---
title: "Neoadjuvant nivolumab plus visugromab in MIBC: phase 2a GDFATHER-NEO findings"
id: "nature-0-neoadjuvant-nivolumab-with-or-without-visugromab-in-muscle-invasive-bladder"
canonical_url: "https://medichelpline.com/clinical-feed/nature-0-neoadjuvant-nivolumab-with-or-without-visugromab-in-muscle-invasive-bladder"
content_type: "clinical_feed_article"
specialty: "Oncology"
source_name: "Nature Medicine"
source_url: "https://www.nature.com/articles/s41591-026-04740-9"
published_at: "2026-10-24T09:20:18.000Z"
evidence_level: "Journal Feed"
license: "CC-BY-NC-4.0 / Informational Use"
---
# Neoadjuvant nivolumab plus visugromab in MIBC: phase 2a GDFATHER-NEO findings
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/nature-0-neoadjuvant-nivolumab-with-or-without-visugromab-in-muscle-invasive-bladder
- **Specialty:** [Oncology](https://medichelpline.com/clinical-feed/oncology.md)
- **Primary Source:** Nature Medicine
- **Source URL:** [Original Journal Publication](https://www.nature.com/articles/s41591-026-04740-9)
- **Published At:** 2026-10-24T09:20:18.000Z
- **Evidence Rating:** Journal Feed
## Executive GIST (TL;DR)
- Investigators conducted an exploratory, stratified, placebo-controlled, single-blinded, nonrandomized phase 2a trial (GDFATHER-NEO) in **muscle-invasive bladder cancer (MIBC)**. - The cohort included 31 cisplatin-ineligible or cisplatin-refusing patients with clinical T2–T4aN0M0 disease who were allocated sequentially to receive neoadjuvant **nivolumab** with either the **GDF-15** neutralizing antibody **visugromab** or placebo. - Regimens comprised three cycles of nivolumab (480 mg every 4 weeks) plus visugromab (20 mg kg−1 every 4 weeks; n = 16) or nivolumab plus placebo (n = 15); subsequent local therapy was radical cystectomy or repeat transurethral resection of the bladder tumour. - Dual primary endpoints were locally assessed pathologic complete response (**pCR**, ypT0N0/x) and RECIST v1.1-based radiographic response; the trial also measured major pathologic response and immune correlates. - pCR was 33% (5 of 15; 95% CI 12–62%) with nivolumab + visugromab versus 8% (1 of 13; 95% CI 0–36%) with nivolumab + placebo. - Major pathologic response rates were 60% (95% CI 32–84%) versus 23% (95% CI 5–54%); radiographic overall response rates were 60% (95% CI 32–84%) versus 15% (95% CI 2–45%), respectively. - Responses to the combination were associated with higher baseline densities of total and proliferating (Ki-67+) **CD8+ T cells**; response rates were independent of PD-L1 combined positive score (CPS) and baseline GDF-15 levels in serum and tumour. - No treatment-related discontinuations or delays to surgery occurred. Grade 3–4 treatment-related adverse events were reported in two patients (13%) on nivolumab + visugromab and three patients (20%) on nivolumab + placebo. - The authors reported that these data support further evaluation of **visugromab** in MIBC and provided the ClinicalTrials.gov identifier NCT06059547. - The source did not report long-term survival outcomes, detailed biomarker thresholds, or randomized comparative efficacy beyond this exploratory cohort.
## Clinical Analysis & Structured Key Points
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[articles](https://www.nature.com/nm/articles?type=article) 4. article Neoadjuvant nivolumab with or without visugromab in muscle-invasive bladder cancer: the phase 2a GDFATHER-NEO trial [ Download PDF ](https://www.nature.com/articles/s41591-026-04740-9.pdf) [ Download PDF ](https://www.nature.com/articles/s41591-026-04740-9.pdf) * Article * [Open access](https://www.springernature.com/gp/open-science/about/the-fundamentals-of-open-access-and-open-research) * Published: 24 October 2026 # Neoadjuvant nivolumab with or without visugromab in muscle-invasive bladder cancer: the phase 2a GDFATHER-NEO trial * [Andrea Necchi](https://www.nature.com/articles/s41591-026-04740-9#auth-Andrea-Necchi-Aff1-Aff2) [ORCID: orcid.org/0000-0002-3007-2756](https://orcid.org/0000-0002-3007-2756)[1](https://www.nature.com/articles/s41591-026-04740-9#Aff1),[2](https://www.nature.com/articles/s41591-026-04740-9#Aff2), * [Chiara Mercinelli](https://www.nature.com/articles/s41591-026-04740-9#auth-Chiara-Mercinelli-Aff1-Aff2) [ORCID: orcid.org/0000-0003-1165-1776](https://orcid.org/0000-0003-1165-1776)[1](https://www.nature.com/articles/s41591-026-04740-9#Aff1),[2](https://www.nature.com/articles/s41591-026-04740-9#Aff2), * [Brigida A. Maiorano](https://www.nature.com/articles/s41591-026-04740-9#auth-Brigida_A_-Maiorano-Aff1)[1](https://www.nature.com/articles/s41591-026-04740-9#Aff1), * [Michela Piacentini](https://www.nature.com/articles/s41591-026-04740-9#auth-Michela-Piacentini-Aff1)[1](https://www.nature.com/articles/s41591-026-04740-9#Aff1), * [Antonio Cigliola](https://www.nature.com/articles/s41591-026-04740-9#auth-Antonio-Cigliola-Aff1-Aff2)[1](https://www.nature.com/articles/s41591-026-04740-9#Aff1),[2](https://www.nature.com/articles/s41591-026-04740-9#Aff2), * [Roberto Iacovelli](https://www.nature.com/articles/s41591-026-04740-9#auth-Roberto-Iacovelli-Aff3-Aff4) [ORCID: orcid.org/0000-0002-1750-2117](https://orcid.org/0000-0002-1750-2117)[3](https://www.nature.com/articles/s41591-026-04740-9#Aff3),[4](https://www.nature.com/articles/s41591-026-04740-9#Aff4), * [Chiara 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orcid.org/0009-0007-3347-4973](https://orcid.org/0009-0007-3347-4973)[8](https://www.nature.com/articles/s41591-026-04740-9#Aff8), * [Michael Metterlein](https://www.nature.com/articles/s41591-026-04740-9#auth-Michael-Metterlein-Aff8)[8](https://www.nature.com/articles/s41591-026-04740-9#Aff8), * [Stefan Ries](https://www.nature.com/articles/s41591-026-04740-9#auth-Stefan-Ries-Aff8)[8](https://www.nature.com/articles/s41591-026-04740-9#Aff8), * [Thorsten Ross](https://www.nature.com/articles/s41591-026-04740-9#auth-Thorsten-Ross-Aff8)[8](https://www.nature.com/articles/s41591-026-04740-9#Aff8), * [Aasim Amin](https://www.nature.com/articles/s41591-026-04740-9#auth-Aasim-Amin-Aff8)[8](https://www.nature.com/articles/s41591-026-04740-9#Aff8), * [Tobias Dreker](https://www.nature.com/articles/s41591-026-04740-9#auth-Tobias-Dreker-Aff8)[8](https://www.nature.com/articles/s41591-026-04740-9#Aff8), * [Frank 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Auckenthaler](https://www.nature.com/articles/s41591-026-04740-9#auth-Alexandra-Auckenthaler-Aff8)[8](https://www.nature.com/articles/s41591-026-04740-9#Aff8), * [Sujata Rao](https://www.nature.com/articles/s41591-026-04740-9#auth-Sujata-Rao-Aff8)[8](https://www.nature.com/articles/s41591-026-04740-9#Aff8), * [Eugen Leo](https://www.nature.com/articles/s41591-026-04740-9#auth-Eugen-Leo-Aff8)[8](https://www.nature.com/articles/s41591-026-04740-9#Aff8) [na1](https://www.nature.com/articles/s41591-026-04740-9#na1) & * … * [Felix S. Lichtenegger](https://www.nature.com/articles/s41591-026-04740-9#auth-Felix_S_-Lichtenegger-Aff8) [ORCID: orcid.org/0000-0003-3990-1802](https://orcid.org/0000-0003-3990-1802)[8](https://www.nature.com/articles/s41591-026-04740-9#Aff8) [na1](https://www.nature.com/articles/s41591-026-04740-9#na1) Show authors [_Nature Medicine_](https://www.nature.com/nm) (2026) [Cite this article](https://www.nature.com/articles/s41591-026-04740-9#citeas) Save article [ View saved research ](https://www.nature.com/saved-research) ## Abstract Growth differentiation factor-15 (GDF-15) is overexpressed in muscle-invasive bladder cancer (MIBC) and was recently identified as a potential therapeutic target to overcome resistance to programmed cell death protein 1/programmed death ligand 1 (PDL1) blockade. We investigated the safety and efficacy of GDF-15 blockade in an exploratory, stratified, placebo-controlled, single-blinded, nonrandomized phase 2a trial (GDFATHER-NEO). Thirty-one cisplatin-ineligible or cisplatin-refusing patients with newly diagnosed MIBC (clinical T2–T4aN0M0) were stratified by tumor stage and PDL1 combined positive score (CPS) and allocated sequentially to receive three cycles of neoadjuvant nivolumab (N, 480 mg 4-weekly) plus the GDF-15-neutralizing antibody visugromab (V, 20 mg kg−1 4-weekly; _n_ = 16) or placebo (P, _n_ = 15), followed by radical cystectomy or repeat transurethral resection of the bladder tumor. Locally assessed pathologic complete response (pCR, ypT0N0/x) and Response Evaluation Criteria in Solid Tumors v1.1-based radiographic response served as dual primary endpoints. pCR was 33% (5 of 15, 95% confidence interval (CI) 12–62%) in patients receiving N + V versus 8% (1 of 13, 95% CI 0–36%) for N + P; major pathologic response was 60% (95% CI 32–84%) versus 23% (95% CI 5–54%), and radiographic overall response rate was 60% (95% CI 32–84%) versus 15% (95% CI 2–45%), respectively. Responses to N + V were associated with higher baseline densities of total and proliferating (Ki-67+) CD8+ T cells, but independent of CPS and baseline GDF-15 levels in serum and tumor. There were no treatment-related discontinuations or treatment-related delays to surgery; grade 3–4 treatment-related adverse events occurred in two (13%) and three (20%) patients treated with N + V or N + P, respectively. These findings support further evaluation of visugromab in MIBC. ClinicalTrials.gov identifier: [NCT06059547](https://clinicaltrials.gov/study/NCT06059547). ### Explore related subjects Discover the latest articles and news in related subjects. * [Bladder cancer](https://www.nature.com/subjects/bladder-cancer) * [Immunotherapy](https://www.nature.com/subjects/immunotherapy) * [Urothelial Carcinoma and Bladder Cancer Management Strategies](https://www.nature.com/subjects/urothelial-carcinoma-and-bladder-cancer-management-strategies) ## Main Bladder cancer is the ninth most commonly diagnosed cancer worldwide, with globally more than 600,000 new cases and approximately 220,000 deaths estimated for 2022 and a male-to-female ratio of about 3:1 (ref. [1](https://www.nature.com/articles/s41591-026-04740-9#ref-CR1 "Filho, A. M., Briganti, A., Jemal, A. & Bray, F. Bladder cancer incidence and mortality: a global overview and recent trends. Eur. Urol. 89, 426–436 \(2026\).")). Around 75% of patients present with non-muscle-invasive bladder cancer (NMIBC). Most patients with muscle-invasive (≥T2) bladder cancer (MIBC) present with primary invasive disease, whereas up to 15% had progressed from NMIBC, almost exclusively from high-risk disease[2](https://www.nature.com/articles/s41591-026-04740-9#ref-CR2 "Powles, T. et al. ESMO Guidelines Committee. Bladder cancer: ESMO clinical practice guideline for diagnosis, treatment and follow-up. Ann. Oncol. 33, 244–258 \(2022\)."). The treatment of MIBC is at a watershed moment: novel, more effective systemic therapies are enabling an increasing number of patients to achieve clearance of the bladder tumor and improved survival compared with the therapies that, until recently, were the only standard-of-care options[3](https://www.nature.com/articles/s41591-026-04740-9#ref-CR3 "Galsky, M. D., Ballas, L. & Kamat, A. M. Muscle-invasive bladder cancer: a watershed moment. J. Clin. Oncol. 43, 3041–3051 \(2025\)."). This change is the culmination of a 10-year evolution of systemic therapy in MIBC, beginning with immune checkpoint inhibitor (ICI) monotherapy trials[4](https://www.nature.com/articles/s41591-026-04740-9#ref-CR4 "Powles, T. et al. Clinical efficacy and biomarker analysis of neoadjuvant atezolizumab in operable urothelial carcinoma in the ABACUS trial. Nat. Med. 25, 1706–1714 \(2019\)."),[5](https://www.nature.com/articles/s41591-026-04740-9#ref-CR5 "Necchi, A. et al. Updated results of PURE-01 with preliminary activity of neoadjuvant pembrolizumab in patients with muscle-invasive bladder carcinoma with variant histologies. Eur. Urol. 77, 439–446 \(2020\)."), then exploring various combination regimens[6](https://www.nature.com/articles/s41591-026-04740-9#ref-CR6 "Necchi, A. et al. Immunotherapy in the treatment of localized genitourinary cancers. JAMA Oncol 9, 1447–1454 \(2023\)."), ultimately resulting in the regulatory approval of durvalumab plus gemcitabine–cisplatin, followed by cystectomy and adjuvant durvalumab, and of enfortumab vedotin plus pembrolizumab (EVP), on the basis of pivotal phase 3 trials[7](https://www.nature.com/articles/s41591-026-04740-9#ref-CR7 "Powles, T. et al. Perioperative durvalumab with neoadjuvant chemotherapy in operable bladder cancer. N. Engl. J. Med. 391, 1773–1786 \(2024\)."),[8](https://www.nature.com/articles/s41591-026-04740-9#ref-CR8 "Galsky, M. D. et al. Enfortumab vedotin and pembrolizumab in cisplatin-eligible bladder cancer. N. Engl. J. Med. 395, 338–348 \(2026\)."),[9](https://www.nature.com/articles/s41591-026-04740-9#ref-CR9 "Vulsteke, C. et al. Perioperative enfortumab vedotin and pembrolizumab in bladder cancer. N. Engl. J. Med. 394, 1257–1269 \(2026\)."). These advances have been paralleled by profound innovation in the monitoring of treatment response, in particular the assessment of minimal residual disease using circulating tumor DNA or urinary tumor DNA[10](https://www.nature.com/articles/s41591-026-04740-9#ref-CR10 "Powles, T. et al. ctDNA-guided adjuvant atezolizumab in muscle-invasive bladder cancer. N. Engl. J. Med. 393, 2395–2408 \(2025\)."),[11](https://www.nature.com/articles/s41591-026-04740-9#ref-CR11 "Necchi, A. et al. Gemcitabine intravesical system plus cetrelimab or cetrelimab alone as neoadjuvant therapy in muscle-invasive bladder cancer: SunRISe-4 primary analysis and biomarker results. J. Clin. Oncol. 44, 586–597 \(2026\)."). ICIs, predominantly antibodies directed against programmed cell death protein 1 (PD-1) or programmed cell death ligand 1 (PD-L1), have entered routine practice for neoadjuvant cancer treatment since 2020[12](https://www.nature.com/articles/s41591-026-04740-9#ref-CR12 "Awada, G. et al. The rapidly evolving paradigm of neoadjuvant immunotherapy across cancer types. Nat. Cancer 6, 967–987 \(2025\)."). In the neoadjuvant and perioperative setting, more than 30 prospective trials in MIBC have been reported since 2016[13](https://www.nature.com/articles/s41591-026-04740-9#ref-CR13 "Suartz, C. V. et al. Neoadjuvant immunotherapy in bladder cancer: ushering in a new era of treatment—a systematic review of current evidence. Eur. Urol. Open Sci. 79, 45–59 \(2025\)."). These trials sought to increase the rate of pathologic complete response (pCR), an established surrogate endpoint in neoadjuvant MIBC trials[14](https://www.nature.com/articles/s41591-026-04740-9#ref-CR14 "Chang, E. et al. Refining neoadjuvant therapy clinical trial design for muscle-invasive bladder cancer before cystectomy: a joint US Food and Drug Administration and Bladder Cancer Advocacy Network workshop. Nat. Rev. Urol. 19, 37–46 \(2022\)."), and to provide options for the estimated ≥50% of patients with MIBC who are ineligible for neoadjuvant cisplatin-based chemotherapy[3](https://www.nature.com/articles/s41591-026-04740-9#ref-CR3 "Galsky, M. D., Ballas, L. & Kamat, A. M. Muscle-invasive bladder cancer: a watershed moment. J. Clin. Oncol. 43, 3041–3051 \(2025\)."),[13](https://www.nature.com/articles/s41591-026-04740-9#ref-CR13 "Suartz, C. V. et al. Neoadjuvant immunotherapy in bladder cancer: ushering in a new era of treatment—a systematic review of current evidence. Eur. Urol. Open Sci. 79, 45–59 \(2025\)."). Neoadjuvant immune checkpoint blockade can downsize tumors, may render initially unresectable tumors resectable and may enable surgical deescalation with organ preservation[12](https://www.nature.com/articles/s41591-026-04740-9#ref-CR12 "Awada, G. et al. The rapidly evolving paradigm of neoadjuvant immunot
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