PharmacokineticsPhase 1NCT03396445
Study of Boserolimab (MK-5890) as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Adults With Advanced Solid Tumors (MK-5890-001)
A Phase 1 study testing Boserolimab, Pembrolizumab and Pemetrexed in people with Pharmacokinetics and Solid Tumor, run by Merck Sharp & Dohme LLC at 18 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pharmacokinetics, Solid Tumor, Carcinoma, Non-Small-Cell Lung
- What is being tested?
- Boserolimab, Pembrolizumab and Pemetrexed
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 18 sitesin 7 countries
- Study dates
- 18 Feb 2018to 27 Sep 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- 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)
Trial locations and contacts
18 sites in 7 countries.
18 sites in 7 countries
Spain4 sites
Instituto Catalan de Oncologia - ICO ( Site 0044)
Barcelona, 08916
Hospital Universitario Fundacion Jimenez Diaz ( Site 0041)
Madrid, 28040
Centro Integral Oncologico Clara Campal START Madrid ( Site 0040)
Madrid, 28050
Hospital Universitario Quiron Madrid ( Site 0043)
Pozuelo de Alarcón, Madrid, 28223
United States3 sites
The West Clinic, P.C. ( Site 0021)
Germantown, Tennessee, 38138
University of South Alabama, Mitchell Cancer Institute ( Site 0020)
Mobile, Alabama, 36604
Florida Cancer Specialists ( Site 0002)
Sarasota, Florida, 34232
Israel3 sites
Soroka Medical Center-Oncology ( Site 0012)
Beersheba, 8400000
Hadassah Ein Kerem Medical Center ( Site 0010)
Jerusalem, 9112001
The Chaim Sheba Medical Center - Oncology Institute ( Site 0001)
Ramat Gan, 5265601
Chile2 sites
FALP-UIDO ( Site 0502)
Santiago, Region M. de Santiago, 6900941
Bradfordhill-Clinical Area ( Site 0501)
Santiago, Region M. de Santiago, 8420383
Netherlands2 sites
Antoni van Leeuwenhoek Ziekenhuis ( Site 0003)
Amsterdam, North Holland, 1066 CX
Erasmus MC ( Site 0031)
Rotterdam, South Holland, 3015 GD
South Korea2 sites
Seoul National University Hospital-Internal Medicine ( Site 0702)
Seoul, 03080
Severance Hospital, Yonsei University Health System-Medical oncology ( Site 0701)
Seoul, 03722
Taiwan2 sites
National Taiwan University Hospital-Oncology ( Site 0801)
Taipei, 100
Koo Foundation Sun Yat-Sen Cancer Center ( Site 0802)
Taipei, 112
About this study
Official title: A Phase 1 Study of MK-5890 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors
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.
Read the detailed description
Participants receiving boserolimab monotherapy who experience disease progression may be eligible to switch to receiving boserolimab plus pembrolizumab combination therapy at an eligible dose for up to 35 cycles (approximately 2 years) at the discretion of the Investigator and approval of the Sponsor.
Per protocol, pharmacokinetic (PK) outcome measures will not be analyzed separately for the switch-over treatment arms.
- Conditions
- Pharmacokinetics, Solid Tumor, Carcinoma, Non-Small-Cell Lung, Triple Negative Breast Neoplasms
- Being tested
- Boserolimab, Pembrolizumab, Pemetrexed, Carboplatin, Nab-paclitaxel
- 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
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Triple Negative Breast Neoplasms, Parkinson Disease 4, Autosomal Dominant Lewy Body
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BoserolimabDrug
Also called MK-5890
IV infusion
PembrolizumabBiological
Also called MK-3475, KEYTRUDA®
IV infusion
PemetrexedDrug
Also called ALIMTA®
IV infusion
CarboplatinDrug
Also called PARAPLATIN®
IV infusion
Nab-paclitaxelDrug
Also called ABRAXANE®
IV infusion
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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 Receives: Drug: Boserolimab; Biological: Pembrolizumab; Drug: Nab-paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Up to 23 months
Secondary outcomes (10)
Area Under the Concentration-Time Curve From Time 0 to Last Quantifiable Concentration (AUC0-last) of Boserolimab
AUC0-last was defined as the area under the concentration versus time curve for boserolimab from 0 to the time of the last quantifiable concentration in serum. Samples were taken predose and at specified times postdose to determine the AUC0-last of boserolimab.
PK collection time frames include: Arms 1, 2 (Cycle = 3 weeks): Predose, at start \& end of infusion on Day 1 Cycle 1, Days 2, 3, 5, 8, 15 of Cycle 1, and predose on Day 1 of Cycle 2; Arms 1a, 2a, 2b, 3 (Cycle = 3 weeks): Predose, at start \& end of infusion on Day 1 Cycle 1, Days 2, 3, 8, 15 of Cycle 1, and predose on Day 1 of Cycle 2; 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 of Cycle 2.
Measured: 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
AUC0-3w was defined as the area under the concentration versus time curve for boserolimab from 0 to 3 weeks in serum. Samples were taken predose and at specified times postdose to determine the AUC0-3w of boserolimab.
PK collection time frames include: Arms 1, 2 (Cycle = 3 weeks): Predose, at start \& end of infusion on Day 1 Cycle 1, Days 2, 3, 5, 8, 15 of Cycle 1, and predose on Day 1 of Cycle 2; Arms 1a, 2a, 2b, 3 (Cycle = 3 weeks): Predose, at start \& end of infusion on Day 1 Cycle 1, Days 2, 3, 8, 15 of Cycle 1, and predose on Day 1 of Cycle 2; 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.
Measured: 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
AUC0-6w was defined as the area under the concentration versus time curve for boserolimab from 0 to 6 weeks in serum. Samples were taken predose and at specified times postdose to determine the AUC0-6w of boserolimab. As pre-specified in the protocol, different arms had different sampling schedules and cycle lengths and therefore AUC0-6w was not analyzed for all Arms; AUC0-6w was only analyzed for Arms 2c and 4 which had 6-week cycles.
Measured: 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
Cmin of boserolimab was defined as the minimum concentration of boserolimab observed in serum. Samples were taken predose and at specified times postdose to determine the Cmin of boserolimab.
PK collection time frames include: Arms 1, 2 (Cycle = 3 weeks): Predose, at start \& end of infusion on Day 1 Cycle 1, Days 2, 3, 5, 8, 15 of Cycle 1, and predose on Day 1 of Cycle 2; Arms 1a, 2a, 2b, 3 (Cycle = 3 weeks): Predose, at start \& end of infusion on Day 1 Cycle 1, Days 2, 3, 8, 15 of Cycle 1, and predose on Day 1 of Cycle 2; 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 of Cycle 2.
Measured: Predose Day 1 Cycle 1 and at designated timepoints up to Day 1 Cycle 2
Maximum Concentration (Cmax) of Boserolimab
Cmax of boserolimab was defined as the maximum concentration of boserolimab observed in serum. Samples were taken predose and at specified times postdose to determine the Cmax of boserolimab.
PK collection time frames include: Arms 1, 2 (Cycle = 3 weeks): Predose, at start \& end of infusion on Day 1 Cycle 1, Days 2, 3, 5, 8, 15 of Cycle 1, and predose on Day 1 of Cycle 2; Arms 1a, 2a, 2b, 3 (Cycle = 3 weeks): Predose, at start \& end of infusion on Day 1 Cycle 1, Days 2, 3, 8, 15 of Cycle 1, and predose on Day 1 of Cycle 2; 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 of Cycle 2.
Measured: Predose Day 1 Cycle 1 and at designated timepoints up to Day 1 Cycle 2
Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
ORR was defined as the percentage of participants who had a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1. As pre-specified in the protocol, ORR was analyzed for participants treated with boserolimab when used as monotherapy in Arm 1a, in combination with pembrolizumab in Switch-over Arm 1a and Arms 2a, 2b, and 2c, or in combination with pembrolizumab + nab-paclitaxel in Arm 4. Per protocol, ORR was not analyzed in Arms 1, 2, or 3. The percentage of participants who experienced a CR or PR, as assessed by the investigator, is reported.
Measured: Up to approximately 78 months
Arm 3: Number of Participants Who Experienced a 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 in Arm 3 is reported
Measured: Up to 21 days in Cycle 1
Arm 4: Number of Participants Who Experienced a 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 in Arm 4 is reported.
Measured: Up to 28 days in Cycle 1
Arm 3 and 4: 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 in Arms 3 and 4 who experienced one or more AEs is reported.
Measured: Up to 57 months
Arm 3 and 4: 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 in Arms 3 or 4 who discontinued study treatment due to an AE is reported.
Measured: Up to 27 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2018
- Study start18 Feb 2018
- Primary completion27 Sep 2024
- Study completion27 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PharmacokineticsStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03396445
- Sponsor's protocol ID
- 5890-001
- Other IDs
- MK-5890-001, 2017-004550-41, 2017
- Status last verified
- Oct 2025
- First submitted
- 4 Jan 2018
- Last updated
- 5 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of MK-5890 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT03396445
- Acronym / sponsor ID
- 5890-001
- 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
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 18 Feb 2018 (actual)
- Primary completion
- 27 Sep 2024 (actual)
- Study completion
- 27 Sep 2024 (actual)
- First posted
- 11 Jan 2018 (actual)
- Results
- Posted 5 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Participants receiving boserolimab monotherapy who experience disease progression may be eligible to switch to receiving boserolimab plus pembrolizumab combination therapy at an eligible dose for up to 35 cycles (approximately 2 years) at the discretion of the Investigator and approval of the Sponsor.
Per protocol, pharmacokinetic (PK) outcome measures will not be analyzed separately for the switch-over treatment arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 17
| Arm | Type | Receives |
|---|---|---|
| Arm 1 Boserolimab 2 mg Q3W | Experimental | Drug: BoserolimabParticipants 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. |
| Arm 1 Boserolimab 7 mg Q3W | Experimental | Drug: BoserolimabParticipants 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. |
| Arm 1 Boserolimab 20 mg Q3W | Experimental | Drug: BoserolimabParticipants 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. |
| Arm 1 Boserolimab 70 mg Q3W | Experimental | Drug: BoserolimabParticipants 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. |
| Arm 1 Boserolimab 200 mg Q3W | Experimental | Drug: BoserolimabParticipants 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. |
| Arm 1 Boserolimab 700 mg Q3W | Experimental | Drug: BoserolimabParticipants 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. |
| Arm 1a Boserolimab 30 mg Q3W (Endometrial) | Experimental | Drug: BoserolimabParticipants 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. |
| Arm 2 Boserolimab 2 mg Q3W + Pembrolizumab 200 mg Q3W | Experimental | Drug: Boserolimab, Biological: PembrolizumabParticipants 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. |
| Arm 2 Boserolimab 7 mg Q3W + Pembrolizumab 200 mg Q3W | Experimental | Drug: Boserolimab, Biological: PembrolizumabParticipants 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. |
| Arm 2 Boserolimab 20 mg Q3W + Pembrolizumab 200 mg Q3W | Experimental | Drug: Boserolimab, Biological: PembrolizumabParticipants 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. |
| Arm 2 Boserolimab 70 mg Q3W + Pembrolizumab 200 mg Q3W | Experimental | Drug: Boserolimab, Biological: PembrolizumabParticipants 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. |
| Arm 2 Boserolimab 200 mg Q3W + Pembrolizumab 200 mg Q3W | Experimental | Drug: Boserolimab, Biological: PembrolizumabParticipants 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. |
| Arm 2a Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (TNBC) | Experimental | Drug: Boserolimab, Biological: PembrolizumabParticipants 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. |
| Arm 2b Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W (Endometrial) | Experimental | Drug: Boserolimab, Biological: PembrolizumabParticipants 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. |
| Arm 2c Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W (Endometrial) | Experimental | Drug: Boserolimab, Biological: PembrolizumabParticipants 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. |
| Arm 3 Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W + Pemetrexed + Carboplatin (NSCLC) | Experimental | Drug: Boserolimab, Biological: Pembrolizumab, Drug: Pemetrexed, Drug: CarboplatinParticipants 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. |
| Arm 4 Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W + Nab-paclitaxel (TNBC) | Experimental | Drug: Boserolimab, Biological: Pembrolizumab, Drug: Nab-paclitaxelParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (28 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BoserolimabAlso: MK-5890IV infusion | Drug | 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) |
| PembrolizumabAlso: MK-3475, KEYTRUDA®IV infusion | Biological | 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) |
| PemetrexedAlso: ALIMTA®IV infusion | Drug | Arm 3 Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W + Pemetrexed + Carboplatin (NSCLC) |
| CarboplatinAlso: PARAPLATIN®IV infusion | Drug | Arm 3 Boserolimab 30 mg Q3W + Pembrolizumab 200 mg Q3W + Pemetrexed + Carboplatin (NSCLC) |
| Nab-paclitaxelAlso: ABRAXANE®IV infusion | Drug | Arm 4 Boserolimab 30 mg Q6W + Pembrolizumab 400 mg Q6W + Nab-paclitaxel (TNBC) |
Primary outcome
Number of Participants Who Experienced a Dose-Limiting Toxicity (DLT)
Time frame: Up to 21 days in Cycle 1
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.
Number of Participants With One or More AEs
Time frame: Up to approximately 78 months
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.
Number of Participants Who Discontinued Study Treatment Due to an AE
Time frame: Up to 23 months
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.
10 secondary outcomes
Area Under the Concentration-Time Curve From Time 0 to Last Quantifiable Concentration (AUC0-last) of Boserolimab
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Predose Day 1 Cycle 1 and at designated timepoints up to Day 1 Cycle 2
Maximum Concentration (Cmax) of Boserolimab
Time frame: Predose Day 1 Cycle 1 and at designated timepoints up to Day 1 Cycle 2
Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Time frame: Up to approximately 78 months
Arm 3: Number of Participants Who Experienced a DLT
Time frame: Up to 21 days in Cycle 1
Arm 4: Number of Participants Who Experienced a DLT
Time frame: Up to 28 days in Cycle 1
Arm 3 and 4: Number of Participants With One or More AEs
Time frame: Up to 57 months
Arm 3 and 4: Number of Participants Who Discontinued Study Treatment Due to an AE
Time frame: Up to 27 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Merck Oncology Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
18 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Boserolimab, Pembrolizumab and Pemetrexed in people with Pharmacokinetics and Solid Tumor, run by Merck Sharp & Dohme LLC at 18 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Spain, United States, Israel, Chile, Netherlands and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Experienced a Dose-Limiting Toxicity (DLT) (time frame: Up to 21 days in Cycle 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2025.