ArticleClinical cancer research : an official journal of the American Association for Cancer Research2025
Phase Ib Study of Pembrolizumab in Combination with Intratumoral Injection of Clostridium novyi-NT in Patients with Advanced Solid Tumors.
Article in Clinical cancer research : an official journal of the American Association for Cancer Research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
19 citing papers in PubMed.
- Leveraging the bacteria for enhanced cancer immunotherapy: from a perspective of synthetic biology.Cancer biology & therapy · 2026Review
- Microbial Signals in Cancer: Dissecting Host-Microbiota-Tumor Interactions and Potential Therapeutic Strategy.MedComm · 2026Review
- Outcomes After Intratumoral Delivery of Immunotherapy in Breast Cancer.Journal of surgical oncology · 2026Observational
- Intratumoral microbiota in cancer: molecular mechanism and therapeutic strategies.Molecular biomedicine · 2026Review
- Magnetic medical microrobots with memory-capable genetic circuits.Science advances · 2026Article
- Review
- Global research trends and emerging frontiers of intratumoral microbiota in cancer immunotherapy: a bibliometric and visualization analysis.Frontiers in immunology · 2026Review
- Oncolytic bacteria therapy for malignant glioma.Frontiers in immunology · 2026Review
- Engineering bacteria for enhanced tumor therapy: from surface modification to synthetic genetic circuits.Journal of hematology & oncology · 2025Review
- Biohybrid system EcN@PB for reshaping tumor immunosuppressive microenvironment to improve photothermal therapy induced antitumor immune response.Materials today. Bio · 2025Article
- Engineered Bacteria-Nano Hybrid System: The Intelligent Drug Factory for Next-Generation Cancer Immunotherapy.Pharmaceutics · 2025Review
- Combination of Irreversible Electroporation andCancers · 2025Review
- Intratumoral Immunotherapy in Breast Cancer.Vaccines · 2025Review
- Intratumoral microbiota for hepatocellular carcinoma: from preclinical mechanisms to clinical cancer treatment.Cancer cell international · 2025Review
- Anti-Cancer Strategies Using Anaerobic Spore-Forming BacteriaLife (Basel, Switzerland) · 2025Review
- Potentiating intratumoral therapy with immune checkpoint inhibitors: shifting the paradigm of multimodality therapeutics.Immuno-oncology technology · 2025Review
- Tumor-targeting bacteria as immune stimulants - the future of cancer immunotherapy?Critical reviews in microbiology · 2024Review
- Clostridium Bacteria: Harnessing Tumour Necrosis for Targeted Gene Delivery.Molecular diagnosis & therapy · 2024Article
- Bacterial carrier-mediated drug delivery systems: a promising strategy in cancer therapy.Frontiers in bioengineering and biotechnology · 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.
Funding
Abstract
purposeIntratumoral injection of Clostridium novyi-nontoxic (C. novyi-NT), lacking alpha-toxin, germinates and subsequently replicates in the tumor hypoxic regions, causing cell lysis and inflammation. This phase Ib study investigated the safety and synergistic effects of pembrolizumab and C. novyi-NT in advanced solid tumors. PATIENTS AND
methodsPatients with injectable solid tumors received one intratumoral C. novyi-NT injection (day 8) across four dose cohorts (3 × 104 to 100 × 104 spores) with pembrolizumab (200 mg intravenously every 3 weeks, day 0-24 months). Sixteen patients were enrolled with a median age of 62.5 years, and the most common tumor types were breast cancer and melanoma.
resultsThe combination therapy demonstrated a manageable safety profile, with one grade 3 dose-limiting toxicity of abscess formation and the remainder of treatment-related adverse events in ≥10% of patients being grade 1 or 2 injection site reaction (25%), pyrexia (19%), pruritus (13%), leukopenia (13%), and anemia (13%). The maximum tolerated dose was determined to be pembrolizumab intravenously at 200 mg every 3 weeks and a single dose of 100 × 104C.novyi-NT spores intratumorally on day 8. The confirmed overall objective response rate of 25% was observed among four patients with nonkeratinizing undifferentiated nasopharyngeal squamous carcinoma, human papilloma virus-positive squamous cell carcinoma of the base of the tongue, vulvar melanoma, and chordoma. Among these patients, we obtained three partial responses and one complete response. The median duration of the response was 10.93 months, and stable disease was observed in 69% of patients.
conclusionsThis study highlights the potential of the C. novyi-NT and pembrolizumab combination as a promising therapeutic strategy for treatment-refractory solid tumors.
Indexed as
Identifiers
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.