Trial reportJournal for immunotherapy of cancer2023
Phase 2 trial of a DNA vaccine (pTVG-HP) and nivolumab in patients with castration-sensitive non-metastatic (M0) prostate cancer.
Trial report in Journal for immunotherapy of cancer, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03600350 (Phase II Trial of a DNA Vaccine Encoding Prostatic Acid Phosphatase), which is not on this map. Cited by 32 papers.
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 II Trial of a DNA Vaccine Encoding Prostatic Acid Phosphatase (pTVG-HP) and Nivolumab in Patients With Non-Metastatic, PSA-Recurrent Prostate Cancer
Who cites it
32 citing papers in PubMed, 33 citations in OpenAlex.
- Phase 2 trial of pTVG-HP ± pTVG-AR DNA vaccines and pembrolizumab in patients with metastatic, castration-resistant prostate cancer (mCRPC).Journal for immunotherapy of cancer · 2026Trial
- Androgen deprivation, androgen receptor-targeted vaccination, and nivolumab in patients with high-risk localized prostate cancer.Journal for immunotherapy of cancer · 2026Trial
- DNA-based vaccines: Advances, applications, and future prospects.Genes & diseases · 2026Review
- Review
- Cancer Vaccines in Genitourinary Malignancies: Current Advances and Future Directions.Vaccines · 2026Review
- Recent advances and future prospects of immunotherapeutic approaches in prostate cancer.Journal of translational medicine · 2026Review
- Prostate tumor immune microenvironment changes following immunotherapy shared by patients who developed anti-tumor response or immune-related adverse events.Oncoimmunology · 2025Article
- Synergistic targeting strategies for prostate cancer.Nature reviews. Urology · 2025Review
- Review
- DNA Vaccines in the Post-mRNA Era: Engineering, Applications, and Emerging Innovations.International journal of molecular sciences · 2025Review
- Clonal diversity shapes the tumour microenvironment leading to distinct immunotherapy responses in metastatic urothelial carcinoma.Nature communications · 2025Article
- Comparison of Current Immunotherapy Approaches and Novel Anti-Cancer Vaccine Modalities for Clinical Application.International journal of molecular sciences · 2025Review
- DNA-based immunotherapy for cancer: In vivo approaches for recalcitrant targets.Molecular therapy : the journal of the American Society of Gene Therapy · 2025Review
- PD-1 blockade employed at the time CD8+ T cells are activated enhances their antitumor efficacy.Journal for immunotherapy of cancer · 2025Article
- Advances in cancer immunotherapy: historical perspectives, current developments, and future directions.Molecular cancer · 2025Review
- Tissue macrophages: origin, heterogenity, biological functions, diseases and therapeutic targets.Signal transduction and targeted therapy · 2025Review
- Recent Advances in the Development and Efficacy of Anti-Cancer Vaccines-A Narrative Review.Vaccines · 2025Review
- Advances in nucleic acid-based cancer vaccines.Journal of biomedical science · 2025Review
- Review
- The application of emerging immunotherapy in the treatment of prostate cancer: progress, dilemma and promise.Frontiers in immunology · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 2 institutions in 1 country.
Funding
Abstract
purposeWe have previously reported that a plasmid DNA vaccine encoding prostatic acid phosphatase (pTVG-HP) had greater clinical activity when given in combination with pembrolizumab to patients with metastatic, castration-resistant prostate cancer. The current trial was conducted to evaluate vaccination with PD-1 blockade, using nivolumab, in patients with early, recurrent (M0) prostate cancer.
methodsPatients with M0 prostate cancer were treated with pTVG-HP (100 µg administered intradermally) and nivolumab (240 mg intravenous infusion) every 2 weeks for 3 months, and then every 4 weeks for 1 year of total treatment. Patients were then followed for an additional year off treatment. The primary objectives were safety and complete prostate-specific antigen (PSA) response (PSA<0.2 ng/mL).
results19 patients were enrolled. No patients met the primary endpoint of complete PSA response; however, 4/19 (21%) patients had a PSA decline >50%. Median PSA doubling times were 5.9 months pretreatment, 25.6 months on-treatment (p=0.001), and 9.0 months in the subsequent year off-treatment. The overall median radiographic progression-free survival was not reached. Grade 3 or 4 events included adrenal insufficiency, fatigue, lymphopenia, and increased amylase/lipase. 9/19 (47%) patients developed immune-related adverse effects (irAE). The development of irAE and increased CXCL9 were associated with increased PSA doubling time. Quantitative NaF PET/CT imaging showed the resolution of subclinical lesions along with the development of new lesions at each time point.
conclusionsIn this population, combining nivolumab with pTVG-HP vaccination was safe, and immunologically active, prolonged the time to disease progression, but did not eradicate disease. Quantitative imaging suggested that additional treatments targeting mechanisms of resistance may be required to eliminate tumors. TRIAL REGISTRATION NUMBER: NCT03600350.
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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.