A Study to Compare Bempegaldesleukin (BEMPEG: NKTR-214) Combined With Nivolumab and Tyrosine Kinase Inhibitor (TKI) to Nivolumab and TKI Alone in Participants With Previously Untreated Kidney Cancer That is Advanced or Has Spread

NCT04540705 on ClinicalTrials.gov Phase 1 Bristol-Myers Squibb (industry) Started 2020-09-11 Completed

Riskier than 56% of active trials

Model scores of the 29,894 trials active now.

Model score 18% 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

Completed on 2024-01-18, after 2020-09-11 start.

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 2024-01-18. 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: cellcarcinomato determinestagethe purpose
Phrases that lowered it: protocol defineddefined inclusionother protocolapplyinclusion exclusion
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 1 (lowers risk) · Design
Sponsor's past termination rate: 10.3% (raises risk) · Sponsor's track record
Drug's FAERS reports with a death: 27.4% (raises risk) · Drug's FDA history
Trials the sponsor started in the prior 2 years: 86 (lowers risk) · Sponsor's track record
Has a data monitoring committee: Yes (raises risk) · Design
Design: parallel (raises risk) · Design
Disease area, cancer: Yes (raises risk) · Disease area
Primary purpose: treatment (raises risk) · Design
Sponsor type: industry (lowers risk) · Sponsor's track record
Minimum age: 18 (raises risk) · Who can join
Drug's FAERS reports in the prior 12 months: 14690 (lowers risk) · Drug's FDA history
Collaborators: 1 (raises risk) · Design
Maximum age: not given (raises risk) · Who can join
Drug's FAERS reports marked serious: 78.8% (lowers risk) · Drug's FDA history
Drugs with FDA adverse-event history: 3 (lowers risk) · Drug's FDA history
Responsible party: sponsor (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: 1 (typical: 2)
Number of arms: 2
Allocation: non randomized (typical: randomized)
Design: parallel
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: Yes (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: 715 (typical: 32)
Sponsor's past termination rate: 10.3% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 86 (typical: 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: 71243 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 14690 (typical: 412.5)
Drug's FAERS reports marked serious: 78.8% (typical: 85.6%)
Drug's FAERS reports with a death: 27.4% (typical: 15.9%)

Disease area and drugs

Disease areas: cancer, urogenital
Drugs matched to FDA substances: axitinib, cabozantinib, 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

A Study of Bempegaldesleukin (NKTR-214: BEMPEG) in Combination With Nivolumab Compared With the Investigator's Choice of a Tyrosine Kinase Inhibitor (TKI) Therapy (Either Sunitinib or Cabozantinib Monotherapy) for Advanced Metastatic Renal Cell Carcinoma (RCC) NCT03729245 · started 2018 · scored riskier than 58% of active trials terminated
BNC105P in Combination With Everolimus/Following Everolimus For Progressive Metastatic Clear Cell Renal Cell Carcinoma NCT01034631 · started 2010 · scored riskier than 99% of active trials completed
Nivolumab Combined With Ipilimumab Versus Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (CheckMate 214) NCT02231749 · started 2014 · scored riskier than 36% of active trials completed
Nivolumab (BMS-936558; MDX-1106) in Combination With Sunitinib, Pazopanib, or Ipilimumab in Subjects With Metastatic Renal Cell Carcinoma (RCC) (CheckMate 016) NCT01472081 · started 2012 · scored riskier than 72% of active trials completed
Substudy 03B: A Study of Immune and Targeted Combination Therapies in Participants With Second Line Plus (2L+) Renal Cell Carcinoma (MK-3475-03B/KEYMAKER-U03) NCT04626518 · started 2020 · scored riskier than 69% 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.