Evidence map›Paper›PMID 39521884›Full record

ArticleNature medicine2025

Oncolytic immunotherapy with nivolumab in muscle-invasive bladder cancer: a phase 1b trial.

Roger Li, Nancy Y Villa, Xiaoqing Yu, Joseph O Johnson, Gustavo Borjas, Jasreman Dhillon, Carlos M Moran-Segura, Youngchul Kim, Natasha Francis, Denise Dorman and 18 more

Registry-linked trialAbstract readClinical Trial, Phase I
In one paragraph

Article in Nature medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04610671 (A Phase 1 Study of CG0070 Combined With Nivolumab in Cisplatin Ineligible Patients With Muscle Invasive Bladder Cancer), which is not on this map. Cited by 20 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 1 pooled it
–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.

NCT04610671 phase1completednot on this map

A Phase 1 Study of CG0070 Combined With Nivolumab in Cisplatin Ineligible Patients With Muscle Invasive Bladder Cancer (MIBC)

TypeinterventionalSponsorH. Lee Moffitt Cancer Center and Research InstituteRan2020 to 2024Enrolled21ConditionsMuscle-Invasive Bladder Carcinoma, Bladder CancerArmsCG0070, Nivolumab
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Modular Vaccine Robots for Spatiotemporal Programming of the CD4Small (Weinheim an der Bergstrasse, Germany) · 2026
    Article
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  6. Association of CCL21Cancer immunology, immunotherapy : CII · 2026
    Article
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

28 authors.

Roger LiDepartment of Genitourinary Oncology, H. Lee Moffitt Cancer Center, Tampa, FL, USA. Roger.Li@moffitt.org.ORCID 0000-0003-1274-7200
Nancy Y VillaDepartment of Genitourinary Oncology, H. Lee Moffitt Cancer Center, Tampa, FL, USA.
Xiaoqing YuDepartment of Biostatistics and Bioinformatics, H. Lee Moffitt Cancer Center, Tampa, FL, USA.ORCID 0000-0003-4585-9372
Joseph O JohnsonAnalytic Microscopy Core, H. Lee Moffitt Cancer Center, Tampa, FL, USA.
Gustavo BorjasDepartment of Immunology, H. Lee Moffitt Cancer Center, Tampa, FL, USA.ORCID 0000-0002-8857-0299
Jasreman DhillonDepartment of Pathology, H. Lee Moffitt Cancer Center, Tampa, FL, USA.ORCID 0000-0001-6785-3487
Carlos M Moran-SeguraAdvanced Analytical and Digital Laboratory, H. Lee Moffitt Cancer Center, Tampa, FL, USA.ORCID 0000-0001-8702-0554
Youngchul KimDepartment of Biostatistics and Bioinformatics, H. Lee Moffitt Cancer Center, Tampa, FL, USA.
Natasha FrancisTissue Core, H. Lee Moffitt Cancer Center, Tampa, FL, USA.
Denise DormanDepartment of Genitourinary Oncology, H. Lee Moffitt Cancer Center, Tampa, FL, USA.
John J PowersDepartment of Immunology, H. Lee Moffitt Cancer Center, Tampa, FL, USA.ORCID 0000-0003-3800-2645
Wade J SextonDepartment of Genitourinary Oncology, H. Lee Moffitt Cancer Center, Tampa, FL, USA.
Philippe E SpiessDepartment of Genitourinary Oncology, H. Lee Moffitt Cancer Center, Tampa, FL, USA.
Michael A PochDepartment of Genitourinary Oncology, H. Lee Moffitt Cancer Center, Tampa, FL, USA.
Logan ZempDepartment of Genitourinary Oncology, H. Lee Moffitt Cancer Center, Tampa, FL, USA.
Scott M GilbertDepartment of Genitourinary Oncology, H. Lee Moffitt Cancer Center, Tampa, FL, USA.
Jingsong ZhangDepartment of Genitourinary Oncology, H. Lee Moffitt Cancer Center, Tampa, FL, USA.ORCID 0000-0003-1192-5116
Julio M Pow-SangDepartment of Genitourinary Oncology, H. Lee Moffitt Cancer Center, Tampa, FL, USA.
Alexander R A AndersonDepartment of Integrated Mathematical Oncology, H. Lee Moffitt Cancer Center, Tampa, FL, USA.ORCID 0000-0002-2536-4383
Tingyi LiDepartment of Biostatistics and Bioinformatics, H. Lee Moffitt Cancer Center, Tampa, FL, USA.
Xuefeng WangDepartment of Biostatistics and Bioinformatics, H. Lee Moffitt Cancer Center, Tampa, FL, USA.ORCID 0000-0001-5775-408X
G Daniel GrassDepartment of Radiation Oncology, H. Lee Moffitt Cancer Center, Tampa, FL, USA.
James M BurkeBig Horn Basin Cancer Center, Cody, WY, USA.
Colin P N DinneyDepartment of Urology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Paulo C RodriguezDepartment of Immunology, H. Lee Moffitt Cancer Center, Tampa, FL, USA.ORCID 0000-0001-7480-6566
Rohit K JainDepartment of Genitourinary Oncology, H. Lee Moffitt Cancer Center, Tampa, FL, USA.
James J Mulé *Department of Immunology, H. Lee Moffitt Cancer Center, Tampa, FL, USA.ORCID 0000-0001-7354-0516
Jose R Conejo-Garcia *Department of Immunology, H. Lee Moffitt Cancer Center, Tampa, FL, USA.ORCID 0000-0001-6431-4074

Funding

TRANSLATIONAL RESEARCHP30CA076292 · NCI · UNIVERSITY OF SOUTH FLORIDA · PI Christine O'Connell · 1998 to 2026
$93.5M
Project 4P01CA250984 · NCI · H. LEE MOFFITT CANCER CTR & RES INST · PI STEWART, PAUL ALLEN · 2021 to 2025
$10.1M
The Delta Ecology of NSCLC TreatmentU54CA274507 · NCI · H. LEE MOFFITT CANCER CTR & RES INST · PI Alexander Robertson Allan Anderson · 2023 to 2026
$9.4M
Plant-derived extracts regulate immunosuppressive myelopoiesis in Breast cancer patientsR01CA262121 · NCI · H. LEE MOFFITT CANCER CTR & RES INST · PI RODRIGUEZ, PAULO CESAR · 2021 to 2025
$2.1M
Mitochondrial stress promotes immunosuppressive potential of myeloid subsets in tumorsR01CA273034 · NCI · H. LEE MOFFITT CANCER CTR & RES INST · PI RODRIGUEZ, PAULO CESAR · 2022 to 2025
$1.9M
NCI NIH HHS P01 CA250984NCI NIH HHS P30 CA076292NCI NIH HHS R01 CA262121NCI NIH HHS R01 CA273034NCI NIH HHS U54 CA274507U.S. Department of Defense (United States Department of Defense) W81XWH-22-1-0395
6 · The paper itself

Abstract

There is a critical unmet need for safe and efficacious neoadjuvant treatment for cisplatin-ineligible patients with muscle-invasive bladder cancer. Here we launched a phase 1b study using the combination of intravesical cretostimogene grenadenorepvec (oncolytic serotype 5 adenovirus encoding granulocyte-macrophage colony-stimulating factor) with systemic nivolumab in cisplatin-ineligible patients with cT2-4aN0-1M0 muscle-invasive bladder cancer. The primary objective was to measure safety, and the secondary objective was to assess the anti-tumor efficacy as measured by pathologic complete response along with 1-year recurrence-free survival. No dose-limiting toxicity was encountered in 21 patients enrolled and treated. Combination treatment achieved a pathologic complete response rate of 42.1% and a 1-year recurrence-free survival rate of 70.4%. Pathologic response was associated with baseline free E2F activity and tumor mutational burden but not PD-L1 status. Although T cell infiltration was broadly induced after intravesical oncolytic immunotherapy, the formation, enlargement and maturation of tertiary lymphoid structures was specifically associated with complete response, supporting the importance of coordinated humoral and cellular immune responses. Together, these results highlight the potential of this combination regimen to enhance therapeutic efficacy in cisplatin-ineligible patients with muscle-invasive bladder cancer, warranting additional study as a neoadjuvant therapeutic option. ClinicalTrials.gov identifier: NCT04610671 .

Indexed as

ImmunotherapyNivolumabOncolytic VirotherapyUrinary Bladder NeoplasmsAgedAged, 80 and overCombined Modality TherapyFemaleGranulocyte-Macrophage Colony-Stimulating FactorHumansMaleMiddle AgedNeoplasm InvasivenessGranulocyte-Macrophage Colony-Stimulating FactorNivolumab

Identifiers

PMID39521884
PMCPMC12302721

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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.