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Monoclonal Antibodies
Ziv-aflibercept + Pembrolizumab for Cancer
Phase 1
Waitlist Available
Led By Frank S Hodi
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have PD-1 resistant melanoma, PD-1 resistant renal cancer, or sarcoma for dose expansion part 2
Renal cell patients must have had at least one prior vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from start of trial treatment to death from any cause, assessed up to 12 months
Awards & highlights
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.
Who is the study for?
Adults with advanced solid tumors, specifically melanoma, renal cancer, ovarian cancer or colorectal cancer that's spread and is resistant to certain treatments. Participants must have adequate organ function, no more than two prior therapies for metastatic disease, and not be pregnant or breastfeeding. They should agree to use contraception and not have a history of severe autoimmune diseases or other conditions that could interfere with the trial.Check my eligibility
What is being tested?
The trial is testing the combination of ziv-aflibercept (which cuts off blood supply to tumors) with pembrolizumab (an immunotherapy drug). It aims to find the safest dose while observing how well this combo works against advanced cancers by leveraging the body's immune system.See study design
What are the potential side effects?
Potential side effects include reactions at the infusion site, fatigue, changes in blood pressure and bleeding risks due to ziv-aflibercept; pembrolizumab may cause immune-related issues like inflammation in organs as well as flu-like symptoms.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is resistant to PD-1 treatment.
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I have had treatment with a VEGF inhibitor for my kidney cancer.
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My kidney function is normal or only slightly below normal.
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I can provide a sample of my tumor, either from previous or new biopsies.
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I have confirmed metastatic melanoma, kidney, ovarian, or colorectal cancer.
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My ovarian cancer does not respond to platinum-based treatments.
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I have had 2 or fewer treatments for my cancer that has spread.
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My colorectal cancer did not respond to a treatment that included oxaliplatin.
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I am 18 years old or older.
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My cancer has spread and this was confirmed through testing.
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I am mostly self-sufficient and can carry out daily activities.
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My liver enzymes are within the required range, even with liver metastases.
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My melanoma or kidney cancer didn't respond to previous PD-1/PD-L1 therapy.
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 moreTrial 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
~850
Computed Tomography
2017
Completed Phase 2
~2720
Ziv-Aflibercept
2008
Completed Phase 2
~240
Biospecimen Collection
2004
Completed Phase 2
~1730
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,075 Total Patients Enrolled
286 Trials studying Ovarian Cancer
73,766 Patients Enrolled for Ovarian Cancer
Frank S HodiPrincipal InvestigatorDana-Farber - Harvard Cancer Center LAO
3 Previous Clinical Trials
1,014 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had severe GI bleeding or uncontrollable blood clot issues in the last 3 months.I have a history of cancer.I am on a full dose of Coumadin for blood thinning.I haven't had any cancer, except for skin cancer, in the last 5 years.My cancer involves areas at high risk of bleeding, like the bowel or lungs.I have had a condition where my lymphocytes grow abnormally.I haven't had cancer treatment or fully recovered from its side effects in the last 4 weeks.Your hemoglobin level is at least 9 g/dL or 5.6 mmol/L.My cancer is resistant to PD-1 treatment.I have had treatment with a VEGF inhibitor for my kidney cancer.I haven't had a heart attack, severe heart issues, or stroke in the last 6 months.My kidney function is normal or only slightly below normal.I can provide a sample of my tumor, either from previous or new biopsies.Patients must have a way to measure their disease according to specific guidelines.My high blood pressure is not well-managed.I have cancer that has spread to my brain.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I had major surgery less than 4 weeks ago.I have confirmed metastatic melanoma, kidney, ovarian, or colorectal cancer.My ovarian cancer does not respond to platinum-based treatments.I have had 2 or fewer treatments for my cancer that has spread.My colorectal cancer did not respond to a treatment that included oxaliplatin.You live outside the United States.I have another cancer that is getting worse or needs treatment.I have not received a live vaccine in the last 30 days.I am 18 years old or older.You have a low count of white blood cells.Your bilirubin levels in the blood should not be too high.I agree to use birth control during the study.My cancer has spread and this was confirmed through testing.I am a woman who can have children and have a recent negative pregnancy test.I have open sores on my skin.You have had allergic reactions to drugs similar to MK-3475 and ziv-aflibercept.I have cancer cells in the fluid around my brain and spinal cord.I have been treated with specific immune-targeting medications before.Your blood clotting test results (INR or PT) should not be more than 1.5 times the normal level.I have an autoimmune disease that needed treatment in the last 3 months or have had a severe case before.Your white blood cell count is at least 1,500 per microliter.Your activated partial thromboplastin time (aPTT) test result is within 1.5 times the normal range.I am mostly self-sufficient and can carry out daily activities.You are expected to live for at least 6 more months.Your platelet count is at least 100,000 per microliter.My liver enzymes are within the required range, even with liver metastases.Your urine test shows a low amount of protein.My melanoma or kidney cancer didn't respond to previous PD-1/PD-L1 therapy.You have a diagnosed mental health condition or problems with drugs or alcohol.I haven't taken steroids or immunosuppressants in the last 7 days.
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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