Trial reportBritish journal of cancer2016
Randomised, open-label, phase II study of gemcitabine with and without IMM-101 for advanced pancreatic cancer.
Trial report in British journal of cancer, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT01303172 (A Randomised, Open-Label, Proof-of-Concept, Phase II Trial Comparing Gemcitabine With and Without IMM-101 in Advanced Pancreatic Cancer), which is not on this map. Cited by 33 papers, 1 of them a synthesis 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.
A Randomised, Open-Label, Proof-of-Concept, Phase II Trial Comparing Gemcitabine With and Without IMM-101 in Advanced Pancreatic Cancer
Who cites it
33 citing papers in PubMed, 1 synthesis or guideline pooled it, 74 citations in OpenAlex.
- Added Value of Radiotherapy Following Neoadjuvant FOLFIRINOX for Resectable and Borderline Resectable Pancreatic Cancer: A Systematic Review and Meta-Analysis.Annals of surgical oncology · 2021Pooled it
- Review
- Review
- Current and future immunotherapeutic approaches in pancreatic cancer treatment.Journal of hematology & oncology · 2024Review
- Tumor-derived interleukin 35 mediates the dissemination of gemcitabine resistance in pancreatic adenocarcinoma.Oncogene · 2024Article
- Disseminated non-tuberculous mycobacterial infection caused by Mycobacterium obuense in an immunocompromised patient: a case report.BMC infectious diseases · 2023Article
- New Treatment Options in Metastatic Pancreatic Cancer.Cancers · 2023Review
- The Role of Immunotherapy in Pancreatic Cancer.Current oncology (Toronto, Ont.) · 2022Review
- Suppression of the malignancy of mammary tumor in mice model by inactivated preparation ofVeterinary research forum : an international quarterly journal · 2022Article
- The role of immune modulation and anti-inflammatory agents in the management of prostate cancer: A case report of six patients.Oncology letters · 2022Article
- Rapidly GrowingInternational journal of molecular sciences · 2021Review
- EZR promotes pancreatic cancer proliferation and metastasis by activating FAK/AKT signaling pathway.Cancer cell international · 2021Article
- Review
- Cytokine/Chemokine Release Patterns and Transcriptomic Profiles of LPS/IFNγ-Activated Human Macrophages Differentiated with Heat-KilledInternational journal of molecular sciences · 2021Article
- The Microbiome and Its Implications in Cancer Immunotherapy.Molecules (Basel, Switzerland) · 2021Review
- Cheap and Commonplace: Making the Case for BCG and γδ T Cells in COVID-19.Frontiers in immunology · 2021Article
- Effect of Gemcitabine based chemotherapy on the immunogenicity of pancreatic tumour cells and T-cells.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2021Article
- Pancreatic Cancer (PDAC): Introduction of Evidence-Based Complementary Measures into Integrative Clinical Management.Cancers · 2020Review
- Is innate immunity our best weapon for flattening the curve?The Journal of clinical investigation · 2020Review
- Review
Corrections and comments
- Erratum issued
Authors and funding
23 authors at 19 institutions in 5 countries.
Funding
Abstract
backgroundImmune Modulation and Gemcitabine Evaluation-1, a randomised, open-label, phase II, first-line, proof of concept study (NCT01303172), explored safety and tolerability of IMM-101 (heat-killed Mycobacterium obuense; NCTC 13365) with gemcitabine (GEM) in advanced pancreatic ductal adenocarcinoma.
methodsPatients were randomised (2 : 1) to IMM-101 (10 mg ml(-l) intradermally)+GEM (1000 mg m(-2) intravenously; n=75), or GEM alone (n=35). Safety was assessed on frequency and incidence of adverse events (AEs). Overall survival (OS), progression-free survival (PFS) and overall response rate (ORR) were collected.
resultsIMM-101 was well tolerated with a similar rate of AE and serious adverse event reporting in both groups after allowance for exposure. Median OS in the intent-to-treat population was 6.7 months for IMM-101+GEM v 5.6 months for GEM; while not significant, the hazard ratio (HR) numerically favoured IMM-101+GEM (HR, 0.68 (95% CI, 0.44-1.04, P=0.074). In a pre-defined metastatic subgroup (84%), OS was significantly improved from 4.4 to 7.0 months in favour of IMM-101+GEM (HR, 0.54, 95% CI 0.33-0.87, P=0.01).
conclusionsIMM-101 with GEM was as safe and well tolerated as GEM alone, and there was a suggestion of a beneficial effect on survival in patients with metastatic disease. This warrants further evaluation in an adequately powered confirmatory study.
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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.