques or 1 centimeter using advanced imaging methods.You must have already undergone at least one round of chemotherapy for ULMS, either as a treatment after surgery or for a recurring case.You should be able to perform daily activities without being restricted due to your medical condition.You have enough white blood cells called neutrophils in your body, specifically at least 1,500 per microliter of blood.Your total bilirubin level cannot be higher than 1.5 times the normal limit, except if you have Gilbert syndrome, in which case it cannot be higher than 3.0 mg/dL.You are currently taking part in another research study.You cannot have had certain types of treatments before, including drugs that target T-cell co-stimulation or immune checkpoint pathways.
- Group 1: Cohort A (nivolumab - closed to accrual on 21-Oct-2015)
- Group 2: Cohort B (nivolumab and 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
How does Nivolumab compare in terms of safety for human usage?
"Nivolumab was assessed to have a safety rating of 2; this is due to the fact that it has not yet been proven efficacious, but there are some data points which support its relative security."
Is this research venture currently open for enrollment?
"As per the information on clinicaltrials.gov, this particular trial has ended its recruitment process. It was first advertised on April 22nd 2015 and last updated October 18th 2022; however, 806 other studies are currently looking for patients to enrol in them."
How many participants is this trial enlisting?
"The recruitment phase for this trial has officially been closed. The posting was first uploaded on April 22nd 2015, with the last update occurring 18th October 2022. For those looking to participate in other studies related Nivolumab and leiomyosarcoma, 41 trials and 765 studies respectively are currently enrolling patients."
Has Nivolumab been evaluated in any previous research projects?
"As of now, 765 different trials are assessing the efficacy and safety of Nivolumab with 86 at Phase 3. Whilst much research is conducted in Pittsburgh, Pennsylvania there are a vast number of medical centres (42755) running studies for this treatment."
What health conditions is Nivolumab typically utilized to address?
"Nivolumab is the most commonly utilized therapy for anti-angiogenic conditions. This immunotherapy can also be beneficial with regards to malignant neoplasms, unresectable melanomas, and squamous cell carcinomas immunotherapy can also be beneficial with regards to malignant neoplasms, unresectable melanomas, and squamous cell carcinoma."
What aims are researchers hoping to accomplish with this clinical experiment?
"This trial's primary outcome is to be monitored for up to 100 days and involves determining the Objective Response Per RECIST 1.1 among ULMS patients treated with Nivolumab and Ipilimumab (Cohort B). Secondary objectives include calculating toxicity levels using NCI Common Terminology Criteria, exploring PDL1 status in relation to treatment response through a Fisher's exact test, and examining progression-free survival rate at 12 weeks via an one-sided exact binomial distribution test set at 10% type I error. With 25 participants enrolled, power of overall progression-free rate is estimated at 87%."
Who else is applying?
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