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L-NMMA + Pembrolizumab for Cancer
Phase 1
Waitlist Available
Led By Jorge Darcourt, M.D.
Research Sponsored by Jorge G. Darcourt
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 weeks
Awards & highlights
No Placebo-Only Group
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.
Who is the study for?
Adults with certain advanced cancers (like melanoma, lung cancer, and others) who have specific health criteria like a good heart function and life expectancy of at least 6 months. They should not be pregnant or breastfeeding and must agree to use contraception. People with HIV, recent vaccines, active infections like TB or hepatitis B/C, autoimmune diseases needing treatment in the last 2 years, or those on immunosuppressants can't join.
What is being tested?
The trial is testing L-NMMA combined with Pembrolizumab for various advanced cancers. L-NMMA inhibits nitric oxide synthase which may enhance immune response against cancer cells. Pembrolizumab blocks PD-1 signals that let cancer hide from the immune system.
What are the potential side effects?
Possible side effects include reactions related to the immune system attacking normal organs (autoimmune reactions), infusion-related reactions where the drug enters the body, fatigue, potential liver issues (hepatitis), skin problems like rash or itchiness.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Maximum tolerated dose (MTD)
Secondary study objectives
Antitumor activity
Dose-limiting toxicities (DLTs) and other adverse events
Plasma concentrations of L-NMMA when combined with pembrolizumab
+1 moreAwards & 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: L-NMMA Plus PembrolizumabExperimental Treatment2 Interventions
L-NMMA and pembrolizumab will be administered for 6 cycles. Cycle length will be 21 days. L-NMMA will be administered as a 2-hour intravenous (IV) infusion on Days 1-5 at each cycle. The dose levels of L-NMMA are as follows: Dose Level -1, 12.5 mg/kg; Dose Level 0 (starting dose), 15.0 mg/kg; and Dose Level 1, 20 mg/kg. L-NMMA dose will escalate/de-escalate based on the occurrence of dose-limiting toxicities. Pembrolizumab at a fixed dose of 200 mg will be IV infused over 30 minutes on Day 5 at each cycle. Pembrolizumab will be administered 1 hour after L-NMMA infusion on Day 5 at each cycle. Subjects without disease progression after 6 cycles of L-NMMA and pembrolizumab will continue pembrolizumab until disease progression or unacceptable AEs.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~2810
L-NMMA
2010
Completed Phase 4
~420
Find a Location
Who is running the clinical trial?
Jorge G. DarcourtLead Sponsor
The Methodist Hospital Research InstituteLead Sponsor
285 Previous Clinical Trials
81,674 Total Patients Enrolled
Jorge Darcourt, M.D.Principal InvestigatorHouston Methodist Cancer Center
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Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: L-NMMA Plus Pembrolizumab
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.
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