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Malignant NeoplasmPhase 1/2NCT07302347

A Study of Pembrolizumab in Japanese Pediatric Participants With Solid Tumors or Lymphomas and Japanese Adult Participants With Merkel Cell Carcinoma (MK-3475-G21/KEYNOTE-G21)

A Phase 1/2 study testing Pembrolizumab in people with Malignant Neoplasm and Carcinoma, Merkel Cell, run by Merck Sharp & Dohme LLC at 7 sites in Japan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Researchers are looking for new ways to treat people with solid tumors, lymphomas (blood cancers), and a certain type of skin cancer. The goals of this study are to learn: About the safety of pembrolizumab (the study medicine) and if people tolerate it What happens to different doses of pembrolizumab in a person's… Read more about this study

Who is it for?
Ages 6 months and older
What is being tested?
Pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
7 sitesJapan
Study dates
23 Jun 2026to 31 Dec 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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 6 months and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • The main inclusion criteria include but are not limited to the following:
  • Arm 1:
  • For participants with relapsed or refractory classical Hodgkin lymphoma (cHL) or primary mediastinal large B-cell lymphoma (PMBCL)
  • Has a confirmed diagnosis of relapsed or refractory cHL or PMBCL after the most recent therapy
  • Has radiographically measurable disease per Lugano classification
  • For participants with completely resected melanoma:
Show all 27Show fewer
  • Has surgically completely resected and histologically/pathologically confirmed diagnosis of Stage IIB, IIC, III or IV cutaneous melanoma
  • Has not received any prior systemic therapy for their melanoma beyond surgical resection
  • All suspicious lesions amenable to biopsy are confirmed negative for malignancy
  • For participants with locally advanced or metastatic melanoma:
  • Has histologically confirmed diagnosis of locally advanced (unresectable Stage III) or metastatic (Stage IV) melanoma (including acral) not amenable to local therapy
  • Has radiographically measurable lesion(s) as defined by RECIST 1.1
  • For participants with microsatellite instability-high (MSI-H)/mismatch repair deficiency (dMMR) solid tumors:
  • Has histologically/cytologically documented, locally-advanced, or metastatic solid malignancy that is incurable and has either (a) failed prior standard therapy, (b) for which no standard therapy exists, or (c) standard therapy is not considered appropriate by the participant and treating physician
  • Has a documented positive local MSI-H or dMMR test result
  • Has radiographically measurable disease based on RECIST 1.1
  • For participants with tumor mutational burden-high (TMB-H) solid tumors:
  • Has histologically/cytologically documented, locally-advanced, or metastatic solid malignancy that is incurable and has either (a) failed prior standard therapy, (b) for which no standard therapy exists, or (c) standard therapy is not considered appropriate by the participant and treating physician
  • Has radiographically measurable disease based on RECIST 1.1
  • For participants with MCC:
  • Has histologically confirmed diagnosis of locoregional MCC that has recurred following standard locoregional therapy with surgery and/or radiation therapy and is not amenable to local therapy or metastatic MCC (Stage IV)
  • Has radiographically measurable disease based on RECIST 1.1
  • Arm 2:
  • For participants with MCC:
  • Has been untreated for advanced or metastatic disease
  • Arm 1 \& Arm 2:
  • Life expectancy of >3 months (Arm 1) or >6 months (Arm 2)

Who cannot join

  • The main exclusion criteria include but are not limited to the following:
  • Has known additional malignancy that is progressing or has required active treatment
  • Has known active (central nervous system) CNS metastases and/or carcinomatous meningitis
  • Has active autoimmune disease that has required systemic treatment in past 2 years
  • Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
  • Has active infection requiring systemic therapy
Show all 10Show fewer
  • Has known history of human immunodeficiency virus (HIV) infection
  • Has known history of Hepatitis B infection or known active Hepatitis C virus
  • Has undergone solid organ transplant at any time, or prior allogeneic hematopoietic stem cell transplantation within the last 5 years
  • Has not adequately recovered from major surgery or has ongoing surgical complications

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Toll Free Number contact

1-888-577-8839

Trialsites@msd.com

7 sites in 1 country

Japan7 sites, 7 recruiting

  • National Cancer Center Hospital ( Site 0002)

    Chūō, Tokyo, 104-0045

    Study Coordinator, +81-3-3542-2511

    Recruiting

  • National Hospital Organization Kyushu Cancer Center ( Site 0001)

    Fukuoka, 811-1395

    Study Coordinator, +81-92-541-3231

    Recruiting

  • Hyogo Prefectural Kobe Children's Hospital ( Site 0006)

    Kobe, Hyōgo, 650-0047

    Study Coordinator, +81-78-945-7300

    Recruiting

  • University Hospital,Kyoto Prefectural University of Medicine ( Site 0004)

    Kyoto, 602-8566

    Study Coordinator, +81-75-251-5111

    Recruiting

  • Nagoya City University Hospital ( Site 0003)

    Nagoya, Aichi-ken, 467-8602

    Study Coordinator, +81-52-851-5511

    Recruiting

  • Nagoya City University Hospital ( Site 0007)

    Nagoya, Aichi-ken, 467-8602

    Study Coordinator, +81-52-851-5511

    Recruiting

  • Sapporo Hokuyu Hospital ( Site 0005)

    Sapporo, Hokkaido, 003-0006

    Study Coordinator, +81-11-865-0111

    Recruiting

Other trials in Japan

About this study

Official title: A Phase I/II Study of Pembrolizumab (MK-3475) in Japanese Pediatric Participants With Specific Solid Tumors or Lymphomas, or in Japanese Adult Participants With Advanced Merkel Cell Carcinoma (KEYNOTE-G21)

Researchers are looking for new ways to treat people with solid tumors, lymphomas (blood cancers), and a certain type of skin cancer. The goals of this study are to learn:

  • About the safety of pembrolizumab (the study medicine) and if people tolerate it
  • What happens to different doses of pembrolizumab in a person's body over time
  • How the cancer responds (gets smaller or goes away) to treatment
Being tested
Pembrolizumab
Medical subject headings
Neoplasms, Carcinoma, Merkel Cell, Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PembrolizumabBiological

    Also called MK-3475

    25 mg/mL solution for intravenous infusion.

Study groups in NCT07302347
Study groupRoleWhat they receive
Arm 1: Pembrolizumab in Pediatric Participants with Solid Tumors or LymphomasExperimentalPediatric participants with solid tumors or lymphomas receive 2 mg/kg pembrolizumab via intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21 day cycle for up to 17 or 35 cycles.
Receives: Biological: Pembrolizumab
Arm 2: Pembrolizumab in Adult Participants with Merkel Cell Carcinoma (MCC)ExperimentalAdult participants with MCC receive 400 mg pembrolizumab via IV infusion on Day 1 of each 42 day (6 week) cycle, for up to 18 cycles.
Receives: Biological: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Arm 1: Number of Participants Who Experience an Adverse Event (AE)

    An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a study intervention. The number of participants with solid tumors or lymphomas who experience an AE will be reported.

    Measured: Up to approximately 28 months

  2. Arm 1: Number of Participants Who Discontinue Study Treatment Due To an AE

    An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a study intervention. The number of participants with solid tumors or lymphomas who discontinue study treatment due to an AE will be reported.

    Measured: Up to approximately 25 months

  3. Arm 1: Area Under the Concentration-Time Curve (AUC) of Pembrolizumab

    AUC is defined as the area under the concentration-time curve of pembrolizumab. Blood samples will be collected at specified intervals for the determination of AUC. AUC in participants with solid tumors or lymphomas will be reported.

    Measured: Predose at Cycle 1, 2, 4, 8 and every 4 cycles thereafter up to 35 cycles; postdose at Cycle 1 and Cycle 8 (a cycle is 21 days)

  4. Arm 1: Maximum Concentration (Cmax) of Pembrolizumab

    Cmax is defined as the maximum concentration of pembrolizumab reached. Blood samples will be collected at pre-specified intervals for the determination of Cmax. Cmax in participants with solid tumors or lymphomas will be reported.

    Measured: Predose at Cycle 1, 2, 4, 8 and every 4 cycles thereafter up to 35 cycles; postdose at Cycle 1 and Cycle 8 (a cycle is 21 days)

  5. Arm 1: Minimum Plasma Concentration (Cmin) of Pembrolizumab

    Cmin is defined as the minimum concentration of pembrolizumab observed in plasma after its administration and just prior to administration of a subsequent dose. Blood samples will be collected at pre-specified timepoints to determine Cmin. Cmin in participants with solid tumors or lymphomas will be reported.

    Measured: Predose at Cycle 1, 2, 4, 8 and every 4 cycles thereafter up to 35 cycles; postdose at Cycle 1 and Cycle 8 (a cycle is 21 days)

  6. Arm 2: Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR)

    ORR is defined as complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by blinded independent central review (BICR). ORR in participants with Merkel cell carcinoma will be reported.

    Measured: Up to approximately 37 months

Secondary outcomes (24)

  1. Arm 1: ORR per RECIST 1.1 by Investigator Assessment

    ORR is defined as complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 by investigator assessment. ORR in participants with solid tumors will be reported.

    Measured: Up to approximately 46 months

  2. Arm 1: ORR per Lugano Classification by Investigator Assessment

    ORR is defined as complete response (CR: all target lymph nodes must have regressed to normal size defined as ≤1.5 cm in longest diameter) or partial response (PR: ≥50% decrease in sum of products of diameters of target lesions from baseline, and no individual lesion meets the criteria for progression), per Lugano classification (Cheson et al, Journal of Clinical Oncology, 2014). ORR in participants with lymphomas as assessed by investigator will be reported.

    Measured: Up to approximately 46 months

  3. Arm 1: Duration of Response (DOR) per RECIST 1.1 by Investigator Assessment

    For participants who demonstrate a complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR per RECIST 1.1 by investigator assessment in participants with solid tumors will be reported.

    Measured: Up to approximately 46 months

  4. Arm 1: DOR per Lugano Classification by Investigator Assessment

    For participants who demonstrate confirmed CR or PR, DOR is defined as the time from the first documented evidence of CR (all target lymph nodes must have regressed to normal size defined as ≤1.5 cm in longest diameter) or PR (≥50% decrease in sum of products of diameters of target lesions from baseline, and no individual lesion meets the criteria for progression) per Lugano classification (Cheson et al, Journal of Clinical Oncology, 2014) until progressive disease (PD: based on the progression of any single lesion and other certain requirements) or death due to any cause, whichever occurs first. DOR in participants with lymphomas as assessed by investigator will be reported.

    Measured: Up to approximately 46 months

  5. Arm 1: Disease Control (DCR) per RECIST 1.1 by Investigator Assessment

    DCR is defined, per RECIST 1.1, as the percentage of participants who have a CR or PR or stable disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD]). DCR per RECIST 1.1 by investigator assessment in participants with solid tumors will be reported.

    Measured: Up to approximately 46 months

  6. Arm 1: DCR per Lugano Classification by Investigator Assessment

    DCR is defined as confirmed CR (all target lymph nodes must have regressed to normal size defined as ≤1.5 cm in longest diameter), PR (≥50% decrease in sum of products of diameters of target lesions from baseline, and no individual lesion meets the criteria for progression), or stable disease (SD: Target lesions do not meet the criteria for CR or PR and no individual lesion meets the criteria for progression) per Lugano classification (Cheson et al, Journal of Clinical Oncology, 2014). DCR in participants with lymphomas as assessed by investigator will be reported.

    Measured: Up to approximately 46 months

  7. Arm 1: Progression-free Survival (PFS) per RECIST 1.1 by Investigator Assessment

    PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by RECIST 1.1. PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS per RECIST 1.1 by investigator assessment in participants with solid tumors will be reported.

    Measured: Up to approximately 46 months

  8. Arm 1: PFS per Lugano Classification by Investigator Assesment

    PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by Lugano classification (Cheson et al, Journal of Clinical Oncology, 2014) by investigator. PD per Lugano classification is defined as based on the progression of any single lesion and other certain requirements. PFS in participants with solid tumors will be reported.

    Measured: Up to approximately 46 months

  9. Arm 1: Relapse-free Survival (RFS) per RECIST 1.1 by Investigator Assessment

    RFS is defined only for adjuvant melanoma participants as the time from first dose to recurrence of melanoma at any site (local, in-transit or regional lymph nodes or distant recurrence) per RECIST 1.1 by investigator assessment or death due to any cause, whichever occurs first. New incident cases of melanoma and second cancer diagnoses are not counted as events for recurrence-free survival. RFS in participants with solid tumors or lymphomas will be reported.

    Measured: Up to approximately 46 months

  10. Arm 1: Distant Metastasis-free Survival (DMFS) per RECIST 1.1 by Investigator Assessment

    DMFS is defined only for adjuvant melanoma participants as the time from first dosing to the first diagnosis of a distant metastasis per RECIST 1.1 by investigator assessment or death (due to any cause), whichever occurs first. Distant metastasis refers to cancer that has spread from the original (primary) tumor and beyond local tissues and lymph nodes to distant organs or distant lymph nodes. DMFS in participants with solid tumors or lymphomas will be reported.

    Measured: Up to approximately 46 months

  11. Arm 1: Overall Survival (OS)

    OS is defined as the time from the first dose of study intervention to death due to any cause. OS in participants with solid tumors or lymphomas will be reported.

    Measured: Up to approximately 46 months

  12. Arm 1: Number of Participants with Anti-Drug Antibodies (ADAs) Against Pembrolizumab

    Blood samples will be collected at multiple time points to determine the ADA response to pembrolizumab. The number of participants with ADA for pembrolizumab in participants with solid tumors or lymphomas will be reported.

    Measured: Predose at Cycle 1, 2, 4, 8 and every 4 cycles thereafter up to 35 cycles (a cycle is 21 days)

  13. Arm 2: ORR per RECIST 1.1 by Investigator Assessment

    ORR is defined as complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 by investigator assessment. ORR in participants with Merkel cell carcinoma will be reported.

    Measured: Up to approximately 46 months

  14. Arm 2: DOR per RECIST 1.1 by BICR

    For participants who demonstrate a complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR per RECIST 1.1 by BICR in participants with Merkel cell carcinoma will be reported.

    Measured: Up to approximately 46 months

  15. Arm 2: DOR per RECIST 1.1 by Investigator Assessment

    For participants who demonstrate a confirmed CR: disappearance of all target lesions or PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR by investigator assessment in participants with Merkel cell carcinoma will be reported.

    Measured: Up to approximately 46 months

  16. Arm 2: DCR per RECIST 1.1 by BICR

    DCR is defined, per RECIST 1.1, as the percentage of participants who have a CR or PR or stable disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD]). DCR per RECIST 1.1 by BICR in participants with Merkel cell carcinoma will be reported.

    Measured: Up to approximate ly 46 months

  17. Arm 2: DCR per RECIST 1.1 by Investigator Assessment

    DCR is defined, per RECIST 1.1, as the percentage of participants who have a CR or PR or stable disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD). DCR per RECIST 1.1 by investigator assessment in participants with Merkel cell carcinoma will be reported.

    Measured: Up to approximately 46 months

  18. Arm 2: PFS per RECIST 1.1 by BICR

    PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by RECIST 1.1. PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS per RECIST 1.1 by BICR in participants with Merkel cell carcinoma will be reported.

    Measured: Up to approximately 46 months

  19. Arm 2: PFS per RECIST 1.1 by Investigator Assesment

    PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by RECIST 1.1. PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS per RECIST 1.1 by investigator assessment in participants with Merkel cell carcinoma will be reported.

    Measured: Up to approximately 46 months

  20. Arm 2: OS

    OS is defined as the time from the first dose of study intervention to death due to any cause. OS in participants with Merkel cell carcinoma will be reported.

    Measured: Up to approximately 46 months

  21. Arm 2: Cmax of Pembrolizumab

    Cmax is defined as the maximum concentration of pembrolizumab reached. Blood samples will be collected at pre-specified intervals for the determination of Cmax. Cmax in participants with Merkel cell carcinoma will be reported.

    Measured: Predose at Cycles 1-4, and every 2 cycles thereafter up to 18 cycles; postdose at Cycle 1 and Cycle 3 (a cycle is 42 days)

  22. Arm 2: Cmin of Pembrolizumab

    Cmin is defined as the minimum concentration of pembrolizumab observed in plasma after its administration and just prior to administration of a subsequent dose. Blood samples will be collected at pre-specified timepoints to determine Cmin. Cmin in participants with Merkel cell carcinoma will be reported.

    Measured: Predose at Cycles 1-4, and every 2 cycles thereafter up to 18 cycles; postdose at Cycle 1 and Cycle 3 (a cycle is 42 days)

  23. Arm 2: Number of Participants Who Experience an Adverse Event (AE)

    An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a study intervention. The number of participants with Merkel cell carcinoma who experience an AE will be reported.

    Measured: Up to approximately 28 months

  24. Arm 2: Number of Participants Who Discontinue Study Treatment Due To an AE

    An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a study intervention. The number of participants with Merkel cell carcinoma who discontinue study treatment due to an AE will be reported.

    Measured: Up to approximately 25 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Dec 2025
  2. Study start23 Jun 2026
  3. Primary completion30 Mar 2029 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07302347
Sponsor's protocol ID
3475-G21
Other IDs
MK-3475-G21, jRCT2041250120
Status last verified
Jul 2026
First submitted
11 Dec 2025
Last updated
13 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Pembrolizumab in people with Malignant Neoplasm and Carcinoma, Merkel Cell, run by Merck Sharp & Dohme LLC at 7 sites in Japan.

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 27 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Japan. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Toll Free Number (1-888-577-8839, Trialsites@msd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Arm 1: Number of Participants Who Experience an Adverse Event (AE) (time frame: Up to approximately 28 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07302347.

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 13 Jul 2026.

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