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

Inclusion Criteria

• 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
• Available pretreatment biopsy, either fresh (optimal) or archival (acceptable)
• Resolution of any adverse events (AEs) from prior treatments must be resolved to baseline or grade = = 4 weeks; and
• Evidence of viral suppression defined as HIV viral load grade 1 by Common Terminology Criteria for Adverse Events (CTCAE) criteria probably or definitely attributed to cART; and
• No laboratory AEs noted on protocol defined screening laboratories > grade 1 by CTCAE criteria probably or definitely attributed to cART, with exceptions noted below
• Note: if cART is modified during the screening period, patients must be on an effective new regimen for >= 2 weeks and otherwise meet eligibility criteria
• Most patients have viral loads that are suppressible to = 50 cells/uL
• Patients must have marrow function and organ function as defined below
• Note: to remain on treatment, any abnormal lab values allowed by the PI must remain stable or improve during treatment; similar off treatment rules will be applied to all patients, except the following: the grade of any abnormal laboratory (lab) value allowed by the protocol principal investigator (PI) at enrollment wi