Boserolimab + Pembrolizumab for Advanced Cancers

Recruiting in Palo Alto (17 mi)

+17 other locations

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.

Research Team

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

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 not pregnant or breastfeeding and agree to use contraception for the required period after treatment.

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

I agree to use contraception and not donate sperm for up to 6 months after treatment.

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Exclusion 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.

You had a serious allergic reaction to a specific type of medication called monoclonal antibody (mAb).

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Treatment Details

Interventions

Boserolimab (Monoclonal Antibodies)
Carboplatin (Other)
Nab-paclitaxel (Other)
Pembrolizumab (Monoclonal Antibodies)
Pemetrexed (Other)

Trial OverviewThe 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.

Participant Groups

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 Canada, Japan for the following indications: