Bladder CancerPhase 3TroFuse-055NCT07829783
A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) and Pembrolizumab (MK-3475A) in Participants With Bladder Cancer (MK-2870-055)
A Phase 3 study testing Sac-TMT, Pembrolizumab and Berahyaluronidase alfa and Cisplatin in people with Bladder Cancer, run by Merck Sharp & Dohme LLC at 10 sites in 2 countries.
Trial summary
Researchers are looking for new ways to treat muscle-invasive bladder cancer (MIBC). MIBC is a type of bladder cancer that has spread into the muscle layer of the bladder but has not spread to other distant parts of the body. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Sac-TMT, Pembrolizumab and Berahyaluronidase alfa and Cisplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 23 Oct 2026to 25 Sep 2036
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The main inclusion criteria include but are not limited to the following:
- Has a diagnosis of muscle-invasive bladder cancer (MIBC) (cT2-T4aN0-N1)
- Has clinically nonmetastatic bladder cancer (N0-N1M0)
- Is either ineligible for radical cystectomy or has opted for bladder preservation and is planned to receive chemoradiotherapy (CRT)
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
Who cannot join
- The main exclusion criteria include but are not limited to the following:
- Has known presence of diffuse carcinoma in situ (CIS) throughout the bladder
- Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing
- Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease
- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
- Has received prior pelvic/local radiation therapy for any reason or any systemic antineoplastic treatment for MIBC
Show all 9Show fewer
- Has not recovered to Grade ≤1 or baseline from AE associated with anticancer therapy before randomization
- Has a known additional malignancy that is progressing or has required active treatment within the past 2 years
- Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids, has current pneumonitis/interstitial lung disease, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments
Trial locations and contacts
10 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
10 sites in 2 countries
Ukraine9 sites, 9 recruiting
- Recruiting
MNPE ClinCenter of Oncology,Hematology,Transplantology and Palliative Care of CherkasyRegCouncil ( Site 3004)
Cherkasy, Cherkasy Oblast, 18009
Study Coordinator, +380472370123
- Recruiting
Communal non-profit enterprise "Regional clinical hospital of Ivano-Frankivsk Regional Council" ( Site 3000)
Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76008
Study Coordinator, +380955171872
- Recruiting
Limited Liability Company Ukrainian Center of Tomotherapy ( Site 3008)
Kropyvnytskyi, Kirovohrad Oblast, 25011
Study Coordinator, +380950590214
- Recruiting
Municipal non-profit enterprise "Kyiv City Clinical Oncology Center" of executive body of Kyiv City ( Site 3006)
Kyiv, 03115
Study Coordinator, +380443650431
- Recruiting
Shalimov Institute of Surgery and Transplantation ( Site 3009)
Kyiv, 03680
Study Coordinator, +380939720596
- Recruiting
Municipal Enterprise "Volyn Regional Medical Oncology Centre" of the Volyn Regional Council ( Site 3007)
Lutsk, Volyn Oblast, 43018
Study Coordinator, +380503782998
- Recruiting
University Hospital of the State Nonprofit Company "Danylo Halytsky Lviv National Medical University ( Site 3002)
Lviv, Lviv Oblast, 79010
Study Coordinator, +380677280861
- Recruiting
MNPE Lviv Oncology Regional Treatment and Diagnostic Center of Lviv Regional Council ( Site 3005)
Lviv, Lviv Oblast, 79031
Study Coordinator, +380322953788
- Recruiting
ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 3010)
Rivne, Rivne Oblast, 33010
Study Coordinator, +380503802915
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital at Kaohsiung ( Site 2702)
Kaohsiung City, 83301
Study Coordinator, +88677317123
About this study
Official title: A Phase 3 Study Evaluating Sacituzumab Tirumotecan Plus Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) as Induction Therapy, Followed by Local Therapy With Chemoradiation and MK-3475A Consolidation Versus Local Therapy With Chemoradiation in Participants With MIBC Who Elect Bladder Preservation
Researchers are looking for new ways to treat muscle-invasive bladder cancer (MIBC). MIBC is a type of bladder cancer that has spread into the muscle layer of the bladder but has not spread to other distant parts of the body.
The usual treatment for MIBC is surgery to remove the bladder but some people choose to have other treatments, such as chemoradiotherapy (CRT), instead of surgery so they can keep their bladder.
Researchers want to know if giving 2 trial treatments with CRT can treat MIBC. One trial treatment is called sacituzumab tirumotecan (sac-TMT) and the other trial treatment is called subcutaneous (SC) pembrolizumab (or pembrolizumab and berahyaluronidase alfa). The main goal of this trial is to learn if participants who receive sac-TMT, SC pembrolizumab, and CRT live longer without their cancer growing, spreading, or coming back compared to those who receive CRT alone.
- Conditions
- Bladder Cancer
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sac-TMTBiological
Also called MK-2870, SKB264, Sacituzumab tirumotecan
IV infusion
Pembrolizumab and Berahyaluronidase alfaBiological
Also called MK-3475A
Pembrolizumab coformulated with berahyaluronidase alfa administered as a SC injection
CisplatinDrug
IV infusion administered at 35 mg/m^2 weekly for up to 6 doses during RT
5-FUDrug
IV infusion administered at 500 mg/m^2 on Days 1 to 5 and Days 22 to 26 during RT
MMCDrug
IV infusion administered at 12 mg/m^2 on Day 1 during RT
CapecitabineDrug
Oral dose administered at 825 mg/m^2 twice daily during RT
GemcitabineDrug
IV infusion administered at 27 mg/m^2 twice weekly for up to 12 doses during RT
Conventional RadiotherapyRadiation
External beam radiation administered per global clinical guidelines (64 Gy at 2 Gy/fraction over approximately 6.5 weeks)
Hypofractionated radiotherapyRadiation
External beam radiation administered per global clinical guidelines (55 Gy at 2.75 Gy/fraction over approximately 4 weeks)
Rescue MedicationsDrug
Participants receive rescue medications at the investigator's discretion, per approved product label. Rescue medications include pegfilgrastim (or equivalent), H1 receptor antagonist, H2 receptor antagonist, acetaminophen (or equivalent), dexamethasone (or equivalent), steroid mouthwash (dexamethasone or equivalent).
| Study group | Role | What they receive |
|---|---|---|
| Sac-TMT + Pembrolizumab and Berahyaluronidase alfa + Chemoradiotherapy | Experimental | Participants will receive sac-TMT 4 mg/kg by intravenous (IV) infusion every 2 weeks (q2w) for up to 6 doses plus pembrolizumab and berahyaluronidase alfa 790 mg SC every 6 weeks (q6w) for up to 2 doses.
CRT (radiotherapy [RT] and concurrent chemotherapy) will then be administered to all participants as standard of care per treatment regimens chosen by the investigator. RT will include conventional radiation or hypofractionated radiation to the bladder for up to approximately 6.5 weeks. Concurrent chemotherapy will be administered with RT and will include cisplatin, or 5-fluorouracil (5-FU) + mitomycin C, or capecitabine + mitomycin C, or gemcitabine.
Pembrolizumab and berahyaluronidase alfa 790 mg SC will be administered q6w for up to additional 7 cycles as consolidation therapy. Each cycle is 42 days (up to approximately 42 weeks). Receives: Biological: Sac-TMT; Biological: Pembrolizumab and Berahyaluronidase alfa; Drug: Cisplatin; Drug: 5-FU; Drug: MMC; Drug: Capecitabine; Drug: Gemcitabine; Radiation: Conventional Radiotherapy; Radiation: Hypofractionated radiotherapy; Drug: Rescue Medications |
| Chemoradiotherapy | Experimental | CRT (radiotherapy [RT] and concurrent chemotherapy) will then be administered to all participants as standard of care per treatment regimens chosen by the investigator. RT will include conventional radiation or hypofractionated radiation to the bladder for up to approximately 6.5 weeks. Concurrent chemotherapy will be administered with RT and will include cisplatin, or 5-fluorouracil (5-FU) + mitomycin C, or capecitabine + mitomycin C, or gemcitabine. Receives: Drug: Cisplatin; Drug: 5-FU; Drug: MMC; Drug: Capecitabine; Drug: Gemcitabine; Radiation: Conventional Radiotherapy; Radiation: Hypofractionated radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-Free Survival (EFS)
EFS is defined as the time from randomization to the first occurrence of any of the following events, as assessed by blinded independent central review (BICR): residual/recurrent MIBC, or locoregional disease, or distant metastases as assessed by imaging and/or biopsy results, or death from any cause. The EFS for all participants will be presented.
Measured: Up to approximately 60 months
Secondary outcomes (8)
Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause. The OS for all participants will be presented.
Measured: Up to approximately 90 months
Distant Metastasis-Free Survival (DMFS)
DMFS is defined as the time from randomization to the first occurrence of any of the following events, as assessed by BICR: distant metastatic disease as assessed by imaging and/or biopsy results, or death due to any cause. DMFS for all participants will be presented.
Measured: Up to approximately 90 months
Bladder Intact (BI)-EFS
BI-EFS is defined as the time from randomization to the first occurrence of any of the following events: residual/recurrent MIBC, or locoregional disease, or distant metastases as assessed by imaging and/or biopsy results, or radical cystectomy, or death from any cause. The BI-EFS for all participants will be presented.
Measured: Up to approximately 90 months
Time to Occurrence of Non-Muscle-Invasive Bladder Cancer (NMIBC)
Time to occurrence of NMIBC, defined as the time from randomization to the first occurrence of NMIBC (<T2 disease in bladder) after CRT as assessed by biopsy results, will be presented for all participants.
Measured: Up to approximately 90 months
Disease-Specific Survival
DSS is defined as the time from randomization to death due to bladder cancer. The DSS for all participants will be presented.
Measured: Up to approximately 90 months
Rate of Radical Cystectomy
Rate of radical cystectomy is defined as the percentage of participants who undergo radical cystectomy at any time after randomization, for any reason. Rate of radical cystectomy for all participants will be presented.
Measured: Up to approximately 90 months
Number of Participants Who Experience One or More Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.
Measured: Up to approximately 90 months
Number of Participants Who Discontinue Study Intervention Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study intervention due to an AE will be reported.
Measured: Up to approximately 90 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start23 Oct 2026
- Primary completion17 Nov 2031 (estimated)
- Study completion25 Sep 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
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
- NCT07829783
- Sponsor's protocol ID
- 2870-055
- Other IDs
- 2026-526407-30-00, U1111-1338-4320, MK-2870-055, TroFuse-055
- Acronym
- TroFuse-055
- Status last verified
- Nov 2026
- First submitted
- 15 Sep 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Study Evaluating Sacituzumab Tirumotecan Plus Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) as Induction Therapy, Followed by Local Therapy With Chemoradiation and MK-3475A Consolidation Versus Local Therapy With Chemoradiation in Participants With MIBC Who Elect Bladder Preservation
- ClinicalTrials.gov ID
- NCT07829783
- Acronym / sponsor ID
- TroFuse-055 / 2870-055
- Conditions
- Bladder Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 23 Oct 2026 (actual)
- Primary completion
- 17 Nov 2031 (estimated)
- Study completion
- 25 Sep 2036 (estimated)
- First posted
- 21 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Researchers are looking for new ways to treat muscle-invasive bladder cancer (MIBC). MIBC is a type of bladder cancer that has spread into the muscle layer of the bladder but has not spread to other distant parts of the body.
The usual treatment for MIBC is surgery to remove the bladder but some people choose to have other treatments, such as chemoradiotherapy (CRT), instead of surgery so they can keep their bladder.
Researchers want to know if giving 2 trial treatments with CRT can treat MIBC. One trial treatment is called sacituzumab tirumotecan (sac-TMT) and the other trial treatment is called subcutaneous (SC) pembrolizumab (or pembrolizumab and berahyaluronidase alfa). The main goal of this trial is to learn if participants who receive sac-TMT, SC pembrolizumab, and CRT live longer without their cancer growing, spreading, or coming back compared to those who receive CRT alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sac-TMT + Pembrolizumab and Berahyaluronidase alfa + Chemoradiotherapy | Experimental | Biological: Sac-TMT, Biological: Pembrolizumab and Berahyaluronidase alfa, Drug: Cisplatin, Drug: 5-FU, Drug: MMC, Drug: Capecitabine, Drug: Gemcitabine, Radiation: Conventional Radiotherapy, Radiation: Hypofractionated radiotherapy, Drug: Rescue MedicationsParticipants will receive sac-TMT 4 mg/kg by intravenous (IV) infusion every 2 weeks (q2w) for up to 6 doses plus pembrolizumab and berahyaluronidase alfa 790 mg SC every 6 weeks (q6w) for up to 2 doses. CRT (radiotherapy [RT] and concurrent chemotherapy) will then be administered to all participants as standard of care per treatment regimens chosen by the investigator. RT will include conventional radiation or hypofractionated radiation to the bladder for up to approximately 6.5 weeks. Concurrent chemotherapy will be administered with RT and will include cisplatin, or 5-fluorouracil (5-FU) + mitomycin C, or capecitabine + mitomycin C, or gemcitabine. Pembrolizumab and berahyaluronidase alfa 790 mg SC will be administered q6w for up to additional 7 cycles as consolidation therapy. Each cycle is 42 days (up to approximately 42 weeks). |
| Chemoradiotherapy | Experimental | Drug: Cisplatin, Drug: 5-FU, Drug: MMC, Drug: Capecitabine, Drug: Gemcitabine, Radiation: Conventional Radiotherapy, Radiation: Hypofractionated radiotherapyCRT (radiotherapy [RT] and concurrent chemotherapy) will then be administered to all participants as standard of care per treatment regimens chosen by the investigator. RT will include conventional radiation or hypofractionated radiation to the bladder for up to approximately 6.5 weeks. Concurrent chemotherapy will be administered with RT and will include cisplatin, or 5-fluorouracil (5-FU) + mitomycin C, or capecitabine + mitomycin C, or gemcitabine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Has a diagnosis of muscle-invasive bladder cancer (MIBC) (cT2-T4aN0-N1)
- Has clinically nonmetastatic bladder cancer (N0-N1M0)
- Is either ineligible for radical cystectomy or has opted for bladder preservation and is planned to receive chemoradiotherapy (CRT)
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
Key exclusion criteria (9 listed)
- Has known presence of diffuse carcinoma in situ (CIS) throughout the bladder
- Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing
- Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease
- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
- Has received prior pelvic/local radiation therapy for any reason or any systemic antineoplastic treatment for MIBC
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 |
|---|---|---|
| Sac-TMTAlso: MK-2870, SKB264, Sacituzumab tirumotecanIV infusion | Biological | Sac-TMT + Pembrolizumab and Berahyaluronidase alfa + Chemoradiotherapy |
| Pembrolizumab and Berahyaluronidase alfaAlso: MK-3475APembrolizumab coformulated with berahyaluronidase alfa administered as a SC injection | Biological | Sac-TMT + Pembrolizumab and Berahyaluronidase alfa + Chemoradiotherapy |
| CisplatinIV infusion administered at 35 mg/m^2 weekly for up to 6 doses during RT | Drug | Chemoradiotherapy, Sac-TMT + Pembrolizumab and Berahyaluronidase alfa + Chemoradiotherapy |
| 5-FUIV infusion administered at 500 mg/m^2 on Days 1 to 5 and Days 22 to 26 during RT | Drug | Chemoradiotherapy, Sac-TMT + Pembrolizumab and Berahyaluronidase alfa + Chemoradiotherapy |
| MMCIV infusion administered at 12 mg/m^2 on Day 1 during RT | Drug | Chemoradiotherapy, Sac-TMT + Pembrolizumab and Berahyaluronidase alfa + Chemoradiotherapy |
| CapecitabineOral dose administered at 825 mg/m^2 twice daily during RT | Drug | Chemoradiotherapy, Sac-TMT + Pembrolizumab and Berahyaluronidase alfa + Chemoradiotherapy |
| GemcitabineIV infusion administered at 27 mg/m^2 twice weekly for up to 12 doses during RT | Drug | Chemoradiotherapy, Sac-TMT + Pembrolizumab and Berahyaluronidase alfa + Chemoradiotherapy |
| Conventional RadiotherapyExternal beam radiation administered per global clinical guidelines (64 Gy at 2 Gy/fraction over approximately 6.5 weeks) | Radiation | Chemoradiotherapy, Sac-TMT + Pembrolizumab and Berahyaluronidase alfa + Chemoradiotherapy |
| Hypofractionated radiotherapyExternal beam radiation administered per global clinical guidelines (55 Gy at 2.75 Gy/fraction over approximately 4 weeks) | Radiation | Chemoradiotherapy, Sac-TMT + Pembrolizumab and Berahyaluronidase alfa + Chemoradiotherapy |
| Rescue MedicationsParticipants receive rescue medications at the investigator's discretion, per approved product label. Rescue medications include pegfilgrastim (or equivalent), H1 receptor antagonist, H2 receptor antagonist, acetaminophen (or equivalent), dexamethasone (or equivalent), steroid mouthwash (dexamethasone or equivalent). | Drug | Sac-TMT + Pembrolizumab and Berahyaluronidase alfa + Chemoradiotherapy |
Primary outcome
Event-Free Survival (EFS)
Time frame: Up to approximately 60 months
EFS is defined as the time from randomization to the first occurrence of any of the following events, as assessed by blinded independent central review (BICR): residual/recurrent MIBC, or locoregional disease, or distant metastases as assessed by imaging and/or biopsy results, or death from any cause. The EFS for all participants will be presented.
8 secondary outcomes
Overall Survival (OS)
Time frame: Up to approximately 90 months
Distant Metastasis-Free Survival (DMFS)
Time frame: Up to approximately 90 months
Bladder Intact (BI)-EFS
Time frame: Up to approximately 90 months
Time to Occurrence of Non-Muscle-Invasive Bladder Cancer (NMIBC)
Time frame: Up to approximately 90 months
Disease-Specific Survival
Time frame: Up to approximately 90 months
Rate of Radical Cystectomy
Time frame: Up to approximately 90 months
Number of Participants Who Experience One or More Adverse Events (AEs)
Time frame: Up to approximately 90 months
Number of Participants Who Discontinue Study Intervention Due to an AE
Time frame: Up to approximately 90 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/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.
Medical Director study director
Merck Sharp & Dohme LLC
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sac-TMT, Pembrolizumab and Berahyaluronidase alfa and Cisplatin in people with Bladder Cancer, run by Merck Sharp & Dohme LLC at 10 sites in 2 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 5 inclusion and 9 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 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Ukraine, Taiwan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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@merck.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-Free Survival (EFS) (time frame: Up to approximately 60 months). 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 6 Nov 2026.