Pembrolizumab and Ziv-aflibercept in Treating Patients With Advanced Solid Tumours

Official Title

A Phase 1 Trial of MK-3475 Plus Ziv-Aflibercept in Patients With Advanced Solid Tumours

Summary:

This phase I trial studies the side effects and best dose of ziv-aflibercept when given together with pembrolizumab in treating patients with solid tumours that have spread to other places in the body. Ziv-afibercept works by decreasing blood and nutrient supply to the tumour, which may result in shrinking the tumour. Monoclonal antibodies, such as pembrolizumab, may block tumour growth in different ways by targeting certain cells. Giving ziv-aflibercept together with pembrolizumab may be a better treatment for patients with advanced solid tumours.

Trial Description

Primary Outcome:

  • Recommended combination dose of ziv-aflibercept and pembrolizumab, assessed by dose-limiting toxicities
Secondary Outcome:
  • Objective response rate (ORR)
  • Overall survival
  • Progression-free survival
  • Time-to-progression
PRIMARY OBJECTIVES:
I. To determine the safety, tolerability and recommended phase II dosing for the combination of ziv-aflibercept plus MK-3475 (pembrolizumab) in patients with unresectable stage III or stage IV melanoma, renal cell cancer, ovarian cancer, or colorectal cancer. SECONDARY OBJECTIVES:
I. To obtain preliminary estimates of progression-free survival at 6 months. II. To obtain preliminary estimates of the rate of 1-year overall survival. III. To obtain preliminary estimates of the response rate. IV. To obtain preliminary estimates of time to progression. V. To perform a pilot assessment of positron emission tomography (PET) response versus Response Evaluation Criteria in Solid Tumours (RECIST) versus immune-related response criteria (irRC) criteria. VI. To perform correlative sciences that provide information regarding the mechanisms of action for this combination treatment. OUTLINE:

This is a dose-escalation study of ziv-aflibercept. Patients receive pembrolizumab intravenously (IV) over approximately 30 minutes and ziv-aflibercept IV over 1-2 hours on day 1. Courses repeat every 2 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for at least 12 weeks.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society