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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
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
Study 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 belowSelect...
My advanced lung cancer progressed after treatment, and I've had targeted therapy if needed.
Select...
I have non-Hodgkin lymphoma that didn't respond to first-line therapy or a stem cell transplant.
Select...
My liver cancer cannot be treated with surgery or transplant.
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
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 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
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%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
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
Pembrolizumab
2017
Completed Phase 2
~2010
Antiretroviral Therapy
2018
N/A
~160
Biospecimen Collection
2004
Completed Phase 2
~1730
Biopsy
2014
Completed Phase 4
~850
Positron Emission Tomography
2008
Completed Phase 2
~2240
Computed Tomography
2017
Completed Phase 2
~2720
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,097 Total Patients Enrolled
Kathryn LurainPrincipal InvestigatorCancer Immunotherapy Trials Network
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently taking any other experimental cancer drugs.I am not on long-term steroids or immune-suppressing drugs.I do not have active TB, severe liver disease, or uncontrolled hepatitis.I have serious heart issues, including recent heart attack or severe heart failure.I have had an organ or tissue transplant and it is still in place.I have not received any live vaccines in the last 30 days.My advanced lung cancer progressed after treatment, and I've had targeted therapy if needed.I have or had an autoimmune disease that needed treatment.I do not have extensive brain cancer, including symptomatic brain metastases or leptomeningeal disease.I do not have any uncontrolled illnesses like infections or heart problems.My advanced cancer has no standard treatment left, or I can't receive it, but anti-PD-1 therapy could work based on studies.My Hodgkin lymphoma has not improved or has worsened after standard treatment.My Kaposi sarcoma affects my health or mood and can't be treated locally.I have non-Hodgkin lymphoma that didn't respond to first-line therapy or a stem cell transplant.My melanoma can't be surgically removed or has spread, and I've had a BRAF inhibitor treatment.I have severe lung problems that need oxygen therapy or had serious lung inflammation.I have severe fluid buildup in my abdomen or around my lungs.My liver cancer cannot be treated with surgery or transplant.I am on HIV treatment with controlled virus levels, no recent severe infections, and a healthy immune cell count.I am on HIV treatment, have low viral load, no severe side effects, and my CD4 count is above 50.I am allergic to medications similar to pembrolizumab.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (pembrolizumab and cART)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it currently possible to enroll in this clinical experiment?
"As displayed on clinicaltrials.gov, this experiment is actively seeking participants. It was initially listed on February 3rd 2016 and then updated November 16th 2022."
Answered by AI
How many participants is the trial's maximum capacity?
"Adhering to the study's inclusion criteria, 60 eligible patients will be needed for this trial. Participants can join from various locations including University of Maryland/Greenebaum Cancer Center in Baltimore, California and UCSF Medical Center-Parnassus in San Francisco, New york."
Answered by AI
To what extent are medical centers within this state participating in the clinical trial?
"This medical trial is taking place at 11 sites, the most prominent of which are University of Maryland/Greenebaum Cancer Center in Baltimore, UCSF Medical Center-Parnassus in San Francisco, and Laura and Isaac Perlmutter Cancer Center at NYU Langone in New york. There are 8 other participating centres as well."
Answered by AI
What are the fundamental goals of this trial?
"This trial seeks to monitor the prevalence of immune-related adverse events over a 90 day period. Secondary objectives include evaluating objective response rate (CR/PR) according to RECIST 1.1 or other cancer-specific criteria, overall survival using Kaplan Meier estimations, and best objective response rate in Cohort 4 as judged by ACTG standards."
Answered by AI
What medical conditions has Pembrolizumab been proven to successfully address?
"Pembrolizumab is a medication frequently employed to combat malignant neoplasms, and it can also be prescribed for unresectable melanoma, microsatellite instability high, or in cases where chemotherapy has failed."
Answered by AI
To what extent can Pembrolizumab be a hazard to people's health?
"Given the extremely limited data surrounding Pembrolizumab, our team at Power assigned it a safety score of 1. This is largely due to the study being in its initial phase with minimal information regarding efficacy and safety available."
Answered by AI
Are there any previous endeavors that have employed Pembrolizumab?
"Since it was first studied in 2010 at City of Hope, pembrolizumab has been subject to 805 clinical trials with positive results. Currently, 961 further studies are actively recruiting participants, many of which are based out of Baltimore and California."
Answered by AI
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