Trial reportNature medicine2022
Pembrolizumab in soft-tissue sarcomas with tertiary lymphoid structures: a phase 2 PEMBROSARC trial cohort.
Trial report in Nature medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02406781 (Combination of MK3475 and Metronomic Cyclophosphamide in Patients With Advanced Sarcomas), which is not on this map. Cited by 182 papers, 3 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.
Combination of MK3475 and Metronomic Cyclophosphamide in Patients With Advanced Sarcomas : Multicentre Phase II Trial
Who cites it
182 citing papers in PubMed, 3 syntheses or guidelines pooled it, 240 citations in OpenAlex.
- Pooled it
- Combination of immune checkpoint inhibitors and anthracyclines as a potential first-line regimen for dedifferentiated liposarcoma: systematic review and meta-analysis.Cancer immunology, immunotherapy : CII · 2025Pooled it
- The prognostic value of the tertiary lymphoid structure in gastrointestinal cancers.Frontiers in immunology · 2023Pooled it
- Sintilimab plus Anlotinib in Patients with Pretreated Locally Advanced or Metastatic Sarcoma: A Prospective, Single-Arm, Phase II Clinical Trial.Cancer immunology research · 2025Trial
- A Single-Arm Phase 2 Trial of Doxorubicin Plus Zalifrelimab (Anti-CTLA-4 Antibody) and Balstilimab (Anti-PD-1 Antibody) in Advanced/Metastatic Soft Tissue Sarcomas.Clinical cancer research : an official journal of the American Association for Cancer 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
- Monocyte-lineage tumor infiltration predicts immunoradiotherapy response in advanced pretreated soft-tissue sarcoma: phase 2 trial results.Signal transduction and targeted therapy · 2025Trial
- Trial
- Trial
- Phase II Study of Eribulin plus Pembrolizumab in Metastatic Soft-tissue Sarcomas: Clinical Outcomes and Biological Correlates.Clinical cancer research : an official journal of the American Association for Cancer Research · 2024Trial
- Camrelizumab combined with apatinib in patients with first-line platinum-resistant or PD-1 inhibitor resistant recurrent/metastatic nasopharyngeal carcinoma: a single-arm, phase 2 trial.Nature communications · 2023Trial
- 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
- Tertiary lymphoid structures in cancer: their development, composition, clinical prognosis, and the drivers of the anti-tumor responses.Molecular biomedicine · 2026Review
- Effect of Tertiary Lymphoid Structures on Immune Cell Infiltration in the Tumor Microenvironment and Prognosis in Lung Adenocarcinoma.Cancer medicine · 2026Article
- Paediatric therapeutic development workshop on osteosarcoma.British journal of cancer · 2026Review
- Beyond TLS Presence: A Functional Framework Integrating Maturity, Location, and Immune Context.Cancers · 2026Review
- Pharmacologic Resistance in Soft Tissue Sarcomas: Mechanisms, Biomarkers, and Translational Therapeutic Strategies.Cancers · 2026Review
- Prognostic value of tertiary lymphoid structures in locally advanced esophageal squamous cell carcinoma treated with neoadjuvant chemoimmunotherapy: a retrospective study.Journal of cardiothoracic surgery · 2026Article
- The Immunological Landscape of the Tumor Microenvironment: Implications for Immunotherapy of Unresectable and Metastatic Soft Tissue Sarcomas.Current treatment options in oncology · 2026Review
- The effect of neoadjuvant radiotherapy on immune cell infiltrates in myxofibrosarcoma.Immuno-oncology technology · 2026Article
122 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
21 authors at 10 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Immune checkpoint inhibitors (ICIs) show limited clinical activity in patients with advanced soft-tissue sarcomas (STSs). Retrospective analysis suggests that intratumoral tertiary lymphoid structures (TLSs) are associated with improved outcome in these patients. PEMBROSARC is a multicohort phase 2 study of pembrolizumab combined with low-dose cyclophosphamide in patients with advanced STS (NCT02406781). The primary endpoint was the 6-month non-progression rate (NPR). Secondary endpoints included objective response rate (ORR), progression-free survival (PFS), overall survival (OS) and safety. The 6-month NPR and ORRs for cohorts in this trial enrolling all comers were previously reported; here, we report the results of a cohort enrolling patients selected based on the presence of TLSs (n = 30). The 6-month NPR was 40% (95% confidence interval (CI), 22.7-59.4), so the primary endpoint was met. The ORR was 30% (95% CI, 14.7-49.4). In comparison, the 6-month NPR and ORR were 4.9% (95% CI, 0.6-16.5) and 2.4% (95% CI, 0.1-12.9), respectively, in the all-comer cohorts. The most frequent toxicities were grade 1 or 2 fatigue, nausea, dysthyroidism, diarrhea and anemia. Exploratory analyses revealed that the abundance of intratumoral plasma cells (PCs) was significantly associated with improved outcome. These results suggest that TLS presence in advanced STS is a potential predictive biomarker to improve patients' selection for pembrolizumab treatment.
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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.