APX005M in Combination With Systemic Pembrolizumab in Patients With Metastatic Melanoma

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT02706353
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • APX005M — DRUG
    Dose Escalation Phase Starting Dose Level of APX005M: 0.1 mg injected directly into 1-3 tumors every 3 weeks (Weeks 0, 3, 6, and 9) for up to 4 doses. Dose Expansion Phase Starting Dose Level of APX005M: Maximum tolerated dose from Dose Escalation Phase.
  • Pembrolizumab — DRUG
    Dose Escalation and Expansion Phase Dose of Pembrolizumab: 2 mg/kg by vein 1 time every 3 weeks (Weeks 0, 3, 6, 9, and 12). First dose of Pembrolizumab given 1-2 days before or after first dose of APX005M.

Study Details

You are being asked to take part in this study because you have metastatic (cancer that has spread) melanoma. The goal of Part 1 of this clinical research study is to find the highest tolerable dose of APX005M that can be given with pembrolizumab that can be given to patients with metastatic melanoma. The goal of Part 2 of this study is to learn if the combination can help to control metastatic melanoma. The safety of this drug combination will also be studied. This is an investigational study. APX005M is not FDA approved or commercially available. It is currently being used for research purposes only. Pembrolizumab is FDA approved and commercially available for the treatment of metastatic melanoma. The combination of these drugs to treat metastatic melanoma is investigational. The study doctor can explain how the study drug is designed to work. Up to 41 participants will be treated in this study. All will take part at MD Anderson.

Key Dates

Start date
Jun 2, 2017
Status verified
Nov 2025
Primary completion
Mar 10, 2025
Completion
Mar 10, 2025

Study Design

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

Arms

  • Experimental: APX005M + Pembrolizumab
    Dose Escalation Phase: Starting dose level of APX005M is 0.1 mg injected directly into 1-3 tumors every 3 weeks (Weeks 0, 3, 6, and 9) for up to 4 doses. Tumor site chosen based on volume to be injected. All participants receive Pembrolizumab at 2 mg/kg by vein 1 time every 3 weeks (Weeks 0, 3, 6, 9, and 12). First dose of Pembrolizumab given 1-2 days before or after first dose of APX005M. Dose Expansion Phase: Starting dose level of APX005M is maximum tolerated dose from Dose Escalation Phase. Participants receive same dosage of Pembrolizumab as in Dose Escalation Phase.

Primary Outcome Measure

Safety and Tolerability [ Time Frame: Baseline to 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

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By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
University of Texas MD Anderson Cancer Center· Houston, TX

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