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L-NMMA + Pembrolizumab for Cancer
Study Summary
This trial is testing the safety of combining two cancer treatments: pembrolizumab and NG-monomethyl-L-arginine (L-NMMA). Pembrolizumab is a type of treatment that stimulates the immune system to attack cancer cells. L-NMMA is a nitric oxide synthase inhibitor. The use of L-NMMA and pembrolizumab together may make the immune system work harder to attack and destroy the cancer cells.
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- You have a known history of HIV.You have a condition where your heart takes longer than normal to recharge between beats.Your heart pumps blood effectively, with a measurement of at least 45%.You are taking medications that can interact with nitrates or nitrites.You are expected to live for at least 6 more months.You have a current case of tuberculosis.You have head and neck cancer that has come back after or didn't respond to platinum-containing chemotherapy.You have received chemotherapy, targeted therapy, or radiation therapy within 4 weeks before the study, and haven't fully recovered from any side effects.You currently have active hepatitis B or hepatitis C.You have advanced lung cancer with high PD-L1 expression and no specific gene mutations.You have advanced or spread-out urothelial carcinoma that cannot be treated with platinum-containing chemotherapy, or the cancer has come back after platinum-containing chemotherapy.You have advanced cervical cancer that has gotten worse after chemotherapy and cannot be treated with certain types of chemotherapy.You are able to take care of yourself and do your normal activities without much difficulty.You have a history of high blood pressure that has not been well managed (systolic blood pressure >150 mmHg).You have taken a specific type of cancer treatment within the last 4 weeks, or have not fully recovered from side effects of a treatment taken more than 4 weeks ago.You have another type of cancer that is getting worse or needs treatment, except for certain types of skin cancer or early-stage cervical cancer.You have been diagnosed with advanced esophageal cancer that has grown despite receiving one or more previous treatments, and your tumors have a specific level of a protein called PD-L1.You have advanced melanoma that has not been treated before or has come back after previous treatment with specific medications.You have advanced lung cancer that has tested positive for a protein called PD-L1, and you have already tried a certain type of chemotherapy. If you have specific genetic changes in your cancer, you must have already received a targeted treatment approved by the FDA for those changes.Your heart takes longer than normal to recharge between beats, even when your potassium and magnesium levels are normal.You have been diagnosed with advanced skin cancer that has come back or spread, and you have not had any treatment for it before.You have a specific type of cancer that has come back after treatment, and there are no other good treatment options for it.You have had a heart attack, stroke, serious heart rhythm problems, or abnormal heart function within the past year.You are currently using any complementary or alternative medicines.You have advanced small cell lung cancer that has gotten worse after platinum-based chemotherapy and at least one other treatment.You have Merkel Cell Carcinoma that has come back or has spread, and you haven't had treatment for it before.You have cancer that has spread to your brain, unless it has been treated and has not gotten worse for at least 4 weeks. If you have cancer in the lining of your brain, you cannot participate in the trial.You have liver cancer (HCC) and have already been treated with sorafenib.You have a condition that weakens your immune system, or you are taking medications that lower your body's ability to fight off infections.You have been diagnosed with advanced kidney cancer and have not started treatment for it yet.You have an autoimmune disease that needed strong medication in the last 2 years.You have had lung inflammation in the past that needed steroids, or you currently have lung inflammation.You currently have an infection that needs medicine to treat it throughout your body.Your disease can be measured using specific criteria called RECIST 1.1.You have a certain type of confirmed cancer that has come back after trying three or more treatments, or it did not respond to treatment.You are allergic to L-NMMA or pembrolizumab.Adults with advanced cancer that has many genetic mutations.You have been treated with a specific type of medication that affects the immune system before.You have a history of serious heart disease classified as New York Heart Association class III or higher.You have a specific type of lymphoma called primary mediastinal large B-cell lymphoma and it has come back after trying different treatments.You have advanced stomach cancer that has not responded to at least two different types of chemotherapy, including a specific test showing your tumor has a certain protein called PD-L1.
- Group 1: L-NMMA Plus Pembrolizumab
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
What pathologies has Pembrolizumab been shown to be efficacious for?
"Patients with malignant neoplasms, unresectable melanoma or microsatellite instability high may benefit from the use of Pembrolizumab."
Could you explain the potential detriments of using Pembrolizumab?
"Clinical data regarding the safety of Pembrolizumab is limited, so it was assigned a score of 1."
How many participants will this clinical trial be recruiting?
"This experimental trial has stopped recruiting new participants, with the initial post being published on August 3rd 2018 and last edited July 8th 2022. For those seeking other studies relating to melanoma or pembrolizumab, there are currently 6954 active trials for malignant conditions and 963 specifically involving pembrolizumab."
Are there any other experiments involving Pembrolizumab that have been conducted previously?
"At present, there are 963 active investigations of Pembrolizumab with 122 trials in the third phase. Houston, Texas is a prominent hub for pembrolizumab research; however, 35733 different sites across the world are conducting studies on this drug."
Are there any current opportunities to enroll in this medical experiment?
"Unfortunately, this research has concluded its recruitment phase. Initial postings were made on August 3rd 2018 and the latest update was July 8th 2022. Nevertheless, if a patient is still looking for clinical trials to be involved in, there are 6954 studies recruiting participants with melanoma or malignant conditions and 963 open opportunities related to pembrolizumab available at present."
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