A Phase I/Ib Study of NIZ985 Alone and in Combination With Spartalizumab
Model scores of the 29,894 trials active now.
Model score 16% for any early termination, 2% 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 (1,938 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2023-12-27, after 2020-02-27 start.
Reason given by the sponsor: “business”
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 2023-12-27. 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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Sponsor's past termination rate: 15.0% (raises risk) · Sponsor's track record
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: to determinetherapypriorscanmelanoma
Phrases that lowered it: participantspatientspsoriasismaleperiod -
Phase: 1 (lowers risk) · Design
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Accepts healthy volunteers: No (raises risk) · Who can join
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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: 143 (lowers risk) · Sponsor's track record
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Design: parallel (raises risk) · Design
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Sponsor's past trials: 1291 (raises risk) · Sponsor's track record
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Drug's FAERS reports with a death: 5.9% (lowers risk) · Drug's FDA history
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 100% (raises risk) · Drug's FDA history
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Primary purpose: treatment (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Responsible party: sponsor (lowers risk) · Design
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Has a data monitoring committee: No (lowers risk) · Design
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Blinding: none (lowers risk) · Design
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Disease area, respiratory: Yes (raises risk) · Disease area
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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
- 1 (typical: 2)
- Number of arms
- 2
- Allocation
- non randomized (typical: randomized)
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 8 (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
- 1291 (typical: 32)
- Sponsor's past termination rate
- 15.0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 143 (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
- 169 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 66 (typical: 412.5)
- Drug's FAERS reports marked serious
- 100% (typical: 85.6%)
- Drug's FAERS reports with a death
- 5.9% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, respiratory, immunology, dermatology, hematology
- Drugs matched to FDA substances
- pdr001, spartalizumab, tislelizumab
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
- LZM009 to Treat Patients With Advanced Solid Tumors NCT03286296 · started 2017 · scored riskier than 35% of active trials completed
- Safety and Efficacy of SB 11285 Alone and in Combination With Atezolizumab in Patients With Advanced Solid Tumors NCT04096638 · started 2019 · scored riskier than 36% of active trials completed
- A Phase 1/2, Open-label, Multicenter, Dose Escalation and Expansion Study of SLC-3010 Monotherapy and in Combination NCT05525247 · started 2022 · scored riskier than 44% of active trials terminated
- A Trial of BI 765063 Monotherapy and in Combination With BI 754091 in Patients With Advanced Solid Tumours NCT03990233 · started 2019 · scored riskier than 22% of active trials completed
- Atezolizumab and Varlilumab in Combination With Radiation Therapy for NSCLC NCT04081688 · started 2019 · scored riskier than 94% 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.