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MK-0482 + Pembrolizumab for Advanced Cancer
Phase 1
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
Part 2 Cohort C only: Has histologically confirmed diagnosis of metastatic PDAC and has received no prior systemic therapy for metastatic pancreatic ductal adenocarcinoma (PDAC) including chemotherapy, biological or targeted therapy and has albumin ≥3.0 g/dL
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 27 months
Awards & highlights
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.
Who is the study for?
This trial is for adults with advanced solid tumors and no remaining treatment options. Specific groups include those with certain types of brain cancer, pancreatic cancer, soft tissue sarcoma, lung cancer, or triple negative breast cancer. Participants must have measurable disease, provide a tumor sample, meet organ function criteria and performance status requirements. Women of childbearing potential must use effective contraception.Check my eligibility
What is being tested?
The study tests MK-0482 alone and combined with pembrolizumab in two parts: dose escalation to find the safest dose (Part 1), followed by expansion cohorts to assess safety and effectiveness in specific cancers when combined with pembrolizumab and chemotherapy (Part 2).See study design
What are the potential side effects?
Possible side effects include reactions at the infusion site, fatigue, nausea, immune-related issues such as inflammation in various organs which can be serious. Each patient's experience may vary.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have metastatic pancreatic cancer, haven't had treatment for it, and my albumin level is at least 3.0 g/dL.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I have HIV and it is well controlled with medication.
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 Adverse Event (AE)
Number of Participants Who Experience a Dose-Limiting Toxicity (DLT) Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Part 1 only)
Number of Participants Who Experience a Dose-Limiting Toxicity (DLT) Graded Using National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (Part 2 only)
+1 moreSecondary outcome measures
AUC of MK-0482 When Administered in Combination with Pembrolizumab (Part 1 only)
Area Under the Concentration-Time Curve (AUC) of MK-0482 When Administered as Monotherapy (Part 1 only)
Cmax of MK-0482 When Administered in Combination with Pembrolizumab (Part 1 only)
+5 moreTrial Design
7Treatment groups
Experimental Treatment
Group I: Part 2: Cohort EExperimental Treatment4 Interventions
Participants with metastatic non-squamous non-small cell lung carcinoma (NSCLC) (1L) receive MK-0482 via IV infusion plus pembrolizumab 200 mg via IV infusion plus Pemetrexed 500 mg/m^2 via IV infusion on Day 1 of each 21-day cycle (Q3W) up to 35 administrations (up to approximately 2 years) plus carboplatin with desired dose of area under the curve (AUC) 5 and pemetrexed 500 mg/m^2, both administered via IV infusion, followed by maintenance therapy with pemetrexed 500 mg/m^2 via IV infusion for up to a total of 35 administrations (up to approximately 2 years).
Group II: Part 2: Cohort DExperimental Treatment2 Interventions
Participants with metastatic soft tissue sarcoma (STS) (2L) receive MK-0482 via IV infusion plus pembrolizumab 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) up to 35 administrations (up to approximately 2 years).
Group III: Part 2: Cohort CExperimental Treatment4 Interventions
Participants with metastatic pancreatic ductal adenocarcinoma (PDAC) (1L) receive MK-0482 via IV infusion plus pembrolizumab 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) up to 35 administrations (up to approximately 2 years), Nab-Paclitaxel 125 mg/m^2 via IV infusion and gemcitabine 1000 mg/m^2 via IV infusion until PD or unacceptable toxicity that requires discontinuation.
Group IV: Part 2: Cohort BExperimental Treatment2 Interventions
Participants with recurrent non-operable glioblastoma (GBM) current treatment of second line (2L) receive MK-0482 via IV infusion plus pembrolizumab 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) up to 35 administrations (up to approximately 2 years).
Group V: Part 2: Cohort AExperimental Treatment3 Interventions
Participants with metastatic triple negative breast cancer (TNBC) first line treatment (1L) receive MK-0482 via IV infusion plus pembrolizumab 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) up to 35 administrations (up to approximately 2 years) and paclitaxel 90 mg/m^2 via IV infusion until PD or discontinuation.
Group VI: Part 1: MK-0482 MonotherapyExperimental Treatment1 Intervention
Participants receive escalating doses of MK-0482 via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 administrations (up to approximately 2 years).
Group VII: Part 1: MK-0482 + Pembrolizumab Combination TherapyExperimental Treatment2 Interventions
Participants receive escalating doses of MK-0482 via IV infusion + pembrolizumab 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 administrations (up to approximately 2 years).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
2011
Completed Phase 4
~5380
Carboplatin
2014
Completed Phase 3
~6670
pembrolizumab
2017
Completed Phase 3
~5750
Nab-paclitaxel
2014
Completed Phase 3
~2030
Gemcitabine
2017
Completed Phase 3
~2070
Pemetrexed
2014
Completed Phase 3
~5250
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Who is running the clinical trial?
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,767 Total Patients Enrolled
5 Trials studying Tumors
149 Patients Enrolled for Tumors
Merck Sharp & Dohme LLCLead Sponsor
3,906 Previous Clinical Trials
5,064,588 Total Patients Enrolled
11 Trials studying Tumors
2,324 Patients Enrolled for Tumors
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,788 Previous Clinical Trials
8,065,822 Total Patients Enrolled
2 Trials studying Tumors
34 Patients Enrolled for Tumors
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- 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
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.
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