CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 58 enrolled
Drug / intervention
Antiretroviral Therapy +5 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02595866
NCT02595866Phase 1Completed
CompareCT.gov

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

National Cancer Institute (NCI)·interventional·Posted Nov 4, 2015·Updated Aug 9, 2024

In Brief

A Phase 1 clinical trial evaluating Antiretroviral Therapy, Biopsy, and 4 other interventions for AIDS-Related Non-Hodgkin Lymphoma and 18 related conditions. Completed, enrolled 58 participants across 12 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAIDS-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
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 4, 2015
Enrollment StartApr 4, 2016
Primary CompletionOct 4, 2023
Study CompletionMar 25, 2024
TodayJul 2, 2026
Enrollment to primary: 7.5 yearsPosted 10.7 years ago

Interventions

Antiretroviral Therapydrug

Given PO

Biopsyprocedure

Undergo biopsy

Biospecimen Collectionprocedure

Undergo blood sample collection

Computed Tomographyprocedure

Undergo CT or PET/CT

Pembrolizumabbiological

Given IV

Positron Emission Tomographyprocedure

Undergo PET/CT