Testing Dabrafenib and Trametinib With or Without Hydroxychloroquine in Stage IIIC or IV BRAF V600E/K Melanoma
Model scores of the 29,894 trials active now.
Model score 32% for any early termination, 7% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 16% of the time (1,198 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2024-01-08, after 2021-06-01 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 2024-01-08. 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
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: randomizationmelanomabraincoronarytherapy
Phrases that lowered it: patients withhcv14 daysnormalsmall -
Sponsor's past termination rate: 53.3% (raises risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 2 (raises risk) · Design
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Design: parallel (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Has a data monitoring committee: Yes (raises risk) · Design
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Drug's FAERS reports with a death: 8.7% (lowers risk) · Drug's FDA history
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
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Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports marked serious: 75.5% (lowers risk) · Drug's FDA history
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Blinding: double (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 17 (lowers risk) · Sponsor's track record
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Drug's FAERS reports in the prior 12 months: 27410 (lowers risk) · Drug's FDA history
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Collaborators: 1 (raises risk) · Design
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Maximum age: not given (raises risk) · Who can join
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Drug's FAERS reports before start: 130546 (lowers risk) · Drug's FDA history
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Drugs with FDA adverse-event history: 5 (lowers risk) · Drug's FDA history
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Number of arms: 2 (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
- parallel
- Primary purpose
- treatment
- Blinding
- double (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 0 (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
- academic or other
- Sponsor's past trials
- 15 (typical: 32)
- Sponsor's past termination rate
- 53.3% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 17 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 5 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 130546 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 27410 (typical: 412.5)
- Drug's FAERS reports marked serious
- 75.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 8.7% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- base, dabrafenib, hydroxychloroquine, trametinib, trametinib dimethyl sulfoxide
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
- Dabrafenib, Trametinib and Hydroxychloroquine in Patients With Advanced BRAF Mutant Melanoma NCT02257424 · started 2014 · scored riskier than 97% of active trials completed
- Overcoming Primary Resistance to Immunotherapy in Metastatic Melanoma NCT05304546 · started 2023 · scored riskier than 66% of active trials completed
- Nivolumab Plus Relatlimab in Patients With Metastatic Uveal Melanoma NCT04552223 · started 2020 · scored riskier than 96% of active trials completed
- Biopsy- and Biology-driven Optimization of Targeted Therapy in Subjects With Advanced Melanoma NCT02410863 · started 2015 · scored riskier than 93% of active trials terminated
- A Basket Trial of an ERK1/2 Inhibitor (LY3214996) in Combination With Abemaciclib. NCT04534283 · started 2020 · scored riskier than 91% of active trials terminated
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.