Trial reportClinical colorectal cancer2016
A Phase II Efficacy and Safety, Open-Label, Multicenter Study of Imprime PGG Injection in Combination With Cetuximab in Patients With Stage IV KRAS-Mutant Colorectal Cancer.
Trial report in Clinical colorectal cancer, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 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
26 citing papers in PubMed, 46 citations in OpenAlex.
- Review
- The Human Mycobiome: Composition, Immune Interactions, and Impact on Disease.International journal of molecular sciences · 2025Review
- Review
- Role of Trained Immunity in Heath and Disease.Current cardiology reports · 2025Review
- Oncolytic Virotherapies and Adjuvant Gut Microbiome Therapeutics to Enhance Efficacy Against Malignant Gliomas.Viruses · 2024Review
- Prospective virtual screening combined with bio-molecular simulation enabled identification of new inhibitors for the KRAS drug target.BMC chemistry · 2024Article
- β-glucan: a potent adjuvant in immunotherapy for digestive tract tumors.Frontiers in immunology · 2024Review
- The mechanisms and cross-protection of trained innate immunity.Virology journal · 2022Review
- Epigenetic and Transcriptional Regulation of Innate Immunity in Cancer.Cancer research · 2022Review
- The Role of TAMs in Tumor Microenvironment and New Research Progress.Stem cells international · 2022Article
- Regorafenib enhances anti-PD1 immunotherapy efficacy in murine colorectal cancers and their combination prevents tumor regrowth.Journal of experimental & clinical cancer research : CR · 2021Article
- Edible Mushrooms and Beta-Glucans: Impact on Human Health.Nutrients · 2021Review
- Strategies to tackle RAS-mutated metastatic colorectal cancer.ESMO open · 2021Review
- Inhibitory affinity modulation of FcγRIIA ligand binding by glycosphingolipids by inside-out signaling.Cell reports · 2021Article
- Review
- Tuberculosis-Cancer Parallels in Immune Response Regulation.International journal of molecular sciences · 2020Review
- An Overview of Advances in Cell-Based Cancer Immunotherapies Based on the Multiple Immune-Cancer Cell Interactions.Methods in molecular biology (Clifton, N.J.) · 2020Review
- Yeast-Derived β-Glucan in Cancer: Novel Uses of a Traditional Therapeutic.International journal of molecular sciences · 2019Review
- Therapeutic targeting of trained immunity.Nature reviews. Drug discovery · 2019Review
- Monoclonal antibody-mediated killing of tumour cells by neutrophils.European journal of clinical investigation · 2018Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 5 institutions in 1 country.
Funding
Abstract
backgroundImprime PGG (β(1,6)-[poly-(1,3)-D-glucopyranosyl]-poly-β(1,3)-D-glucopyranose) is an innate immune cell modulator that primes neutrophils and monocytes/macrophages to exert antitumor activity against complement opsonized tumor cells. In patients with KRAS-mutant colorectal cancer (CRC), cetuximab alone is ineffective; however, it can bind to tumor cells and induce opsonization for recognition by Imprime PGG-bound innate immune cells. The primary objective of this study was to determine the antitumor activity of Imprime PGG in combination with cetuximab in patients with KRAS-mutant metastatic CRC. PATIENTS AND
methodsThe study had a 2-stage Simon optimal design with 80% power to detect a target objective response rate (ORR) of ≥10% at a 10% significance level. Patients received weekly Imprime PGG (4 mg/kg) and cetuximab (loading dose, 400 mg/m(2), then 250 mg/m(2)) intravenously. The primary end point was ORR; secondary end points included duration of response (DOR), time to progression (TTP), overall survival (OS), disease control rate, progression-free survival, and safety. Stage 1 of the study was to enroll 17 evaluable patients.
resultsOne partial response (5.6%) was observed among 18 patients enrolled into stage 1. Median DOR was 4.2 months, TTP 2.7 months, and OS 6.6 months. Overall, observed toxicity was as expected from cetuximab alone. The most common (≥20%) adverse events related to Imprime PGG were fatigue (7 patients; 38.9%), infusion reaction (4 patients; 22.2%), and headache (4 patients; 22.2%). There was no Grade 4 toxicity nor treatment-related deaths.
conclusionImprime PGG in combination with cetuximab treatment in patients with KRAS-mutant CRC showed compelling, albeit modest, clinical activity. This study provides proof of principle that Imprime PGG, in combination with complement-activating antibodies, is associated with clinical activity.
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