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MK-0482 + Pembrolizumab for Advanced Cancer
Study Summary
This trial is testing a new drug, MK-0482, to see if it is safe and effective when used alone or in combination with another drug, pembrolizumab, to treat patients with advanced solid tumors.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have not had active treatment for another cancer, except for certain skin, bladder cancers, or in situ cancers, in the last 2 years.I have metastatic pancreatic cancer, haven't had treatment for it, and my albumin level is at least 3.0 g/dL.I am currently being treated for an infection.My cancer has spread to my brain or the membranes around my brain.I have triple negative breast cancer that has returned or spread, not treated before for this stage, and my tumor is PD-L1 positive.My organs are functioning well.My cancer can be measured using specific criteria.I am HIV-positive and have had Kaposi's sarcoma or Multicentric Castleman's Disease.I have an advanced cancer and cannot take or have tried all known beneficial treatments.I haven't had cancer treatment or investigational drugs in the last 4 weeks.I have not had a live vaccine in the last 30 days.I have an autoimmune disease treated with medication in the last 2 years.I am fully active or restricted in physically strenuous activity but can do light work.I have HIV and it is well controlled with medication.I am a male agreeing to not donate sperm and either remain abstinent or use contraception for 95 days post-treatment.1) You have had heart failure, stroke, unstable angina, or heart attack within the past 6 months.
2) You have noticeable fluid buildup in your abdomen causing discomfort.
3) You are allergic to nab-paclitaxel or gemcitabine, or any of the ingredients they contain.I have advanced NSCLC, not treatable with EGFR, ALK, or ROS1 therapy, and haven't had systemic treatment for it.I have a history of lung scarring or fibrosis.I am not pregnant or breastfeeding, and I either cannot become pregnant or am using effective birth control.For Part 2 Cohort E only:
1) You have been diagnosed with small cell lung cancer.
2) You have fluid build-up in your abdomen or lungs that is causing symptoms.
3) You are currently taking medications that strongly or moderately affect certain enzymes in your body and cannot stop taking them during the study.
4) You are unable to take a break from aspirin or other NSAIDs, unless you take a low dose of aspirin.
5) You cannot or do not want to take supplements of folic acid or vitamin B12.
6) You are allergic to carboplatin or pemetrexed or any ingredients in these medications.I stopped immunotherapy due to a severe side effect.I have advanced soft tissue sarcoma and it got worse after one treatment.I have had or currently have lung inflammation treated with steroids.I have at least one cancerous lesion that can be biopsied.I have had a transplant from another person in the last 5 years or have signs of my body rejecting the transplant.I have an immune system disorder or have been on steroids or other immune-weakening medicines recently.I had another cancer but was treated successfully and have been cancer-free for 2 years.I have previously been treated with specific immune-targeting cancer therapies.I've had a severe allergic reaction to specific cancer treatments before.You have taken a new experimental medicine or used a new medical device within the past 4 weeks.
- Group 1: Part 1: MK-0482 Monotherapy
- Group 2: Part 1: MK-0482 + Pembrolizumab Combination Therapy
- Group 3: Part 2: Cohort A
- Group 4: Part 2: Cohort B
- Group 5: Part 2: Cohort C
- Group 6: Part 2: Cohort D
- Group 7: Part 2: Cohort E
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Has MK-0482 been granted the green light by the FDA?
"The limited data on MK-0482's safety and efficacy gives it a score of 1."
In which geographic areas are participants able to access this trial?
"This clinical trial is running at five different sites, three of which are in Hackensack, Vancouver and San Antonio. To minimize travel demands it would be beneficial to pick the site closest to you if you choose to enrol."
How many participants have been admitted to this research endeavor?
"Merck Sharp & Dohme LLC is sponsoring this clinical trial, which necessitates 230 participants to meet the study's required criteria. It will be conducted in two locations: John Theurer Cancer Center at Hackensack University Medical Centre (Site 0003) in New jersey and BC Cancer - Vancouver Center ( Site 0010) in British Columbia."
Is this medical study actively seeking participants?
"Affirmative. Clinicaltrials.gov data implies that this research is presently looking for participants, after being initially posted on June 19th 2019 and most recently updated on November 9th 2022. A total of 230 individuals need to be enrolled across 5 medical facilities."
What medical conditions has MK-0482 proven most effective in treating?
"MK-0482 is typically prescribed to combat diseases, however it has also been demonstrated to have beneficial effects on hodgkin disease, previous adjuvant anthracycline-containing therapy, and metastatic cutaneous squamous cell carcinoma."
Are there any documented investigations involving MK-0482 previously conducted?
"The initial experiments with MK-0482 were conducted at the City of Hope Comprehensive Cancer Centre in 1997. Since then, there have been a total of 2567 trials completed and 2246 studies are still ongoing, many located in Hackensack, New jersey."
What objectives is this clinical trial attempting to accomplish?
"This 24-month study will be assessing the number of participants who experience adverse events, objective response rate as assessed by Investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), Objective Response Rate as Assessed by Investigator per Response Assessment in Neuro-Oncology (RANO) and Cmax of MK-0482 When Administered in Combination with Pembrolizumab (Part 1 only). Blood samples will be collected at regular intervals to monitor patient progress and determine efficacy of treatment."
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