Pembrolizumab in Treating Patients With HIV and Relapsed, Refractory, or Disseminated Malignant Neoplasms
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 36
Summary
- Conditions
- Clinical Stage III Cutaneous Melanoma AJCC v8
- AIDS Related Non-Hodgkin Lymphoma
- Classic Hodgkin Lymphoma
- Pathologic Stage IV Cutaneous Melanoma AJCC v8
- Refractory Neoplasm
- Unresectable Melanoma
- Stage IIIB Lung Cancer AJCC v8
- Refractory Kaposi Sarcoma
- Clinical Stage IV Cutaneous Melanoma AJCC v8
- Recurrent Kaposi Sarcoma
- Stage IVA Lung Cancer AJCC v8
- Hepatocellular Carcinoma
- Pathologic Stage III Cutaneous Melanoma AJCC v8
- Recurrent Classic Hodgkin Lymphoma
- HIV Infection
- Locally Advanced Lung Non-Small Cell Carcinoma
- Stage IV Lung Cancer AJCC v8
- Locally Advanced Malignant Neoplasm
- Stage III Lung Cancer AJCC v8
- Stage IIIC Lung Cancer AJCC v8
- Stage IIIA Lung Cancer AJCC v8
- Pathologic Stage IIIC Cutaneous Melanoma AJCC v8
- Metastatic Lung Non-Small Cell Carcinoma
- Pathologic Stage IIIA Cutaneous Melanoma AJCC v8
- Stage IVB Lung Cancer AJCC v8
- Refractory Classic Hodgkin Lymphoma
- Metastatic Melanoma
- Pathologic Stage IIIB Cutaneous Melanoma AJCC v8
- Pathologic Stage IIID Cutaneous Melanoma AJCC v8
- Metastatic Neoplasm
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVES: 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 saf...
PRIMARY OBJECTIVES: 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 therapy. SECONDARY OBJECTIVES: 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. EXPLORATORY OBJECTIVES: 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 blood cells. 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 antiretroviral therapy. 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. OUTLINE: 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 toxicity. After completion of study treatment, patients are followed up 30 days and then every 12 weeks.
Tracking Information
- NCT #
- NCT02595866
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Thomas S Uldrick Cancer Immunotherapy Trials Network