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MK-1484 + Pembrolizumab for Cancer
Phase 1
Recruiting
Research Sponsored by Merck Sharp & Dohme LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has provided an evaluable archival or newly obtained tumor tissue sample for biomarker analysis.
Has normal cardiac function based on transthoracic echocardiogram (TTE) or multigated acquisition scan (MUGA).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 27 months
Awards & highlights
Study Summary
This trial is testing a new cancer drug to see if it is safe and effective.
Who is the study for?
Adults with advanced or metastatic solid tumors who have tried all other treatments or can't tolerate them are eligible. They must have measurable disease, normal heart function, and adequate organ function. Participants need to provide a tumor sample for analysis and agree to use contraception. Excluded are those with certain lung conditions, recent transplants, active infections including HIV/HBV/HCV, uncontrolled diseases or conditions that could affect the trial's outcome.Check my eligibility
What is being tested?
The study is testing MK-1484 alone and combined with Pembrolizumab in patients with advanced solid tumors. It aims to find out how safe these treatments are and determine the best dose for Phase 2 trials.See study design
What are the potential side effects?
While not specified here, common side effects of cancer immunotherapy like MK-1484 and Pembrolizumab may include fatigue, skin reactions, inflammation in organs such as lungs (pneumonitis), liver problems, hormonal changes affecting glands like thyroid; also possible immune system reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have given a tissue sample for cancer marker tests.
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My heart function is normal as confirmed by a heart scan.
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My advanced cancer is confirmed by tests and I've tried or can't tolerate all beneficial treatments.
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I am not pregnant or breastfeeding and either cannot become pregnant or will follow birth control guidelines for 120 days after treatment.
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
Number of Participants Who Discontinue Study Treatment Due to an AE
Number of Participants Who Experience At Least One AE
Number of Participants with a Dose-Limiting Toxicity (DLT) Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events (AEs) Version 5.0
Secondary outcome measures
Area Under the Curve (AUC) of MK-1484
Maximum Serum Concentration (Cmax) of MK-1484
Minimum Serum Concentration (Cmin) of MK-1484
Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
2Treatment groups
Experimental Treatment
Group I: MK-1484 + PembrolizumabExperimental Treatment2 Interventions
Participants will receive MK-1484 Q3W at escalating dose levels from 10-60 mg plus pembrolizumab 200 mg once every 21-day cycle for up to a total of 35 cycles (up to approximately 24 months).
Group II: MK-1484Experimental Treatment1 Intervention
Participants will receive MK-1484 every 3 weeks (Q3W) or 21-day cycle at escalating dose levels from 0.2-60 mg for up to a total of 35 cycles (up to approximately 24 months).
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 LLCLead Sponsor
3,890 Previous Clinical Trials
5,060,267 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,063,670 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have previously received IL-2 based therapy.I have not had a live vaccine in the last 30 days.I have had or currently have lung inflammation treated with steroids.My organs are functioning well.I have had a transplant from another person in the last 5 years or have signs of my body rejecting the transplant.I have not needed treatment for an autoimmune disease in the last 2 years, except for vitiligo or childhood asthma.I have given a tissue sample for cancer marker tests.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.I agree to use birth control and not donate sperm for 120 days after the study.You have experienced a serious allergic reaction to a specific type of medication called monoclonal antibodies.My cancer has spread to my brain or spinal cord.My heart function is normal as confirmed by a heart scan.My advanced cancer is confirmed by tests and I've tried or can't tolerate all beneficial treatments.I am currently being treated for an infection.I don't have any health issues that could affect the study or make it unsafe for me.I haven't had cancer treatment in the last 4 weeks and have recovered from side effects.I have recovered from major surgery and have no infections.I am not pregnant or breastfeeding and either cannot become pregnant or will follow birth control guidelines for 120 days after treatment.I have a history of lung scarring or fibrosis.I had another cancer but was treated successfully and have been cancer-free for 2 years.
Research Study Groups:
This trial has the following groups:- Group 1: MK-1484
- Group 2: MK-1484 + 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.
Is this scientific experiment actively seeking participants?
"This research project, posted on June 16th 2022 and recently updated on October 20th has been actively enrolling participants."
Answered by AI
What has been revealed concerning the safety of MK-1484 for patients?
"Our team at Power has estimated MK-1484's safety to be a 1 due to its Phase 1 status, which implies there is limited data assessing the drug's efficacy and safety."
Answered by AI
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