Your session is about to expire
← Back to Search
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 27 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Select...
My advanced cancer is confirmed and I've tried or can't tolerate all known beneficial treatments.
Select...
My lung cancer is non-squamous and at stage IV.
Select...
My breast cancer is triple-negative, has returned, can't be surgically removed or cured, and hasn't been treated with chemotherapy.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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 moreTrial 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
Pemetrexed
2014
Completed Phase 3
~5250
Pembrolizumab
2017
Completed Phase 2
~2010
Carboplatin
2014
Completed Phase 3
~6670
Nab-paclitaxel
2014
Completed Phase 3
~2030
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,620 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,886 Previous Clinical Trials
5,054,369 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,063,278 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What conditions has MK-5890 been demonstrated to address?
"MK-5890 is a highly sought after medication due to its ability to treat malignant neoplasms, unresectable melanoma, microsatellite instability high cases, and locally advanced nonsquamous non-small cell lung cancer."
Answered by AI
Are there still available openings for this clinical investigation?
"The details posted on clinicaltrials.gov indicate that this particular trial is no longer recruiting patients, with initial posting dating back to February 18th 2018 and the last update taking place November 7th 2022. Nevertheless, 6150 other studies are presently accepting candidates for participation."
Answered by AI
What ambitions does this research endeavor hope to accomplish?
"The principal goal of this research, which will be evaluated during Cycle 1 (up to 21 days), is determining the number of participants with adverse events in Arms 1 and 2. Secondary objectives include analyzing study discontinuation due to an AE across all four arms, establishing response rate for MK-5890 via RECIST 1.1 criteria in Arms 1, 2 and 4; as well as appraising dose-limiting toxicities through NCI CTCAE v4 or later grading system within Arm 3."
Answered by AI
How can individuals be sure that MK-5890 is not posing any risks to their health?
"While there is limited data surrounding the safety and effectiveness of MK-5890, it received a score of 1 on Power's scale."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger