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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 below

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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:

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 27 months for reporting.

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 more

Awards & 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