A Study of Atezolizumab in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer (Cohort 1)

NCT02951767 on ClinicalTrials.gov Phase 2 Hoffmann-La Roche (industry) Started 2014-05-31 Completed

Riskier than 35% of active trials

Model scores of the 29,894 trials active now.

Model score 14% 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 22% of the time (1,598 trials).

Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.

How it ended

Completed on 2023-02-28, after 2014-05-31 start.

The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.

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 2023-02-28. 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

Phase: 2 (raises risk) · Design
Accepts healthy volunteers: No (raises risk) · Who can join
Has a data monitoring committee: not given (lowers risk) · Design
Drug's FAERS reports with a death: 33.3% (raises risk) · Drug's FDA history
Trials the sponsor started in the prior 2 years: 187 (lowers risk) · Sponsor's track record
Sponsor's past termination rate: 8.8% (raises risk) · Sponsor's track record
Sponsor type: industry (lowers risk) · Sponsor's track record
Design: single group (raises risk) · Design
Disease area, cancer: Yes (raises risk) · Disease area
Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: chemotherapycisplatinadvancedcancergreater
Phrases that lowered it: participantswithin weekspulmonarydiseasesautoimmune
Drug's FAERS reports marked serious: 100% (raises risk) · Drug's FDA history
Minimum age: 18 (raises risk) · Who can join
Primary purpose: treatment (raises risk) · Design
Blinding: none (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: 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: not given (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 7 (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: 731 (typical: 32)
Sponsor's past termination rate: 8.8% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 187 (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: 3 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 1 (typical: 412.5)
Drug's FAERS reports marked serious: 100% (typical: 85.6%)
Drug's FAERS reports with a death: 33.3% (typical: 15.9%)

Disease area and drugs

Disease areas: cancer, urogenital
Drugs matched to FDA substances: atezolizumab

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

A Study of Atezolizumab in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer (Cohort 2) NCT02108652 · started 2014 · scored riskier than 37% of active trials completed
A Study of Atezolizumab Compared With Chemotherapy in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer [IMvigor211] NCT02302807 · started 2015 · scored riskier than 19% of active trials completed
Study of Atezolizumab as Monotherapy and in Combination With Platinum-Based Chemotherapy in Participants With Untreated Locally Advanced or Metastatic Urothelial Carcinoma NCT02807636 · started 2016 · scored riskier than 43% of active trials completed
CV301 Combined With PD-1/L1 Blockade in Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer NCT03628716 · started 2018 · scored riskier than 83% of active trials completed
A Study of Pembrolizumab (MK-3475) Versus Paclitaxel, Docetaxel, or Vinflunine for Participants With Advanced Urothelial Cancer (MK-3475-045/KEYNOTE-045) NCT02256436 · started 2014 · scored riskier than 46% 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.