Trial reportBMC cancer2019
Phase I/II trial of Durvalumab plus Tremelimumab and stereotactic body radiotherapy for metastatic head and neck carcinoma.
Trial report in BMC cancer, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 32 papers, 3 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.
Phase I/II of Durvalumab (MEDI4736) + Tremelimumab + Stereotactic Body Radiotherapy for Metastatic Head and Neck Carcinoma
Phase II Clinical Study of Sintilimab Combined With Platinum-based Chemotherapy and SBRT in the First-line Treatment of Limited Metastatic Head and Neck Squamous Cell Carcinoma
Who cites it
32 citing papers in PubMed, 3 syntheses or guidelines pooled it, 61 citations in OpenAlex.
- 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
- Durvalumab Plus Tremelimumab in Solid Tumors: A Systematic Review.Advances in therapy · 2021Pooled it
- Optimizing the Treatment Schedule of Radiotherapy Combined With Anti-PD-1/PD-L1 Immunotherapy in Metastatic Cancers.Frontiers in oncology · 2021Pooled it
- High-dose irradiation in combination with non-ablative low-dose radiation to treat metastatic disease after progression on immunotherapy: Results of a phase II trial.Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology · 2021Trial
- Survival analysis of patients with metastatic head and neck squamous cell carcinoma treated with metastasis-directed radiotherapy and immunotherapy.Radiation oncology (London, England) · 2025Article
- Combination therapy with oncolytic viruses and immune checkpoint inhibitors in head and neck squamous cell carcinomas: an approach of complementary advantages.Cancer cell international · 2023Review
- Top Ten Lessons Learned from Trials in Oligometastatic Cancers.Cancer research and treatment · 2023Review
- The immunogenic radiation and new players in immunotherapy and targeted therapy for head and neck cancer.Frontiers in oral health · 2023Review
- Inflammatory Cytokines and Radiotherapy in Pancreatic Ductal Adenocarcinoma.Biomedicines · 2022Review
- Nanoradiosensitizer with good tissue penetration and enhances oral cancer radiotherapeutic effect.Biomaterials · 2022Article
- Head and Neck Squamous Cell Carcinoma in Elderly Patients: Role of Radiotherapy and Chemotherapy.Cancers · 2022Review
- A multi-institutional analysis of outcomes following stereotactic body radiation therapy for management of metastases from squamous cell carcinomas of the head and neck.Journal of radiosurgery and SBRT · 2022Article
- PYHIN1 correlates with CD8+ T cells infiltration and confers good patient survival in oral cancer.Journal of dental sciences · 2022Article
- Harnessing the immune system against cancer: current immunotherapy approaches and therapeutic targets.Molecular biology reports · 2021Review
- Review
- Guillain-Barré syndrome in patients treated with immune checkpoint inhibitors.Journal of neurology · 2021Article
- Review
- TREM2: Keeping Pace With Immune Checkpoint Inhibitors in Cancer Immunotherapy.Frontiers in immunology · 2021Review
- Synergies Radiotherapy-Immunotherapy in Head and Neck Cancers. A New Concept for Radiotherapy Target Volumes-"Immunological Dose Painting".Medicina (Kaunas, Lithuania) · 2020Article
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
17 authors at 1 institution in 1 country.
Funding
Abstract
backgroundThe efficacy of immunotherapy targeting the PD-1/PD-L1 pathway has previously been demonstrated in metastatic head and neck squamous cell carcinoma (HNSCC). Stereotactic Body Radiotherapy (SBRT) aims at ablating metastatic lesions and may play a synergistic role with immunotherapy. The purpose of this study is to assess the safety and efficacy of triple treatment combination (TTC) consisting of the administration of durvalumab and tremelimumab in combination with SBRT in metastatic HNSCC.
methodThis is a phase I/II single arm study that will include 35 patients with 2-10 extracranial metastatic lesions. Patients will receive durvalumab (1500 mg IV every 4 weeks (Q4W)) and tremelimumab (75 mg IV Q4W for a total of 4 doses) until progression, unacceptable toxicity or patient withdrawal. SBRT to 2-5 metastases will be administered between cycles 2 and 3 of immunotherapy. The safety of the treatment combination will be evaluated through assessment of TTC-related toxicities, defined as grade 3-5 toxicities based on Common Terminology Criteria for Adverse Events (v 4.03), occurring within 6 weeks from SBRT start, and that are definitely, probably or possibly related to the combination of all treatments. We hypothesize that dual targeting of PD-L1 and CTLA-4 pathways combined with SBRT will lead to < 35% grade 3-5 acute toxicities related to TTC. Progression free survival (PFS) will be the primary endpoint of the phase II portion of this study and will be assessed with radiological exams every 8 weeks using the RECIST version 1.1 criteria. DISCUSSION: The combination of synergistic dual checkpoints inhibition along with ablative radiation may significantly potentiate the local and systemic disease control. This study constitutes the first clinical trial combining effects of SBRT with dual checkpoint blockade with durvalumab and tremelimumab in the treatment of metastatic HNSCC. If positive, this study would lead to a phase III trial testing this treatment combination against standard of care in metastatic HNSCC.
trial registrationNCT03283605 . Registration date: September 14, 2017; version 1.
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What OpenQuestion holds
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.