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Dose De-escalation Study of the PI3k Alpha/Delta Inhibitor, Copanlisib Given in Combination With the Immunotherapeutic Agents, Nivolumab and Rituximab in Patients With Relapsed/Refractory Indolent Lymphoma

NCT04431635 on ClinicalTrials.gov Phase 1 University of Michigan Rogel Cancer Center (academic or other) Started 2020-06-15 Terminated
Riskier than 58% of active trials
this trial: 18% 0% 36%

Model scores of the 29,894 trials active now.

Model score 18% 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 11% of the time (918 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

How it ended

Terminated on 2023-11-14, after 2020-06-15 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

0% 12% 25% 37% 49% 0123456 yr completed 43% terminated 23%

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2023-11-14. 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

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
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
Collaborators
4 (typical: 0)
Keywords listed
0 (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
127 (typical: 32)
Sponsor's past termination rate
28.3% (typical: 9.9%)
Trials the sponsor started in the prior 2 years
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
144962 (typical: 2148)
Drug's FAERS reports in the prior 12 months
31122 (typical: 412.5)
Drug's FAERS reports marked serious
90.1% (typical: 85.6%)
Drug's FAERS reports with a death
21.1% (typical: 15.9%)

Disease area and drugs

Disease areas
none of the 14 tracked areas
Drugs matched to FDA substances
copanlisib, nivolumab, rituximab

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

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.