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Cabozantinib + Nivolumab for Endometrial Cancer
Study Summary
This trial is testing cabozantinib and nivolumab to see if they're effective in treating endometrial cancer.
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2019 Phase 2 trial • 13 Patients • NCT02315430Trial Design
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Who is running the clinical trial?
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- My cancer is in an advanced stage, has come back, or has spread from where it started.I have been diagnosed with endometrial cancer.I am 18 years old or older.I am able to care for myself and perform daily activities.You have a sufficient number of a type of white blood cell called neutrophils, with a count of at least 1500/mcL.I have received platinum-based chemotherapy before.My MS/MMR status is known and was tested using a standard method.I have tissue samples available for testing.My condition is advanced, recurrent, or metastatic endometrial cancer.I am 18 years old or older.My kidney function is within the normal range.I haven't had chemotherapy, biologic agents, or radiotherapy in the last 4 weeks.My cancer has spread to my digestive system.I had a tumor biopsy when my cancer progressed after being on Arm B of the study.I have no active cancer other than endometrial cancer.I need medication to prevent blood clots.I am still experiencing side effects from previous cancer treatments.You are currently taking part in any other research studies.I have a large pelvic mass that could lead to abnormal connections or I've had a blocked intestine.I have not received a live vaccine in the last 4 weeks.You have an autoimmune disease that needed treatment within the past two years.I do not have any severe illnesses that are not under control.I cannot swallow pills.I have not had serious bleeding issues recently.My tumor is growing into or around major blood vessels.I have not had major surgery recently.I do not have active HIV, AIDS-related illnesses, or hepatitis B/C.I have an immune system disorder or am on medication that weakens my immune system.You have a mental health condition or social situation that could make it difficult for you to follow the study requirements.You are currently pregnant or breastfeeding.I have had platinum-based chemotherapy before for my cancer.I have lung lesions with cavities.My latest treatment didn't stop my cancer from growing.I have previously received treatment targeting my immune system.My cancer is a type of endometrial carcinoma confirmed by lab tests.I can take care of myself and perform daily activities.My condition allows for a biopsy and I agree to have one.I have cancer that has spread to my brain.I am not on any strong medication that affects liver enzyme levels.You are not currently breastfeeding a baby.I have been treated with cabozantinib before.I am not allergic to cabozantinib or nivolumab.You must have a measurable tumor that can be evaluated using RECIST v1.1 criteria.My latest scans show my cancer has grown since my last treatment.
- Group 1: Arm A (cabozantinib s-malate, nivolumab)
- Group 2: Arm B (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
What is the Cabozantinib S-malate's FDA standing?
"At Power, we rate the safety of Cabozantinib S-malate as a 2. This is because it is a Phase 2 trial, meaning that while there is some data supporting its safety, there is no data yet supporting its efficacy."
Are we still able to add new participants to this research project?
"According to the latest update on clinicaltrials.gov, this particular medical trial is not currently recruiting patients. The study was first posted on 1/26/2018 but has since been updated on 11/1/2022. There are 4425 other trials that are actively recruiting right now."
How many research centers are conducting this experiment?
"There are a total of 35 hospitals and clinics running this trial, including Parkland Memorial Hospital in Dallas, University of Wisconsin Hospital and Clinics in Madison, Mayo Clinic in Arizona in Scottsdale, and 32 other locations."
Are there any other ongoing research projects that are using Cabozantinib S-malate?
"H. Lee Moffitt Cancer Center and Research Institute first studied cabozantinib S-malate in 2010 and, since then, 302 clinical trials have completed while 830 more are ongoing. A large concentration of these studies originated from Dallas, Texas."
What other trials are similar to this one?
"Cabozantinib S-malate has been studied since 2010. The earliest study was completed in 2010 and was sponsored by Medarex. Following the first trial in 2010, which involved 127 participants, Cabozantinib S-malate received its Phase 1 drug approval. Today there are 830 active studies for Cabozantinib S-malate across 2596 cities and 54 countries."
What are the medical conditions that Cabozantinib S-malate is most often used to treat?
"While malignant neoplasms is the primary condition that Cabozantinib S-malate treats, this medication can also be useful for patients with unresectable melanoma, squamous cell carcinoma, and metastatic esophageal adenocarcinoma."
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