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NL-201 + Pembrolizumab for Cancer

Phase 1
Waitlist Available
Research Sponsored by Neurogene Inc.
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up upto 36 months
Awards & highlights

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.

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.Check my eligibility
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.See study design
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 below
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I have an advanced solid tumor (not prostate cancer) and no standard treatments work for me.
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I have the target disease or have been treated with pembrolizumab.
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I am fully active or can carry out light work.
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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.
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I am fully active or can carry out light work.
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My cancer can be measured by tests.
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I have kidney or skin cancer and my first treatment didn’t work.
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I have had at least one treatment for my advanced or metastatic solid tumor.
Select...
My cancer can be measured by tests.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~upto 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and upto 36 months for reporting.

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 more
Secondary 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 more
Other 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 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
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

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
3,862 Previous Clinical Trials
5,049,641 Total Patients Enrolled

Media Library

NL-201 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04659629 — Phase 1
NL-201 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04659629 — Phase 1
Solid Tumors Clinical Trial 2023: NL-201 Highlights & Side Effects. Trial Name: NCT04659629 — Phase 1
Solid Tumors Research Study Groups: Part 1: NL-201 Monotherapy Dose Escalation, Part 2: NL201 Monotherapy Expansion Cohorts, Part 3: NL-201 in Combination with Pembrolizumab Dose Escalation, Part 4: NL-201 in Combination with Pembrolizumab Expansion Cohorts

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
Kentucky
How old are they?
65+
18 - 65
What site did they apply to?
Mayo Clinic Jacksonville
Seattle Cancer Care Alliance
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
~15 spots leftby Mar 2025