NCT03030378

Pembrolizumab and Recombinant Interleukin-12 in Treating Patients With Solid Tumors

A Phase 1 Study of Pembrolizumab (MK-3475) in Combination With Recombinant Interleukin-12 in Patients With Solid Tumors

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the side effects and best dose of pembrolizumab and recombinant interleukin-12 in treating patients with solid tumors. 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. Recombinant interleukin-12 may kill tumor cells by blocking blood flow to the tumor and by stimulating white blood cells to kill tumor cells. Giving pembrolizumab and recombinant interleukin-12 may work better than giving pembrolizumab alone in treating patients with solid tumors.

Detailed description

PRIMARY OBJECTIVE: I. Establish the maximum tolerated dose (MTD) and the recommended phase II dose (RP2D) of edodekin alfa (recombinant human interleukin \[rhIL\]-12) in combination with pembrolizumab (MK-3475). SECONDARY OBJECTIVES: I. Evaluate the safety of the regimen by continuously monitoring adverse events that will be documented utilizing Common Terminology Criteria for Adverse Events (CTCAE) version (v).5.0. II. Evaluate the overall response rate (Response Evaluation Criteria in Solid Tumors \[RECIST\] v.1.1) and the progression free survival of patients enrolled on the study. III. Measure CD8+ T cell infiltration by immunohistochemistry in tumor biopsies obtained pre-treatment, after one week of rhIL-12 and after 2 cycles of pembrolizumab (MK-3475) in combination with rhIL-12. EXPLORATORY OBJECTIVE: I. Conduct exploratory translational laboratory correlative studies utilizing banked biospecimens (tumor, blood, and stool) obtained pre-treatment and during therapy. OUTLINE: This is a dose-escalation study of recombinant interleukin-12. Patients receive recombinant interleukin-12 subcutaneously (SC) on days 2, 5, 9, and 12 and pembrolizumab intravenously (IV) over 30 minutes on day 8 of cycle 1 and day 1 of subsequent cycles. Treatment continues for 28 days for cycle 1 and repeats every 21 days for subsequent cycles for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Patient then receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 8 additional cycles in the absence of disease progression or unacceptable toxicity. Patients undergo a computed tomography (CT), positron emission tomography (PET), and/or magnetic resonance imaging (MRI), as well as collection of blood during screening, on study, and during follow-up. Patients also undergo a tumor biopsy during screening and on study. After completion of study treatment, patients are followed up every 12 weeks for 2 year and then every 24 weeks for up to 5 years.

Conditions

• Metastatic Malignant Solid Neoplasm
• Unresectable Malignant Solid Neoplasm

Interventions

Type	Name	Description
PROCEDURE	Biopsy Procedure	Undergo a tumor biopsy
PROCEDURE	Biospecimen Collection	Undergo collection of blood
PROCEDURE	Computed Tomography	Undergo a CT scan
BIOLOGICAL	Edodekin alfa	Given SC
PROCEDURE	Magnetic Resonance Imaging	Undergo a MRI
BIOLOGICAL	Pembrolizumab	Given IV
PROCEDURE	Positron Emission Tomography	Undergo a PET scan

Timeline

• Start date: 2018-05-30
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2017-01-25
• Last updated: 2026-04-13

Locations

27 sites across 1 country: United States

Regulatory

• FDA-regulated drug study