Ziv-Aflibercept for Sarcoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Sarcoma+30 More
Ziv-Aflibercept - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

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
  • Sarcoma
  • Cutaneous Melanoma
  • Malignant neoplasm of ovary
  • Renal Cell Carcinoma
  • Metastatic Colorectal Carcinoma
  • Metastatic Malignant Solid Neoplasm
  • Platinum-Resistant Ovarian Carcinoma
  • Colorectal Carcinoma
  • Recurrent Melanoma
  • Pathologic Stage IV Cutaneous Melanoma AJCC v8
  • Refractory Melanoma
  • Refractory Renal Cell Carcinoma
  • Metastatic Ovarian Carcinoma
  • Metastatic Melanoma
  • Metastatic Renal Cell Carcinoma ( mRCC)
  • Stage IV Ovarian Cancer AJCC v8
  • Stage IV Renal Cell Cancer AJCC v8

Treatment Effectiveness

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Time from start of trial treatment to death from any cause, assessed up to 12 months

4 weeks
Recommended combination dose of ziv-aflibercept and pembrolizumab
Week 12
Changes in antigen specific responses to known melanoma antigen epitopes (melanoma antigen recognized by T cells 1, NY-ESO-1)
Phenotype changes in cell populations
Week 12
Objective response rate (ORR)
Month 12
Overall survival
Month 6
Progression-free survival
Week 12
Time-to-progression
Up to 12 weeks
Effects on tumor vasculature and vascular active molecules
Humoral and cellular immune responses
Tie-2 expressing monocytes

Trial Safety

Trial Design

1 Treatment Group

Treatment (pembrolizumab and ziv-aflibercept)
1 of 1

Experimental Treatment

78 Total Participants · 1 Treatment Group

Primary Treatment: Ziv-Aflibercept · No Placebo Group · Phase 1

Treatment (pembrolizumab and ziv-aflibercept)Experimental Group · 2 Interventions: Ziv-Aflibercept, Pembrolizumab · Intervention Types: Biological, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aflibercept
FDA approved
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: time from start of trial treatment to death from any cause, assessed up to 12 months

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,005 Previous Clinical Trials
41,301,849 Total Patients Enrolled
445 Trials studying Sarcoma
235,650 Patients Enrolled for Sarcoma
Frank S HodiPrincipal InvestigatorDana-Farber - Harvard Cancer Center LAO
3 Previous Clinical Trials
1,013 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are a woman with ovarian cancer and you have received no prior platinum therapy.
Patients with colorectal cancer should have failed at least one oxaliplatin-containing regimen.
You have received no more than two prior therapies for metastatic disease.
Patients will be enrolled in this study if they are 18 years of age or older
You have leukocytes greater than 2,000/mcL (within 10 days of treatment initiation).
Patients must have histologically or cytologically confirmed metastatic disease from any solid tumor (NOS 10029000).
You have a neutrophil count of at least 1,500/mcL (within 10 days of treatment initiation).

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 13th, 2021

Last Reviewed: November 26th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.