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Guadecitabine + Durvalumab for Kidney Cancer
Study Summary
This trial is testing a new cancer treatment combining two drugs, given to patients who have had one or no previous treatments. The study will last up to 52 weeks.
- Clear Cell Renal Cell Carcinoma
- Kidney Cancer
- Renal Cell Carcinoma
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 3 trial • 417 Patients • NCT02907359Trial Design
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Who is running the clinical trial?
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- You are still experiencing moderate or severe side effects from previous cancer treatments, except for hair loss, skin discoloration, and specific lab test results mentioned in the inclusion criteria.You have received an organ transplant and are taking medicines to lower your immune system.You weigh more than 30 kilograms.You have an ongoing infection that needs to be treated with medication throughout your body.You have taken medication that weakens your immune system in the past 28 days before starting durvalumab.You have a current infection like tuberculosis, hepatitis B, hepatitis C, or HIV.Women who could become pregnant must have a negative pregnancy test within 28 days before joining the study.You weigh less than 30 kilograms.You have a history of lung disease that needed treatment with steroids.You have cancer that has spread to your brain or is pressing on your spinal cord.You had another type of cancer in the past, but it was treated and there is a low chance of it coming back. Skin cancers that were treated successfully are okay.You have had a documented autoimmune or inflammatory disorder in the past 3 years.You have a serious illness that is not under control, such as an ongoing infection, heart problems, or lung disease.You have a history of cancer spreading to the tissues surrounding the brain and spinal cord.You have a known allergic reaction to the study drugs or similar types of medications.Your heart's electrical activity is measured and if the result is higher than 470 milliseconds, you may not be able to participate in the study.You have been diagnosed with clear cell renal cell carcinoma and have evidence of the cancer spreading to other parts of the body.You need to have a tumor that is at least 10 millimeters in size and can be accurately measured by CT or MRI. If it's in a lymph node, it needs to be at least 15 millimeters.For cohort 1, you can have had only one prior treatment for your advanced cancer, but not with specific types of drugs. You cannot have had a specific type of immunotherapy called anti-PD-1/PD-L1/CTLA4 therapy.You may have had up to 2 previous treatments, including 1 anti-PD-1/PD-L1 therapy, but it did not work for you. You may have also received anti-CTLA4 therapy before.
- Group 1: Single Arm
- 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 other preliminary research has been conducted on Guadecitabine?
"343 studies are currently being conducted to research Guadecitabine. Of these, 51 are in Phase 3. Hat Yai and Texas have the most live trials for this medication, with 12928 and 51 locations respectively."
How many people are going to be participating in this clinical trial?
"As of February 16th, 2022, this particular trial is no longer searching for participants. The trial was originally posted on December 19th, 2017. However, if you are still interested in participating in a clinical trial, there are currently 436 trials for carcinoma, renal cell and 343 studies for Guadecitabine that are actively recruiting participants."
Are we still able to sign people up for this research?
"According to clinicaltrials.gov, this trial is not looking for patients as of right now. This particular study was first posted on December 19th, 2017 and was last updated on February 16th, 2022. However, there are 779 other trials that are currently looking for patients to enroll."
What is Guadecitabine most commonly used to treat?
"Guadecitabine is a chemotherapy drug used to treat conditions like stage III non-small cell lung cancer and metastatic urothelial carcinoma. It can also be effective in treating patients with advance directives."
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