Non-comparative Study of IFX-1 Alone or IFX-1+Pembrolizumab in Patients With Locally Advanced or Metastatic cSCC.
Model scores of the 29,894 trials active now.
Model score 20% for any early termination, 7% 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
Terminated on 2024-06-04, after 2021-03-31 start.
Reason given by the sponsor: “efficacy”
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 2024-06-04. 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: stagelocallymetastaticadvancedcell
Phrases that lowered it: patients whoimagingpdprogressionrna -
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 2 (raises risk) · Design
-
Disease area, cancer: Yes (raises risk) · Disease area
-
Trials the sponsor started in the prior 2 years: 3 (raises risk) · Sponsor's track record
-
Number of arms: 4 (lowers risk) · Design
-
Drug's FAERS reports with a death: 25.2% (raises risk) · Drug's FDA history
-
Design: parallel (raises risk) · Design
-
Minimum age: 18 (raises risk) · Who can join
-
Maximum age: not given (raises risk) · Who can join
-
Sponsor's past trials: 5 (raises risk) · Sponsor's track record
-
Primary purpose: treatment (raises risk) · Design
-
Collaborators: 1 (raises risk) · Design
-
Blinding: none (raises risk) · Design
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Drug's FAERS reports in the prior 12 months: 6894 (lowers risk) · Drug's FDA history
-
Has a data monitoring committee: No (lowers 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
- 4 (typical: 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
- 1 (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
- industry (typical: academic or other)
- Sponsor's past trials
- 5 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 3 (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
- 27914 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 6894 (typical: 412.5)
- Drug's FAERS reports marked serious
- 83.7% (typical: 85.6%)
- Drug's FAERS reports with a death
- 25.2% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer
- Drugs matched to FDA substances
- pembrolizumab, vilobelimab
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
- Study of Pembrolizumab (MK-3475) in Adults With Recurrent/Metastatic Cutaneous Squamous Cell Carcinoma (cSCC) or Locally Advanced Unresectable cSCC (MK-3475-629/KEYNOTE-629) NCT03284424 · started 2017 · scored riskier than 86% of active trials completed
- High-Risk Skin Cancers With Atezolizumab Plus NT-I7 NCT03901573 · started 2019 · scored riskier than 79% of active trials terminated
- Dose Escalation and Expansion Study of WTX-124 as Monotherapy and in Combination With Pembrolizumab (Pembro) in Patients With Selected Advanced or Metastatic Solid Tumors NCT05479812 · started 2022 · scored riskier than 16% of active trials completed
- Study of Pembrolizumab as First Line Therapy in Patients With Unresectable Squamous Cell Carcinoma of the Skin NCT02883556 · started 2017 · scored riskier than 77% of active trials completed
- Trial of Pembrolizumab for Advanced Penile Squamous Cell Carcinoma NCT02837042 · started 2016 · scored riskier than 77% 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.