Testing the Addition of an Experimental Medication MK-3475 (Pembrolizumab) to Usual Anti-Retroviral Medications in Patients With HIV and Cancer

Summary

This phase I trial studies the side effects of pembrolizumab in treating patients with human immunodeficiency virus (HIV) and malignant neoplasms that have come back (relapsed), do not respond to treatment (refractory), or have distributed over a large area in the body (disseminated). 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.

Conditions

• AIDS-Related Non-Hodgkin Lymphoma
• Clinical Stage III Cutaneous Melanoma AJCC v8
• Clinical Stage IV Cutaneous Melanoma AJCC v8
• Hepatocellular Carcinoma
• HIV Infection
• Kaposi Sarcoma
• Locally Advanced Lung Non-Small Cell Carcinoma
• Locally Advanced Malignant Solid Neoplasm
• Metastatic Lung Non-Small Cell Carcinoma
• Metastatic Malignant Solid Neoplasm
• Metastatic Melanoma
• Non-Hodgkin Lymphoma
• Recurrent Classic Hodgkin Lymphoma
• Recurrent Malignant Neoplasm
• Refractory Classic Hodgkin Lymphoma
• Refractory Malignant Neoplasm
• Stage III Lung Cancer AJCC v8
• Stage IV Lung Cancer AJCC v8
• Unresectable Melanoma

Interventions

DRUG

Antiretroviral Therapy

Given PO

PROCEDURE

Biopsy

Undergo biopsy

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Computed Tomography

Undergo CT or PET/CT

BIOLOGICAL

Pembrolizumab

Given IV

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Kathryn Lurain · Cancer Immunotherapy Trials Network

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-04-04

Primary Completion

2023-10-04

Completion

2024-03-25

Countries

• United States

Study Locations