Evidence map›Paper›PMID 39540661›Full record

Trial reportCancer2025

Nivolumab and sunitinib in patients with advanced bone sarcomas: A multicenter, single-arm, phase 2 trial.

Emanuela Palmerini, Antonio Lopez Pousa, Giovanni Grignani, Andres Redondo, Nadia Hindi, Salvatore Provenzano, Ana Sebio, Jose Antonio Lopez Martin, Claudia Valverde, Javier Martinez Trufero and 10 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03277924 (Phase I-II Trial of Sunitinib and/or Nivolumab Plus Chemotherapy in Advanced Soft Tissue and Bone Sarcomas), which is not on this map. Cited by 24 papers.

0numbers the graph read from it
0cells of the map it votes in
24citing 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.

NCT03277924 phase1 / phase2completednot on this map

Phase I-II Trial of Sunitinib and/or Nivolumab Plus Chemotherapy in Advanced Soft Tissue and Bone Sarcomas

TypeinterventionalSponsorGrupo Espanol de Investigacion en SarcomasRan2017 to 2024Enrolled197ConditionsSoft Tissue Sarcoma, Bone SarcomaArmsSunitinib 37.5 MG, Sunitinib 25 MG [Sutent], Nivolumab 100 MG/10 ML [Opdivo], Epirubicin, Ifosfamide, Doxorubicin
3 · Its place in the literature

Who cites it

24 citing papers in PubMed.

  1. Trial
  2. Article
  3. Review
  4. Review
  5. Sarcomas in Adolescents and Young Adults.Current oncology reports · 2026
    Review
  6. Article
  7. Review
  8. Article
  9. Article
  10. Review
  11. Article
  12. Review
  13. Article
  14. Review
  15. Article
  16. Review
  17. Article
  18. Article
  19. Review
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors.

Emanuela PalmeriniOsteoncology, Bone and Soft Tissue Tumors and Innovative Therapies, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.ORCID https://orcid.org/0000-0003-3406-6705
Antonio Lopez PousaHospital de la Santa Creu i Sant Pau, Barcelona, Spain.
Giovanni GrignaniCandiolo Cancer Institute, FPO-IRCCS, Candiolo (TO), Italy.
Andres RedondoMedical Oncology Department, Hospital Universitario La Paz-IdiPAZ, Madrid, Spain.
Nadia HindiMedical Oncology Department, Hospital Universitario Fundación Jiménez Díaz, Madrid, Spain.
Salvatore ProvenzanoAdult Mesenchymal and Rare Tumour Unit, Fondazione IRCCS Istituto Nazionale Tumori Milan, Milano, Italy.
Ana SebioHospital de la Santa Creu i Sant Pau, Barcelona, Spain.
Jose Antonio Lopez MartinHospital Universitario 12 de Octubre, Madrid, Spain.
Claudia ValverdeHospital Universitari Vall d'Hebron, Barcelona, Spain.
Javier Martinez TruferoHospital Universitario Miguel Servet, Zaragoza, Spain.ORCID https://orcid.org/0000-0002-0997-2573
Antonio GutierrezHospital Universitari Son Espases, Palma de Mallorca, Spain.
Enrique de AlavaInstitute of Biomedicine of Sevilla, IBiS/Virgen del Rocio University Hospital/CSIC/University of Sevilla/CIBERONC, Seville, Spain.
Maria Pilar Aparisi GomezDepartment of Radiology, Auckland City Hospital, Auckland District Health Board, Grafton, Auckland, New Zealand.
Lorenzo D'AmbrosioCandiolo Cancer Institute, FPO-IRCCS, Candiolo (TO), Italy.
Paola ColliniSoft Tissue Tumor Pathology, Advanced Diagnostics Department, IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Alberto BazzocchiDiagnostic and Interventional Radiology, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.
David S MouraMedical Oncology Department, Instituto de Investigación Sanitaria Fundación Jiménez Díaz, Madrid, Spain.
Toni IbrahimOsteoncology, Bone and Soft Tissue Tumors and Innovative Therapies, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.
Silvia StacchiottiAdult Mesenchymal and Rare Tumour Unit, Fondazione IRCCS Istituto Nazionale Tumori Milan, Milano, Italy.ORCID https://orcid.org/0000-0002-1742-8666
Javier Martin BrotoMedical Oncology Department, Hospital Universitario Fundación Jiménez Díaz, Madrid, Spain.

Funding

Bristol-Myers SquibbCARISBO 2019.0574Italian Sarcoma GroupPfizerSpanish Group for Research on Sarcoma
6 · The paper itself

Abstract

backgroundHerein, we present the results of the phase 2 IMMUNOSARC study (NCT03277924), investigating sunitinib and nivolumab in adult patients with advanced bone sarcomas (BS).

methodsProgressing patients with a diagnosis of BS were eligible. Treatment was comprised of sunitinib (37.5 mg/day on days 1-14, 25 mg/day afterword) plus nivolumab (3 mg/kg every 2 weeks). Primary end point was progression-free survival rate (PFSR) at 6 months based on central radiology review. Secondary end points were overall survival (OS), overall response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, and safety.

resultsA total of 46 patients were screened, 40 patients entered the study, and 38 underwent central radiological review and were evaluable for primary end point. Median age was 47 years (range, 21-74). Histologies include 17 (43%) osteosarcoma, 14 chondrosarcoma (35%, 10 conventional, four dedifferentiated [DDCS]), eight (20%) Ewing sarcoma, and one (2%) undifferentiated pleomorphic sarcoma. The PFSR at 6 months was 42% (95% confidence interval [CI], 27-58). With a median follow-up of 39.8 months (95% CI, 37.9-41.7), the median PFS and OS were 3.8 months (95% CI, 2.7-4.8) and 11.9 months (95% CI, 5.6-18.2). ORR by RECIST was 5%, with two of 38 partial responses (one of four DDCS and one of 17 osteosarcoma), 19 of 38 (50%) stable disease, and 17 of 38 (45%) progressions. Grade ≥3 adverse events were neutropenia (six of 40, 15%), anemia (5/40, hypertension (6/40, 15%), 12.5%), ALT/AST elevation (5/40, 12.5%), and pneumonitis (1/40, 2.5%). Seventeen percent of patients discontinued treatment due to toxicity, including a treatment-related grade 5 pneumonitis

conclusionThe trial met its primary end point in the BS cohort with >15% of patients progression-free at 6 months. However, the toxicity profile of this regimen was relevant.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsBone NeoplasmsNivolumabSunitinibAdultAgedFemaleHumansMaleMiddle AgedOsteosarcomaProgression-Free SurvivalYoung AdultNivolumabSunitinibanti‐angiogeninicbonededifferentiated chondrosarcomaEwing sarcomaimmunotherapynivolumabosteosarcomaPD‐L1 inhibitorsarcomasunitinib

Identifiers

PMID39540661
PMCPMC11694334

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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.