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Checkpoint Inhibitor

Pembrolizumab for Cancer in Patients with HIV

Phase 1
Waitlist Available
Led By Kathryn Lurain
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Non-small cell lung cancer (NSCLC) - Metastatic or locally advanced disease that progressed after at least one prior therapy; 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
Must not have
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
Active tuberculosis (TB) or atypical mycobacterial infection; cirrhosis with Child-Pugh score of B or C; uncontrolled hepatitis B virus (HBV) infection; uncontrolled hepatitis C virus (HCV) infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the first dose of study drug to death due to any cause, assessed up to 3 years
Awards & highlights

Summary

This trial studies the side effects of pembrolizumab in treating patients with HIV and cancer.

Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
Pembrolizumab may cause side effects such as fatigue, skin reactions, diarrhea, liver inflammation (hepatitis), hormonal gland problems (like thyroid dysfunction), infusion-related reactions, lung issues (pneumonitis), and can potentially worsen the immune system.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My advanced lung cancer progressed after treatment, and I've had targeted therapy if needed.
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I have non-Hodgkin lymphoma that didn't respond to first-line therapy or a stem cell transplant.
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My liver cancer cannot be treated with surgery or transplant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not on long-term steroids or immune-suppressing drugs.
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I do not have active TB, severe liver disease, or uncontrolled hepatitis.
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I have serious heart issues, including recent heart attack or severe heart failure.
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I have had an organ or tissue transplant and it is still in place.
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I have or had an autoimmune disease that needed treatment.
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I do not have extensive brain cancer, including symptomatic brain metastases or leptomeningeal disease.
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I do not have any uncontrolled illnesses like infections or heart problems.
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I have severe lung problems that need oxygen therapy or had serious lung inflammation.
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I have severe fluid buildup in my abdomen or around my lungs.
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I am allergic to medications similar to pembrolizumab.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the first dose of study drug to death due to any cause, assessed up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the first dose of study drug to death due to any cause, assessed up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Frequency of observed adverse events (AEs)
Incidence of cART-related ECIs of grade 2 or higher AEs
Incidence of immune-related events of clinical interest (ECIs)
Secondary outcome measures
Best objective response rate (partial response + completion response)(Cohort 4)
Duration of response (Cohort 4)
Duration of response (Cohorts 1-3)
+5 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Pneumothorax
5%
Malnutrition, Hypercalcemia and Weakness
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1720
Pembrolizumab
2017
Completed Phase 2
~2010
Antiretroviral Therapy
2018
N/A
~160
Biopsy
2014
Completed Phase 4
~1090
Positron Emission Tomography
2008
Completed Phase 2
~2210
Computed Tomography
2017
Completed Phase 2
~2720

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for HIV/AIDS include antiretroviral therapy (ART) and immune-based therapies. ART works by inhibiting the replication of the virus at various stages of its life cycle, using drugs such as reverse transcriptase inhibitors, protease inhibitors, and integrase inhibitors. This reduces the viral load, helps maintain immune function, and prevents the progression to AIDS. Immune-based therapies, like pembrolizumab, are being studied for their potential to enhance the immune system's ability to fight HIV. Pembrolizumab, a monoclonal antibody, helps the immune system attack cancer cells and may interfere with tumor cell growth and spread. This approach is significant for HIV/AIDS patients as it could offer a novel way to control the virus and improve immune function, potentially leading to better long-term outcomes.
Review Article: Immune Landscape and Immunotherapy Options in Cervical Carcinoma.A Comparative and Comprehensive Review of Antibody Applications in the Treatment of Lung Disease.Targeting the JAK/STAT Pathway in T Cell Lymphoproliferative Disorders.

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,748 Previous Clinical Trials
40,959,345 Total Patients Enrolled
Kathryn LurainPrincipal InvestigatorCancer Immunotherapy Trials Network

Media Library

Pembrolizumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02595866 — Phase 1
HIV/AIDS Research Study Groups: Treatment (pembrolizumab and cART)
HIV/AIDS Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT02595866 — Phase 1
Pembrolizumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02595866 — Phase 1
~6 spots leftby Jul 2025