Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2022
A Phase 1/2 Trial Combining Avelumab and Trabectedin for Advanced Liposarcoma and Leiomyosarcoma.
Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 2 of them syntheses that pooled 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.
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
26 citing papers in PubMed, 2 syntheses or guidelines pooled it, 31 citations in OpenAlex.
- 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
- Primary breast leiomyosarcoma: prognostic factors and treatment outcomes - a systematic review and case report (1969-2023).Frontiers in oncology · 2025Pooled it
- 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
- 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
- Therapeutic Vulnerabilities of the Key Genetic Drivers in Leiomyosarcoma.Medical sciences (Basel, Switzerland) · 2026Review
- Revisiting the Immune Frontier in Soft Tissue Sarcomas.Current oncology reports · 2026Review
- Immunotherapy for Leiomyosarcoma: Current Status and Perspectives.Journal of immunology research · 2026Review
- Successful Sequential Multimodal Therapy for Lingual Rhabdomyosarcoma in a Young Adult: Case Report.Case reports in oncological medicine · 2026Article
- Real-world data on immune checkpoint inhibitors in advanced sarcomas across multiple European institutions.Acta oncologica (Stockholm, Sweden) · 2025Article
- OncoImmune machine-learning model predicts immune response and prognosis in leiomyosarcoma.Biomolecules & biomedicine · 2025Article
- Current perspectives in drug targeting intrinsically disordered proteins and biomolecular condensates.BMC biology · 2025Review
- Challenges and hope: latest research trends in the clinical treatment and prognosis of liposarcoma.Frontiers in pharmacology · 2025Review
- Novel Therapeutics in Soft Tissue Sarcoma.Cancers · 2024Review
- B7-H3 is widely expressed in soft tissue sarcomas.BMC cancer · 2024Article
- Role of Immunotherapy in Sarcomas.International journal of molecular sciences · 2024Review
- Trabectedin and Lurbinectedin Modulate the Interplay between Cells in the Tumour Microenvironment-Progresses in Their Use in Combined Cancer Therapy.Molecules (Basel, Switzerland) · 2024Review
- Immune checkpoint inhibitors in sarcomas: a systematic review.Immuno-oncology technology · 2023Review
- Current Landscape of Immunotherapy for Advanced Sarcoma.Cancers · 2023Review
- Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors at 5 institutions in 2 countries.
Funding
Abstract
purposeLeiomyosarcoma and liposarcoma frequently express PD-L1 but are generally resistant to PD-1/PD-L1 inhibition (immune checkpoint inhibitor). Trabectedin is FDA approved for leiomyosarcoma and liposarcoma. This study aimed to evaluate the safety and efficacy of trabectedin with anti-PD-L1 antibody avelumab in patients with advanced leiomyosarcoma and liposarcoma. PATIENTS AND
methodsA single-arm, open-label, Phase 1/2 study tested avelumab with trabectedin for advanced leiomyosarcoma and liposarcoma. The phase I portion evaluated safety and feasibility of trabectedin (1, 1.2, and 1.5 mg/m2) with avelumab at standard dosing. Primary endpoint of the phase II portion was objective response rate (ORR) by RECIST 1.1. Correlative studies included T-cell receptor sequencing (TCRseq), multiplex IHC, and tumor gene expression.
results33 patients were evaluable: 24 with leiomyosarcoma (6 uterine and 18 non-uterine) and 11 with liposarcoma. In Phase 1, dose-limiting toxicities (DLT) were observed in 2 of 6 patients at both trabectedin 1.2 and 1.5 mg/m2. The recommended Phase 2 dose (RP2D) was 1.0 mg/m2 trabectedin and 800-mg avelumab. Of 23 patients evaluable at RP2D, 3 (13%) had partial response (PR) and 10 (43%) had stable disease (SD) as best response. Six-month PFS was 52%; median PFS was 8.3 months. Patients with PR had higher Simpson Clonality score on TCRseq from peripheral blood mononuclear cells versus those with SD (0.182 vs. 0.067, P = 0.02) or progressive disease (0.182 vs. 0.064, P = 0.01).
conclusionsAlthough the trial did not meet the primary objective response rate endpoint, PFS compared favorably with prior studies of trabectedin warranting further investigation.
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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.