Trial reportThe oncologist2023
Phase II Trial of MEDI0457 and Durvalumab for Patients With Recurrent/Metastatic Human Papillomavirus-Associated Cancers.
Trial report in The oncologist, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 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.
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, 24 citations in OpenAlex.
- Sintilimab plus HPV vaccine for recurrent or metastatic cervical cancer.Journal for immunotherapy of cancer · 2024Trial
- A Spike-Linked HPV16 E7 DNA Vaccine Induces Potent Antitumor and Anti-Spike Immune Responses.International journal of molecular sciences · 2026Article
- Advances in anal cancer treatment: current standards, the role of immunotherapy and emerging strategies.ESMO gastrointestinal oncology · 2026Review
- Penile squamous cell carcinomas with the usual-type morphology can be HPV-associated - Routine p16/HPV testing should be performed in all penile squamous cell carcinomas regardless of morphology.Virchows Archiv : an international journal of pathology · 2026Article
- Tumor-infiltrating plasma cells are a prognostic factor in penile squamous cell carcinoma.Virchows Archiv : an international journal of pathology · 2025Article
- Emerging advances and future opportunities in the molecular and therapeutic landscape of anal cancer.Nature reviews. Clinical oncology · 2025Review
- Therapeutic options for human papillomavirus-positive tonsil and base of tongue cancer.Journal of internal medicine · 2025Review
- Review
- PRGN-2009 and bintrafusp alfa for patients with advanced or metastatic human papillomavirus-associated cancer.Cancer immunology, immunotherapy : CII · 2025Article
- Clinicopathologic Features Associated with Survival for Immune Checkpoint Blockade in Patients with Metastatic Anal Cancer.Cancers · 2025Article
- Potentiating intratumoral therapy with immune checkpoint inhibitors: shifting the paradigm of multimodality therapeutics.Immuno-oncology technology · 2025Review
- Roles of human papillomavirus in cancers: oncogenic mechanisms and clinical use.Signal transduction and targeted therapy · 2025Review
- Advancing the Fight Against Cervical Cancer: The Promise of Therapeutic HPV Vaccines.Vaccines · 2025Review
- Cancer vaccines: advances, hurdles, and future directions.Exploration of targeted anti-tumor therapy · 2025Review
- Lymphatic dissemination of HPV-positive oropharyngeal squamous cell carcinoma: underlying mechanisms and treatment innovations.Frontiers in immunology · 2025Review
- Complete remission of recurrent human papillomavirus-associated cervical cancer managed with camrelizumab and nanoparticle albumin-bound paclitaxel as second-line treatment: a case report.Frontiers in immunology · 2025Article
- HPV Infections-Classification, Pathogenesis, and Potential New Therapies.International journal of molecular sciences · 2024Review
- Preclinical Immunogenicity and Efficacy Studies for Therapeutic Vaccines for Human Papillomavirus-Type-16-Associated Cancer.Vaccines · 2024Article
- Advances in the Management of Recurrent Cervical Cancer: State of the Art and Future Perspectives.Current oncology reports · 2023Review
- Human papillomavirus associated cervical lesion: pathogenesis and therapeutic interventions.MedComm · 2023Review
Corrections and comments
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Authors and funding
13 authors at 1 institution in 1 country.
Funding
Abstract
backgroundHuman papillomavirus (HPV) types 16/18 drive oncogenesis for most patients with cervical, anal, and penile cancers. MEDI0457, a therapeutic DNA vaccine containing plasmids for E6 and E7 HPV-16/18 viral oncogenes and IL-12 adjuvant, is safe and provokes an immune response against E6/E7. We tested MEDI0457 with the anti-PD-L1 antibody durvalumab for patients with HPV-associated cancers.
methodsPatients with recurrent/metastatic, treatment-refractory HPV-16/18 cervical cancer, or rare HPV-associated (anal and penile) cancers were eligible. Prior immune checkpoint inhibition was not permitted. Patients received MEDI0457 7 mg intramuscularly (weeks 1, 3, 7, 12, and every 8 weeks thereafter) and durvalumab 1500 mg intravenously every 4 weeks. The primary endpoint was overall response (RECIST 1.1). In this Simon two-stage phase 2 trial (Ho: p < 0.15; Ha: p ≥ 0.35), ≥2 responses were needed in both cervical and non-cervical cohorts during the first stage for the trial to proceed to stage 2 with an additional 25 patients (34 total) enrolled.
resultsTwenty-one patients (12 cervical, 7 anal, and 2 penile) were evaluable for toxicity and 19 for response Overall response rate was 21% (95% CI, 6%-46%) among evaluable patients. Disease control rate was 37% (95% CI, 16%-62%). Median duration of response among responders was 21.8 months (95% CI, 9.7%-not estimable). Median progression-free survival was 4.6 months (95% CI, 2.8%-7.2%). Median overall survival was 17.7 months (95% CI, 7.6%-not estimable). Grades 3-4 treatment-related adverse events occurred in 6 (23%) participants.
conclusionsThe combination of MEDI0457 and durvalumab demonstrated acceptable safety and tolerability in patients with advanced HPV-16/18 cancers. The low ORR among patients with cervical cancer led to study discontinuation despite a clinically meaningful disease control rate.
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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.