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

Completed · Phase 1

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT02595866

Run by

National Cancer Institute (NCI)

People needed

58

Starts

2016-04-04

Expected to finish

2024-03-25

Last updated by the study team

2024-08-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically proven metastatic or locally advanced tumors for which no standard therapy exists, or where standard therapy has failed, or in patients otherwise ineligible for standard therapy, or for an indication that anti-PD-1 therapy has been shown to be effective in studies in HIV-uninfected participants; disease-specific criteria will be applied for certain common cancers and cancers strongly associated with HIV; however, enrollment will not be confined to these tumors
• Non-small cell lung cancer (NSCLC)
• Metastatic or locally advanced disease that progressed after at least one prior therapy
• Note: patients that have actionable molecular targets (e.g., epidermal growth factor receptor [EGFR], anaplastic lymphoma kinase [ALK], c-ros oncogene 1[ROS1] mutations) must have received (when indicated) prior appropriate targeted therapy using Food and Drug Administration (FDA)-approved agents
• AIDS-related non-Hodgkin lymphoma and other non-Hodgkin lymphoma
• Failed standard first-line therapy; and
• Failed autologous stem cell transplant if indicated for histology (i.e diffuse large B-cell lymphoma) or autologous stem cell transplant is not feasible
• Classical Hodgkin lymphoma
• Relapsed or refractory de novo classical Hodgkin lymphoma having failed standard first-line therapy; and
• May have failed to achieve a response or progressed after treatment with brentuximab vedotin or may be brentuximab vedotin naive but is ineligible or unable to receive brentuximab vedotin; and
• May have failed to achieve a response to, progressed after, or is ineligible for autologous stem cell transplant (auto-SCT)
• Hepatocellular carcinoma (HCC)
• Not eligible for curative attempt resection or liver transplant
• Kaposi sarcoma impacting physical and/or psychological wellbeing and not amenable to local therapy. Patients who have received prior therapy and treatment naive patients are both potentially eligible to participate.
• On antiretrovival therapy (ART) with suppressed HIV viral load for > 3 months (Note: an extended washout period is needed to avoid treatment during the period of risk for the highly toxic and often fatal "Immune Reconstitution Inflammatory Syndrome (IRIS)"
• No KSHV-associated multicentric Castleman disease in past 5 years
• No symptomatic pulmonary Kapsoi sarcoma (KS) or chest X-rays positive for un-evaluated abnormalities
• Disease evaluable by AIDS Clinical Trial Group (ACTG) KS response criteria
• CD4+ T-cell count >= 50 cells/uL
• For KS patients, the following laboratory values supersede values below:
• Platelets > lower limit of normal
• Hemoglobin > 10 g/dL
• Melanoma
• Unresectable or metastatic disease progression following a BRAF inhibitor if BRAF V600 positive
• Note: Prior therapy with ipilimumab not required

You may not qualify if…

• Active systemic immunosuppressive therapy
• Systemic steroid therapy or steroid therapy that cannot be discontinued with more than 7 consecutive days of steroids within the prior 2 weeks
• Note: the use of prednisone or equivalent < 0.125 mg/kg/day (absolute maximum of 15 mg/day) as replacement therapy is permitted; inhaled or topical corticosteroids are permitted
• Current or history of systemic autoimmune disease requiring systemic therapy
• Note: the following will NOT be exclusionary:
• The presence of laboratory evidence of autoimmune disease (e.g., positive antinuclear antibody [ANA] titer or lupus anticoagulant) without associated symptoms
• Clinical evidence of vitiligo or other forms of depigmenting illness
• Mild autoimmunity not impacting the function of major organs (e.g., limited psoriasis)
• Grade 3 or 4 immune related toxicity associated with prior ipilimumab therapy that has not resolved to grade 0 or 1
• Cardiovascular disease that meets one of the following: congestive heart failure (New York Heart Association class III or IV), active angina pectoris, or recent myocardial infarction (within the last 6 months)
• Active tuberculosis (TB) or atypical mycobacterial infection:
• Patients who are undergoing systemic antibiotics for active mycobacterial infection
• Patients with TB immune reconstitution syndrome (IRIS) requiring corticosteroids
• Note: patients who are receiving treatment for latent tuberculosis (isonicotinylhydrazide [INH] or alternative) may be eligible after discussion with the protocol P.I.
• Cirrhosis with Child-Pugh score of B or C
• Uncontrolled hepatitis B virus (HBV) infection, defined as acute liver failure or protracted, severe course, as indicated by total bilirubin > 3 mg/dL (or direct bilirubin > 1.5 mg/dL), international normalized ratio > 1.5, encephalopathy, or ascites
• Note: the following will NOT be exclusionary:
• A positive hepatitis B serology indicative of previous immunization (i.e., hepatitis B surface antibody [HBsAb] positive and hepatitis B core antibody [HBcAb] negative), or a fully resolved acute HBV infection
• Patients with chronic HBV infection suppressed by appropriate antiretroviral therapy with activity against HBV, as outlined in DHHS guidelines
• Uncontrolled hepatitis C virus (HCV) infection, defined as plasma HCV RNA detectable by PCR
• Note: the following will NOT be exclusionary:
• Positive HCV serology but no detectable HCV RNA, indicative of spontaneously cleared HCV infection
• Patients who have been successfully treated for HCV as long as therapy for HCV has been completed
• Patients who are receiving any other investigational agents for cancer
• Extensive active brain disease including symptomatic brain metastases or the presence of leptomeningeal disease, and all patients with infratentorial tumors

Where it is running

• University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States
• Zuckerberg San Francisco General Hospital — San Francisco, California, United States
• UCSF Medical Center-Parnassus — San Francisco, California, United States
• Yale University — New Haven, Connecticut, United States
• Louisiana State University Health Science Center — New Orleans, Louisiana, United States
• University of Maryland/Greenebaum Cancer Center — Baltimore, Maryland, United States
• Johns Hopkins University/Sidney Kimmel Cancer Center — Baltimore, Maryland, United States
• National Institutes of Health Clinical Center — Bethesda, Maryland, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• Laura and Isaac Perlmutter Cancer Center at NYU Langone — New York, New York, United States
• Mount Sinai Hospital — New York, New York, United States
• FHCC South Lake Union — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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