Evidence map›Paper›PMID 40956664›Full record

Trial reportThe Journal of urology2026

Prolonged Progression-Free Survival, Disease-Free Survival, and Cystectomy Avoidance With IL-15 Receptor Lymphocyte-Stimulating Agent NAI Plus Bacillus Calmette-Guérin in Bacillus Calmette-Guérin-Unresponsive Papillary-Only Nonmuscle-Invasive Bladder Cancer.

Sam S Chang, Karim Chamie, Eugene Kramolowsky, Mark L Gonzalgo, Piyush Kumar Agarwal, Jeffrey C Bassett, Marc Bjurlin, Michael L Cher, William Clark, Barrett E Cowan and 21 more

Registry-linked trialAbstract readClinical Trial, Phase IIClinical Trial, Phase IIIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Journal of urology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03022825 (QUILT-3.032), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03022825 phase2 / phase3active not recruitingnot on this map

QUILT-3.032: A Multicenter Clinical Trial of Intravesical Bacillus Calmette-Guerin (BCG) in Combination With ALT-803 (N-803) in Patients With BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer

TypeinterventionalSponsorImmunityBio, Inc.Ran2017 to 2029Enrolled190ConditionsBladder CancerArmsN-803 and BCG, N-803
3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Review
  2. Article
  3. Review
  4. Review
  5. Review
  6. Roundup.Indian journal of urology : IJU : journal of the Urological Society of India
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

31 authors.

Sam S ChangDepartment of Urology, Vanderbilt Ingram Cancer Center, Vanderbilt University Medical Center, Nashville, Tennessee.
Karim ChamieDepartment of Urology, UCLA Medical Center, Los Angeles, California.
Eugene KramolowskyVirginia Urology, Richmond, Virginia.
Mark L GonzalgoDesai Sethi Urology Institute, University of Miami Miller School of Medicine, Miami, Florida.
Piyush Kumar AgarwalDepartment of Surgery, Section of Urology, University of Chicago, Chicago, Illinois.
Jeffrey C BassettHoag Urologic Oncology, Hoag Memorial Presbyterian Hospital, Newport Beach, California.
Marc BjurlinDepartment of Urology, Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, North Carolina.
Michael L CherDepartment of Urology, Wayne State University, Detroit, Michigan.
William ClarkAlaska Urological Institute, Soldotna, Alaska.
Barrett E CowanUrology Associates, Englewood, Colorado.
Richard DavidGenesis Healthcare Partners, Greater Los Angeles Division, Sherman Oaks, California.
Evan GoldfischerPremier Medical Group, Poughkeepsie, New York.
Khurshid GuruRoswell Park Comprehensive Cancer Center, Buffalo, New York.
Mark W JalkutAssociated Urologists of North Carolina, Raleigh, North Carolina.
Samuel D KaffenbergerDepartment of Urology, University of Michigan, Ann Arbor, Michigan.
Jed KaminetskyUniversity Urology, New York, New York.
Anthony CorcoranNYU Winthrop Hospital, Garden City, New York.
Alec S KooGenesis Healthcare Partners, Torrance, California.
Wade J SextonMoffitt Cancer Center, Tampa, Florida.
Sergei N TikhonenkovUniversity of Hawaii Cancer Center, Honolulu, Hawaii.
Mihir S ShahDepartment of Urology, Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, Pennsylvania.
Edouard J TrabulsiJefferson Einstein Medical Center, Philadelphia, Pennsylvania.
Andrew F TrainerAdult and Pediatric Urology, Omaha, Nebraska.
Patricia SpilmanImmunityBio, Culver City, California.
Megan HuangImmunityBio, Culver City, California.
Paul BharImmunityBio, Culver City, California.
Leylah M DrusboskyImmunityBio, Culver City, California.
Lennie SenderImmunityBio, Culver City, California.
Bruce BrownImmunityBio, Culver City, California.
Sandeep ReddyImmunityBio, Culver City, California.
Patrick Soon-ShiongImmunityBio, Culver City, California.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeIn QUILT-3.032, the efficacy of interleukin-15 receptor agonist, nogapendekin alfa inbakicept (NAI), in combination with bacillus Calmette-Guérin (BCG) for BCG-unresponsive high-grade papillary-only nonmuscle-invasive bladder cancer was assessed. In this study, we report the 36-month follow-up among participants with BCG-unresponsive papillary disease (cohort B). MATERIALS AND

methodsNCT03022825 is an open-label, multicenter study of patients with BCG-unresponsive high-grade Ta/T1 papillary nonmuscle-invasive bladder cancer who received 400 μg NAI plus 50 mg BCG intravesically weekly for 6 consecutive weeks. The primary end point is disease-free survival (DFS) at 12 months. Progression-free survival (PFS), disease-specific survival (DSS), and cystectomy avoidance were assessed. Treatment-related adverse events were assessed.

resultsAt July 15, 2024, data cutoff, the DFS rates at 12, 24, and 36 months were 58.2% (95% CI: 46.6, 68.2), 52.1% (95% CI: 40.3, 62.7), and 38.2% (95% CI: 25.6, 50.6), respectively. The PFS rates at 12 and 36 months were 94.9% (95% CI: 86.9, 98.0) and 83.1% (95% CI: 69.5, 91.0). The DSS rates at 12 and 36 months were 98.7% (95% CI: 91.4, 99.8) and 96.0% (95% CI: 88.2, 98.7). The median DSS has not been reached. Cystectomy avoidance rates at 12 and 36 months were 92.2% (95% CI: 83.4, 96.4) and 81.8% (95% CI: 68.1, 90.1), with median time to cystectomy not reached. Most treatment-related adverse events were grade 1 to 2 (61%) with 3% grade 3 and no grade 4 to 5.

conclusionsThe 12-month and 36-month DFS, PFS, DSS, and cystectomy avoidance rates demonstrate the effectiveness and safety of NAI plus BCG in the management of BCG-unresponsive papillary disease.

trial registrationClinicalTrials.gov Identifier: NCT03022825.

Indexed as

BCG VaccineCystectomyUrinary Bladder NeoplasmsAdjuvants, ImmunologicAdministration, IntravesicalAgedAged, 80 and overDisease-Free SurvivalFemaleFollow-Up StudiesHumansMaleMiddle AgedNeoplasm InvasivenessProgression-Free SurvivalAdjuvants, ImmunologicBCG VaccineBCG-unresponsiveN-803papillary NMIBC

Identifiers

PMID40956664
PMCPMC12708036

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.