A Phase 2 Open Label Study of BA3021 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Model scores of the 29,894 trials active now.
Model score 18% 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 in 2015 or later: the model never saw it during training.
How it ended
Completed on 2025-09-22, after 2022-12-13 start.
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 2025-09-22. 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: patients muststagesquamouscellradiation
Phrases that lowered it: and safetyefficacy andcombinationsafety ofthe efficacy -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
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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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Number of arms: 6 (lowers risk) · Design
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Drug's FAERS reports with a death: 19.1% (lowers risk) · Drug's FDA history
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Design: single group (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 2 (raises risk) · Sponsor's track record
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Has a data monitoring committee: Yes (raises risk) · Design
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Maximum age: not given (raises risk) · Who can join
-
Primary purpose: treatment (raises risk) · Design
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Blinding: none (raises risk) · Design
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Drug's FAERS reports in the prior 12 months: 13333 (lowers risk) · Drug's FDA history
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Minimum age: 18 (raises risk) · Who can join
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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
- 6 (typical: 2)
- Allocation
- randomized
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 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
- 0 (typical: 32)
- Sponsor's past termination rate
- no earlier finished trials (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 2 (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
- 72647 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 13333 (typical: 412.5)
- Drug's FAERS reports marked serious
- 83.8% (typical: 85.6%)
- Drug's FAERS reports with a death
- 19.1% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer
- Drugs matched to FDA substances
- cetuximab, pembrolizumab
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 to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-368 Plus Tilsotolimod and Other Therapy Combinations in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma NCT04196283 · started 2020 · scored riskier than 89% of active trials completed
- Enoblituzumab Plus Retifanlimab or Tebotelimab in Head and Neck Cancer NCT04634825 · started 2021 · scored riskier than 99% of active trials terminated
- Phase 1 Study of BAY1905254 - An Early Clinical Research Study to Evaluate a New Drug Called Bapotulimab (BAY1905254) in the Expansion Cohort in Combination With Pembrolizumab in Head and Neck Cancer That Has Returned or is Discovered to be Metastatic and is Expressing PDL1. NCT03666273 · started 2018 · scored riskier than 66% of active trials completed
- Study to Assess MEDI4736 With Either AZD9150 or AZD5069 in Advanced Solid Tumors & Relapsed Metastatic Squamous Cell Carcinoma of Head & Neck NCT02499328 · started 2015 · scored riskier than 65% of active trials completed
- A Phase Ib/II Study of BYL719 and Cetuximab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma NCT01602315 · started 2012 · scored riskier than 84% 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.