Trial reportJournal for immunotherapy of cancer2020
Nivolumab and sunitinib combination in advanced soft tissue sarcomas: a multicenter, single-arm, phase Ib/II trial.
Trial report in Journal for immunotherapy of cancer, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 112 papers, 2 of them syntheses that pooled it.
What it found
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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.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
112 citing papers in PubMed, 2 syntheses or guidelines pooled it, 172 citations in OpenAlex.
- Immune checkpoint inhibitors combined with tyrosine kinase inhibitors for soft-tissue sarcomas: a systematic review and single-arm meta-analysis.The oncologist · 2025Pooled it
- UK guidelines for the management of soft tissue sarcomas.British journal of cancer · 2025Guideline
- IMMUNOSARC II Master Trial: Phase II Study of Sunitinib and Nivolumab in Clear Cell Sarcoma Cohort.Cancer communications (London, England) · 2026Trial
- Sintilimab plus Anlotinib in Patients with Pretreated Locally Advanced or Metastatic Sarcoma: A Prospective, Single-Arm, Phase II Clinical Trial.Cancer immunology research · 2025Trial
- Reshaping the tumor microenvironment of cold soft-tissue sarcomas with anti-angiogenics: a phase 2 trial of regorafenib combined with avelumab.Signal transduction and targeted therapy · 2025Trial
- Nivolumab and sunitinib in patients with advanced bone sarcomas: A multicenter, single-arm, phase 2 trial.Cancer · 2025Trial
- Durvalumab plus pazopanib combination in patients with advanced soft tissue sarcomas: a phase II trial.Nature communications · 2024Trial
- Atezolizumab for Advanced Alveolar Soft Part Sarcoma.The New England journal of medicine · 2023Trial
- Trial
- Phase II Study of TQB2450, a Novel PD-L1 Antibody, in Combination with Anlotinib in Patients with Locally Advanced or Metastatic Soft Tissue Sarcoma.Clinical cancer research : an official journal of the American Association for Cancer Research · 2022Trial
- The promise of immunotherapy in the treatment of sarcoma: A state-of-the-art review of practice changing research and future directions.Human vaccines & immunotherapeutics · 2026Review
- Epithelioid Sarcoma: A Review and Update.Cancers · 2026Review
- Pharmacologic Resistance in Soft Tissue Sarcomas: Mechanisms, Biomarkers, and Translational Therapeutic Strategies.Cancers · 2026Review
- The extracellular matrix in cancer-associated fibrosis: molecular mechanisms and clinical relevance.JCI insight · 2026Review
- Systemic Therapy for Solitary Fibrous Tumor.Current treatment options in oncology · 2026Review
- Macrophage-centered immunotherapy for osteosarcoma: mechanisms, repolarization, and translational strategies.World journal of surgical oncology · 2026Review
- Drug-eluting bead transarterial chemoembolization combined with immune checkpoint inhibitors is associated with improved progression-free survival in locally advanced or metastatic sarcoma: a retrospective propensity score-matched analysis.Therapeutic advances in medical oncology · 2026Article
- Advances in the multimodal management of central nervous system solitary fibrous tumors.Frontiers in oncology · 2026Review
- Durable remission of metastatic myxoid liposarcoma following the cautious addition of pembrolizumab to ongoing pazopanib treatment: A case report.Rare tumors · 2026Article
- Biomarkers of prognosis and pazopanib response in soft tissue sarcoma: An exploratory analysis.Therapeutic advances in medical oncology · 2026Article
52 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
20 authors at 12 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundSarcomas exhibit low expression of factors related to immune response, which could explain the modest activity of PD-1 inhibitors. A potential strategy to convert a cold into an inflamed microenvironment lies on a combination therapy. As tumor angiogenesis promotes immunosuppression, we designed a phase Ib/II trial to test the double inhibition of angiogenesis (sunitinib) and PD-1/PD-L1 axis (nivolumab).
methodsThis single-arm, phase Ib/II trial enrolled adult patients with selected subtypes of sarcoma. Phase Ib established two dose levels: level 0 with sunitinib 37.5 mg daily from day 1, plus nivolumab 3 mg/kg intravenously on day 15, and then every 2 weeks; and level -1 with sunitinib 37.5 mg on the first 14 days (induction) and then 25 mg per day plus nivolumab on the same schedule. The primary endpoint was to determine the recommended dose for phase II (phase I) and the 6-month progression-free survival rate, according to Response Evaluation Criteria in Solid Tumors 1.1 (phase II).
resultsFrom May 2017 to April 2019, 68 patients were enrolled: 16 in phase Ib and 52 in phase II. The recommended dose of sunitinib for phase II was 37.5 mg as induction and then 25 mg in combination with nivolumab. After a median follow-up of 17 months (4-26), the 6-month progression-free survival rate was 48% (95% CI 41% to 55%). The most common grade 3-4 adverse events included transaminitis (17.3%) and neutropenia (11.5%).
conclusionsSunitinib plus nivolumab is an active scheme with manageable toxicity in the treatment of selected patients with advanced soft tissue sarcoma, with almost half of patients free of progression at 6 months.
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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.