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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Part 1 Only: Patients with relapsed or refractory advanced solid tumor, other than prostate cancer, who have progressed, not tolerated or are ineligible for all approved lines of therapy
Part 4 Only: Patients with diagnosed target disease OR previously received pembrolizumab
Must not have
Prior IL-2-based cancer therapy
Concurrent therapy with any other investigational agent, vaccine, or device
Timeline
Screening 3 weeks
Treatment Varies
Follow Up upto 36 months
Awards & highlights
Summary
This trial tests the safety and effectiveness of NL-201 alone and with pembrolizumab in patients with advanced cancer. NL-201 may directly affect cancer cells, and pembrolizumab helps the immune system attack cancer. The goal is to find a safe and effective dose and schedule for these treatments. Pembrolizumab has shown efficacy and safety in treating various cancers, including melanoma.
Who is the study for?
This trial is for adults with advanced solid tumors who have tried all approved treatments without success, or can't tolerate them. They must be at least 6 weeks out from certain cancer drugs and have a good performance status. People with prostate cancer, active COVID-19, recent transplants, ongoing immunosuppression, another progressing cancer within the last 2 years (except some skin cancers), or those on other investigational therapies are excluded.
What is being tested?
The study tests NL-201 alone (Parts 1 & 2) and combined with Pembrolizumab (Parts 3 & 4) in patients with relapsed or refractory cancer. It aims to find safe dosages and schedules by evaluating how well participants tolerate these drugs and observing any potential benefits.
What are the potential side effects?
Possible side effects of NL-201 and Pembrolizumab may include reactions at the infusion site, immune-related issues affecting organs like lungs or intestines, fatigue, skin conditions, changes in blood counts leading to increased infection risk or bleeding problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have an advanced solid tumor (not prostate cancer) and no standard treatments work for me.
Select...
I have the target disease or have been treated with pembrolizumab.
Select...
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.
Select...
I am fully active or can carry out light work.
Select...
My cancer can be measured by tests.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have previously received IL-2-based cancer treatment.
Select...
I am not currently using any experimental treatments or devices.
Select...
I have previously received CAR-T or allogeneic cellular therapy.
Select...
I am currently on medication to suppress my immune system.
Select...
I have had a solid organ or bone marrow transplant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ upto 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~upto 36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of treatment-emergent adverse events
Recommended dose schedule for NL-201 (Parts 1 and 2)
Recommended dose schedule for NL-201 in combination with Pembrolizumab (Parts 3 and 4)
+3 moreSecondary outcome measures
Best Objective Response according to RECIST version 1.1
Duration of Response (DOR) according to RECIST version 1.1
Immunogenicity of NL-201
+7 moreOther outcome measures
Analysis of immune characteristics of the tumor microenvironment
Estimate additional measures of anti-tumor activity of NL- 201 per iRECIST criteria
Flow cytometry analysis of immune cells in blood
+1 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Diarrhea
9%
Anemia
9%
Shortness of Breath
9%
Abdominal pain
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Weight Loss
7%
Dyspnea
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Atrial fibrillation with rapid ventricular response
4%
Pleural effusion
2%
colitis
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
4Treatment groups
Experimental Treatment
Group I: Part 4: NL-201 in Combination with Pembrolizumab Expansion CohortsExperimental Treatment2 Interventions
NL-201 in combination with Pembrolizumab in indication specific cohorts at a dose and schedule determined in Part 3
Group II: Part 3: NL-201 in Combination with Pembrolizumab Dose EscalationExperimental Treatment2 Interventions
NL-201, in combination with a set Pembrolizumab dose, testing ascending doses and two different schedules
Group III: Part 2: NL201 Monotherapy Expansion CohortsExperimental Treatment1 Intervention
NL-201 given as monotherapy by intravenous administration in indication specific cohorts at a dose and schedule determined in Part 1.
Group IV: Part 1: NL-201 Monotherapy Dose EscalationExperimental Treatment1 Intervention
NL-201 given as monotherapy by intravenous administration testing ascending doses and two different schedules.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
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
Common treatments for solid tumors include chemotherapy, immunotherapy, and targeted therapy. Chemotherapy works by killing rapidly dividing cells, which includes cancer cells, but also affects normal cells, leading to side effects.
Immunotherapy, such as the combination of NL-201 and pembrolizumab, enhances the body's immune system to recognize and attack cancer cells. Targeted therapy involves drugs designed to target specific genetic mutations or proteins that are involved in tumor growth and progression.
These treatments are crucial for solid tumor patients as they offer different mechanisms to control or eliminate cancer, potentially improving survival rates and quality of life.
Current trends and future directions in the genetic therapy of human neoplastic disease.
Current trends and future directions in the genetic therapy of human neoplastic disease.
Find a Location
Who is running the clinical trial?
Neurogene Inc.Lead Sponsor
5 Previous Clinical Trials
81 Total Patients Enrolled
Neoleukin Therapeutics, Inc.Lead Sponsor
Merck Sharp & Dohme LLCIndustry Sponsor
3,919 Previous Clinical Trials
5,068,204 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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 or had lung inflammation not caused by infection, treated with steroids.I have previously received CAR-T or allogeneic cellular therapy.I am currently on medication to suppress my immune system.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.
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.
Awards:
This trial has 2 awards, including:- 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.
Research Study Groups:
This trial has the following groups:- 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
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