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Monoclonal Antibodies
Boserolimab + Pembrolizumab for Advanced Cancers
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
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Arms 1 & 2: Histologically or cytologically confirmed advanced/metastatic solid tumor by pathology report and has received or been intolerant to all treatment known to confer clinical benefit
Must not have
History of (noninfectious) pneumonitis that required steroids or current pneumonitis
Symptomatic ascites or pleural effusion
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 27 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will assess the safety and how the body processes MK-5890 when given alone or with pembrolizumab over the course of 35 administrations. Additionally, the trial will assess the safety of MK-5890 when given with pemetrexed and carboplatin to adults with nonsquamous non-small cell lung cancer or with nab-paclitaxel to adults with triple-negative breast cancer.
Who is the study for?
Adults with advanced solid tumors, including non-squamous NSCLC and triple-negative breast cancer. Participants must have measurable disease, agree to contraception use, provide a tumor sample for analysis, and have an ECOG status of 0 or 1. Exclusions include recent live vaccines, certain allergies or medical conditions like heart failure or active infections.
What is being tested?
The trial is testing Boserolimab alone and combined with Pembrolizumab in treating advanced cancers. It will also assess the combination of these drugs with chemotherapies (Pemetrexed/Carboplatin for NSCLC; Nab-paclitaxel for TNBC) over approximately two years.
What are the potential side effects?
Potential side effects may include immune-related reactions due to monoclonal antibodies such as inflammation in organs, infusion reactions similar to allergic responses, fatigue from treatment burden, digestive issues from chemotherapy agents used alongside the tested drugs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
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My advanced cancer is confirmed and I've tried or can't tolerate all known beneficial treatments.
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My lung cancer is non-squamous and at stage IV.
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My breast cancer is triple-negative, has returned, can't be surgically removed or cured, and hasn't been treated with chemotherapy.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had pneumonitis treated with steroids or have it now.
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I have fluid buildup in my abdomen or around my lungs that causes symptoms.
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I have HIV or active Hepatitis B or C.
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I have recovered from major surgery without any significant infection.
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I am on high doses of steroids or other drugs that weaken my immune system.
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I will not need other cancer treatments during this study.
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I have had a stem cell or bone marrow transplant in the past.
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I have had an organ transplant.
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I have a history of lung scarring or fibrosis.
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I am currently being treated for an infection.
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My cancer has spread to my brain or its coverings.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 27 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 27 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Mutagenicity Tests
Arms 1 and 2: Number of Participants with Adverse Events (AEs)
Arms 1 and 2: Number of Study Treatment Discontinuations Due to an Adverse Event (AE)
Secondary study objectives
All Arms: Area Under the Concentration-Time Curve (AUC) of boserolimab
All Arms: Maximum Serum Concentration (Cmax) of boserolimab
All Arms: Minimum Serum Concentration (Cmin) of boserolimab
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Group I: Arm 4: Boserolimab + Pembrolizumab + Nab-paclitaxelExperimental Treatment3 Interventions
Participants receive boserolimab at the selected dose via IV infusion PLUS pembrolizumab via IV infusion PLUS nab-paclitaxel 100 mg/m\^2 via IV infusion. Boserolimab and pembrolizumab will be given on Day 1 of each 6-week cycle (Q6W). Nab-paclitaxel will be given on a 3-week on (Days 1, 8 and 15)/ 1-week off schedule every 28 days. Boserolimab and pembrolizumab will be given for up to a total of 18 cycles (approximately 2 years).
Group II: Arm 3: Boserolimab + Pembrolizumab + Pemetrexed + CarboplatinExperimental Treatment4 Interventions
Participants receive boserolimab at the selected dose via IV infusion PLUS pembrolizumab 200 mg via IV infusion PLUS pemetrexed 500 mg/m\^2 via IV infusion PLUS carboplatin Area Under the Curve (AUC) 5 mg/mL/min via IV infusion, all given on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).
Group III: Arm 2: Boserolimab + PembrolizumabExperimental Treatment2 Interventions
Participants receive escalating doses of boserolimab via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years) PLUS pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).
Group IV: Arm 1: BoserolimabExperimental Treatment1 Intervention
Participants receive escalating doses of boserolimab via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Boserolimab
2018
Completed Phase 1
~190
Carboplatin
2014
Completed Phase 3
~6120
Pembrolizumab
2017
Completed Phase 3
~2810
Nab-paclitaxel
2014
Completed Phase 3
~1950
Pemetrexed
2014
Completed Phase 3
~5550
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,582,174 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,981 Previous Clinical Trials
5,177,825 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,866 Previous Clinical Trials
8,082,398 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had another cancer but was treated successfully and have been cancer-free for 2 years.I have had pneumonitis treated with steroids or have it now.I am not pregnant or breastfeeding and agree to use contraception for the required period after treatment.You had a serious allergic reaction to a specific type of medication called monoclonal antibody (mAb).I am fully active or restricted in physically strenuous activity but can do light work.I have fluid buildup in my abdomen or around my lungs that causes symptoms.I agree to use contraception and not donate sperm for up to 6 months after treatment.You use illegal drugs regularly or have a recent history of substance abuse, unless it's for medical reasons approved by the doctor.My advanced cancer is confirmed and I've tried or can't tolerate all known beneficial treatments.I haven't needed treatment for an autoimmune disease in the last 2 years, except for vitiligo or childhood asthma.I have HIV or active Hepatitis B or C.I have recovered from major surgery without any significant infection.I am on high doses of steroids or other drugs that weaken my immune system.I have not received a live-virus vaccine in the last 28 days.I haven't had cancer treatment in the last 4 weeks or have recovered from its side effects.I will not need other cancer treatments during this study.My lung cancer is non-squamous and at stage IV.You are allergic to nab-paclitaxel or its components, have severe nerve problems, have had serious heart issues recently, or have received certain previous treatments.My breast cancer is triple-negative, has returned, can't be surgically removed or cured, and hasn't been treated with chemotherapy.My cancer can be measured by scans and has grown in previously treated areas.I have had a stem cell or bone marrow transplant in the past.I have had an organ transplant.You have received high-dose radiation to the lung in the past 6 months, are unable to stop taking aspirin or certain pain relievers for a short time, or cannot or do not want to take folic acid or vitamin B12 supplements.I have a history of lung scarring or fibrosis.You need to provide a tumor sample for analysis, either a new sample or one saved from before.I am currently being treated for an infection.My cancer has spread to my brain or its coverings.My organs are working well.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1: Boserolimab
- Group 2: Arm 2: Boserolimab + Pembrolizumab
- Group 3: Arm 3: Boserolimab + Pembrolizumab + Pemetrexed + Carboplatin
- Group 4: Arm 4: Boserolimab + Pembrolizumab + Nab-paclitaxel
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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