Pembrolizumab for Cancer in Patients with HIV

Recruiting in Palo Alto (17 mi)

+13 other locations

Overseen byKathryn Lurain

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Breakthrough Therapy

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial studies pembrolizumab, an immunotherapy drug, in HIV patients with hard-to-treat cancers. The drug helps the immune system attack cancer cells by blocking a protein that stops the immune response. Pembrolizumab has shown efficacy in various cancers, including melanoma, lung cancer, and head and neck cancer. The goal is to see if it is safe and effective for these patients.

Research Team

Kathryn Lurain

Principal Investigator

Cancer Immunotherapy Trials Network

Eligibility Criteria

This trial is for adults with HIV and advanced or treatment-resistant cancers, including lung cancer, melanoma, lymphomas, and other solid tumors. Participants must have previously undergone therapy without success or be ineligible for standard treatments. They should be on effective anti-HIV drugs with a suppressed viral load and adequate organ function. Pregnant women, those with severe illnesses or autoimmune diseases that require systemic treatment are excluded.

Inclusion Criteria

My advanced lung cancer progressed after treatment, and I've had targeted therapy if needed.

Patients must have marrow function and organ function as defined below; leukocytes no lower limit; absolute neutrophil count > 500/mcL; platelets > 50,000/mcL; hemoglobin > 9 g/dL; total bilirubin < 1.5 X upper limit of normal (ULN); aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) < 2.5 X institutional ULN; creatine kinase < 5 X institutional ULN; serum creatinine < 2.5 X institutional ULN OR measured or calculated* creatinine clearance (CrCl) (glomerular filtration rate [GFR] can also be used in place of creatinine or CrCl) >= 30 mL/min for subject with creatinine levels > 2.5 X institutional ULN; thyroid stimulating hormone (TSH) within institutional limits (ie: normal); Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 1; at least 2 weeks from end of chemotherapy with resolution of neutropenia to above level; at least 2 weeks from end of radiation therapy; at least 4 weeks from end of monoclonal antibody therapy; at least 2 weeks from end of targeted therapy; female patients of childbearing potential must have a negative urine or serum pregnancy within 72 hours before receiving the first dose of study medication; age >= 18 years; ability to understand and willingness to sign a written informed consent document

My advanced cancer has no standard treatment left, or I can't receive it, but anti-PD-1 therapy could work based on studies.

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Exclusion Criteria

You are currently taking any other experimental cancer drugs.

I am not on long-term steroids or immune-suppressing drugs.

Pregnancy or nursing or unwilling to take adequate birth control during therapy

See 11 more

Treatment Details

Interventions

Pembrolizumab (Checkpoint Inhibitor)

Trial OverviewThe study tests pembrolizumab's safety in patients who have both HIV and various types of advanced cancers. Pembrolizumab is an immunotherapy drug designed to boost the body's immune response against cancer cells by blocking a specific pathway known as PD-1/PD-L1.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (pembrolizumab and cART)Experimental Treatment6 Interventions

Patients receive pembrolizumab IV over 30 minutes on day 1. Patients continue receiving their recommended combination antiretroviral therapy PO QD. Cycles repeat every 21 days for up to 2 years or 35 doses in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or PET/CT and blood sample collection throughout the trial. Patients may also undergo biopsies during screening and on study.