Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2022
A Phase 2 Trial of Enhancing Immune Checkpoint Blockade by Stereotactic Radiation and In Situ Virus Gene Therapy in Metastatic Triple-Negative Breast Cancer.
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 23 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
23 citing papers in PubMed, 2 syntheses or guidelines pooled it, 35 citations in OpenAlex.
- Modulation of tumor-associated lymphangiogenesis by combination immunotherapy approaches in triple-negative breast cancer: a systematic review.Frontiers in immunology · 2026Pooled it
- Combining radiotherapy and immune checkpoint inhibitors in metastatic cancers: a 25-year review of safety outcomes by the ENRSO Group.Cancer metastasis reviews · 2025Pooled it
- Designs of the clinical trials aiming at evaluating cell and gene therapy products: A critical appraisal from a literature review.Molecular therapy. Advances · 2026Review
- Synergizing Radiotherapy and Immune Checkpoint Inhibitors in Malignant Solid Tumours: Mechanistic Insights and Translational Frontiers.Expert reviews in molecular medicine · 2026Review
- Neoadjuvant intratumoral immune stimulation using gene-mediated cytotoxic immunotherapy for resectable non-small cell lung cancer: 5-Year outcomes.JTCVS open · 2026Article
- Optimizing immunotherapy-radiotherapy synergy in triple-negative breast cancer: mechanisms, clinical evidence, and therapeutic windows.Frontiers in immunology · 2026Review
- Cancer Immunotherapy in Combination with Radiotherapy and/or Chemotherapy: Mechanisms and Clinical Therapy.MedComm · 2025Review
- Tailoring an intravenously injectable oncolytic virus for augmenting radiotherapy.Cell reports. Medicine · 2025Article
- Application of mass cytometry in the immune microenvironment of breast cancer.Medical oncology (Northwood, London, England) · 2025Review
- Immunotherapy in Breast Cancer: Beyond Immune Checkpoint Inhibitors.International journal of molecular sciences · 2025Review
- Harnessing Oncolytic Viruses for Targeted Therapy in Triple-Negative Breast Cancer.International journal of medical sciences · 2025Review
- An insight into the role of innate immune cells in breast tumor microenvironment.Breast cancer (Tokyo, Japan) · 2025Review
- Tumor microenvironment and immunotherapy for triple-negative breast cancer.Biomarker research · 2024Review
- Biomarkers in the Immuno-oncology Interface of Triple Negative Breast Cancer: A Scoping Review with Perioperative Considerations.Current oncology reports · 2024Article
- DNA damage response in breast cancer and its significant role in guiding novel precise therapies.Biomarker research · 2024Review
- Emerging roles of intratumor microbiota in cancer: tumorigenesis and management strategies.Journal of translational medicine · 2024Review
- Adenoviral Vector System: A Comprehensive Overview of Constructions, Therapeutic Applications and Host Responses.Journal of microbiology (Seoul, Korea) · 2024Review
- Bioengineered Mesenchymal Stem/Stromal Cells in Anti-Cancer Therapy: Current Trends and Future Prospects.Biomolecules · 2024Review
- Harnessing adenovirus in cancer immunotherapy: evoking cellular immunity and targeting delivery in cell-specific manner.Biomarker research · 2024Review
- Patterns of immune evasion in triple-negative breast cancer and new potential therapeutic targets: a review.Frontiers in immunology · 2024Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
25 authors at 6 institutions in 1 country.
Funding
Abstract
purposeA Phase 2 trial of stereotactic radiotherapy and in situ cytotoxic virus therapy in patients with metastatic triple-negative breast cancer (mTNBC) followed by pembrolizumab (STOMP) was designed to evaluate dual approach of enhancing single-agent immune checkpoint blockade with adenovirus-mediated expression of herpes-simplex-virus thymidine-kinase (ADV/HSV-tk) plus valacyclovir gene therapy and stereotactic body radiotherapy (SBRT) in patients with mTNBC. PATIENTS AND
methodsIn this single-arm, open-label Phase 2 trial, patients with mTNBC were treated with ADV/HSV-tk [5 × 1011 virus particles (vp)] intratumoral injection, followed by SBRT to the injected tumor site, then pembrolizumab (200 mg, every 3 weeks). The primary endpoint was clinical benefit rate [CBR; complete response (CR), partial response (PR), or stable disease (SD) ≥ 24 weeks per RECIST version1.1 at non-irradiated site]. Secondary endpoints included duration on treatment (DoT), overall survival (OS), and safety. Exploratory endpoints included immune response to treatment assessed by correlative tissue and blood-based biomarkers.
resultsTwenty-eight patients were enrolled and treated. CBR was seen in 6 patients (21.4%), including 2 CR (7.1%), 1 PR (3.6%), and 3 SD (10.7%). Patients with clinical benefit had durable responses, with median DoT of 9.6 months and OS of 14.7 months. The median OS was 6.6 months in the total population. The combination was well tolerated. Correlative studies with Cytometry by Time of Flight (CyTOF) and imaging mass cytometry (IMC) revealed a significant increase of CD8 T cells in responders and of myeloid cells in non-responders.
conclusionsThe median OS increased by more than 2-fold in patients with clinical benefit. The therapy is a well-tolerated treatment in heavily pretreated patients with mTNBC. Early detection of increased effector and effector memory CD8 T cells and myeloids correlate with response and non-response, respectively.
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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.