Boserolimab + Pembrolizumab for Advanced Cancers

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Merck Sharp & Dohme Corp.

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?The purpose of this study is to assess the safety and pharmacokinetics of boserolimab (MK-5890) when administered alone and in combination with pembrolizumab (MK-3475) in adults with advanced solid tumors. The initial course of boserolimab monotherapy or boserolimab plus pembrolizumab combination therapy will be for up to 35 administrations (approximately 2 years). The safety and pharmacokinetics of boserolimab when administered with pembrolizumab, pemetrexed and carboplatin in adults with non squamous non-small cell lung cancer (NSCLC) and boserolimab when administered with pembrolizumab and nab-paclitaxel in adults with triple-negative breast cancer (TNBC) will also be assessed.

Eligibility Criteria

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.

Inclusion Criteria

I am fully active or restricted in physically strenuous activity but can do light work.

My advanced cancer is confirmed and I've tried or can't tolerate all known beneficial treatments.

My lung cancer is non-squamous and at stage IV.

My breast cancer is triple-negative, has returned, can't be surgically removed or cured, and hasn't been treated with chemotherapy.

Exclusion Criteria

I have had pneumonitis treated with steroids or have it now.

I have fluid buildup in my abdomen or around my lungs that causes symptoms.

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 will not need other cancer treatments during this study.

I have had a stem cell or bone marrow transplant in the past.

I have had an organ transplant.

I have a history of lung scarring or fibrosis.

I am currently being treated for an infection.

My cancer has spread to my brain or its coverings.

Treatment Details

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.

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).

Boserolimab is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as KEYTRUDA for: