Sarcoma
Recent clinical, regulatory, research and industry developments relating to this disease.
Approval: Trabectedin Accord (EMA)
Soft Tissue Sarcoma, Version 2.2022, NCCN Clinical Practice Guidelines in Oncology.
What's happening now
An analyst briefing on current research, clinical, regulatory and industry activity surrounding this disease.
- 3 clinical trials expected to report results, the earliest in Q1 2027.
- 1 safety action from EMA issued.
- Q1 2027A Randomized Phase II Trial of Cabozantinib Combined With PD-1 and CTLA-4 Inhibition in Metastatic Soft Tissue Sarcoma
- Q1 2027Bintrafusp Alfa and Doxorubicin Hydrochloride in Treating Patients With Advanced Sarcoma. TRUST Study
- Q4 2027Randomized Phase 2/3 Trial of Vincristine-Irinotecan-Regorafenib in Combination With Vincristine-Doxorubicin-Cyclophosphamide (VDC) and Ifosfamide-Etoposide (IE) in Patients With Newly Diagnosed Metastatic Ewing Sarcoma
Clinical MilestonesView all 10Hide
- 2026-07-24Bintrafusp Alfa and Doxorubicin Hydrochloride in Treating Patients With Advanced Sarcoma. TRUST StudyResults expected Q1 2027
- 2026-06-23Randomized Phase 2/3 Trial of Vincristine-Irinotecan-Regorafenib in Combination With Vincristine-Doxorubicin-Cyclophosphamide (VDC) and Ifosfamide-Etoposide (IE) in Patients With Newly Diagnosed Metastatic Ewing SarcomaResults expected Q4 2027
- 2025-11-12A Randomized Phase II Trial of Cabozantinib Combined With PD-1 and CTLA-4 Inhibition in Metastatic Soft Tissue SarcomaResults expected Q1 2027
- 2026-05-26Neoadjuvant Intralesional Injection of Talimogene Laherparepvec With Concurrent Preoperative Radiation in Patients With Locally Advanced Soft Tissue SarcomasPrimary completion
- 2025-08-06Randomized Phase II Study of Neoadjuvant Chemotherapy Plus Retifanlimab (INCMGA00012) in Patients With Selected SarcomasPrimary completion
- 2030-08-01A Phase 2 Study of 9-ING-41, a Glycogen Synthase Kinase-3 Beta (GSK-3β) Inhibitor, Combined With Chemotherapy in Advanced Soft Tissue and Bone SarcomasWithdrawn
- 2030-02-01A Phase II Single-arm Study of Pembrolizumab Plus Lenvatinib in Previously Treated Classic Kaposi Sarcoma (CKS)Withdrawn
- 2028-10-13Brightline-3: A Phase III, Randomized, Open-label, Multi-center Trial of Brigimadlin + Ezabenlimab Compared to Gemcitabine + Docetaxel for Second-line Treatment of Patients With Advanced TP53 Wild-type Soft Tissue Sarcoma SubtypesWithdrawn
- 2026-05-25ADI-PEG 20 or Placebo Plus Gemcitabine and Docetaxel in Previously Treated Subjects With Leiomyosarcoma (ARGSARC): A Randomized, Double Blind, Multi-Center Phase 3 TrialTerminated
- 2025-10-01Time to Secondary Resistance to Trabectedin After Interruption Versus Continuation in Responding Patients With Liposarcoma, Leiomyosarcoma and Synovial SarcomaWithdrawn
Regulatory UpdatesViewHide
- 2025-09-22Market withdrawal — DoxorubicinCeldoxome pegylated liposomal is indicated in adults: as monotherapy for patients with metastatic breast cancer, where there is an increased cardiac risk. or treatment of advanced ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen. in combination with bortezomib for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant. for treatment of AIDS-related Kaposi’s sarcoma (KS) in patients with low CD4 counts (< 200 CD4 lymphocytes/mm3) and extensive mucocutaneous or visceral disease. Celdoxome pegylated liposomal may be used as first-line systemic chemotherapy, or as second line chemotherapy in AIDS-KS patients with disease that has progressed with, or in patients intolerant to, prior combination systemic chemotherapy comprising at least two of the following agents: a vinca alkaloid, bleomycin and standard doxorubicin (or other anthracycline).
- 2030-08-01ClinicalA Phase 2 Study of 9-ING-41, a Glycogen Synthase Kinase-3 Beta (GSK-3β) Inhibitor, Combined With Chemotherapy in Advanced Soft Tissue and Bone SarcomasWithdrawn
- 2030-02-01ClinicalA Phase II Single-arm Study of Pembrolizumab Plus Lenvatinib in Previously Treated Classic Kaposi Sarcoma (CKS)Withdrawn
- 2028-10-13ClinicalBrightline-3: A Phase III, Randomized, Open-label, Multi-center Trial of Brigimadlin + Ezabenlimab Compared to Gemcitabine + Docetaxel for Second-line Treatment of Patients With Advanced TP53 Wild-type Soft Tissue Sarcoma SubtypesWithdrawn
- 2026-07-24ClinicalBintrafusp Alfa and Doxorubicin Hydrochloride in Treating Patients With Advanced Sarcoma. TRUST StudyResults expected Q1 2027
- 2026-06-23ClinicalRandomized Phase 2/3 Trial of Vincristine-Irinotecan-Regorafenib in Combination With Vincristine-Doxorubicin-Cyclophosphamide (VDC) and Ifosfamide-Etoposide (IE) in Patients With Newly Diagnosed Metastatic Ewing SarcomaResults expected Q4 2027
- 2026-05-26ClinicalNeoadjuvant Intralesional Injection of Talimogene Laherparepvec With Concurrent Preoperative Radiation in Patients With Locally Advanced Soft Tissue SarcomasPrimary completion
- 2026-05-25ClinicalADI-PEG 20 or Placebo Plus Gemcitabine and Docetaxel in Previously Treated Subjects With Leiomyosarcoma (ARGSARC): A Randomized, Double Blind, Multi-Center Phase 3 TrialTerminated
- 2025-11-12ClinicalA Randomized Phase II Trial of Cabozantinib Combined With PD-1 and CTLA-4 Inhibition in Metastatic Soft Tissue SarcomaResults expected Q1 2027
- 2025-10-01ClinicalTime to Secondary Resistance to Trabectedin After Interruption Versus Continuation in Responding Patients With Liposarcoma, Leiomyosarcoma and Synovial SarcomaWithdrawn
- 2025-09-22RegulatoryMarket withdrawal — DoxorubicinCeldoxome pegylated liposomal is indicated in adults: as monotherapy for patients with metastatic breast cancer, where there is an increased cardiac risk. or treatment of advanced ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen. in combination with bortezomib for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant. for treatment of AIDS-related Kaposi’s sarcoma (KS) in patients with low CD4 counts (< 200 CD4 lymphocytes/mm3) and extensive mucocutaneous or visceral disease. Celdoxome pegylated liposomal may be used as first-line systemic chemotherapy, or as second line chemotherapy in AIDS-KS patients with disease that has progressed with, or in patients intolerant to, prior combination systemic chemotherapy comprising at least two of the following agents: a vinca alkaloid, bleomycin and standard doxorubicin (or other anthracycline).
Therapeutic landscape
Therapies with a regulatory footing for this condition, alongside the wider set of agents co-studied with it in the literature.
Approval — Trabectedin Accord is indicated for the treatment of adult patients with advanced soft ti… (2025)
Approval — Zolsketil pegylated liposomal is a medicine used to treat the following types of cancer i… (2022)
Approval — Renal-cell carcinoma (RCC) Votrient is indicated in adults for the first-line treatment o… (2010)
Approval — Beromun is indicated in adults as an adjunct to surgery for subsequent removal of the tum… (1999)
Approval — Caelyx pegylated liposomal is indicated: as monotherapy for patients with metastati… (1996)
Clinical trials
The current development programme across all trial phases.
Regulatory timeline
Drug regulatory events matched to this condition by indication — EMA.
European Medicines Agency (CC BY 4.0). Events are matched to this condition by drug indication text — approvals/updates for drugs indicated for it, not disease-specific acts.
Research activity
Key research shaping understanding of this disease, combining the latest publications with the most influential evidence.
Major themes6
- Sarcoma5
- Soft Tissue Neoplasms4
- Immunotherapy1
- Neoplasms, Second Primary1
- Nivolumab1
- Sarcoma, Ewing1
Leading journals6
- Cancer research communications1
- Frontiers in immunology1
- Journal of the National Comprehensive Cancer Network : JNCCN1
- Nature1
- Oncoimmunology1
- Pathologica1
Leading researchers8
- Clancy T2
- Keung EZ2
- Stratford R2
- Tawbi HA2
- Adam J1
- Agulnik M1
- Albieri B1
- Anzar I1
Affiliations (unnormalised)6
- The University of Texas MD Anderson Cancer Center2
- 10O'Neal Comprehensive Cancer Center at UAB.1
- 11UT Southwestern Simmons Comprehensive Cancer Center.1
- 12Vanderbilt-Ingram Cancer Center.1
- 13Memorial Sloan Kettering Cancer Center.1
- 14Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance.1
Related conditions
Diseases frequently studied alongside this one. Number shows shared papers.
Disease profile
A grounded synthesis of the condition — overview, causes, mechanism, risk factors and current standard of care.
Sarcoma is a malignant neoplasm of connective tissue arising from mesodermal cells. It includes a heterogeneous group of tumors that can originate in fat, muscle, nerves, blood vessels, and other connective tissues, and it is usually highly malignant.
The supplied grounding does not identify a specific cause or aetiology for sarcoma. It does indicate that classification and diagnosis are important because sarcomas comprise multiple distinct mesenchymal tumor entities, including some with defined genetic features such as NTRK-rearranged soft tissue tumors.
Sarcoma is a mesenchymal tumor driven by proliferation of connective-tissue-derived cells. The literature grounding emphasizes heterogeneity in clinical and pathologic behavior, the importance of pathologic classification, and the role of genetics in defining entities and guiding treatment; tumor microenvironment is also a co-studied mechanism.
The supplied grounding does not provide specific risk factors for sarcoma. It does support that diagnosis and risk assessment are influenced by tumor subtype and pathologic classification, including risk assessment schemes for some entities such as solitary fibrous tumor.
Management is centered on multidisciplinary evaluation, diagnosis, and treatment guided by pathology and tumor subtype. The grounding supports therapy at the level of surgery and broader treatment planning, with drug therapy used in some settings and classification-informed approaches for entities such as NTRK-rearranged soft tissue tumors.
AI-generated summary grounded in MeSH and 2 peer-reviewed sources. Informational only — not medical advice. Generated 2026-07-07.
Reference
Authoritative identity, definition & identifiers.
A connective tissue neoplasm formed by proliferation of mesodermal cells; it is usually highly malignant.
- Disease identity & definition — NLM Medical Subject Headings (MeSH), public domain
- Clinical trials — ClinicalTrials.gov (U.S. National Library of Medicine)
- Research activity — Europe PMC (EMBL-EBI) + OpenAlex-derived paper links
- Related entities are derived from literature co-mention (studied together) — associative, not causal.