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Pembrolizumab + Cabozantinib for Kidney Cancer
Study Summary
This trial is testing a new cancer treatment combining two drugs. The first part will see if the combination is safe and what the best dose is. The second part will test how well the combination works.
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 2024 Phase 2 trial • 57 Patients • NCT03004183Trial Design
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Who is running the clinical trial?
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- You have a current, active Hepatitis B or Hepatitis C infection.I have not received a live vaccine in the last 30 days.My kidney cancer diagnosis was confirmed through lab tests.My cancer has spread or come back and is advanced.I have not been in a clinical trial for a new treatment or device within the last 4 weeks.You have a disease that can be measured or assessed using a specific set of guidelines.I have an immune system disorder or have been on strong immune system drugs recently.I have been treated with pembrolizumab before.I haven't had cancer treatment in the last 2 weeks or still have side effects.I have available tumor samples in paraffin blocks or at least 10 slides.I am a man who can father a child and agree to use birth control as the study requires.I have not had major surgery in the last 4 weeks or minor surgery in the last 2 weeks.I have an autoimmune disease treated with medication in the last 2 years.I have had an organ transplant.I have had osteonecrosis of the jaw.I have had reversible posterior leukoencephalopathy syndrome.I am fully active or restricted in physically strenuous activity but can do light work.My organ functions are within the required range.I have taken a pregnancy test within the last 72 hours and it was negative.I have cancer that has spread to my brain or spinal cord.I do not have any major uncontrolled health issues.I cannot swallow pills.I have been diagnosed with HIV.My cancer has not spread to my bones.I am willing to use birth control as required by the study.I have recovered from previous treatment side effects, or they are minor and stable.My biopsy was taken using a core needle or through surgical methods.I've had immune therapy without severe side effects and it's been over 28 days since my last dose.I am currently on IV antibiotics for an infection.I have another cancer that is getting worse or needs treatment.I haven't had cancer treatment with monoclonal antibodies in the last 4 weeks.I have been treated with cabozantinib before.I have an active tuberculosis infection.I have had pneumonitis treated with steroids or currently have it.I had wound healing issues needing medical help in the last 6 months.I am 18 years old or older.
- Group 1: Phase 1: Pembrolizumab 200 mg plus Cabozantinib 60mg
- Group 2: Phase 1: Pembrolizumab 200 mg plus Cabozantinib 40mg
- Group 3: Phase 2: Pembrolizumab 200 mg plus Cabozantinib at the RP2D
- 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
How many research centers are participating in this project?
"This research is being conducted at 5 centres, which are based in Lone Tree, Fort Collins and Aurora. To limit the amount of travel required, please select the location nearest to you."
How many candidates will be selected for this experiment?
"Presently, this study is not enrolling new patients. The trial was initially posted on September 28th, 2017 and has had its information updated as recently as August 1st, 2022. There are 2665 other trials for carcinoma and 1108 for Pembrolizumab that are actively recruiting participants if you wish to look into alternative studies."
Are there any restrictions for who can join this clinical trial?
"This clinical trial is enrolling 45 individuals that have been diagnosed with carcinoma. The age range for participants is 18 to 100 years old. It's important to note that applicants must meet the following requirements: a) Subjects must have locally advanced, recurrent, or metastatic disease., b) Subjects must have histological or cytological documentation of renal cell carcinoma, c) Be willing and able to provide written informed consent/assent for the trial., d) Stated willingness to complywith all study procedures and be available for the duration of the trial., e) Be ≥ 18 years of age on day of signing informed consent., f"
What types of cancer does Pembrolizumab help to treat?
"Pembrolizumab is a medication that oncologists often prescribe to patients with unresectable melanoma. It can also help those with microsatellite instability high, high risk of recurrence, and disease."
Are middle-aged adults welcome to join this clinical trial?
"According to the inclusion criteria laid out by the study, people aged 18 to 100 are eligible. There are 121 studies for people under that age bracket and 3742 for seniors."
What other treatments has Pembrolizumab been studied in relation to?
"As of now, there are 1108 clinical trials studying Pembrolizumab. 135 of those trials are currently in Phase 3. However, these trials for Pembrolizumab are not just limited to Houston as 43132 locations across the globe are running them."
If a patient meets the requirements, can they join the trial at this time?
"Unfortunately, this particular trial is not actively looking for patients to enroll at the moment. The last time it was updated was on August 1st, 2022. However, there are 2665 other trials recruiting patients with carcinoma and 1108 studies involving Pembrolizumab that are searching for participants."
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