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Monoclonal Antibodies
Evolocumab + Immunotherapy for Lung Cancer (TOP2101 Trial)
Phase 2
Recruiting
Led By Scott Antonia, MD
Research Sponsored by Scott Antonia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No autoimmune disease that would constitute contraindication to receive nivolumab
Performance Status ECOG 0-1 (Appendix B).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up two years
Awards & highlights
TOP2101 Trial Summary
This trial will test the safety and tolerability of combining the drug evolucumab with standard immunotherapy in people with advanced lung cancer.
Who is the study for?
This trial is for adults over 18 with advanced non-small cell lung cancer (NSCLC) who haven't had chemotherapy, radiation, or biologic therapy for their current metastatic condition. They should have a performance status indicating they can carry out daily activities with little to no assistance and must not have other active cancers or serious autoimmune diseases.Check my eligibility
What is being tested?
The study tests the combination of Evolocumab with standard immunotherapy drugs Nivolumab and Ipilimumab in treatment-naïve patients. It aims to determine if this new mix can enhance the immune system's ability to fight lung tumors more effectively than existing treatments.See study design
What are the potential side effects?
Possible side effects include immune-related reactions that could affect various organs, infusion-related symptoms, increased risk of infections due to immune suppression, fatigue, skin issues like rash or itching, gastrointestinal problems such as diarrhea or colitis.
TOP2101 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I do not have an autoimmune disease that prevents me from taking nivolumab.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I will undergo a biopsy for research purposes only, as I don't need one for diagnosis.
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My lung cancer is at stage 4 or is incurable and has come back.
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I have a biopsy sample available for research.
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I haven't had any cancer except for non-melanoma skin cancer in the last 2 years.
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I am older than 18 years.
TOP2101 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ two years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~two years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in CD3+ tumor infiltrating lymphocytes
DLTs
Secondary outcome measures
Change in MHC-1 expression
Objective Response Rate (ORR)
Overall survival (OS)
+1 moreSide effects data
From 2020 Phase 4 trial • 259 Patients • NCT030962885%
chest pain
5%
gastrointestinal bleeding
100%
80%
60%
40%
20%
0%
Study treatment Arm
HPR - Evolocumab
HPR - Placebo
NPR - Evolocumab
NPR - Placebo
TOP2101 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: ipilimumab/nivolumab/evolucumabExperimental Treatment3 Interventions
Subjects receive ipilimumab 1 mg/kg IV every 6 weeks and nivolumab 240 mg IV every 2 weeks plus evolocumab 140 mg SC every 2 weeks
Group II: Ipilimumab/nivolumabActive Control2 Interventions
Subjects receive ipilimumab 1 mg/kg IV every 6 weeks and nivolumab 240 mg IV every 2 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
2014
Completed Phase 3
~2620
Evolocumab
2011
Completed Phase 4
~13010
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
Scott AntoniaLead Sponsor
Scott Antonia, MDPrincipal InvestigatorDuke University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You don't have a place where the doctor can take a small sample of tissue for testing before starting treatment.I have a history of active tuberculosis.My brain metastases are treated and controlled without high dose steroids.I do not have an autoimmune disease that prevents me from taking nivolumab.I have been treated with a PD1, PDL1, or PDL2 inhibitor before.I am fully active or restricted in physically strenuous activity but can do light work.I have not received live vaccines around my treatment, except for flu shots and COVID-19 vaccines.I have been diagnosed with HIV.I will undergo a biopsy for research purposes only, as I don't need one for diagnosis.I have not been in a clinical trial for a new treatment or device in the last 4 weeks.You are allergic to nivolumab or ipilimumab or any of the ingredients in these drugs.I have a history of or currently have non-infectious lung inflammation.My lung cancer is at stage 4 or is incurable and has come back.I have lung disease that could affect treatment side effect monitoring.I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.I have a biopsy sample available for research.I haven't had a heart attack in the last 6 months and my heart condition is under control.I take more than 10 mg of prednisone or an equivalent steroid daily.I do not have an active infection needing strong medication that would affect my treatment.I haven't had chemo, radiation, or targeted therapy for my current advanced lung cancer.I haven't had any cancer except for non-melanoma skin cancer in the last 2 years.My doctors agree I can safely have a biopsy.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.I haven't had major surgery other than for lung cancer in the last 2 weeks and don't have serious health issues that would make the study unsafe for me.Your TPS PD-L1 is less than 50%.You have an active Hepatitis B or C infection.You are allergic to evolocumab or any of its ingredients.I have been treated with a PCSK9 inhibitor in the last 90 days.I am older than 18 years.I am not receiving any other cancer treatments.Your lab test results must be within the normal range set by the hospital.
Research Study Groups:
This trial has the following groups:- Group 1: ipilimumab/nivolumab/evolucumab
- Group 2: Ipilimumab/nivolumab
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.
Is enrollment still available for this research project?
"According to clinicaltrials.gov, this trial is seeking volunteers as of the moment and was originally published on March 22nd 2022 before being modified last May 16th 2022."
Answered by AI
Has Evolocumab been given the greenlight by the FDA?
"The safety of Evolocumab is estimated to be a 2 as this Phase 2 trial has only produced data that suggests its security, not efficacy."
Answered by AI
How many participants are enrolled in this clinical research?
"Affirmative. According to clinicaltrials.gov, this medical research was first posted on March 22nd 2022 and has been seeking new candidates since then. 38 participants are expected from one centre of operations."
Answered by AI
What additional research has been conducted involving Evolocumab?
"At present, 786 trials are underway that explore the efficacy of Evolocumab. Of these experiments, 89 have proceeded to Phase 3 and 43683 medical centres worldwide are hosting one or more related clinical studies. Notably, many of them take place in Pittsburgh, Pennsylvania."
Answered by AI
What aims do the researchers hope to accomplish through this investigation?
"This clinical trial's primary endpoint is to observe the alteration in CD3+ tumor infiltrating lymphocyte populations over a 30-day period. Secondary endpoints include progression free survival (PFS), MHC-1 expression modification, and objective response rate (ORR). PFS is determined by tracking from treatment initiation until either disease progression or mortality occurs first, whereas ORR gauges complete or partial responses amongst treated subjects."
Answered by AI
What medical purposes does Evolocumab predominantly serve?
"Evolocumab is commonly prescribed to treat cutaneous melanoma, as well as other serious illnesses such as malignant neoplasms, unresectable melanomas and diseases previously treated with anti-angiogenic therapy."
Answered by AI
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