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Berahyaluronidase alfa

  • Biologic
  • Still being tested
  • Identity checked
  • Sources last checked 2026-09-04

This page shows what was measured, who it was measured in, and what that does not settle.

What Berahyaluronidase alfa does in the body

Unresectable or metastatic melanoma

From the FDA-approved label: Binding of the PD-1 ligands, PD-L1 and PD-L2, to the PD-1 receptor found on T cells, inhibits T cell proliferation and cytokine production. Upregulation of PD-1 ligands occurs in some tumors and signaling through this pathway can contribute to inhibition of active T-cell immune surveillance of tumors. Pembrolizumab is a monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response. In syngeneic mouse tumor models, blocking PD-1 activity resulted in decreased tumor growth.

What happened in people

RNAWiki has not yet published a reviewed conclusion for this use.

A fixed RNAWiki sentence

Where this came from

Wording RNAWiki always uses, not a finding about this substance.

No reviewed claim names a result for any goal on this record.

No source is stored against this line.

The limit that matters most

Not recorded.

Where it acts
Not recorded.
Kind of result
No result is published, so no kind of result applies yet
Supervision
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.

What the registries record it as

  • The substance registry classes this as protein.

    FDA substance registry · 9X4R4A4HQQ · read 2026-08-29

Where each sentence above came from

No recorded sentence describes the change this makes in a way that stands on its own. The page opens with what it is taken for instead, and the recorded explanation follows below.

Shown as the opening line on this page.

No statement of the main limit is recorded.

The four opening statements run to 113 words.

Words this page uses

Four words worth knowing first

Chosen from what this page shows, with each one explained before the word it depends on.

Biomarker

A biomarker is a number from a test that stands in for something about health.

A picture of it, and where the picture fails

A biomarker is like a fuel gauge.

Where that stops being true. A gauge is wired to the tank. Many biomarkers are only loosely tied to health.

What people get wrong. A better number is read as a better life. Several medicines improved a number and helped nobody.

A measurable indicator used as a substitute for a clinical outcome of interest.

Placebo

A placebo is a dummy treatment given so the real one can be compared with it.

A picture of it, and where the picture fails

A placebo is like a blank control in an experiment.

Where that stops being true. A blank does nothing. People given a placebo often do get better.

What people get wrong. A placebo effect is read as imaginary. The improvement is measured and real.

An inactive intervention matched in appearance to the test intervention, used to control for non-specific effects.

Comparator

A comparator is whatever the treatment was measured against.

A picture of it, and where the picture fails

It is like the other runner in a race.

Where that stops being true. A race has one winner. A study can show both arms improved.

What people get wrong. Results are read without asking what the other group got. Beating nothing is not beating a treatment.

The control condition against which the experimental intervention is assessed.

What happened in peopleRead from sources, not yet reviewed

What happened in people

Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.

Overall Survival (OS)

The study did not show it

Who was studied
NCT03486873
How many people
3500
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Subcutaneous

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • FDA label (openFDA SPL) · a recorded source, not a stored snapshot

Disease-Free Survival (DFS) as Assessed by Blinded Independent Central Review (BICR) in Participants With Nonsquamous Non-Small Cell Lung Cancer (NSCLC) in Arm A and Arm C

The study did not show it

Who was studied
NCT07513376
How many people
876
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Subcutaneous

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • FDA label (openFDA SPL) · a recorded source, not a stored snapshot

Progression Free Survival (PFS) in Participants with Programmed Death-Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1%

The study did not show it

Who was studied
NCT07190248
How many people
675
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Subcutaneous

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • FDA label (openFDA SPL) · a recorded source, not a stored snapshot

Disease-Free Survival (DFS) in Zanzalintinib + MK-3475A Versus Placebo as Assessed by the Investigator

The study did not show it

Who was studied
NCT07750158
How many people
600
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Subcutaneous

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • FDA label (openFDA SPL) · a recorded source, not a stored snapshot

Disease-free Survival (DFS)

The study did not show it

Who was studied
NCT07431827
How many people
400
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Subcutaneous

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • FDA label (openFDA SPL) · a recorded source, not a stored snapshot

Cycle 1: Area Under the Curve From Time 0 to 6 Weeks (AUC0-6 Weeks) of Pembrolizumab After the First Dose

The study did not show it

Who was studied
NCT05722015
How many people
377
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Subcutaneous

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • FDA label (openFDA SPL) · a recorded source, not a stored snapshot
What we know
RNAWiki holds 6 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.

What is missing or unclearRead from sources, not yet reviewed

Were people like you studied?

RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.

Who was studied

People similar to this profile were included.

  • KEYTRUDA QLEX is a combination of pembrolizumab, a programmed death receptor-1 (PD-1)-blocking antibody, and berahyaluronidase alfa, an endoglycosidase, indicated: Melanoma for the treatment of adult patients with unresectable or metastatic melanoma. ( 1.1 ) for the adjuvant treatment of adult and pediatric patients 12 years and older with Stage IIB, IIC, or III melanoma following complete resection.

Who is missing from the studies

  • Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

Where the result stopped carrying

  • This is a scope explorer, not a diagnosis engine.
  • It shows who was studied so you can see whether people similar to you were included.

RNAWiki cannot tell whether a study fits you. It can show who was in it.

What it would be like to takeRead from sources, not yet reviewed

Why it might seem to do nothing

A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.

It was studied in different people

The people in the studies were not much like the reader.

On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

The evidence may simply be wrong

Small early studies often do not hold up.

On this record: RNAWiki has not yet published a reviewed conclusion for this use.

Other reasons RNAWiki checked and found nothing for (11)
It was studied for a different goal
The studies measured something else entirely. Nothing in this record points to this reason.
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.

None of these is a reason to take more. Taking more is not a step this page ever suggests.

What it would be like to takeRead from sources, not yet reviewed

What taking it involves

The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.

How it is supplied

Still being tested

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

Read from the recorded approval status.

No source is stored against this line.

Form and route

Subcutaneous

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The form and route recorded on this substance.

No source is stored against this line.

Who oversees it

Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

Suppression classes recorded: S1, S4.

No source is stored against this line.

What is in the pack

Sold as injection, solution, given by the subcutaneous route.

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

Recorded notes on how this is sold and what that means for what is in the pack.

No source is stored against this line.

Where it is registered

Regulatory records are listed in the technical disclosure at the foot of this page.

Counted from records

Where this came from

A count of rows RNAWiki holds. It describes our records, not your body.

Register entries are stored per jurisdiction and shown with their dates.

No source is stored against this line.

Why people stop

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

No record of why people stopped taking it is stored for this substance.

No source is stored against this line.

What it would be like to takeNothing found in the sources checked

What can go wrong

Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.

Nothing found in the sources checked

No harm is recorded against this substance in the sources RNAWiki checked. Finding nothing is not the same as showing there is nothing.

The sources listed were searched and held nothing. That is not the same as nothing existing.

Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.

Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

What is missing or unclearRead from sources, not yet reviewed

Does the exact form matter?

Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.

The form that was studied

Subcutaneous

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The form used in the studies cited on this page.

No source is stored against this line.

What is sold

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

Nothing further is recorded about which forms are sold.

No source is stored against this line.

What is recorded as being sold

  • 5 products list this as an active ingredient in the United States drug directory. 1 of them contain it and nothing else.

    FDA National Drug Code directory · 43624-030 · read 2026-08-29

  • They are sold as injection, solution and liquid, taken subcutaneous.

    FDA National Drug Code directory · 43624-030 · read 2026-08-29

  • 1 published label names it as an active ingredient. None of them describes this substance alone, so no label text on this page can be attributed to it rather than to a combination.

    US prescribing information · 097d166f-b73b-41d3-9b37-7653cd2a0c41 · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · 097d166f-b73b-41d3-9b37-7653cd2a0c41 · read 2026-08-29

  • 13 marketed supplement labels list this ingredient, classed as botanical, fat/fatty acid and other combinations.

    NIH Dietary Supplement Label Database · 206723 · read 2026-08-29

  • Those labels carry all other, nutrient and structure/function claims. A claim of that kind is written by the manufacturer and is not assessed by any regulator, so its presence says nothing about whether it is true.

    NIH Dietary Supplement Label Database · 206723 · read 2026-08-29

  • KEYTRUDA QLEX is subcutaneous at 3 DOSAGE FORMS AND STRENGTHS KEYTRUDA QLEX is a clear to slightly opalescent, colorless to slightly yellow solution provided as: Injection: 395 mg pembrolizumab and 4,800 units berahyaluronidase alfa per 2.4 mL (165 mg/…, recorded as fda label in effect 2026-07-31 in the United States.

    US prescribing information · 097d166f-b73b-41d3-9b37-7653cd2a0c41 · read 2026-08-30

Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.

What it would be like to takeRead from sources, not yet reviewed

What you could measure

This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.

Self-experiment planning is not offered for a prescription or clinician-supervised medicine, investigational agent. The questions below are for a clinician or pharmacist.

Questions worth asking

  • Which of the trials of Berahyaluronidase alfa studied people like me?
  • What was measured, and for how long?
  • Was the result a laboratory value or a health outcome?
  • What would we watch for, and when would we stop?

Tracking can show whether something changed for you. It cannot show what caused it.

RNAWiki records evidence. It does not say whether this substance is right for you.

What is missing or unclearRead from sources, not yet reviewed

What nobody knows yet

Open questions, each with why it is open and what would close it.

Missing populations

Which groups were under-represented in the studies has not been recorded.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Missing long-term data

No completed tested study window is recorded.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

No reviewed conclusion

RNAWiki has not yet published a reviewed conclusion for this use.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Missing interaction studies

No interaction was found in the registers checked. Not finding one is not the same as showing there is none.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Formulation uncertainty

Several salts, forms or products of Berahyaluronidase alfa are recorded. Results from one form may not transfer to another.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Mechanism not reviewed

No reviewed mechanism story exists for this substance.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

What happened in peopleRead from sources, not yet reviewed

Check any of this yourself

Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.

Where else this substance is registered

FDA substance identifier (UNII)
9X4R4A4HQQ
CAS registry number
2636716-20-4
WHO international nonproprietary name list entry
12445
EMA substance identifier
300000053748

Checks this page had to pass

  • Passed

    Identity resolved

    no open identity hold

  • Passed

    No unresolved merge across substance families

    no quarantine open

  • Passed

    Every public sentence names a source

    The opening statement carries the origin: Written into the record, not signed off.

  • Not passed

    Trial roles classified for highlighted evidence

    No registered study is classified as testing this substance.

  • Passed

    No internal keys in reader text

    enforced by the copy-contract test over the rendered page

  • Passed

    Safety mode resolved

    Suppression classes recorded: S1, S4.

  • Passed

    Canonical metadata present

    slug and display name present

What is missing or unclearRead from sources, not yet reviewed

How this medicine reached us

Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.

What the approval register records

  • The earliest marketing start date recorded for a listed product is 20250919.

    FDA National Drug Code directory · 43624-030 · read 2026-08-29

What is missing or unclearRead from sources, not yet reviewed

What to learn next

Ordered by what would most change how you read this page, starting with what is easiest to misunderstand.

This order is fixed in code and does not count clicks or time on the page.

What is not here

9 questions this page could not answer

These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.

  • What was measured, goal by goal — found nothing in the sources checked.
  • How close this is to real life — found nothing in the sources checked.
  • The path through the body — found nothing in the sources checked.
  • Felt, measured, or meaningful — found nothing in the sources checked.
  • How long anything takes — found nothing in the sources checked.
  • What it may clash with — found nothing in the sources checked.
  • Other ways to the same goal — found nothing in the sources checked.
  • Claims that go past the evidence — found nothing in the sources checked.
  • What changed on this page — found nothing in the sources checked.

The record as stored

The full record, for auditing

Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.

Recorded evidence blocks (6)

1342 registered trials of Berahyaluronidase alfa — at which phases?


Registered studies posting no result
813 of 1342

1342 registered studies of Berahyaluronidase alfa: 847 phase2, 498 phase1, 190 phase3, 21 early phase1, 12 na or unstated, 9 na, 4 phase4. CLINICALTRIALS_SNAPSHOT · 2026-09-01

2 with a PubMed record

Show the evidence
  • phase2
    847
  • phase1
    498
  • phase3
    190
  • early phase1
    21
  • na or unstated
    12
  • na
    9
11 more recorded rows
  • phase4
    4
  • completed
    450
  • active not recruiting
    270
  • recruiting
    238
  • terminated
    206
  • withdrawn
    69
  • unknown
    64
  • not yet recruiting
    35
  • suspended
    7
  • enrolling by invitation
    2
  • temporarily not available
    1

recorded 2026-09-01 · last checked 2026-09-04

278 of Berahyaluronidase alfa's trials stopped: safety, futility/efficacy, accrual/recruitment, funding/business, sponsor decision unspecified, other?


safety (26), futility/efficacy (19), accrual/recruitment (78), funding/business (60), sponsor decision unspecified (18) and other (77): Berahyaluronidase alfa's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01

"Business Reasons"; 278 of 1342 registered studies

Show the evidence

Trial

  • NCT02036502
    terminated; "Business Reasons"
  • NCT02054520
    terminated; "Withdrawal of IND"
  • NCT02212730
    terminated; "Terminated early due to low enrollment"
  • NCT02318901
    terminated; "PI no longer at sight. Results not collected"
  • NCT02331251
    terminated; "PI not longer at site."
  • NCT02359851
    terminated; "Slow accrual"
14 further recorded trials
  • NCT02376699
    terminated; "Study closed due to portfolio prioritization"
  • NCT02395627
    terminated; "Insufficient efficacy in an unselected patient population"
  • NCT02419495
    terminated; "Administratively Complete"
  • NCT02501473
    terminated; "Business reasons"
  • NCT02530502
    terminated; "The protocol was amendment to be stopped after phase I (phase 2 removed from protocol)"
  • NCT02553499
    terminated; "Enrollment prematurely discontinued due to program prioritization \& not due to any safety concerns."
  • NCT02575807
    terminated; "Study was stopped due to low enrollment and lack of clinical activity."
  • NCT02576977
    terminated; "The study was terminated early due to business reasons"
  • NCT02587962
    terminated; "Based on a futility analysis, the data monitoring committee recommended to stop enrollment."
  • NCT02625961
    terminated; "Business Reasons"
  • NCT02684617
    terminated; "Business Reasons"
  • NCT02691026
    terminated; "Slow enrollment as a result of low incidence of MPNST and the COVID-19 pandemic."
  • NCT02706353
    terminated; "\<75% participant accrual"
  • NCT02710396
    terminated; "Frontline pembrolizumab approved in NSCLC as monotherapy and in combination with chemotherapy representing a new standard of care."

recorded 2026-09-01 · last checked 2026-09-04

Human studies of Berahyaluronidase alfa used Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA] — over how long?


studies of Berahyaluronidase alfa used the recorded amount. ClinicalTrials.gov · 2026-09-01

4 recorded entries; human; also "Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA]", "Pembrolizumab 25 MG/ML [KEYTRUDA®]", "Pembrolizumab 25 MG/ML [Keytruda]"

Show the evidence

human

  • NCT03637803
    Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA]
  • NCT04260529
    Pembrolizumab 25 MG/ML [KEYTRUDA®]
  • NCT04713514
    Pembrolizumab 25 MG/ML [Keytruda]
  • NCT07178730
    Pembrolizumab 25 mg/1 ML Intravenous Solution [KEYTRUDA]

recorded 2026-09-01 · last checked 2026-09-04

Which running trial of Berahyaluronidase alfa could settle lifespan?


NCT02621151 measures Percentage of Participants Who Achieved Two-year Bladder-intact Disease-free Survival, reading out 2025-12.

150 open trials; n 60; "Pembrolizumab (MK3475), Gemcitabine, and Concurrent Hypofractionated Radiation Therapy for Muscle-Invasive Urothelial Cancer of the Bladder"

Show the evidence

Trial

  • NCT02621151
    "Pembrolizumab (MK3475), Gemcitabine, and Concurrent Hypofractionated Radiation Therapy for Muscle-Invasive Urothelial Cancer of the Bladder"; n 60; "Percentage of Participants Who Achieved Two-year Bladder-intact Disease-free Survival"; 2025-12
  • NCT04713514
    "OSE2101 Alone or in Combination With Pembrolizumab vs BSC in Patient With Platinum-sensitive Recurrent OC"; n 180; "Progression free survival (PFS)"; 2025-12
  • NCT02769520
    "Efficacy Study of Pembrolizumab in Relapsed, Locally Recurrent Squamous Cell Cancer of the Head and Neck"; n 27; "Disease-Free Survival"; 2026-04
  • NCT04032418
    "Pembrolizumab Every 12 Weeks Versus Every 3 Weeks in Treating Patients With Non-small Cell Lung Cancer"; n 9; "1-year progression-free survival (PFS)"; 2026-06-14
  • NCT04634877
    "Study of Pembrolizumab (MK-3475) in Combination With Adjuvant Chemotherapy With or Without Radiotherapy in Participants With Newly Diagnosed Endometrial Cancer After Surgery With Curative Intent (MK-3475-B21 / KEYNOTE-B21 / ENGOT-en11 / GOG-3053)"; n 990; "Disease-Free Survival (DFS) as Assessed Radiographically by Investigator or by Histopathologic Confirmation of Suspected Disease Recurrence"; 2026-09-15
  • NCT03914612
    "Testing the Addition of the Immunotherapy Drug Pembrolizumab to the Usual Chemotherapy Treatment (Paclitaxel and Carboplatin) in Stage III-IV or Recurrent Endometrial Cancer"; n 813; "Progression-free Survival (PFS)"; 2026-09-26
14 further recorded trials
  • NCT05689671
    "Pemetrexed-free vs. Pemetrexed-based Immunochemotherapy in Metastatic TTF-1 Negative Lung Adenocarcinoma"; n 136; "Overall Survival (OS)"; 2026-10
  • NCT04548752
    "Testing the Addition of Pembrolizumab, an Immunotherapy Cancer Drug to Olaparib Alone as Therapy for Patients With Pancreatic Cancer That Has Spread With Inherited BRCA Mutations"; n 88; "Progression-free survival (PFS)"; 2026-10-01
  • NCT03425643
    "Efficacy and Safety of Pembrolizumab (MK-3475) With Platinum Doublet Chemotherapy as Neoadjuvant/Adjuvant Therapy for Participants With Resectable Stage II, IIIA, and Resectable IIIB (T3-4N2) Non-small Cell Lung Cancer (MK-3475-671/KEYNOTE-671)"; n 797; "Event Free Survival (EFS)"; 2026-10-15
  • NCT03698019
    "A Study to Compare the Administration of Pembrolizumab After Surgery Versus Administration Both Before and After Surgery for High-Risk Melanoma"; n 313; "Two-Year Event-Free Survival Rate"; 2026-10-30
  • NCT03244384
    "Testing MK-3475 (Pembrolizumab) After Surgery for Localized Muscle-Invasive Bladder Cancer and Locally Advanced Urothelial Cancer"; n 739; "Overall survival"; 2026-10-31
  • NCT02362594
    "Study of Pembrolizumab (MK-3475) Versus Placebo After Complete Resection of High-Risk Stage III Melanoma (MK-3475-054/1325-MG/KEYNOTE-054)"; n 1019; "Part 1: Percentage of Participants With Recurrence-Free Survival (RFS) At 6 Months Among All Participants"; 2026-11-01
  • NCT04887805
    "Lenvatinib and Pembrolizumab Maintenance Therapy for the Treatment of Patients of Advanced Unresectable Pancreatic Cancer"; n 28; "Progression free survival"; 2026-11-05
  • NCT03765918
    "Study of Pembrolizumab Given Prior to Surgery and in Combination With Radiotherapy Given Post-surgery for Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-689)"; n 714; "Event-free Survival (EFS)"; 2026-11-17
  • NCT04417166
    "Pembrolizumab and Radiotherapy for Patients With NK/T Cell Lymphoma"; n 30; "Progression Free Survival (PFS) rate at 2 years - The proportion of patients without disease progression after 2 years from treatment start"; 2026-12
  • NCT04166487
    "Plasma-Adapted First-Line Pembro In NSCLC"; n 40; "6-month Progression Free Survival rate"; 2026-12-01
  • NCT05078931
    "A Study to Evaluate Pembrolizumab Plus Lenvatinib in PD-L1 Positive TKI Resistant NSCLC Patients"; n 35; "Progression-free survival"; 2026-12-30
  • NCT02337686
    "Pembrolizumab in Treating Patients With Recurrent Glioblastoma"; n 18; "Number of Participants With Progression Free Survival at 6 Months"; 2026-12-31
  • NCT03279692
    "Phase II Trial of Pembrolizumab in Recurrent or Residual High Grade Meningioma"; n 26; "Progression-free Survival at 6 Months (PFS6)"; 2026-12-31
  • NCT03712605
    "Testing Pembrolizumab Versus Observation in Patients With Merkel Cell Carcinoma After Surgery, STAMP Trial"; n 280; "Recurrence free survival (RFS)"; 2026-12-31

Which 69 trials of Berahyaluronidase alfa posted no result?


Posted no result
69 of 69 completed trials
Registrations
NCT02303366, NCT02574533, NCT02823405, NCT02620423, NCT02950220 and NCT02665650, and 63 more
Completion dates
oldest 2017-04; newest 2024-07-31
Show the evidence

Trial

  • NCT02303366
    2017-04
  • NCT02574533
    2017-09
  • NCT02823405
    2018-03-15
  • NCT02620423
    2018-08
  • NCT02950220
    2019-01-03
  • NCT02665650
    2019-03
14 further recorded trials
  • NCT02483247
    2019-05
  • NCT02843204
    2019-07-01
  • NCT03139851
    2019-09-18
  • NCT02909348
    2019-10
  • NCT02733250
    2019-12-13
  • NCT02840994
    2020-01
  • NCT03224871
    2020-01-10
  • NCT02437370
    2020-03-10
  • NCT02902042
    2020-11-30
  • NCT03371979
    2021-01-01
  • NCT02013154
    2021-01-11
  • NCT02546531
    2021-01-11
  • NCT03289819
    2021-01-22
  • NCT02467361
    2021-01-29

At the median, Berahyaluronidase alfa's trials enrolled 42 people — anything larger?


Median enrolment
42
Largest enrolment
8300
Registered trials counted
1341
Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL5314725
CAS number
2636716-20-4
Development code
ALT-B4
Also called
Berahyaluronidasa alfa, mk-3475a, pembrolizumab (+) berahyaluronidase alfa, 3-305-Hyaluronidase PH-20 (human) fusion protein with 303-322-hyaluronidase HYAL-1 (human) fusion protein with 327-433-hyaluronidase PH-20 (human), BERAHYALURONIDASE ALFA [USAN], Berahyaluronidase alfa [WHO-DD], berahyaluronidase alfa [INN], human hyaluronidase isozyme-5 (HYAL5, sperm adhesion molecule 1, SPAM1, hyaluronidase PH-20, EC:3.2.1.35) fragment (3-433, 1-431 in the current sequence) engineered variant with the structural domain replaced by the corresponding region of human hyaluronidase isozyme-1 (HYAL1)(<sup>306</sup>TLSIMRSMKSCLLDDNYMETI<sup>326</sup>><sup>304</sup>SWENTRTKESCQAIKEYMDTT<sup>324</sup>), produced in Chinese hamster ovary (CHO) cells, cell line DG44, glycoform alfa
Trade name
Keytruda, KEYTRUDA QLEX COMPONENT Berahyaluronidase Alfa
Sources (4)

Sources

  • CLINICALTRIALS_SNAPSHOT K1:9X4R4A4HQQ ·
  • ClinicalTrials.gov clinicaltrials.gov ·
  • ema ema ·
  • Drugs@FDA K1:9X4R4A4HQQ ·

ClinicalTrials.gov — US Government work · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md

How these records are assembled · Which registers were checked

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  • required summary fields resolved: 4 required field(s) not terminal: Why people use it, Best-supported result, Biggest unanswered question, Human evidence
  • public claims reviewed: 0 reviewed claim(s); drafts are never rendered
  • source coverage passed: 4 source rows
  • no critical contamination: no quarantine open
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