Pembrolizumab (Anti-PD-1) and AMG386 (Angiopoietin-2 (Ang-2) in Patients With Advanced Solid Tumor

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT03239145
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Solid Tumor

Eligibility Criteria

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

Interventions

  • Pembrolizumab — DRUG
    Pembrolizumab is designed to augment the natural ability of the immune system to recognize and target cancer cells
  • Trebananib — DRUG
    AMG386 is a drug that may kill tumor cells and blocks blood vessels that supply the tumor with nutrients and oxygen

Study Details

This research study is studying an investigational combination of drugs as a possible treatment for advanced solid tumors: melanoma, ovarian, renal, or colorectal cancer. The drugs involved in this study are: * Pembrolizumab * AMG386

Key Dates

Start date
May 1, 2018
Status verified
Jan 2026
Primary completion
Dec 13, 2024
Completion
Dec 13, 2024

Study Design

Enrollment
62 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: [Dose Escalation Dose Level I] Pembrolizumab + Trebananib
    Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 15 mg/kg weekly.
  • Experimental: [Dose Expansion] Pembrolizumab + Trebananib (Ovarian)
    Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 30 mg/kg weekly.
  • Experimental: [Dose Expansion] Pembrolizumab + Trebananib (Colorectal)
    Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 30 mg/kg weekly.
  • Experimental: [Dose Expansion] Pembrolizumab + Trebananib (Renal Cell Carcinoma)
    Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 30 mg/kg weekly.
  • Experimental: [Dose Escalation Dose Level II] Pembrolizumab + Trebananib
    Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 30 mg/kg weekly.

Primary Outcome Measure

Number of Participants Experienced Dose Limit Toxicities (DLT) [ Time Frame: 3 weeks ]

Locations (2)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Dana Farber Cancer InstituteBostonMassachusetts02215-

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By research site
Beth Israel Deaconess Medical Center· Boston, MADana Farber Cancer Institute· Boston, MA

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