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Pembrolizumab + Investigational Agents for Non-Small Cell Lung Cancer
Phase 2
Waitlist Available
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has not received prior systemic treatment for metastatic NSCLC
Has a histologically- or cytologically-confirmed diagnosis of Stage IV squamous or non-squamous NSCLC
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 27 months
Awards & highlights
Study Summary
This trial is testing a new cancer treatment and its side effects.
Who is the study for?
This trial is for adults with advanced Non-Small Cell Lung Cancer (NSCLC) that tests positive for PD-L1 and haven't had treatment before. They must have good organ function, agree to use contraception, and not be pregnant or breastfeeding. Excluded are those with certain infections, heart conditions, other cancers within 2 years, severe allergies to monoclonal antibodies, or prior treatments like chemotherapy.Check my eligibility
What is being tested?
The study examines the effectiveness and safety of pembrolizumab combined with MK-4830 or MK-0482 in patients who haven't been treated previously for their lung cancer. It's part of a larger research project looking at different substudies under one main protocol.See study design
What are the potential side effects?
Potential side effects may include immune-related reactions such as inflammation in various organs, infusion-related symptoms like fever or chills, fatigue, possible infection risks due to immune system suppression by the drugs being tested.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have not had any treatment for my advanced lung cancer.
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My lung cancer is at stage IV, confirmed by lab tests.
Select...
My lung cancer is non-squamous and I can't have approved targeted treatments.
Select...
My cancer tests show at least 1% of cells have PD-L1.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 27 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 27 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Secondary outcome measures
Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)
Number of Participants Who Experience One or More Adverse Events (AEs)
Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Trial Design
2Treatment groups
Experimental Treatment
Group I: Pembrolizumab + MK-4830Experimental Treatment2 Interventions
On Day 1 of each 3-week cycle, participants receive pembrolizumab 200 mg intravenously (IV) PLUS MK-4830 IV for a maximum of 35 cycles (approximately 2 years)
Group II: Pembrolizumab + MK-0482Experimental Treatment2 Interventions
On Day 1 of each 3-week cycle, participants receive pembrolizumab 200 mg intravenously (IV) PLUS MK-0482 IV for a maximum of 35 cycles (approximately 2 years)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,702 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,886 Previous Clinical Trials
5,054,451 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,063,360 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant or breastfeeding and either cannot become pregnant or will use contraception for 120 days after treatment.I have been diagnosed with HIV.I have an autoimmune disease treated with medication in the last 2 years.I have serious heart problems, including recent heart attacks or severe heart failure.I have not had any treatment for my advanced lung cancer.I stopped immunotherapy due to a severe side effect.I have been diagnosed with small cell lung cancer.I have not received any live vaccines other than approved COVID-19 vaccines in the last 30 days.I have a history of Hepatitis B or active Hepatitis C.I had major surgery less than 3 weeks ago.I've had lung radiation over 30 Gray in the last 6 months.I can provide a recent or archived tumor sample not previously treated with radiation.I haven't had cancer treatment in the last 4 weeks or still have side effects from past treatments.My organs are functioning well enough for treatment.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.I have previously been treated with immunotherapy for my cancer.I agree to use contraception and not donate sperm for 120 days after my last treatment dose.I have cancer that has spread to my brain or spinal cord.I have another cancer that is getting worse or was treated in the last 2 years.My lung cancer is at stage IV, confirmed by lab tests.I have had pneumonitis treated with steroids or have it now.I am currently being treated for an infection.I have received a transplant from another person.You had a bad reaction to a specific type of medicine called monoclonal antibodies, including pembrolizumab.My lung cancer is non-squamous and I can't have approved targeted treatments.My cancer tests show at least 1% of cells have PD-L1.I have received chemotherapy or targeted therapy for my cancer after it spread.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab + MK-4830
- Group 2: Pembrolizumab + MK-0482
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 is the maximum enrollment for this experimental procedure?
"In order to move forward, this clinical study requires 120 willing and eligible participants. These individuals can enroll at different sites, such as UCSF Medical Center at Mission Bay ( Site 0007) located in Washington, District of Columbia or Georgetown University ( Site 0036) in Boston, Massachusetts."
Answered by AI
For what sorts of health issues is MK-4830 generally prescribed?
"While malignant neoplasms are the primary condition that MK-4830 treats, this medication can also be used to help patients with unresectable melanoma, microsatellite instability high, and disease progression after chemotherapy."
Answered by AI
Are there still places available in this experiment for new participants?
"That is correct. The clinical trial is recruiting patients as the information on clinicaltrials.gov indicates. The trial was first posted on December 22nd 2020 and was most recently edited on October 31st 2022. The trial is looking for 120 patients at 15 sites."
Answered by AI
Can you tell me if MK-4830 has been studied before?
"At the moment, there are a total of 1000 ongoing studies that are investigating MK-4830. Out of those, 122 are in Phase 3. The majority of these trials are situated in Houston, Texas; however, there are 35906 locations worldwide where research is being conducted."
Answered by AI
Could you please list the potential side effects of MK-4830?
"MK-4830's safety is estimated to be a 2. In clinical trials, Phase 2 means that there is some evidence that the drug is safe, but no efficacy data yet."
Answered by AI
Where are the patients for this trial being seen?
"Right now, there are 15 active sites for this trial. If you live near Washington, Boston, or Lexington, you may have a location nearby. Keep in mind, if you decide to participate it is best to select a site close to you to reduce travel time and expenses."
Answered by AI
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