An Open-Label, Randomized, Multicenter Trial of Encorafenib + Binimetinib Evaluating a Standard-dose and a High-dose Regimen in Patients With BRAFV600-mutant Melanoma Brain Metastasis
Model scores of the 29,894 trials active now.
Model score 24% for any early termination, 6% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 22% of the time (1,598 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2022-01-27, after 2019-04-30 start.
Reason given by the sponsor: “enrollment”
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
Termination over time, as the model saw it at the start
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2022-01-27. The rest of the way to 100% is still running.
From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.
What moved the score
-
Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: priorradiationmelanomatherapybrain
Phrases that lowered it: openlabelstart ofefficacy andlocal -
Sponsor's past termination rate: 15.7% (raises risk) · Sponsor's track record
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 2 (raises risk) · Design
-
Sponsor's past trials: 1811 (raises risk) · Sponsor's track record
-
Drug's FAERS reports marked serious: 43.5% (lowers risk) · Drug's FDA history
-
Disease area, cancer: Yes (raises risk) · Disease area
-
Trials the sponsor started in the prior 2 years: 165 (lowers risk) · Sponsor's track record
-
Drug's FAERS reports with a death: 12.3% (lowers risk) · Drug's FDA history
-
Disease area, dermatology: Yes (raises risk) · Disease area
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Minimum age: 18 (raises risk) · Who can join
-
Disease area, neurology: Yes (raises risk) · Disease area
-
Primary purpose: treatment (raises risk) · Design
-
Design: sequential (lowers risk) · Design
-
Has a data monitoring committee: No (lowers risk) · Design
-
Maximum age: not given (raises risk) · Who can join
-
Collaborators: 0 (raises risk) · Design
Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.
The trial
Design
- Phase
- 2
- Number of arms
- 2
- Allocation
- randomized
- Design
- sequential (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 3 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 1811 (typical: 32)
- Sponsor's past termination rate
- 15.7% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 165 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 1034 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 991 (typical: 412.5)
- Drug's FAERS reports marked serious
- 43.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 12.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, neurology, dermatology
- Drugs matched to FDA substances
- binimetinib, encorafenib
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- Study to Evaluate Treatment of Dabrafenib Plus Trametinib in Subjects With BRAF Mutation-Positive Melanoma That Has Metastasized to the Brain NCT02039947 · started 2014 · scored riskier than 72% of active trials completed
- A Study of Vemurafenib in Metastatic Melanoma Participants With Brain Metastases NCT01378975 · started 2011 · scored riskier than 32% of active trials completed
- Encorafenib and Binimetinib Before Local Treatment in Patients With BRAF Mutant Melanoma Metastatic to the Brain NCT03898908 · started 2019 · scored riskier than 72% of active trials completed
- Evaluating the Efficacy and Safety of a Sequencing Schedule of Cobimetinib Plus Vemurafenib Followed by Immunotherapy With an Anti- PD-L1 Antibody in Patients With Unresectable or Metastatic BRAF V600 Mutant Melanoma NCT02902029 · started 2016 · scored riskier than 74% of active trials completed
- A Study of GSK2118436 in BRAF Mutant Metastatic Melanoma to the Brain NCT01266967 · started 2011 · scored riskier than 81% of active trials completed
Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.