A Phase I/II Trial to Evaluate a Peptide Vaccine Plus Ipilimumab in Patients With Melanoma
Model scores of the 29,894 trials active now.
Model score 29% for any early termination, 12% 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 (851 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2019-09-18, after 2015-04-30 start.
Reason given by the sponsor: “other”
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 2019-09-18. 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: melanomabrainipilimumabivstage
Phrases that lowered it: participantsevaluate thelesionsapplyto evaluate -
Sponsor's past termination rate: 28.6% (raises risk) · Sponsor's track record
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 1/2 (raises risk) · Design
-
Disease area, cancer: Yes (raises risk) · Disease area
-
Responsible party: sponsor investigator (raises risk) · Design
-
Design: single group (raises risk) · Design
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Drug's FAERS reports with a death: 22.8% (raises risk) · Drug's FDA history
-
Minimum age: 18 (raises risk) · Who can join
-
Disease area, dermatology: Yes (raises risk) · Disease area
-
Primary purpose: treatment (raises risk) · Design
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Trials the sponsor started in the prior 2 years: 3 (raises risk) · Sponsor's track record
-
Maximum age: not given (raises risk) · Who can join
-
Blinding: none (raises risk) · Design
-
Collaborators: 0 (raises risk) · Design
-
Number of arms: 1 (raises risk) · Design
-
Drug's FAERS reports marked serious: 84.0% (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
- 1/2 (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
- Yes (typical: 56% yes)
- Responsible party
- sponsor investigator (typical: 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
- academic or other
- Sponsor's past trials
- 7 (typical: 32)
- Sponsor's past termination rate
- 28.6% (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
- 5365 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1934 (typical: 412.5)
- Drug's FAERS reports marked serious
- 84.0% (typical: 85.6%)
- Drug's FAERS reports with a death
- 22.8% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, dermatology
- Drugs matched to FDA substances
- ipilimumab
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
- Safety Study of a Helper Peptide Vaccine Plus Adjuvant Combinations for the Treatment of Melanoma NCT02425306 · started 2015 · scored riskier than 96% of active trials terminated
- Melanoma Vaccine Against Neoantigen and Shared Antigens by CD40 Activation and TLR Agonists In Patients With Melanoma (Including Ocular Melanoma) NCT04364230 · started 2020 · scored riskier than 97% of active trials completed
- Safety Study of a Helper Peptide Vaccine Plus Pembrolizumab NCT02515227 · started 2016 · scored riskier than 98% of active trials completed
- Vaccination With 6MHP, With or Without Systemic CDX-1127, in Patients With Stage II-IV Melanoma NCT03617328 · started 2018 · scored riskier than 95% of active trials completed
- Evaluating the Safety and the Biological Effects of Intratumoral Interferon Gamma and a Peptide-Based Vaccine in Patients With Melanoma NCT00977145 · started 2009 · scored riskier than 82% 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.