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.
I. To assess the safety and tolerability of MK-3475 (pembrolizumab) in HIV-infected patients
on effective antiretroviral therapy and with relapsed/refractory or disseminated acquired
immune deficiency syndrome (AIDS)-defining or non-AIDS defining malignancy.
II. To assess the safety and feasibility of MK-3475 (pembrolizumab) administration as first
systemic therapy for HIV associated Kaposi sarcoma in patients on effective antiretroviral
I. To obtain preliminary insights into clinical benefit (e.g., tumor shrinkage or
stabilization >= 24 weeks) across a variety of tumors in patients infected with HIV and on
effective antiretroviral therapy.
II. To evaluate the response rate in Kaposi sarcoma impacting physical and/or psychological
wellbeing and not amenable to local therapy.
I. To assess the correlation of pre-therapy tumor programmed death-ligand 1 (PD-L1)
expression and T-cell infiltration on clinical benefit.
II. To assess the effect of MK-3475 (pembrolizumab) on circulating HIV and the HIV viral
reservoir in patients on effective combination anti-retroviral therapy (cART), as measured by
plasma HIV single copy ribonucleic acid (RNA), cluster of differentiation (CD)4+ T-cell
associated HIV unspliced RNA, CD4+ T-cell associated integrated HIV deoxyribonucleic acid
(DNA) provirus, ratio of HIV unspliced RNA/DNA, "Tat/Rev induced limiting dilution assay"
(TILDA), and phylogenetic analysis of HIV-1 molecular evolution.
III. To evaluate the effect of MK-3475 (pembrolizumab) on host gene expression in circulating
IV. To evaluate the effect of MK-3475 (pembrolizumab) on circulating HIV-specific CD8+ T-cell
cytotoxicity against autologous HIV infected CD4+ T-cells in patients on effective
V. To evaluate the effect of MK-3475 (pembrolizumab) on circulating lymphocyte and monocyte
numbers and phenotypes.
VI. To assess biopsied tumors from participants that progress by immunohistochemistry arrays
and gene expression analysis to evaluate potential reasons for the lack of response to
MK-3475 (pembrolizumab) or progression such as a lack of T cells within or around tumor.
VII. To evaluate the effect of pembrolizumab on Kaposi sarcoma-associated herpesvirus (KSHV)
viral load in the blood, KSHV seroreactivity and KSHV specific CD8+ T-cell activity.
Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Patients continue
receiving their recommended combination antiretroviral therapy orally daily. Cycles repeat
every 21 days for up to 2 years in the absence of disease progression or unacceptable
After completion of study treatment, patients are followed up 30 days and then every 12 weeks
up to 1 year.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.