Ziv-aflibercept + Pembrolizumab for Cancer

Recruiting at8 trial locations

Overseen by Frank S Hodi

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This phase I trial studies the side effects and best dose of ziv-aflibercept when given together with pembrolizumab in treating patients with solid tumors that that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Ziv-afibercept works by decreasing blood and nutrient supply to the tumor, which may result in shrinking the tumor. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving ziv-aflibercept together with pembrolizumab may be a better treatment for patients with advanced solid tumors.

Research Team

Frank S Hodi

Principal Investigator

Dana-Farber - Harvard Cancer Center LAO

Eligibility Criteria

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.

Inclusion Criteria

Ability to understand and the willingness to sign a written informed consent document

Your hemoglobin level is at least 9 g/dL or 5.6 mmol/L.

My cancer is resistant to PD-1 treatment.

Exclusion 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.

Treatment Details

Interventions

• Pembrolizumab (Monoclonal Antibodies)
• Ziv-Aflibercept (Angiogenesis Inhibitor)

Trial Overview 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.

Participant Groups

Group I: Treatment (pembrolizumab and ziv-aflibercept) Experimental Treatment 6 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.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School