Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)

May 19, 2026 updated by: Merck Sharp & Dohme LLC

An Open-label Randomized Phase 2 Study to Evaluate Safety and Efficacy of Patritumab Deruxtecan Plus Pembrolizumab Administered Either Before or After Carboplatin/Paclitaxel Plus Pembrolizumab Compared With Pembrolizumab in Combination With Chemotherapy Followed by Surgery and Adjuvant Pembrolizumab for High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/Human Epidermal Growth Factor Receptor-2 Negative Breast Cancer (HERTHENA-Breast03)

Researchers are looking for new ways to treat triple-negative breast cancer (TNBC) and hormone receptor (HR) low positive/human epidermal growth factor receptor-2 (HER2) negative breast cancer. The main goals of this study are to learn:

  • About the safety of the study treatments and if people tolerate them
  • If people who receive patritumab deruxtecan, pembrolizumab, and chemotherapy before surgery have fewer cancer cells removed during surgery compared to those who receive only pembrolizumab (pembro) and chemotherapy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
372

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • South Korea
      • Seoul, South Korea, 03080
        • Recruiting
        • Seoul National University Hospital ( Site 2400)
        • Contact:
          • Study Coordinator
          • Phone Number: +82220720850
      • Seoul, South Korea, 05505
        • Recruiting
        • Asan Medical Center ( Site 2401)
        • Contact:
          • Study Coordinator
          • Phone Number: +82230103217
      • Seoul, South Korea, 03722
        • Recruiting
        • Severance Hospital, Yonsei University Health System ( Site 2402)
        • Contact:
          • Study Coordinator
          • Phone Number: +82222288135
  • Spain
      • Córdoba, Spain, 14004
        • Recruiting
        • Hospital Universitario Reina Sofia ( Site 1702)
        • Contact:
          • Study Coordinator
          • Phone Number: +34 957012408
    • Catalonia
      • Badalona, Catalonia, Spain, 08916
        • Recruiting
        • Institut Català d'Oncologia (ICO) - Badalona ( Site 1700)
        • Contact:
          • Study Coordinator
          • Phone Number: +34934978925
    • Madrid, Comunidad de
      • Madrid, Madrid, Comunidad de, Spain, 28027
        • Recruiting
        • Clinica Universidad de Navarra ( Site 1703)
        • Contact:
          • Study Coordinator
          • Phone Number: +34913531920
  • Taiwan
      • Taichung, Taiwan, 407
        • Recruiting
        • Taichung Veterans General Hospital ( Site 2502)
        • Contact:
          • Study Coordinator
          • Phone Number: +886423592525
      • Tainan, Taiwan, 704
        • Recruiting
        • National Cheng Kung University Hospital ( Site 2503)
        • Contact:
          • Study Coordinator
          • Phone Number: +88662353535
      • Taipei, Taiwan, 112
        • Recruiting
        • Koo Foundation Sun Yat-Sen Cancer Center ( Site 2501)
        • Contact:
          • Study Coordinator
          • Phone Number: 886228970011x1686
  • United States
    • California
      • Santa Monica, California, United States, 90404
        • Recruiting
        • UCLA Hematology/Oncology - Parkside ( Site 0021)
        • Contact:
          • Study Coordinator
          • Phone Number: 424-402-9520
    • Illinois
      • Skokie, Illinois, United States, 60077
        • Recruiting
        • Orchard Healthcare Research Inc. ( Site 0006)
        • Contact:
          • Study Coordinator
          • Phone Number: 847-568-9932
    • Montana
      • Billings, Montana, United States, 59102
        • Recruiting
        • Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana ( Site 0003)
        • Contact:
          • Study Coordinator
          • Phone Number: 406-238-6685
    • Oregon
      • Tigard, Oregon, United States, 97223
        • Recruiting
        • Northwest Cancer Specialists (Compass Oncology) ( Site 8003)
        • Contact:
          • Study Coordinator
          • Phone Number: 360-944-9889
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • SCRI Oncology Partners ( Site 7000)
        • Contact:
          • Study Coordinator
          • Phone Number: 844-482-4812
    • Texas
      • Dallas, Texas, United States, 75246
        • Recruiting
        • Texas Oncology - DFW ( Site 8000)
        • Contact:
          • Study Coordinator
          • Phone Number: 214-370-1067
      • Houston, Texas, United States, 77030
        • Recruiting
        • Houston Methodist Hospital ( Site 0022)
        • Contact:
          • Study Coordinator
          • Phone Number: 713-441-9948
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Recruiting
        • Virginia Oncology Associates (VOA) ( Site 8001)
        • Contact:
          • Study Coordinator
          • Phone Number: 844-482-4812

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

  • Has locally advanced, non-metastatic (M0), breast cancer, defined as any of the following combined primary tumor (T) and regional lymph node (N) staging per current American Joint Committee on Cancer (AJCC) criteria: cT1c, N1-N2; cT2, N0-N2; cT3, N0-N2; or cT4a-d, N0-N2
  • Has centrally confirmed diagnosis of breast cancer that is triple-negative or HR-low+/HER2- breast cancer that will be treated according to the triple-negative breast cancer (TNBC) paradigm
  • Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load
  • Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 28 days prior to allocation/randomization
  • Has left ventricular ejection fraction (LVEF) of ≥50% or ≥ lower limit of normal (LLN) as assessed by echocardiogram (ECHO) or multigate acquisition scan (MUGA) scan

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

  • Has uncontrolled or significant cardiovascular disease before randomization
  • Has any history of or evidence of any current leptomeningeal carcinomatosis.
  • Has clinically significant corneal disease
  • Has human immunodeficiency virus (HIV) infection with a history of Kaposi sarcoma and/or multicentric Castleman disease
  • Has evidence of ongoing, uncontrolled, systemic bacterial, fungal, or viral infection
  • Has received prior therapy with an anti-programmed death (PD)-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor
  • Has received any prior treatment, including radiation, systemic therapy, and/or definitive surgery for currently diagnosed breast cancer
  • Has received prior treatment with an anti-human epidermal growth factor receptor 3 (HER3) antibody and/or antibody-drug conjugate (ADC) that consists of an exatecan derivative that is a topoisomerase I inhibitor (e.g., trastuzumab deruxtecan)
  • Has metastatic (Stage IV) breast cancer or cN3 nodal involvement
  • Has known additional malignancy that is progressing or has required active treatment within the past 5 years
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Has any history of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use, or current or suspected ILD
  • Has an active infection requiring systemic therapy
  • Has concurrent active HBV and HCV infection
  • Has clinically severe respiratory compromise resulting from intercurrent pulmonary illness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part 1, A: Pembrolizimab + patritumab deruxtecan → Pembrolizumab + paclitaxel + carboplatin
In Part 1, participants receive neoadjuvant pembrolizumab 200 mg via intravenous (IV) infusion every 3 weeks (Q3W) plus patritumab deruxtecan via IV infusion Q3W for 12 weeks, followed by pembrolizumab 200 mg via IV infusion Q3W plus paclitaxel 80 mg/m^2 via IV infusion every week (QW) and carboplatin AUC1.5 mg/ml/min via IV infusion QW for 12 weeks. At 3 to 6 weeks after last dose of neoadjuvant treatment, participants will undergo surgery for their breast cancer.
Biological: Patritumab deruxtecan
Administered via IV infusion as neoadjuvant treatment
Other Names:
  • U3-1402
  • HER3-DXd
  • MK-1022
Biological: Pembrolizumab
Administered via IV infusion as neoadjuvant treatment in Part 1 and via IV infusion as neoadjuvant and adjuvant treatment in Part 2
Other Names:
  • MK-3475
  • KEYTRUDA®
Drug: Paclitaxel
Administered via IV infusion as neoadjuvant treatment
Other Names:
  • TAXOL®
  • ONXAL®
Drug: Carboplatin
Administered via IV infusion as neoadjuvant treatment
Other Names:
  • PARAPLATIN®
Experimental: Part 2, A: Pembrolizimab + patritumab deruxtecan → Pembrolizumab + paclitaxel + carboplatin
In Part 2, participants receive neoadjuvant pembrolizumab 200 mg IV infusion every Q3W plus patritumab deruxtecan (dose to be determined in part 1) IV infusion Q3W for 12 weeks, followed by pembrolizumab 200 mg IV infusion Q3W plus paclitaxel 80 mg/m^2 IV infusion QW and carboplatin AUC1.5 mg/ml/min IV infusion QW for 12 weeks. At 3-6 weeks after last dose of neoadjuvant treatment, participants undergo surgery for breast cancer. After surgery, participants receive adjuvant pembrolizumab 400 mg IV every 6 weeks (Q6W) for ~30 weeks. Additional adjuvant treatment of physician's choice (TPC) may be given to participants with residual disease. TPC options are olaparib 300 mg oral twice daily (BID) for 1 year (participants with germline BRCA mutation [gBRCAm] only), capecitabine 1000-1250 mg/m^2 oral BID days 1-14 and 22-35 Q6W for 4 six-week cycles or doxorubicin 60mg/m^2 (or epirubicin 90 mg/m^2) IV Q3W or every 2 weeks (Q2W) and cyclophosphamide 600 mg/m^2 IV Q3W or Q2W for 4 doses.
Biological: Patritumab deruxtecan
Administered via IV infusion as neoadjuvant treatment
Other Names:
  • U3-1402
  • HER3-DXd
  • MK-1022
Biological: Pembrolizumab
Administered via IV infusion as neoadjuvant treatment in Part 1 and via IV infusion as neoadjuvant and adjuvant treatment in Part 2
Other Names:
  • MK-3475
  • KEYTRUDA®
Drug: Paclitaxel
Administered via IV infusion as neoadjuvant treatment
Other Names:
  • TAXOL®
  • ONXAL®
Drug: Carboplatin
Administered via IV infusion as neoadjuvant treatment
Other Names:
  • PARAPLATIN®
Drug: Doxorubicin hydrochloride
Administered via IV infusion as neoadjuvant treatment in Arm C and an option for adjuvant treatment for participants with residual disease in Arms A and B in Part 2
Other Names:
  • ADRIAMYCIN®
Drug: Epirubicin hydrochloride
Administered via IV infusion as neoadjuvant treatment in Arm C and an option for adjuvant treatment for participants with residual disease in Arms A and B in Part 2
Other Names:
  • ELLENCE®
Drug: Cyclophosphamide
Administered via IV infusion as neoadjuvant treatment in Arm C and an option for adjuvant treatment for participants with residual disease in Arms A and B in Part 2
Other Names:
  • CYTOXAN®
Drug: Capecitabine
Administered via oral tablets as an option for adjuvant treatment for participants with residual disease in Part 2
Other Names:
  • XELODA®
Drug: Olaparib
Administered via oral tablets as an option for adjuvant treatment for participants with germline BRCA mutations and residual disease in Part 2
Other Names:
  • LYNPARZA®
Experimental: Part 2, B: Pembrolizumab + paclitaxel + carboplatin → Pembrolizumab + patritumab deruxtecan
In Part 2, participants receive neoadjuvant pembrolizumab 200 mg IV infusion Q3W plus paclitaxel 80 mg/m^2 IV infusion QW and carboplatin AUC1.5 mg/ml/min IV infusion QW for 12 weeks, followed by pembrolizumab 200 mg IV infusion Q3W plus patritumab deruxtecan (dose to be determined in part 1) via IV infusion Q3W for 12 weeks. At 3 to 6 weeks after last dose of neoadjuvant treatment, participants will undergo surgery for their breast cancer. After surgery, participants will receive adjuvant pembrolizumab 400 mg IV infusion Q6W for ~30 weeks. Additional adjuvant TPC may be administered to participants with residual disease. TPC options include olaparib 300 mg oral BID for 1 year (participants with gBRCAm only), capecitabine 1000-1250 mg/m^2 oral BID days 1-14 and 22-35 Q6W for 4 six-week cycles or doxorubicin 60mg/m^2 (or epirubicin 90 mg/m^2) IV infusion Q3W or Q2W and cyclophosphamide 600 mg/m^2 IV infusion Q3W or Q2W for 4 doses.
Biological: Patritumab deruxtecan
Administered via IV infusion as neoadjuvant treatment
Other Names:
  • U3-1402
  • HER3-DXd
  • MK-1022
Biological: Pembrolizumab
Administered via IV infusion as neoadjuvant treatment in Part 1 and via IV infusion as neoadjuvant and adjuvant treatment in Part 2
Other Names:
  • MK-3475
  • KEYTRUDA®
Drug: Paclitaxel
Administered via IV infusion as neoadjuvant treatment
Other Names:
  • TAXOL®
  • ONXAL®
Drug: Carboplatin
Administered via IV infusion as neoadjuvant treatment
Other Names:
  • PARAPLATIN®
Drug: Doxorubicin hydrochloride
Administered via IV infusion as neoadjuvant treatment in Arm C and an option for adjuvant treatment for participants with residual disease in Arms A and B in Part 2
Other Names:
  • ADRIAMYCIN®
Drug: Epirubicin hydrochloride
Administered via IV infusion as neoadjuvant treatment in Arm C and an option for adjuvant treatment for participants with residual disease in Arms A and B in Part 2
Other Names:
  • ELLENCE®
Drug: Cyclophosphamide
Administered via IV infusion as neoadjuvant treatment in Arm C and an option for adjuvant treatment for participants with residual disease in Arms A and B in Part 2
Other Names:
  • CYTOXAN®
Drug: Capecitabine
Administered via oral tablets as an option for adjuvant treatment for participants with residual disease in Part 2
Other Names:
  • XELODA®
Drug: Olaparib
Administered via oral tablets as an option for adjuvant treatment for participants with germline BRCA mutations and residual disease in Part 2
Other Names:
  • LYNPARZA®
Active Comparator: Part 2, C: Pembro + paclitaxel + carboplatin→ Pembro + doxorubicin (or epirubicin) +cyclophosphamide
In Part 2, participants receive neoadjuvant pembrolizumab 200 mg IV infusion Q3W plus paclitaxel 80 mg/m^2 IV infusion QW and carboplatin AUC1.5 mg/ml/min via IV infusion QW for 12 weeks, followed by pembrolizumab 200 mg IV infusion Q3W plus doxorubicin 60mg/m^2 (or epirubicin 90 mg/m^2) IV infusion Q3W and cyclophosphamide 600 mg/m^2 IV infusion Q3W for 12 weeks. At 3 to 6 weeks after last dose of neoadjuvant treatment, participants will undergo surgery for their breast cancer. After surgery, participants will receive adjuvant pembrolizumab 400 mg IV infusion Q6W for approximately 30 weeks. Additional adjuvant TPC may be administered to participants with residual disease. TPC options include olaparib 300 mg oral BID for 1 year (participants with gBRCAm only) or capecitabine 1000-1250 mg/m^2 oral BID days 1-14 and 22-35 Q6W for 4 six-week cycles.
Biological: Pembrolizumab
Administered via IV infusion as neoadjuvant treatment in Part 1 and via IV infusion as neoadjuvant and adjuvant treatment in Part 2
Other Names:
  • MK-3475
  • KEYTRUDA®
Drug: Paclitaxel
Administered via IV infusion as neoadjuvant treatment
Other Names:
  • TAXOL®
  • ONXAL®
Drug: Carboplatin
Administered via IV infusion as neoadjuvant treatment
Other Names:
  • PARAPLATIN®
Drug: Doxorubicin hydrochloride
Administered via IV infusion as neoadjuvant treatment in Arm C and an option for adjuvant treatment for participants with residual disease in Arms A and B in Part 2
Other Names:
  • ADRIAMYCIN®
Drug: Epirubicin hydrochloride
Administered via IV infusion as neoadjuvant treatment in Arm C and an option for adjuvant treatment for participants with residual disease in Arms A and B in Part 2
Other Names:
  • ELLENCE®
Drug: Cyclophosphamide
Administered via IV infusion as neoadjuvant treatment in Arm C and an option for adjuvant treatment for participants with residual disease in Arms A and B in Part 2
Other Names:
  • CYTOXAN®
Drug: Capecitabine
Administered via oral tablets as an option for adjuvant treatment for participants with residual disease in Part 2
Other Names:
  • XELODA®
Drug: Olaparib
Administered via oral tablets as an option for adjuvant treatment for participants with germline BRCA mutations and residual disease in Part 2
Other Names:
  • LYNPARZA®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Part 1: Number of Participants Experiencing an Adverse Event (AE)
Time Frame: Up to ~43 weeks
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who experience an AE will be presented for Part 1.
Up to ~43 weeks
Part 1: Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs)
Time Frame: Up to 21 days
A DLT is defined by the National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE) Version 5.0, assessed by investigator as drug-related: Grade (gr) 3 or 4 nonhematologic toxicity (with exceptions); gr 3 or gr 4 laboratory values (with exceptions); gr 3 or 4 febrile neutropenia; prolonged delay (>2 weeks) in initiating Cycle 2 (cycle length = 3 weeks) due to intervention-related toxicity; any intervention-related toxicity that causes the participant to discontinue intervention during Cycle 1; interstitial lung disease as per investigator; any other gr ≥3 pulmonary toxicity; or gr 5 toxicity.
Up to 21 days
Part 1: Number of Participants who Discontinued Study Treatment Due to an AE
Time Frame: Up to ~30 weeks
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who discontinued study treatment due to an AE will be presented for Part 1.
Up to ~30 weeks
Part 2: Pathological Complete Response (pCR) Rate Using the Definition of ypT0/Tis ypN0
Time Frame: Up to ~30 weeks
pCR (ypT0/Tis ypN0) is defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes after completion of neoadjuvant systemic therapy at the time of definitive surgery.
Up to ~30 weeks
Part 2: Number of Participants Experiencing an AE
Time Frame: Up to ~103 weeks
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who experience an AE will be presented for Part 2.
Up to ~103 weeks
Part 2: Number of Participants who Discontinued Study Treatment Due to an AE
Time Frame: Up to ~90 weeks
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who discontinued study treatment due to an AE will be presented for Part 2.
Up to ~90 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Part 2: pCR-No Ductal Carcinoma in Situ (DCIS) Rate Using the Definition of ypT0 ypN0
Time Frame: Up to ~30 weeks
pCR-no DCIS (ypT0 ypN0) is defined as the absence of residual invasive and in situ cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes after completion of neoadjuvant systemic therapy at the time of definitive surgery.
Up to ~30 weeks
Part 2: Event-Free Survival (EFS)
Time Frame: Up to ~100 months
EFS is defined as the time from randomization to disease progression that precludes surgery, local or distant recurrence, or death due to any cause, whichever occurs first.
Up to ~100 months
Part 2: Overall Survival (OS)
Time Frame: Up to ~100 months
OS is defined as the time from randomization to date of death due to any cause.
Up to ~100 months
Part 2: Distant Progression or Distant Recurrence-Free Survival (DPDRFS)
Time Frame: Up to ~100 months
DPDRFS is defined as the time from randomization to first distant progression or distant recurrence event as assessed or death due to any cause, whichever occurs first.
Up to ~100 months
Part 2: Residual Cancer Burden (RCB)
Time Frame: Up to ~30 weeks
RCB is defined as residual disease in either the breast or lymph node at the time of surgery. RCB score provides a continuous measurement of the extent of residual cancer. There are four RCB classes: RCB-0 (RCB score 0), RCB-1 (0< RCB score <1.36), RCB-2 (1.36 <RCB score <3.28), and RCB-3 (RCB score >3.28).
Up to ~30 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Merck Sharp & Dohme LLC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Daiichi Sankyo

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 20, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2034

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 21, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 28, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1022-010
  • MK-1022-010 (Other Identifier: MSD)
  • U1111-1307-7867 (Registry Identifier: UTN)
  • 2024-514376-40-00 (Registry Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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