Study of Boserolimab (MK-5890) as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Adults With Advanced Solid Tumors (MK-5890-001)

NCT03396445 | Completed Phase 1 Results FDA Drug

• 3 other identifiers: 5890-001MK-5890-0012017-004550-41
• Study Type: interventional
• Target: 182
• Locations: 7 countries
• Sites: 18

Brief Summary

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. Boserolimab monotherapy or boserolimab plus pembrolizumab combination therapy will be administered in adults with advanced solid tumors, including endometrial cancer, 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.

Conditions

Pharmacokinetics; Solid Tumor; Carcinoma, Non-Small-Cell Lung; Triple Negative Breast Neoplasms

Keywords

Programmed Cell Death Receptor 1 (PD-1); Programmed Cell Death Receptor Ligand 1 (PD-L1); Programmed Cell Death Receptor Ligand 2 (PD-L2); PD-1; PDL1; PD-L1; PD-L2

Outcome Measures

Primary Outcomes (3)

• Number of Participants Who Experienced a Dose-Limiting Toxicity (DLT)

  DLTs were assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5. A DLT was defined as any of the following events: Grade 4 nonhematologic toxicity; Grade 4 hematologic toxicity lasting ≥7 days, except thrombocytopenia; Grade 4 thrombocytopenia; Grade 3 thrombocytopenia requiring a platelet transfusion; Nonhematologic adverse event (AE) Grade ≥3, with exceptions; Grade 3 or 4 nonhematologic laboratory abnormality; Prolonged delay (\>2 weeks) in initiating Cycle 2 due to treatment-related toxicity; Treatment-related toxicity resulting in study drug discontinuation during the DLT evaluation period; Missing \>25% of any study drug during the DLT evaluation period due to a treatment-related AE; or Grade 5 toxicity. The number of participants who experienced one or more DLTs is reported.

  Up to 21 days in Cycle 1

• Number of Participants With One or More AEs

  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experienced one or more AEs is reported.

  Up to approximately 78 months

• Number of Participants Who Discontinued Study Treatment Due to an AE

  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinued study treatment due to an AE is reported.

  Up to 23 months

Secondary Outcomes (10)

• Area Under the Concentration-Time Curve From Time 0 to Last Quantifiable Concentration (AUC0-last) of Boserolimab

  Predose Day 1 Cycle 1 and at designated timepoints up to Day 1 Cycle 2

• Area Under the Concentration-Time Curve From Time 0 to 3 Weeks (AUC0-3w) of Boserolimab

  Predose Day 1 Cycle 1 and at designated timepoints up to Day 1 Cycle 2

• Area Under the Concentration-Time Curve From Time 0 to 6 Weeks (AUC0-6w) of Boserolimab

  Arms 2c and 4 (Cycle = 6 weeks): Predose, at start & end of infusion on Day 1 Cycle 1, Days 2, 3, 8, 15, 22 of Cycle 1, and predose on Day 1 Cycle 2

• Minimum Concentration (Cmin) of Boserolimab

  Predose Day 1 Cycle 1 and at designated timepoints up to Day 1 Cycle 2

• Maximum Concentration (Cmax) of Boserolimab

  Predose Day 1 Cycle 1 and at designated timepoints up to Day 1 Cycle 2

Study Arms (17)

Arm 1 Boserolimab 2 mg Q3W

EXPERIMENTAL

Participants receive boserolimab 2 mg via intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle is 3 weeks long.

Drug: Boserolimab

Arm 1 Boserolimab 7 mg Q3W

EXPERIMENTAL

Participants receive boserolimab 7 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle is 3 weeks long.

Drug: Boserolimab

Arm 1 Boserolimab 20 mg Q3W

EXPERIMENTAL

Participants receive boserolimab 20 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle is 3 weeks long.

Drug: Boserolimab

Arm 1 Boserolimab 70 mg Q3W

EXPERIMENTAL

Participants receive boserolimab 70 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle is 3 weeks long.

Drug: Boserolimab

Arm 1 Boserolimab 200 mg Q3W

EXPERIMENTAL

Participants receive boserolimab 200 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle is 3 weeks long.

Drug: Boserolimab

Arm 1 Boserolimab 700 mg Q3W

EXPERIMENTAL

Participants receive boserolimab 700 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle is 3 weeks long.

Drug: Boserolimab

Arm 1a Boserolimab 30 mg Q3W (Endometrial)

EXPERIMENTAL

Participants with endometrial cancer receive boserolimab 30 mg via IV infusion once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle is 3 weeks long.

Drug: Boserolimab

Arm 2 Boserolimab 2 mg Q3W + Pembrolizumab 200 mg Q3W

EXPERIMENTAL

Participants receive separate IV infusions of boserolimab 2 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab are administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle is 3 weeks long.

Drug: Boserolimab; Biological: Pembrolizumab

Arm 2 Boserolimab 7 mg Q3W + Pembrolizumab 200 mg Q3W

EXPERIMENTAL

Participants receive separate IV infusions of boserolimab 7 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab are administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle is 3 weeks long.

Drug: Boserolimab; Biological: Pembrolizumab

Arm 2 Boserolimab 20 mg Q3W + Pembrolizumab 200 mg Q3W

EXPERIMENTAL

Participants receive separate IV infusions of boserolimab 20 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab are administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle is 3 weeks long.

Drug: Boserolimab; Biological: Pembrolizumab

Arm 2 Boserolimab 70 mg Q3W + Pembrolizumab 200 mg Q3W

EXPERIMENTAL

Participants receive separate IV infusions of boserolimab 70 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab are administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle is 3 weeks long.

Drug: Boserolimab; Biological: Pembrolizumab

Arm 2 Boserolimab 200 mg Q3W + Pembrolizumab 200 mg Q3W

EXPERIMENTAL

Participants receive separate IV infusions of boserolimab 200 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab are administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle is 3 weeks long.

Drug: Boserolimab; Biological: Pembrolizumab

Arm 2a Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (TNBC)

EXPERIMENTAL

Participants with triple-negative breast cancer (TNBC) receive separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab are administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle is 3 weeks long.

Drug: Boserolimab; Biological: Pembrolizumab

Arm 2b Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (Endometrial)

EXPERIMENTAL

Participants with endometrial cancer receive separate IV infusions of boserolimab 30 mg and pembrolizumab 200 mg. Boserolimab and pembrolizumab are administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Each cycle is 3 weeks long.

Drug: Boserolimab; Biological: Pembrolizumab

Arm 2c Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W (Endometrial)

EXPERIMENTAL

Participants with endometrial cancer receive separate IV infusions of boserolimab 30 mg and pembrolizumab 400 mg. Boserolimab was administered once every 6 weeks (Q6W) on Day 1 of each cycle for a total of up to approximately 4 cycles (up to approximately 6 months). Pembrolizumab is administered once Q6W on Day 1 of each cycle for a total of up to approximately 18 cycles (up to approximately 27 months). Each cycle is 6 weeks long.

Drug: Boserolimab; Biological: Pembrolizumab

Arm 3 Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W + Pemetrexed + Carboplatin (NSCLC)

EXPERIMENTAL

Participants with non-small cell lung cancer (NSCLC) receive separate IV infusions of boserolimab 30 mg, pembrolizumab 200 mg, pemetrexed 500 mg/m\^2, and carboplatin area under the curve (AUC) 5 mg/mL/min. Boserolimab is administered once Q3W on Day 1 of each cycle for a total of up to approximately 8 cycles (up to approximately 6 months). Pembrolizumab and pemetrexed are administered once Q3W on Day 1 of each cycle for a total of up to approximately 35 cycles (up to approximately 2 years). Carboplatin is administered once Q3W on Day 1 of each cycle for a total of up to approximately 4 cycles (up to approximately 3 months). Each cycle is 3 weeks long.

Drug: Boserolimab; Biological: Pembrolizumab; Drug: Pemetrexed; Drug: Carboplatin

Arm 4 Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W + Nab-paclitaxel (TNBC)

EXPERIMENTAL

Participants with TNBC receive separate IV infusions of boserolimab 30 mg, pembrolizumab 400 mg, and nab-paclitaxel 100 mg/m\^2. Boserolimab and pembrolizumab are administered once Q6W on Day 1 of each cycle for a total of up to approximately 18 cycles (up to approximately 27 months). Nab-paclitaxel is administered on a 3-weeks on/1-week off schedule every 28 days (Days 1, 8, 15, 29, and 36 of odd-numbered cycles and Days 1, 15, 22, and 29 of even-numbered cycles). Each cycle is 6 weeks long

Drug: Boserolimab; Biological: Pembrolizumab; Drug: Nab-paclitaxel

Interventions

Boserolimab DRUG

IV infusion

Also known as: MK-5890

Arm 1 Boserolimab 2 mg Q3W; Arm 1 Boserolimab 20 mg Q3W; Arm 1 Boserolimab 200 mg Q3W; Arm 1 Boserolimab 7 mg Q3W; Arm 1 Boserolimab 70 mg Q3W; Arm 1 Boserolimab 700 mg Q3W; Arm 1a Boserolimab 30 mg Q3W (Endometrial); Arm 2 Boserolimab 2 mg Q3W + Pembrolizumab 200 mg Q3W; Arm 2 Boserolimab 20 mg Q3W + Pembrolizumab 200 mg Q3W; Arm 2 Boserolimab 200 mg Q3W + Pembrolizumab 200 mg Q3W; Arm 2 Boserolimab 7 mg Q3W + Pembrolizumab 200 mg Q3W; Arm 2 Boserolimab 70 mg Q3W + Pembrolizumab 200 mg Q3W; Arm 2a Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (TNBC); Arm 2b Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (Endometrial); Arm 2c Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W (Endometrial); Arm 3 Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W + Pemetrexed + Carboplatin (NSCLC); Arm 4 Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W + Nab-paclitaxel (TNBC)

Pembrolizumab BIOLOGICAL

IV infusion

Also known as: MK-3475, KEYTRUDA®

Arm 2 Boserolimab 2 mg Q3W + Pembrolizumab 200 mg Q3W; Arm 2 Boserolimab 20 mg Q3W + Pembrolizumab 200 mg Q3W; Arm 2 Boserolimab 200 mg Q3W + Pembrolizumab 200 mg Q3W; Arm 2 Boserolimab 7 mg Q3W + Pembrolizumab 200 mg Q3W; Arm 2 Boserolimab 70 mg Q3W + Pembrolizumab 200 mg Q3W; Arm 2a Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (TNBC); Arm 2b Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (Endometrial); Arm 2c Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W (Endometrial); Arm 3 Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W + Pemetrexed + Carboplatin (NSCLC); Arm 4 Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W + Nab-paclitaxel (TNBC)

Pemetrexed DRUG

IV infusion

Also known as: ALIMTA®

Arm 3 Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W + Pemetrexed + Carboplatin (NSCLC)

Carboplatin DRUG

IV infusion

Also known as: PARAPLATIN®

Arm 3 Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W + Pemetrexed + Carboplatin (NSCLC)

Nab-paclitaxel DRUG

IV infusion

Also known as: ABRAXANE®

Arm 4 Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W + Nab-paclitaxel (TNBC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Arm 3: Histologically or cytologically confirmed diagnosis of stage IV (M1a or M1b per current American Joint Committee on Cancer criteria) non-squamous NSCLC
• Arm 4: Triple-negative breast cancer (TNBC) that is locally recurrent, inoperable, not previously treated with chemotherapy, and which cannot be treated with curative intent OR metastatic disease not previously treated with chemotherapy
• Measurable disease by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by the local site investigator/radiologist. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions
• Adequate organ function
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Male participants must agree to use adequate contraception during the treatment period and for at least 120 days after the last dose of boserolimab or pembrolizumab OR 180 days after the last dose of chemotherapeutic agents and refrain from donating sperm during this period
• Female participants must not be pregnant or breastfeeding and agree to follow use adequate contraception during the treatment period and for at least 120 days after the last dose of boserolimab or pembrolizumab OR 180 days after the last dose of chemotherapeutic agents
• Submit an evaluable baseline tumor sample for analysis (either a newly obtained or archival tumor sample)

You may not qualify if:

• History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years
• Clinically active central nervous system metastases and/or carcinomatous meningitis
• Has had a severe hypersensitivity reaction to treatment with a monoclonal antibody (mAb) and/or other components of the study treatment
• Active infection requiring systemic treatment
• History of interstitial lung disease
• History of (noninfectious) pneumonitis that required steroids or current pneumonitis
• Symptomatic ascites or pleural effusion
• Previously had a stem cell or bone marrow transplant
• Previously had a solid organ transplant
• Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs) except vitiligo or resolved childhood asthma/atopy
• Known human immunodeficiency virus (HIV) and/or active and acute Hepatitis B or C infections
• Not fully recovered from any effects of major surgery without significant detectable infection
• Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study
• Had chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks (2 weeks for palliative radiation) before the first dose of study treatment, or has not recovered to Grade ≤1 or better from any AEs that were due to cancer therapeutics administered more than 4 weeks earlier
• Expected to require any other form of antineoplastic therapy while participating in this study

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (18)

University of South Alabama, Mitchell Cancer Institute ( Site 0020)

Mobile, Alabama, 36604, United States

Location

Florida Cancer Specialists ( Site 0002)

Sarasota, Florida, 34232, United States

Location

The West Clinic, P.C. ( Site 0021)

Germantown, Tennessee, 38138, United States

Location

FALP-UIDO ( Site 0502)

Santiago, Region M. de Santiago, 6900941, Chile

Location

Bradfordhill-Clinical Area ( Site 0501)

Santiago, Region M. de Santiago, 8420383, Chile

Location

Soroka Medical Center-Oncology ( Site 0012)

Beersheba, 8400000, Israel

Location

Hadassah Ein Kerem Medical Center ( Site 0010)

Jerusalem, 9112001, Israel

Location

The Chaim Sheba Medical Center - Oncology Institute ( Site 0001)

Ramat Gan, 5265601, Israel

Location

Antoni van Leeuwenhoek Ziekenhuis ( Site 0003)

Amsterdam, North Holland, 1066 CX, Netherlands

Location

Erasmus MC ( Site 0031)

Rotterdam, South Holland, 3015 GD, Netherlands

Location

Seoul National University Hospital-Internal Medicine ( Site 0702)

Seoul, 03080, South Korea

Location

Severance Hospital, Yonsei University Health System-Medical oncology ( Site 0701)

Seoul, 03722, South Korea

Location

Hospital Universitario Quiron Madrid ( Site 0043)

Pozuelo de Alarcón, Madrid, 28223, Spain

Location

Instituto Catalan de Oncologia - ICO ( Site 0044)

Barcelona, 08916, Spain

Location

Hospital Universitario Fundacion Jimenez Diaz ( Site 0041)

Madrid, 28040, Spain

Location

Centro Integral Oncologico Clara Campal START Madrid ( Site 0040)

Madrid, 28050, Spain

Location

National Taiwan University Hospital-Oncology ( Site 0801)

Taipei, 100, Taiwan

Location

Koo Foundation Sun Yat-Sen Cancer Center ( Site 0802)

Taipei, 112, Taiwan

Location

Related Links

• Merck Oncology Clinical Trials Information

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Triple Negative Breast Neoplasms; Parkinson Disease 4, Autosomal Dominant Lewy Body

Interventions

pembrolizumab; Pemetrexed; Carboplatin; 130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Breast Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Coordination Complexes; Organic Chemicals; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Albumins; Proteins

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@msd.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2018
• First Posted: January 11, 2018
• Study Start: February 18, 2018
• Primary Completion: September 27, 2024
• Study Completion: September 27, 2024
• Last Updated: November 5, 2025
• Results First Posted: November 5, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

IL (3); NL (2); US (3); CL (2); KR (2); ES (4); TW (2)