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Monoclonal Antibodies

PD-1 Antibody + Ziv-aflibercept for Advanced Cancer

Moffitt Cancer Center-International Plaza, Tampa, FL
Targeting 15 different conditionsZiv-Aflibercept +5 morePhase 1Waitlist AvailableLed by Frank S HodiResearch Sponsored by National Cancer Institute (NCI)

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 below
Your white blood cell count is at least 2000 cells per microliter within 10 days before the study begins.
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.
Your white blood cell count is high enough to participate in the trial.
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.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from start of trial treatment to death from any cause, assessed up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and time from start of trial treatment to death from any cause, assessed up to 12 months for reporting.

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 more
Other 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 more

Awards & 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.
First Studied
Drug Approval Stage
How many patients have taken this drug
Completed Phase 4
Biospecimen Collection
Completed Phase 1
Computed Tomography
Completed Phase 2
Completed Phase 2
Completed Phase 3

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

Pembrolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT02298959 — Phase 1
Melanoma Research Study Groups: Treatment (pembrolizumab and ziv-aflibercept)
Melanoma Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT02298959 — Phase 1
Pembrolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02298959 — Phase 1

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
~1 spots leftby Dec 2023