Trial reportJournal for immunotherapy of cancer2020
Randomized phase II study of stereotactic body radiotherapy and interleukin-2 versus interleukin-2 in patients with metastatic melanoma.
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. It is linked to trial NCT01416831 (Phase II Randomized Study of High Dose Interleukin-2 Versus Stereotactic Body Radiation), which is not on this map. Cited by 27 papers.
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.
Phase II Randomized Study of High Dose Interleukin-2 Versus Stereotactic Body Radiation (SBRT) and High Dose Interleukin-2 (IL-2) in Patients With Metastatic Melanoma
Who cites it
27 citing papers in PubMed, 44 citations in OpenAlex.
- Radiotherapy and High-Dose Interleukin-2: Clinical and Immunological Results of a Proof of Principle Study in Metastatic Melanoma and Renal Cell Carcinoma.Frontiers in immunology · 2021Trial
- Radiotherapy and cytokines: A systems view of immunotherapy and toxicity (Review).International journal of molecular medicine · 2026Review
- Strategic trimodal therapy enhances radiation-induced abscopal response in renal cancer.Journal of translational medicine · 2025Article
- Current landscape and future prospects of interleukin-2 receptor (IL-2R) agonists in cancer immunotherapy.Oncoimmunology · 2025Review
- Recent Advances in Molecular Research and Treatment for Melanoma in Asian Populations.International journal of molecular sciences · 2025Review
- The Multifaceted Role of the IL-2 Cytokine Family in Melanoma: Mechanisms, Therapeutic Implications, and Immune Modulation.Journal of immunology research · 2025Review
- Radiotherapy combined with locoregional hyperthermia for oligoprogression in metastatic melanoma local control.Therapeutic advances in medical oncology · 2025Article
- Microbial Therapeutics in Oncology: A Comprehensive Review of Bacterial Role in Cancer Treatment.Cureus · 2024Review
- Clinical outcomes of multisite moderate to high dose radiotherapy for patients with metastatic melanoma.Precision radiation oncology · 2024Article
- TLR3 activation enhances abscopal effect of radiotherapy in HCC by promoting tumor ferroptosis.EMBO molecular medicine · 2024Article
- Radiotherapy Combined with Intralesional Immunostimulatory Agents for Soft Tissue Sarcomas.Seminars in radiation oncology · 2024Review
- Recent advances in immunotherapy and its combination therapies for advanced melanoma: a review.Frontiers in oncology · 2024Review
- Harnessing the cGAS-STING pathway to potentiate radiation therapy: current approaches and future directions.Frontiers in pharmacology · 2024Review
- Radiation dose, schedule, and novel systemic targets for radio-immunotherapy combinations.Journal of the National Cancer Institute · 2023Article
- Article
- Expansion of circulating stem-like CD8Nature communications · 2023Article
- The immunogenic radiation and new players in immunotherapy and targeted therapy for head and neck cancer.Frontiers in oral health · 2023Review
- A Phase 1 Safety Study of Avelumab Plus Stereotactic Body Radiation Therapy in Malignant Pleural Mesothelioma.JTO clinical and research reports · 2023Article
- Revisiting mechanisms of resistance to immunotherapies in metastatic clear-cell renal-cell carcinoma.Cancer drug resistance (Alhambra, Calif.) · 2023Review
- A new target of radiotherapy combined with immunotherapy: regulatory T cells.Frontiers in immunology · 2023Review
Corrections and comments
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Authors and funding
11 authors at 3 institutions in 2 countries.
Funding
Abstract
backgroundA pilot study of stereotactic body radiation therapy (SBRT) followed by high-dose interleukin-2 (IL-2) showed a higher than anticipated objective response rate (ORR) among patients with metastatic melanoma (MM). We performed a prospective randomized study to determine if the ORR of SBRT + IL-2 was greater than IL-2 monotherapy in patients with advanced melanoma.
methodsPatients with MM who had adequate physiological reserve for IL-2 and at least one site suitable for SBRT were eligible. There was a 1:1 randomization to SBRT + IL-2 or IL-2 monotherapy. Patients received one or two doses of SBRT (20 Gy per fraction) with the last dose administered 3 days before starting the first cycle of IL-2. IL-2 (600,000 IU per kg via intravenous bolus infusion) was given every 8 hours for a maximum of 14 doses with a second cycle after a 2-week rest. Responding patients received up to six IL-2 cycles. Patients assigned to IL-2 monotherapy who exhibited progression of melanoma after cycle 2 were allowed to crossover and receive SBRT and additional IL-2. Response Evaluation Criteria in Solid Tumors 1.1 criteria were applied to non-irradiated lesions for response assessment.
results44 patients were included in the analysis. The ORR in the SBRT + IL-2 group was 54%: 21% complete response (CR), 33% partial response (PR), 21% stable disease (SD) and 25% progressive disease (PD). The ORR in patients receiving IL-2 monotherapy was 35%: 15% CR, 20% PR, 25% SD and 40% PD. Seven patients assigned to IL-2 subsequently received SBRT + IL-2. One CR and two PRs were observed in the crossover group. There was no difference in progression-free or overall survival (OS). At 5 years the OS was 26% in the SBRT + IL-2 group and 25% in the IL-2 monotherapy group. The disease control rate (DCR) was higher in the SBRT + IL-2 group (75% vs 60%, p=0.34).
conclusionsSBRT + IL-2 induced more objective responses with a higher DCR compared to IL-2 monotherapy in MM. IL-2 monotherapy resulted in a significantly higher ORR than anticipated. Some patients in the crossover group also achieved objective responses. TRIAL REGISTRATION NUMBER: NCT01416831.
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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.