Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
36

Summary

Conditions
  • Metastatic Melanoma
  • Clinical Stage IV Cutaneous Melanoma AJCC v8
  • Metastatic Colorectal Carcinoma
  • Stage IVC Colorectal Cancer AJCC v8
  • Metastatic Malignant Solid Neoplasm
  • Metastatic Ovarian Carcinoma
  • Metastatic Renal Cell Carcinoma
  • Pathologic Stage IV Cutaneous Melanoma AJCC v8
  • Stage IV Ovarian Cancer AJCC v8
  • Stage IVB Ovarian Cancer AJCC v8
  • Platinum-Resistant Ovarian Carcinoma
  • Stage IV Colorectal Cancer AJCC v8
  • Recurrent Melanoma
  • Recurrent Renal Cell Carcinoma
  • Sarcoma
  • Stage IVB Colorectal Cancer AJCC v8
  • Stage IV Renal Cell Cancer AJCC v8
  • Refractory Renal Cell Carcinoma
  • Stage IVA Colorectal Cancer AJCC v8
  • Stage IVA Ovarian Cancer AJCC v8
  • Refractory Melanoma
Type
Interventional
Phase
Phase 1
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

PRIMARY OBJECTIVE: 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, colorectal cancer, or sarcoma. SECONDARY OB...

PRIMARY OBJECTIVE: 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, colorectal cancer, or sarcoma. 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 correlative sciences that provide information regarding the mechanisms of action for this combination treatment. OUTLINE: This is a dose-escalation and dose expansion study of ziv-aflibercept. 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. After completion of study treatment, patients are followed up for at least 12 weeks.

Tracking Information

NCT #
NCT02298959
Collaborators
Not Provided
Investigators
Principal Investigator: Frank S Hodi Dana-Farber - Harvard Cancer Center LAO