New drug combo shows promise in early cancer trial
NCT ID NCT03396445
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase study tested a new drug called boserolimab (MK-5890), either alone or combined with the immunotherapy pembrolizumab (KEYTRUDA), in 182 adults with advanced solid tumors, including lung and breast cancers. The main goals were to check safety and how the drug moves through the body. Researchers also looked at adding chemotherapy for certain cancer types. The trial is complete, but results are not yet widely available.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- boserolimab (MK-5890) and pembrolizumab (KEYTRUDA)
- What this could lead to
- If successful, this could point toward a new combination treatment option for people with advanced solid tumors that have not responded to other therapies.
- What could go wrong
- This is an early Phase 1 trial focused on safety and dosing, so it is too soon to know if the combination will be effective. Side effects are possible, and the results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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182 people
The number who actually took part.
- Started
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Feb 2018
- Finished
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Sep 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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) Exclusion Criteria: * 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 * On chronic systemic steroid therapy in excess of replacement doses (e.g., exceeding 10 mg/day of prednisone equivalent), or on any other form of immunosuppressive medication * Regular user (including "recreational use") of any illicit drugs at the time of signing informed consent, or has a recent history (within the last year) of substance abuse (including alcohol), as determined by the treating investigator. Participants who use cannabis for medicinal purposes or to treat specific symptoms will not be excluded unless it is being abused in the opinion of the treating investigator * Received a live-virus vaccine within 28 days before the first dose of study treatment * Currently participating and receiving study treatment in a study of an investigational agent or has participated and received study treatment in a study of an investigational agent or has used an investigational device within 28 days before the first dose of study treatment Additional Exclusion Criteria for Participants in Arm 3: * Has received radiation therapy to the lung that is \>30 Gray (Gy) within 6 months before the first dose of study treatment * Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose ≤1.3 g per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam). * Is unable or unwilling to take folic acid or vitamin B12 supplementation Additional Exclusion Criteria for Participants in Arm 4: * Has a known history of hypersensitivity or allergy to nab-paclitaxel or any of its components * Has neuropathy ≥Grade 2 * Has a history of class II-IV congestive heart failure or myocardial infarction within 6 months of randomization * Has received previous treatment with immune checkpoint inhibitor(s) (eg, Programmed Cell Death Receptor 1 (PD-1)/PD-L1)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Antoni van Leeuwenhoek Ziekenhuis ( Site 0003)
Amsterdam, North Holland, 1066 CX, Netherlands
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Bradfordhill-Clinical Area ( Site 0501)
Santiago, Region M. de Santiago, 8420383, Chile
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Centro Integral Oncologico Clara Campal START Madrid ( Site 0040)
Madrid, 28050, Spain
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Erasmus MC ( Site 0031)
Rotterdam, South Holland, 3015 GD, Netherlands
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FALP-UIDO ( Site 0502)
Santiago, Region M. de Santiago, 6900941, Chile
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Florida Cancer Specialists ( Site 0002)
Sarasota, Florida, 34232, United States
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Hadassah Ein Kerem Medical Center ( Site 0010)
Jerusalem, 9112001, Israel
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Hospital Universitario Fundacion Jimenez Diaz ( Site 0041)
Madrid, 28040, Spain
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Hospital Universitario Quiron Madrid ( Site 0043)
Pozuelo de Alarcón, Madrid, 28223, Spain
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Instituto Catalan de Oncologia - ICO ( Site 0044)
Barcelona, 08916, Spain
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Koo Foundation Sun Yat-Sen Cancer Center ( Site 0802)
Taipei, 112, Taiwan
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National Taiwan University Hospital-Oncology ( Site 0801)
Taipei, 100, Taiwan
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Seoul National University Hospital-Internal Medicine ( Site 0702)
Seoul, 03080, South Korea
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Severance Hospital, Yonsei University Health System-Medical oncology ( Site 0701)
Seoul, 03722, South Korea
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Soroka Medical Center-Oncology ( Site 0012)
Beersheba, 8400000, Israel
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The Chaim Sheba Medical Center - Oncology Institute ( Site 0001)
Ramat Gan, 5265601, Israel
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The West Clinic, P.C. ( Site 0021)
Germantown, Tennessee, 38138, United States
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University of South Alabama, Mitchell Cancer Institute ( Site 0020)
Mobile, Alabama, 36604, United States
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