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Monoclonal Antibodies
NC410 + Pembrolizumab for Advanced Cancer
Phase 1 & 2
Recruiting
Research Sponsored by NextCure, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants with solid tumors known to be associated as MSS/MSI-low in the majority including: CRC, Gastric including GE junction, Esophageal, Ovarian, and H&N cancer (regardless of prior treatment with ICIs) with disease progression after at least one line of systemic standard of care therapy prior to enrollment
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Study Summary
This trial tests a new cancer therapy to see if it's safe and effective. It's for people with advanced, hard-to-treat or never-treated tumors.
Who is the study for?
Adults with advanced unresectable/metastatic solid tumors, including specific cancers like colorectal, stomach, esophageal, and ovarian. Participants must have progressed after standard therapy or be ICI refractory. They should agree to contraception use and not expect a child soon. Adequate organ function and an ECOG status of 0-1 are required.Check my eligibility
What is being tested?
The trial is testing the combination of NC410 with Pembrolizumab for safety, tolerability, and effectiveness in treating various advanced solid tumors that are either resistant to immune checkpoint inhibitors (ICIs) or haven't been treated with ICIs if they're microsatellite stable/low.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system affecting organs, infusion-related reactions from the drug administration process, fatigue, digestive issues such as nausea or diarrhea, blood disorders like anemia or clotting problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is not highly mutated and has worsened after treatment.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My cancer is advanced, cannot be surgically removed, and may have spread.
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My cancer has worsened despite treatment with specific immune therapy.
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I am a man and agree to use birth control and not donate sperm for 120 days after my last treatment.
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My cancer is not highly mutated and I haven't been treated with immune checkpoint inhibitors after it worsened following standard treatment.
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My organs are functioning well.
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I am at least 18 years old.
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I had hepatitis C but my viral load is now undetectable.
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I am not pregnant or breastfeeding, and if I can have children, I agree to use birth control as per the study's requirements.
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I can provide a recent (within 5 years) or new biopsy of my tumor that hasn't been treated with radiation.
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I am HBsAg positive but have been on HBV therapy for 4 weeks with an undetectable viral load.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Define a recommended Phase 2 dose (RP2D) of NC410 when combined with standard dose Pembrolizumab
Number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0
Secondary outcome measures
Disease Control Rate per RECIST
Duration of Response per RECIST
Objective Response Rate per RECIST
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: NC410 and pembrolizumabExperimental Treatment2 Interventions
All participants will receive NC410 (IV) and pembrolizumab (IV) according to the treatment schedule until a reason for treatment discontinuation is reached.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
pembrolizumab
2017
Completed Phase 3
~5750
Find a Location
Who is running the clinical trial?
NextCure, Inc.Lead Sponsor
6 Previous Clinical Trials
417 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,422 Total Patients Enrolled
Han Myint, MDStudy DirectorNextCure, Inc.
4 Previous Clinical Trials
258 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is not highly mutated and has worsened after treatment.My organs are functioning well.I have or had lung inflammation that needed steroids.I am currently being treated for an infection.I have received a transplant from another person.My cancer is advanced, cannot be surgically removed, and may have spread.I haven't had any cancer treatment or experimental drugs in the last 4 weeks.My cancer has worsened despite treatment with specific immune therapy.My cancer is not highly mutated and I haven't been treated with immune checkpoint inhibitors after it worsened following standard treatment.I have not received a live vaccine in the last 30 days.I have another cancer that is getting worse or was treated in the last 3 years.I am fully active or restricted in physically strenuous activity but can do light work.I am a man and agree to use birth control and not donate sperm for 120 days after my last treatment.I have an immune system disorder or have been on steroids or other immune-weakening drugs recently.I am severely allergic to Pembrolizumab, NC410, or their ingredients.I am at least 18 years old.You have a condition that can be measured by the local doctor or radiologist using specific guidelines.I have received G-CSF or GM-CSF treatment within the last week.I have a known history of HIV.I have been treated for an autoimmune disease in the last 2 years.I have not had radiotherapy in the last 2 weeks or suffered from radiation pneumonitis.I had hepatitis C but my viral load is now undetectable.I am not pregnant or breastfeeding, and if I can have children, I agree to use birth control as per the study's requirements.I stopped a cancer treatment due to severe side effects.I received a COVID-19 vaccine less than 14 days before starting the study treatment.I have active brain metastases or cancer in the lining of my brain.I can provide a recent (within 5 years) or new biopsy of my tumor that hasn't been treated with radiation.I am HBsAg positive but have been on HBV therapy for 4 weeks with an undetectable viral load.
Research Study Groups:
This trial has the following groups:- Group 1: NC410 and 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the aims of this clinical investigation?
"Merck Sharp & Dohme LLC, the sponsor of this medical trial, has outlined that its primary outcome - to be evaluated over a 24 month period - is determining an appropriate dosage level for NC410 when administered alongside pembrolizumab. Additionally, secondary endpoints such as Disease Control Rate according to RECIST v1.1 and Progression-free Survival per Response Evaluation Criteria in Solid Tumors (RECIST) will also be evaluated throughout this study's duration."
Answered by AI
How many facilities are involved in the oversight of this research?
"The clinical trial is being conducted out of Northwest Cancer Specialist in Vancouver, Washington, MD Anderson Cancer Center in Houston, Texas and UT Health San Antonio in San Antonio, Colorado as well as eleven other medical centres."
Answered by AI
What is the enrollment capacity for this research endeavor?
"The sponsor, Merck Sharp & Dohme LLC is in search of 131 eligible patients to participate in this trial. Potential locations include Northwest Cancer Specialist located in Vancouver, Washington and MD Anderson Cancer Center situated within Houston, Texas."
Answered by AI
Are there still patient slots available for this clinical investigation?
"This clinical trial is actively enrolling participants. Data from clinicaltrials.gov indicates the study was first published on October 6th 2022 and subsequently updated November 9th of that same year."
Answered by AI
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