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This trial is testing ziv-aflibercept given with pembrolizumab to see if it is safe and effective in treating patients with advanced solid tumors.
- Renal Cell Carcinoma
- Ovarian Cancer
- Cutaneous Melanoma
- Kidney Cancer
- Colorectal Cancer
Inclusion CriteriaYou will be eligible if you check “Yes” for the criteria below
Study ObjectivesOutcome measures can provide a clearer picture of what you can expect from a treatment.
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Who is running the clinical trial?
- You must be at least 18 years old to participate in this study. Children are not allowed in this study, but may be included in future studies.Your white blood cell count is at least 2000 cells per microliter within 10 days before the study begins.You have mental health or substance abuse issues that would make it difficult for you to follow the trial requirements.You are currently in or have recently participated in a study involving an experimental drug or device.You have a weakened immune system or have been taking medication to suppress your immune system within a week before starting the trial.You are currently pregnant or breastfeeding.You have experienced severe gastrointestinal bleeding, peptic ulcer disease, or other serious clotting issues in the last 3 months.You cannot have previously been treated with certain types of drugs, including anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or ziv-aflibercept, for the first part of the study.You have been diagnosed with advanced melanoma, kidney, ovarian, or colorectal cancer.You have other types of cancer that are getting worse or require treatment, except for certain types that have been successfully treated in the past.You have open wounds on your skin.Your blood pressure is very high and not well managed, with repeated measurements showing systolic pressure higher than 180mmHg or diastolic pressure higher than 100mmHg within the last 3 months.Your white blood cell count is high enough to participate in the trial.You are expected to live for at least 6 more months.In the first part of the study, you must have been diagnosed with metastatic solid tumors. In the second part of the study, you must have been diagnosed with specific types of metastatic cancers such as melanoma, renal cell carcinoma, ovarian cancer, colorectal cancer, or sarcoma.You have received a maximum of two treatments for cancer that has spread to other parts of your body.If you have renal cell cancer, you must have already received treatment with a medication called VEGF tyrosine kinase inhibitor (TKI) at least once before.You have ovarian cancer that has not responded to platinum-based treatments, or you have received more than two platinum-based treatments in the past six months.If you have colorectal cancer, you must have already tried and failed at least one treatment that included oxaliplatin.You should be able to perform daily activities without much difficulty.
- Group 1: Treatment (pembrolizumab and ziv-aflibercept)
- 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
Has Ziv-Aflibercept been authorized by the Food and Drug Administration?
"Due to the preliminary nature of this medical trial, our team has rated Ziv-Aflibercept's safety a 1. This score reflects the limited data supporting both its efficacy and safety."
What is the enrollment size for this investigation?
"This trial is no longer accepting applicants. It was initially posted on March 13th 2015, and the last update occurred on November 29th 2022. Alternatively, there are 5540 sarcoma studies currently enrolling patients and 1007 trials for Ziv-Aflibercept that can be pursued."
Has Ziv-Aflibercept been the subject of prior research studies?
"Currently, 1007 studies concerning Ziv-Aflibercept are taking place. Of these, 146 have reached Phase 3. Houston is the epicenter for many of these research projects; yet 37864 sites around the world house live trials related to this drug."
What medical conditions has Ziv-Aflibercept been demonstrated to mitigate?
"Ziv-Aflibercept has been proven to be an effective treatment for malignant tumours, unresectable cases of melanoma, and microsatellite instability high."
Are there any open spots available to join this research project?
"The clinical trial hosted on clinicialtrials.gov is not currently recruiting participants, as it was posted in March 2015 and updated November 2022. Conversely, there are 6547 other trials actively searching for candidates right now."
In what capacity are these trials supervised at various sites?
"There are 8 clinical trial sites that have started recruiting patients. These include University Health Network-Princess Margaret Hospital in Toronto, Dana-Farber Cancer Institute in Boston, Moffitt Cancer Center - McKinley Campus in Bethesda and others."
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