What side effects are associated with this type of intervention?

Common treatments for HIV/AIDS include antiretroviral therapy (ART) and monoclonal antibodies like pembrolizumab. ART can cause side effects such as nausea, fatigue, and diarrhea, while long-term use may lead to metabolic changes and cardiovascular issues. Monoclonal antibodies, which help the immune system attack cancer and interfere with tumor cell growth, can cause immune-related adverse events (irAEs) such as dermatologic reactions, gastrointestinal issues, hepatic inflammation, and endocrine disturbances. These side effects arise from the general enhancement of the immune system.

What prior FDA approvals exist?

The FDA has approved several treatments for HIV/AIDS, primarily focusing on antiretroviral therapies (ART) that inhibit the virus's ability to replicate. These include nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), protease inhibitors (PIs), integrase strand transfer inhibitors (INSTIs), and entry inhibitors. While pembrolizumab is a monoclonal antibody used in cancer treatment, similar immunotherapeutic approaches for HIV/AIDS are still largely investigational. One example is the use of broadly neutralizing antibodies (bNAbs) that target the HIV envelope protein to enhance the immune response against the virus. These therapies aim to control HIV replication and potentially achieve a functional cure.

What other types of research exist?

Promising alternatives to Pembrolizumab for HIV/AIDS patients in 2024 include Avelumab and Nivolumab. Avelumab targets PD-L1 and has shown durable responses in clinical trials. Nivolumab, which targets PD-1, has demonstrated efficacy in various cancers and may be a viable option for HIV/AIDS patients.

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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

No Placebo-Only Group

Summary

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.

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the first dose of study drug to death due to any cause, assessed up to 3 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Frequency of Observed Adverse Events (AEs)

Incidence of Immune-related Events of Clinical Interest (irECI)

Incidence of cART-related ECIs of Grade 2 or Higher AEs

Secondary study objectives

Duration of Response (Cohorts 1-3)

Duration of Response (Kaposi Sarcoma Cohort)

Objective Response Rate (Cohorts 1-3)

+5 more

Side effects data

From 2024 Phase 3 trial • 804 Patients • NCT03040999

64%

Radiation skin injury

63%

Stomatitis

58%

Anaemia

56%

Nausea

48%

Dry mouth

45%

Constipation

45%

Weight decreased

44%

Dysphagia

42%

Neutrophil count decreased

33%

Dysgeusia

33%

Vomiting

32%

Fatigue

31%

White blood cell count decreased

28%

Hypomagnesaemia

26%

Decreased appetite

25%

Hypothyroidism

25%

Hypokalaemia

24%

Lymphocyte count decreased

24%

Platelet count decreased

23%

Oropharyngeal pain

23%

Blood creatinine increased

22%

Diarrhoea

22%

Odynophagia

20%

Hypoacusis

20%

Alanine aminotransferase increased

20%

Hyponatraemia

19%

Tinnitus

19%

Oral candidiasis

19%

Asthenia

16%

Pyrexia

16%

Cough

15%

Aspartate aminotransferase increased

15%

Rash

14%

Insomnia

13%

Acute kidney injury

13%

Pharyngeal inflammation

13%

Pruritus

12%

Dysphonia

12%

Gamma-glutamyltransferase increased

11%

Pneumonia

11%

Dehydration

10%

Hyperthyroidism

10%

Hypoalbuminaemia

10%

Hypocalcaemia

10%

Headache

10%

Productive cough

Neck pain

Peripheral sensory neuropathy

Gastrooesophageal reflux disease

Hiccups

Hyperglycaemia

Hyperuricaemia

Dizziness

Hypophosphataemia

Urinary tract infection

Ear pain

Localised oedema

Hyperkalaemia

Erythema

Oral pain

Abdominal pain upper

Arthralgia

Anxiety

Febrile neutropenia

Dyspepsia

Saliva altered

Back pain

Oedema peripheral

Hypertension

Dyspnoea

Nasopharyngitis

Alopecia

Dry skin

Sepsis

Pneumonia aspiration

Trismus

Pneumonitis

Laryngeal oedema

Malnutrition

Pharyngeal haemorrhage

Cellulitis

Septic shock

Systemic infection

Clostridium difficile colitis

Cardiac arrest

Death

Bronchitis

Hepatitis

Immune-mediated hepatitis

Oesophagitis

General physical health deterioration

Hypophagia

Tumour haemorrhage

Cerebrovascular accident

Syncope

Acute respiratory failure

Aspiration

Colitis

Mouth haemorrhage

Hypersensitivity

Acute myocardial infarction

Abscess neck

Device related infection

Stoma site infection

Vascular device infection

Wound infection

Hypercalcaemia

Pulmonary embolism

Respiratory failure

100%

80%

60%

40%

20%

Study treatment Arm

Pembrolizumab + CRT Followed by Pembrolizumab

Placebo + CRT Followed by Placebo

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Antiretroviral Therapy

2016

Completed Phase 1

~220

Biopsy

2014

Completed Phase 4

~1150

Biospecimen Collection

2004

Completed Phase 3

~2030

Computed Tomography

2017

Completed Phase 2

~2790

Pembrolizumab

2017

Completed Phase 3

~3150

Positron Emission Tomography

2011

Completed Phase 2

~2200

0 / 14Eligibility criteria met

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.