Study to Assess the Efficacy and Safety of Nivolumab in Combination With Paclitaxel in Subjects With Head and Neck Cancer Unable for Cisplatin-based Chemotherapy (NIVOTAX)
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 26% of the time (3,728 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2024-03-21, after 2020-06-03 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 2024-03-21. 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: cancerchemotherapymetastaticpaclitaxelradiation
Phrases that lowered it: mgaccordingfirst dosedrugthe efficacy -
Sponsor's past termination rate: 25% (raises risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 2 (raises risk) · Design
-
Disease area, cancer: Yes (raises risk) · Disease area
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Design: parallel (raises risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
-
Drug's FAERS reports in the prior 12 months: 20396 (lowers risk) · Drug's FDA history
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Drug's FAERS reports with a death: 22.7% (raises risk) · Drug's FDA history
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Minimum age: 18 (raises risk) · Who can join
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Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
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Collaborators: 2 (lowers risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Drug's FAERS reports before start: 125827 (lowers risk) · Drug's FDA history
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Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports marked serious: 90.6% (raises risk) · Drug's FDA history
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Maximum age: not given (raises risk) · Who can join
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Blinding: none (raises risk) · Design
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Drugs with FDA adverse-event history: 3 (lowers risk) · Drug's FDA history
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
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 2 (typical: 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
- academic or other
- Sponsor's past trials
- 4 (typical: 32)
- Sponsor's past termination rate
- 25% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 0 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 3 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 125827 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 20396 (typical: 412.5)
- Drug's FAERS reports marked serious
- 90.6% (typical: 85.6%)
- Drug's FAERS reports with a death
- 22.7% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer
- Drugs matched to FDA substances
- cetuximab, nivolumab, paclitaxel
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
- De-Escalation Therapy for Human Papillomavirus Negative Disease NCT03944915 · started 2019 · scored riskier than 96% of active trials completed
- Nivolumab in Recurrent and/or Metastatic SCCHN NCT03226756 · started 2017 · scored riskier than 78% of active trials completed
- Ficlatuzumab w/wo Cetuximab in Patients w/Cetuximab-Resistant, Recurrent or Metastatic Head/Neck Squamous Cell Carcinoma NCT03422536 · started 2017 · scored riskier than 90% of active trials completed
- Ficlatuzumab, Cisplatin and IMRT in Locally Advanced Head and Neck Squamous Cell Carcinoma NCT02277184 · started 2015 · scored riskier than 64% of active trials terminated
- Adjuvant De-Escalated Radiation + Adjuvant Nivolumab for Intermediate-High Risk P16+ Oropharynx Cancer NCT03715946 · started 2018 · scored riskier than 98% 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.