Study of HBI-8000 With Nivolumab in Melanoma, Renal Cell Carcinoma and Non-Small Cell Lung Cancer
Model scores of the 29,894 trials active now.
Model score 24% for any early termination, 4% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 29% of the time (655 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2023-12-12, after 2016-08-18 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 2023-12-12. 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: subjects withcancercellstudy drugin subjects
Phrases that lowered it: evaluatepharmacokineticsefficacyaminotransferasethe effect -
Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 1/2 (raises risk) · Design
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Drug's FAERS reports with a death: 30.4% (raises risk) · Drug's FDA history
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Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
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Disease area, cancer: Yes (raises risk) · Disease area
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Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
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Design: single group (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
-
Maximum age: not given (raises risk) · Who can join
-
Primary purpose: treatment (raises risk) · Design
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Disease area, dermatology: Yes (raises risk) · Disease area
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Number of arms: 1 (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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Sponsor's past trials: 0 (raises risk) · Sponsor's track record
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Has a data monitoring committee: No (lowers risk) · Design
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Disease area, respiratory: Yes (raises risk) · Disease area
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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
- 1/2 (typical: 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
- 5 (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
- 0 (typical: 32)
- Sponsor's past termination rate
- no earlier finished trials (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
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 6358 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 5140 (typical: 412.5)
- Drug's FAERS reports marked serious
- 85.9% (typical: 85.6%)
- Drug's FAERS reports with a death
- 30.4% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, respiratory, dermatology, urogenital
- Drugs matched to FDA substances
- nivolumab
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
- Pilot Study of the Safety/Efficacy of Combination Checkpoint Blockade + External Beam Radiotherapy in Stage IV Melanoma NCT02659540 · started 2016 · scored riskier than 48% of active trials completed
- A Study Evaluating the Safety, Tolerance and Anti-tumor Activity of a Study Drug in Subjects With Advanced Solid Tumors NCT04135261 · started 2019 · scored riskier than 32% of active trials completed
- A Study of HBI-8000 (Tucidinostat) With Pembrolizumab in Non-Small Cell Lung Cancer NCT05141357 · started 2022 · scored riskier than 88% of active trials terminated
- CMP-001 in Combination With Nivolumab in Subjects With Advanced Melanoma NCT04698187 · started 2021 · scored riskier than 87% of active trials terminated
- A Study of the Safety and Tolerance of CAN04 and Pembrolizumab in Combination With and Without Carboplatin and Pemetrexed in Subjects With Solid Tumors NCT04452214 · started 2020 · scored riskier than 79% 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.