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Talazoparib + Avelumab for Kidney Cancer
Study Summary
This trial will test whether combining avelumab with talazoparib can effectively treat metastatic renal cell carcinoma.
- Renal Cell Carcinoma
- Kidney Cancer
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.Trial Design
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Who is running the clinical trial?
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- You have a specific genetic alteration called VHL, which can be identified through a special genetic testing method.You have recovered from any side effects from previous treatments and they are now mild or gone.Your kidneys work well enough, with a filtration rate of at least 30 milliliters per minute.You have difficulty swallowing capsules, are allergic to talazoparib, have trouble absorbing nutrients from food, or have a condition that affects how your body absorbs things from your intestines.You have had a serious blood vessel disease within 6 months before starting the treatment.You can do regular daily activities without limitations or with a little limitation due to your health condition.You have a disease that can be measured using a specific method called RECIST v1.1.You have brain metastasis or leptomeningeal disease that is causing symptoms and requires steroid medication.You are currently taking or planning to take strong P-gp inhibitor medicines within 7 days before starting the study or during the study.Your medical images show that your condition has gotten worse after trying certain medications.You stopped a certain type of treatment because it caused a bad reaction from your immune system.You were diagnosed with a specific type of blood disorder or another type of cancer that required treatment in the last 24 months.You have a bleeding disorder or unexplained blood clotting problem.You are experiencing symptoms of a blockage in your digestive system.You have not managed your body's buildup of fluid well.You are taking medications that weaken your immune system, except in certain situations.You have an autoimmune disease that could get worse with this treatment.You have been diagnosed with HIV/AIDS before.You have a history of hepatitis C virus (HCV) infection or hepatitis B virus (HBV) infection.Your liver function tests should show normal levels of total bilirubin, AST, and ALT, unless you have liver metastasis, in which case slightly higher levels may be acceptable.Your blood counts need to be at a certain level, and you should not have received a blood transfusion within the last 21 days before starting the trial.You have been diagnosed with kidney cancer or a specific type of kidney cancer, and your diagnosis has been confirmed by a review from Memorial Sloan Kettering Cancer Center if your surgery and biopsy were done at a different hospital.You have already been treated with talazoparib or other drugs that work like PARP inhibitors.Patients with FH or SDH-related cancers must show loss of FH or SDH expression through specific tests approved by the state for Cohort 2.You need to have a confirmed diagnosis of Renal Medullary Carcinoma.You have received other cancer treatments within the last 21 days or within five times the length of time it takes for the treatment to leave your body.You have received an organ or stem cell transplant from another person in the past.You have a serious infection that needs intravenous antibiotics.You are allergic to talazoparib or avelumab, or any ingredients in the medications.You had radiation treatment less than 2 weeks before starting the study.
- Group 1: Talazoparib and Avelumab (VHL-deficiency) (Closed to Accrual)
- Group 2: Talazoparib and Avelumab (FH- or SDH-deficiency)
- 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 multiple locations in the city administering this clinical investigation?
"Seven distinct medical centres are currently recruiting for this trial, with Memorial Sloan Kettering Westchester in Harrison having all protocol activities and both Memorial Sloan Kettering Bergen in Montvale and Memorial Sloan Kettering Monmouth in Middletown hosting limited protocol activities. Additional sites have been identified as well."
How many participants is this experiment recruiting?
"Affirmative. Clinicaltrials.gov hosts information that indicates the current recruitment of 44 patients from 7 medical centres for this trial, first posted on August 22nd 2019 and recently updated on December 21st 2021."
Are there still openings for participation in this experiment?
"Published on clinicaltrials.gov, this medical experiment is actively seeking participants. It was initially shared on August 22nd 2019 and recently updated December 21st 2021."
What health conditions is Avelumab typically administered to address?
"Avelumab is typically prescribed for treating advanced medical cases. This medication can also reduce the symptoms of brca1 gene, merkel cell carcinoma, and malignant neoplasms."
What prior experiments have included Avelumab as a key element?
"Currently, 162 trials for Avelumab are in progress with 12 at the Phase 3 level. Though most of these tests take place near Boston, Massachusetts, 5461 sites worldwide provide testing services."
Can you evaluate the security of utilizing Avelumab?
"There is preliminary evidence suggesting the safety of avelumab, thus it was given an estimated score of 2. This Phase 2 trial lacks data to prove efficacy."
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