Testing the PD-1 Antibody, MK3475, Given With Ziv-aflibercept in Patients With Advanced Cancer

Part of paid clinical trials in Tampa, Florida.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT02298959
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Clinical Stage IV Cutaneous Melanoma AJCC v8
  • Metastatic Colorectal Carcinoma
  • Metastatic Malignant Solid Neoplasm
  • Metastatic Melanoma
  • Metastatic Ovarian Carcinoma
  • Metastatic Renal Cell Carcinoma
  • Platinum-Resistant Ovarian Carcinoma
  • Recurrent Melanoma
  • Recurrent Renal Cell Carcinoma
  • Refractory Melanoma
  • Refractory Renal Cell Carcinoma
  • Sarcoma
  • Stage IV Colorectal Cancer AJCC v8
  • Stage IV Ovarian Cancer AJCC v8
  • Stage IV Renal Cell Cancer AJCC v8

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biopsy Procedure — PROCEDURE
    Undergo tumor biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Computed Tomography — PROCEDURE
    Undergo CT scan
  • Magnetic Resonance Elastography — PROCEDURE
    Undergo MRI
  • Pembrolizumab — BIOLOGICAL
    Given IV
  • Ziv-Aflibercept — BIOLOGICAL
    Given IV

Study Details

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.

Key Dates

Start date
Apr 8, 2015
Status verified
Jan 2026
Primary completion
May 21, 2025
Completion
Jan 20, 2027

Study Design

Enrollment
59 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (pembrolizumab and 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. Patients undergo CT scan, MRI, blood sample collection and tumor biopsy throughout the study.

Primary Outcome Measure

Recommended combination dose of ziv-aflibercept and pembrolizumab [ Time Frame: 4 weeks ]

Locations (7)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612-
Moffitt Cancer Center - McKinley CampusTampaFlorida33612-
Moffitt Cancer Center-International PlazaTampaFlorida33607-
National Cancer Institute Developmental Therapeutics ClinicBethesdaMaryland20892-
National Institutes of Health Clinical CenterBethesdaMaryland20892-
Brigham and Women's HospitalBostonMassachusetts02115-
Dana-Farber Cancer InstituteBostonMassachusetts02215-

Find similar trials in Tampa, FL

By condition
MelanomaKidney cancer
By specialty
OncologySkin cancerDermatologyUrology
By research site
Moffitt Cancer Center· Tampa, FLMoffitt Cancer Center - McKinley Campus· Tampa, FLMoffitt Cancer Center-International Plaza· Tampa, FLNational Cancer Institute Developmental Therapeutics Clinic· Bethesda, MDNational Institutes of Health Clinical Center· Bethesda, MDBrigham and Women's Hospital· Boston, MA

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