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Sitravatinib + Nivolumab for Advanced Kidney Cancer
Study Summary
This trial is testing sitravatinib & nivolumab to treat patients with metastatic clear cell renal cell cancer. Sitravatinib may stop growth by blocking enzymes & nivolumab may help the body's immune system attack the 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.Side effects data
From 2023 Phase 2 trial • 25 Patients • NCT03680521Trial Design
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- Your hemoglobin level is at least 9 grams per deciliter.I have or had an autoimmune disease.I have not had major surgery or significant injury within the last 28 days.I am not on medications that affect heart rhythm significantly.You have a weakened immune system.I am currently receiving treatment for kidney cancer.Your total bilirubin level should be less than or equal to 1.5 mg/dL.I have not had any live vaccines in the week before or during the study.I am not pregnant, breastfeeding, and if capable of having children, I am using effective birth control.I have untreated brain or spinal cord cancer spread.My kidney function is normal and I don't need dialysis.I have advanced kidney cancer treated with specific drugs.You must have at least one place in your body where the disease can be measured.Your platelet count is at least 75,000 per microliter.My total bilirubin level is 3 mg/dL or less, even with Gilbert's disease.My heart's pumping ability is below 40%.Your liver enzyme levels should not be too high, unless you have known cancer spread to your liver.Your blood clotting tests (INR and PTT) should be within a certain range before joining the study.I am not currently on cancer treatment and haven't been for the last 2 weeks.I have had severe side effects from previous immunotherapy.I haven't had any cancer in the past 2 years, except for certain skin cancers or early-stage cervical cancer.I am able to care for myself but may not be able to do active work.I am 18 years old or older.I am a woman who can have children and have a negative pregnancy test.My cancer progressed after my last treatment with a PD-1/PD-L1 inhibitor within the past 6 months.You have enough infection-fighting white blood cells in your body.My brain cancer was treated with surgery or targeted radiation and has not worsened in the last month.
- Group 1: Treatment (sitravatinib, 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 ailments is Sitravatinib commonly employed to ameliorate?
"Sitravatinib can be utilized to treat malignant tumors, non-operable melanomas and squamous cell carcinoma."
Does this investigation currently have any openings for participants?
"The latest information on clinicaltrials.gov reveals that recruiting for this medical study is still in progress, with the first post appearing on May 3rd and the most recent update occurring June 29th 2022."
How many participants are partaking in this experiment?
"Affirmative. Clinicaltrials.gov's records demonstrate that this medical experiment, which was first displayed on May 3rd 2022, is currently recruiting candidates. Approximately 88 volunteers are sought from a single clinical site."
Is this experimental research new to the medical field?
"Currently, there are 728 live Sitravatinib trials being conducted in 2366 cities across 49 countries. Ono Pharmaceutical Co. Ltd was the first to sponsor this drug's trial back in 2012 with 659 participants and completed Phase 1 & 2 approval stages. In total, 483 studies have been run since then."
What is the ultimate aim of this medical experiment?
"The primary outcome measure of this 24 week clinical trial is the Objective Response Rate, while secondary outcomes include Progression Free Survival (assessed with Kaplan-Meier survival curves and Cox regression models), Duration of response (also assessed with Kaplan-Meier survival curves and Cox regression models) as well as Adverse Events which will be recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 using descriptive statistics such a frequency and 95% confidence intervals)."
Has Sitravatinib been greenlit by the FDA?
"The safety profile of Sitravatinib has been evaluated as a 2 on our scale, since it is only in Phase 2 testing and thus far there are no efficacy data available."
What other research endeavors have included Sitravatinib as a focus?
"Currently, there are 728 active clinical trials researching Sitravatinib, with 83 of these encompassing Phase 3. Though the primary location for investigating this treatment is Basel, BE; 40412 sites worldwide are running studies related to it."
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