Study of Pharmacokinetic, Safety, Immunogenicity and Efficacy of CMAB819 and Nivolumab in R/M HNSCC
Model scores of the 29,894 trials active now.
Model score 23% for any early termination, 3% 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 2023-10-16, after 2020-09-24 start.
Reason given by the sponsor: “enrollment”
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 2023-10-16. 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
-
Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: subjects withulnrandomizationcelldisease
Phrases that lowered it: dailywithin weekssuspectedmgknown or -
Phase: 1 (lowers risk) · Design
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
-
Drug's FAERS reports with a death: 30.1% (raises risk) · Drug's FDA history
-
Disease area, cancer: Yes (raises risk) · Disease area
-
Trials the sponsor started in the prior 2 years: 2 (raises risk) · Sponsor's track record
-
Design: parallel (raises risk) · Design
-
Maximum age: 75 (lowers risk) · Who can join
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Primary purpose: treatment (raises risk) · Design
-
Sponsor's past trials: 2 (raises risk) · Sponsor's track record
-
Minimum age: 18 (raises risk) · Who can join
-
Has a data monitoring committee: No (lowers risk) · Design
-
Blinding: quadruple (lowers risk) · Design
-
Drug's FAERS reports marked serious: 90.2% (raises risk) · Drug's FDA history
-
Number of arms: 2 (raises risk) · Design
-
Drug's FAERS reports in the prior 12 months: 9371 (lowers risk) · Drug's FDA history
-
Drug's FAERS reports before start: 48069 (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
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- quadruple (typical: 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
- 18
- Maximum age
- 75 (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
- 2 (typical: 32)
- Sponsor's past termination rate
- 0% (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
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 48069 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 9371 (typical: 412.5)
- Drug's FAERS reports marked serious
- 90.2% (typical: 85.6%)
- Drug's FAERS reports with a death
- 30.1% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer
- 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
- Nivolumab in Recurrent and/or Metastatic SCCHN NCT03226756 · started 2017 · scored riskier than 78% of active trials completed
- NIVolumab in Subjects With Recurrent or Metastatic Platinum-refrACTORy SCCHN NCT05802290 · started 2017 · scored riskier than 90% of active trials completed
- A Phase 1 Study in Patients With HPV16+ Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma NCT03978689 · started 2019 · scored riskier than 74% of active trials completed
- KL-A167 Injection in Recurrent or Metastatic Nasopharyngeal Carcinoma NCT03848286 · started 2019 · scored riskier than 59% of active trials completed
- Trial of Ibrutinib Combined With Nivolumab or Cetuximab to Treat Recurrent/Metastatic HNSCC NCT03646461 · started 2018 · scored riskier than 87% 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.