OncRef

Clinical Trial: NCT02595866

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

Status:

COMPLETED

Phase:

Phase 1

Lead Sponsor:National Cancer Institute (NCI)
Information Provided By:National Cancer Institute (NCI)
Last Update Posted:2024-08-09

Study Overview

Brief 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.

Official Title

Phase I Study of MK-3475 (Pembrolizumab) in Patients With Human Immunodeficiency Virus (HIV) and Relapsed/Refractory or Disseminated Malignant Neoplasm

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

Intervention / Treatment

  • Drug: Antiretroviral Therapy
  • Procedure: Biopsy
  • Procedure: Biospecimen Collection
  • Procedure: Computed Tomography
  • Biological: Pembrolizumab
  • Procedure: Positron Emission Tomography

Other Study ID Numbers

  • NCI-2015-01906
  • NCI-2015-01906
  • s16-01365
  • CITN-12
  • CITN-12
  • P30CA015704
  • U01CA154967

Start Date (Actual)

2016-04-04

Primary Completion Date (Actual)

2023-10-04

Study Completion Date (Actual)

2024-03-25

Enrollment (Actual)

58

Study Type

Interventional

Phase

Phase 1