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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Leukocytes >= 2,000/mcL (within 10 days of treatment initiation)
In dose escalation, patients must have histologically or cytologically confirmed metastatic disease from any solid tumor (NOS 10029000). In dose expansion part 1, patients must have histologically or cytologically confirmed metastatic melanoma (10053571), renal cell carcinoma (NOS 10038485), ovarian cancer (NOS 10033272), or colorectal cancer (10009951,10038045). In dose expansion part 2, patients must have PD-1 resistant melanoma (10053571), PD-1 resistant renal cancer (NOS 10038485), or sarcoma (10061271)
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Uptime from start of trial treatment to death from any cause, assessed up to 12 months
Awards & highlights
No Placebo-Only Group
Study Summary
This trial is testing ziv-aflibercept given with pembrolizumab to see if it is safe and effective in treating patients with advanced solid tumors.
Eligible Conditions
- Melanoma
- Renal Cell Carcinoma
- Ovarian Cancer
- Cutaneous Melanoma
- Cancer
- Kidney Cancer
- Colorectal Cancer
- Sarcoma
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
Your white blood cell count is at least 2000 cells per microliter within 10 days before the study begins.
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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.
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Your white blood cell count is high enough to participate in the trial.
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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.
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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.
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If you have colorectal cancer, you must have already tried and failed at least one treatment that included oxaliplatin.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time from start of trial treatment to death from any cause, assessed up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from start of trial treatment to death from any cause, assessed up to 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Recommended combination dose of ziv-aflibercept and pembrolizumab
Secondary outcome measures
Objective response rate (ORR)
Overall survival
Progression-free survival
+1 moreOther outcome measures
Changes in antigen specific responses to known melanoma antigen epitopes (melanoma antigen recognized by T cells 1, NY-ESO-1)
Effects on tumor vasculature and vascular active molecules
Humoral and cellular immune responses
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (pembrolizumab and ziv-aflibercept)Experimental Treatment6 Interventions
Patients receive pembrolizumab intravenously (IV) over approximately 30 minutes and ziv-aflibercept IV over 1-2 hours on day 1. Cycles repeat every 2 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI, blood sample collection and tumor biopsy throughout the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biopsy
2014
Completed Phase 4
~1180
Biospecimen Collection
2004
Completed Phase 1
~1540
Computed Tomography
2017
Completed Phase 2
~2890
Ziv-Aflibercept
2008
Completed Phase 2
~150
Pembrolizumab
2017
Completed Phase 3
~2030
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,486 Previous Clinical Trials
41,264,799 Total Patients Enrolled
556 Trials studying Melanoma
160,532 Patients Enrolled for Melanoma
Frank S HodiPrincipal InvestigatorDana-Farber - Harvard Cancer Center LAO
3 Previous Clinical Trials
1,013 Total Patients Enrolled
3 Trials studying Melanoma
1,013 Patients Enrolled for Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (pembrolizumab and ziv-aflibercept)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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