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Study Summary
This trial is testing the safety of NL-201 given alone or with pembrolizumab to patients with advanced cancer. The goal is to find the best dose and schedule for further testing.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT03004183Trial Design
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- I have kidney or skin cancer and my first treatment didn’t work.I have previously received IL-2-based cancer treatment.I have an advanced solid tumor (not prostate cancer) and no standard treatments work for me.I have another cancer besides the one being studied, but it hasn't needed treatment in the last 2 years.I am not currently using any experimental treatments or devices.I do not have COVID-19 or have tested negative for it recently.I have the target disease or have been treated with pembrolizumab.You haven't received nitrosurea or mitomycin C therapy for at least 6 weeks, any other chemotherapy or checkpoint inhibitor for at least 4 weeks, and any kinase inhibitor for at least 2 weeks. For Part 1 only: You have advanced solid tumor (excluding prostate cancer) that has either progressed, not responded well, or you are not eligible for any approved treatment options.I have the target disease or have been treated with pembrolizumab before.I have or had lung inflammation not caused by infection, treated with steroids.I have had at least one treatment for my advanced cancer.I have previously received CAR-T or allogeneic cellular therapy.I am currently on medication to suppress my immune system.I am fully active or can carry out light work.I have had a solid organ or bone marrow transplant.You have a serious medical condition, mental health condition, or any other unstable illness that could make it hard for you to follow the study plan or make it difficult to evaluate the safety of the study drug.It's been over 6 weeks since my last nitrosurea or mitomycin C therapy, 4 weeks since any chemotherapy or checkpoint inhibitor, and 2 weeks since any kinase inhibitor.I am fully active or can carry out light work.I have prostate cancer.My cancer can be measured by tests.I have kidney or skin cancer and my first treatment didn’t work.I have had at least one treatment for my advanced or metastatic solid tumor.My cancer can be measured by tests.
- 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.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Group 1: Part 1: NL-201 Monotherapy Dose Escalation
- Group 2: Part 2: NL201 Monotherapy Expansion Cohorts
- Group 3: Part 3: NL-201 in Combination with Pembrolizumab Dose Escalation
- Group 4: Part 4: NL-201 in Combination with Pembrolizumab Expansion Cohorts
Frequently Asked Questions
In what geographic areas is this research endeavor taking place?
"This trial can be found in 14 different medical centres, such as the Mayo Clinic Rochester in Rochester, Westchester Medical Center in Valhalla and Memorial Sloan Kettering Cancer Center. Additionally, there are other 11 sites recruiting participants for this trail."
What is the goal of this research endeavor?
"As the trial sponsor Merck Sharp & Dohme LLC have indicated, the primary outcome of this clinical study will be evaluated over a 33-day period. This assessment will measure any treatment-induced adverse effects. Other secondary outcomes include evaluating NL-201's PK profile by volume distribution, RECIST version 1.1 parameters for duration of response, and immunogenicity as it relates to anti-drug antibodies in serum during and after administration of NL-201."
Is this research endeavor accepting participants at the present time?
"The clinicaltrials.gov database confirms that this medical trial is currently not accepting participants; the initial posting was on April 26th 2021, and there have been no updates since November 30th 2022. Nevertheless, there are presently 2706 other active trials searching for volunteers to enrol in their respective studies."
To what degree could NL-201 be detrimental to one's health?
"As NL-201 is currently in Phase 1 trials, the safety rating of this medication has been assessed as a 1 due to limited data demonstrating its efficacy and security."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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