Papillary renal cell carcinoma – exploratory results of the SUNNIFORECAST trial comparing Ipilimumab plus Nivolumab vs standard of care as first line therapy based on central pathological review

Ahrens M, Haanen J, Albiges L, Goupil MG, Boleti E, Gravis G, Fléchon A, Grimm MO, Bedke J, Barthélémy P, Castellano D, Mellado B, Ivanyi P, Rottey S, Flörcken A, Suárez C, Maroto JP, Grünwald V, Oosting S, Kopecky J, Zschäbitz S, Boegemann M, Buchler T, Niegisch G, Goebell P, Waddell T, Joly F, Priou F, Retz M, Siemer S, Zimmermann U, Deckbar D, Burkholder I, Hartmann A, Bergmann L (2026)

Publication Type: Journal article

Publication year: 2026

Journal

Book Volume: 243

Article Number: 116816

DOI: 10.1016/j.ejca.2026.116816

Abstract

Background Papillary renal cell cancer (pRCC) represents the largest subgroup within non-clear cell (ncc) RCC. Compared with clear cell RCC (ccRCC), pRCC is considered less sensitive to currently available systemic therapies. Here, we report exploratory results from the pRCC subgroup of the SUNNIFORECAST trial comparing ipilimumab/nivolumab with standard of care (SOC) based on central pathological review. Methods and patients SUNNIFORECAST was a prospective, investigator-initiated, phase II trial evaluating ipilimumab/nivolumab versus SOC in patients with untreated, advanced nccRCC. The primary endpoint was the 12-month overall survival (OS) rate. Secondary endpoints included OS, progression-free survival (PFS), and overall response rate (ORR). PD-L1 expression was assessed exploratory. Results Of 309 randomized patients, 127 had confirmed papillary histology, in 56/173 cases the local diagnosis of pRCC required revision. Among the 127 patients with pRCC, 64 received ipilimumab/nivolumab and 63 SOC, predominantly TKI monotherapy. In the pRCC subgroup, the 12-month OS rate was 74.77% in the ipilimumab/nivolumab arm and 63.44% in the SOC arm (p = 0.085). Median OS was 24.89 months with ipilimumab/nivolumab versus 18.88 months with SOC. PD-L1 expression was evaluable in 116 of 127 patients. A CPS > 1 was more frequently observed with increasing IMDC risk category. Among patients with CPS < 1, the 12-month OS rate was 75.00% with ipilimumab/nivolumab and 68.36% with SOC (p = 0.963). In patients with CPS > 1, the 12-month OS rate was 82.38% in the ipilimumab/nivolumab arm and 63.33% in the SOC arm. Discussion This exploratory analysis has several limitations; however, it suggests that patients with pRCC treated with ipilimumab/nivolumab may derive a benefit in terms of 12-month OS rate, median OS, and ORR compared with SOC, particularly among those with CPS > 1. (Funded by Bristol Myers Squibb grant CA209–499; ClinicalTrials.gov, EUDRACT Number: 2016–000706–12; NCT03075423.)

Authors with CRIS profile

Involved external institutions

Institut Gustave-Roussy France (FR) Goethe-Universität Frankfurt am Main Germany (DE) Leiden University Medical Center Netherlands (NL) Universitätsklinikum Heidelberg Germany (DE) Universitätsklinikum Münster Germany (DE) Univerzita Karlova v Praze / Charles University in Prague Czech Republic (CZ) Universitätsklinikum Düsseldorf Germany (DE) Berliner Institut für Gesundheitsforschung in der Charité / Berlin Institute of Health at Charité (BIH) Germany (DE) Vall d'Hebron University Hospital / Hospital Universitari Vall d'Hebron Spain (ES) Universitätsmedizin Greifswald / Universitätsklinikum Greifswald Germany (DE) Hochschule Fulda Germany (DE) Christie NHS Foundation Trust United Kingdom (GB) Center François Baclesse / Centre Régional de Lutte contre le Cancer François Baclesse (CRLCC) France (FR) Centre Hospitalier Départemental Vendée France (FR) Technische Universität München (TUM) Germany (DE) Universitätsklinikum des Saarlandes (UKS) Germany (DE) Centre Hospitalier Universitaire de Bordeaux / CHU Bordeaux France (FR) Royal Free London NHS Foundation Trust / Royal Free Hampstead NHS Trust United Kingdom (GB) CRCM Centre de Recherche en Cancérologie de Marseille France (FR) Universitätsklinikum Jena Germany (DE) Centre Léon-Bérard (UNICANCER) France (FR) Universitätsklinikum Tübingen Germany (DE) Hôpitaux universitaires de Strasbourg (HUS) / University Hospital Strasbourg France (FR) Hospital Universitario 12 de Octubre Spain (ES) Hospital Clínic de Barcelona Spain (ES) Medizinische Hochschule Hannover (MHH) / Hannover Medical School Germany (DE) University Hospital Ghent Belgium (BE) Hospital de la Santa Creu i Sant Pau Spain (ES) Universitätsklinikum Essen Germany (DE) University Medical Center Groningen (UMCG) / Universitair Medisch Centrum Groningen Netherlands (NL) University Hospital Hradec Králové / Fakultní Nemocnice Hradec Králové Czech Republic (CZ)

How to cite

APA:

Ahrens, M., Haanen, J., Albiges, L., Goupil, M.G., Boleti, E., Gravis, G.,... Bergmann, L. (2026). Papillary renal cell carcinoma – exploratory results of the SUNNIFORECAST trial comparing Ipilimumab plus Nivolumab vs standard of care as first line therapy based on central pathological review. European Journal of Cancer, 243. https://doi.org/10.1016/j.ejca.2026.116816

MLA:

Ahrens, Marit, et al. "Papillary renal cell carcinoma – exploratory results of the SUNNIFORECAST trial comparing Ipilimumab plus Nivolumab vs standard of care as first line therapy based on central pathological review." European Journal of Cancer 243 (2026).

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