Phase II Safety Study of Vemurafenib Followed by Ipilimumab in Subjects With V600 BRAF Mutated Advanced Melanoma
Model scores of the 29,894 trials active now.
Model score 23% for any early termination, 5% 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 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
How it ended
Completed on 2015-05-12, after 2012-09-13 start.
The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
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 2015-05-12. 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: melanomaadvancedmetastasescancerbrain
Phrases that lowered it: visitdiseasesweekskeycorticosteroid -
Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 2 (raises risk) · Design
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Disease area, cancer: Yes (raises risk) · Disease area
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Sponsor's past termination rate: 9.4% (raises risk) · Sponsor's track record
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Drug's FAERS reports with a death: 27.1% (raises risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 100 (lowers risk) · Sponsor's track record
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Design: single group (raises risk) · Design
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Sponsor's past trials: 340 (lowers risk) · Sponsor's track record
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Minimum age: not given (raises risk) · Who can join
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Maximum age: not given (raises risk) · Who can join
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Primary purpose: treatment (raises risk) · Design
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Blinding: none (raises risk) · Design
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Collaborators: 0 (raises risk) · Design
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Has a data monitoring committee: No (lowers risk) · Design
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Drug's FAERS reports marked serious: 89.2% (lowers risk) · Drug's FDA history
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Number of arms: 1 (raises risk) · Design
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Drug's FAERS reports before start: 2702 (raises risk) · Drug's FDA history
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Responsible party: sponsor (lowers risk) · Design
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Disease area, dermatology: Yes (raises risk) · Disease area
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
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- not given (typical: 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
- 340 (typical: 32)
- Sponsor's past termination rate
- 9.4% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 100 (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
- 2702 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 2381 (typical: 412.5)
- Drug's FAERS reports marked serious
- 89.2% (typical: 85.6%)
- Drug's FAERS reports with a death
- 27.1% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, dermatology
- Drugs matched to FDA substances
- ipilimumab, vemurafenib
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
- A Study of Vemurafenib in Previously Treated Patients With Metastatic Melanoma NCT00949702 · started 2009 · scored riskier than 68% 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
- A Study of Vemurafenib (Zelboraf) in Chinese Participants With BRAF V600 Mutation-Positive Unresectable or Metastatic Melanoma NCT01910181 · started 2013 · scored riskier than 37% of active trials completed
- A Study of Vemurafenib in Participants With BRAF V600 Mutation-Positive Cancers NCT01524978 · started 2012 · scored riskier than 34% of active trials completed
- Ph I Ipilimumab Vemurafenib Combo in Patients With v-Raf Murine Sarcoma Viral Oncogene Homolog B1 (BRAF) NCT01400451 · started 2011 · scored riskier than 41% 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.