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MEDI5752 + Axitinib/Lenvatinib for Kidney Cancer
Study Summary
This trial will test a new drug, MEDI5752, in combination with Lenvatinib or Axitinib, to see if it is effective in treating advanced renal cell carcinoma.
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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- I have not taken immunosuppressive medication in the last 14 days.I have been treated with specific immune system drugs for kidney cancer.I have been treated with VEGF inhibitors before.My blood pressure is high (≥ 140/90 mmHg) and hasn't been controlled before starting treatment.I have not received a live vaccine in the last 30 days.I have had an organ transplant.You need to have at least one specific spot that can be measured to see how the treatment is working.I have had significant coughing up of blood or tumor bleeding in the last 2 weeks.I have not had a blood clot in the last 6 months.You are expected to live for at least 12 more weeks.My organs and bone marrow are working well.My partner will use a condom and spermicide until 7.6 months after my last dose.I have a serious wound, ulcer, or bone fracture that won't heal.I still have side effects from past cancer treatments.My cancer has spread to major blood vessels.I do not have active infections like TB, HIV, or hepatitis B/C.I can provide at least 5 slides or a tissue block from my tumor.I have or had an autoimmune or inflammatory disorder.I have a major issue with my digestive system.I am 18 years old or older.I am fully active or can carry out light work.I have a heart rhythm problem that is noticeable, treated, or not controlled.I am not breastfeeding and won't donate or use my eggs until 3 months after my last treatment dose.I have not had any serious illnesses in the last 6 months.I haven't had major surgery or radiation in the last 4 and 2 weeks, respectively, and have recovered from any side effects.I have had another type of cancer.My cancer has spread to my brain or spinal cord and is either untreated or getting worse.I am not pregnant and will use effective birth control during the study.I weigh more than 35 kilograms.I am not currently receiving any treatment for cancer.My advanced kidney cancer has not been treated yet.My kidney cancer is confirmed and has clear cell features.
- Group 1: Dose Expansion
- Group 2: Dose Exploration
- 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
Who fits the criteria to be accepted into this trial?
"This medical trial is accepting 70 individuals aged 18 to 101 who currently have advanced renal cell carcinoma (ARCC). Moreover, applicants must meet the following conditions: minimum age of eighteen at screening, body weight greater than 35 kilograms, no history of ARCC treatment in this setting, a measurable lesion according to RECIST v1.1 criteria, life expectancy exceeding 12 weeks and ECOG performance status 0 or 1."
What further research has been undertaken with MEDI5752?
"As of now, 194 studies are underway concerning MEDI5752. Of these investigations, 36 have moved into Phase 3 trials. This medication is being studied in Iowa City, IA and 5981 other locations worldwide."
Is this research pioneering any new techniques?
"Currently, 194 live trials of MEDI5752 are active in 1231 cities within 54 nations. The first trial of the drug began a decade ago and was sponsored by Pfizer; it enrolled 39 participants and achieved Phase 2 regulatory clearance. Since then, 132 additional clinical studies have been launched worldwide."
Is there any availability for enrollment in this scientific experiment?
"This medical study is presently accepting enrolments, with the initial posting on August 5th 2020 and most recent update occurring on November 3rd 2022. Data can be found in full detail at clinicaltrials.gov."
How many sites are actively coordinating this clinical trial?
"At present, 6 medical sites are participating in this trial; these include Saint Louis, Fort Myers and Cleveland as well as other cities. For the comfort of participants, it is advisable to select a study site that is near their residence."
What are the prime directives of this investigation?
"This research programme, which is set to be monitored from the point of consent until 90 days post-treatment, aims to analyse the number of adverse side effects and serious adverse events. Secondary objectives include an assessment of MEDI5752's pharmacokinetics (AUC and t1/2), as well as its antitumour activity when combined with lenvatinib via progression free survival (PFS) according to RECIST v1.1 guidelines."
Has MEDI5752 received clearance from the FDA?
"Our experts gave MEDI5752 a rating of 1 since it is in the initial stages of research and there are limited data points to demonstrate safety or efficacy."
Does the enrollment window for this clinical trial include individuals aged 25 and above?
"This clinical trial is accepting patients who are of legal adulthood, between 18 and 101 years old."
What is the cap on participants for this research endeavor?
"Affirmative. Clinicaltrials.gov records show that this research initiative, which was initiated on August 5th 2020, is actively in the process of recruitment. 70 individuals are required across 6 different clinical trial sites."
What health concerns does MEDI5752 purport to alleviate?
"MEDI5752 is widely prescribed for aplastic anemia but can also be beneficial to those with advanced renal cell carcinoma (ARCC), malignant neoplasms, and more severe forms of thyroid cancer."
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