Trial reportThe oncologist2022
A Randomized Phase II Trial of mFOLFOX6 + Bevacizumab Alone or with AdCEA Vaccine + Avelumab Immunotherapy for Untreated Metastatic Colorectal Cancer.
Trial report in The oncologist, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 6 of them syntheses 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
27 citing papers in PubMed, 6 syntheses or guidelines pooled it, 48 citations in OpenAlex.
- Safety Profiles of Immune Checkpoint Inhibitor Strategies in Gastrointestinal Cancers and Their Association With Clinical Outcomes: A Systematic Review and Meta-Analysis.Cancer medicine · 2026Pooled it
- Pooled it
- Efficacy and safety of first-line targeted and immunotherapy for metastatic colorectal cancer: a network meta-analysis.Frontiers in immunology · 2025Pooled it
- The Efficacy of Immune Checkpoint Inhibitors in Microsatellite Stable Colorectal Cancer: A Systematic Review.The oncologist · 2024Pooled it
- Efficacy and safety of PD-1/L1 inhibitors as first-line therapy for metastatic colorectal cancer: a meta-analysis.Frontiers in immunology · 2024Pooled it
- Hypertransaminasemia in cancer patients receiving immunotherapy and immune-based combinations: the MOUSEION-05 study.Cancer immunology, immunotherapy : CII · 2023Pooled it
- The Randomized Phase II ARC-9 Study of Etrumadenant-Based Therapy versus Regorafenib in Patients with Previously Treated Metastatic Colorectal Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026Trial
- Harnessing live vectors for cancer vaccines: Advancing therapeutic immunotherapy.Human vaccines & immunotherapeutics · 2025Review
- The Current Role of Antiangiogenics in Colorectal Cancer.International journal of molecular sciences · 2025Review
- Adding programmed death 1/programmed death ligand 1 inhibitors to first-line standard-of-care therapy for metastatic colorectal cancer: A meta-analysis.World journal of clinical oncology · 2025Article
- Therapeutic Cancer Vaccines in Colorectal Cancer: Platforms, Mechanisms, and Combinations.Cancers · 2025Article
- Therapeutic Colorectal Cancer Vaccines: Emerging Modalities and Translational Opportunities.Vaccines · 2025Review
- Changes in T-lymphocyte subpopulations in patients with colorectal cancer before and after acupoint catgut embedding acupuncture observation.Open life sciences · 2025Article
- Evaluation of immune checkpoint inhibitors for colorectal cancer: A network meta‑analysis.Oncology letters · 2024Article
- From Crypts to Cancer: A Holistic Perspective on Colorectal Carcinogenesis and Therapeutic Strategies.International journal of molecular sciences · 2024Review
- Cardiovascular Eligibility Criteria and Adverse Event Reporting in Combined Immune Checkpoint and VEGF Inhibitor Trials.JACC. CardioOncology · 2024Article
- The characteristics of the tumor immune microenvironment in colorectal cancer with different MSI status and current therapeutic strategies.Frontiers in immunology · 2024Review
- CEA vaccines.Human vaccines & immunotherapeutics · 2023Review
- Clinical Applications of Combined Immunotherapy Approaches in Gastrointestinal Cancer: A Case-Based Review.Vaccines · 2023Review
- Avelumab in Patients With Metastatic Colorectal Cancer.The oncologist · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
19 authors at 3 institutions in 1 country.
Funding
Abstract
backgroundFOLFOX plus bevacizumab is a standard of care (SOC) for first-line treatment of microsatellite-stable metastatic colorectal cancer (MSS mCRC). This study randomized patients to SOC or SOC plus avelumab (anti-PD-L1) plus CEA-targeted vaccine.
methodsPatients with untreated MSS mCRC enrolled to a lead-in arm assessing safety of SOC + immuno-oncology agents (IO). Next, patients were randomized to SOC or SOC + IO. The primary endpoint was progression-free survival (PFS). Multiple immune parameters were analyzed.
resultsSix patients enrolled to safety lead-in, 10 randomized to SOC, and 10 to SOC + IO. There was no difference in median PFS comparing SOC versus SOC + IO (8.8 months (95% CI: 3.3-17.0 months) versus 10.1 months (95% CI: 3.6-16.1 months), respectively; hazard ratio 1.061 [P = .91; 95% CI: 0.380-2.966]). The objective response rate was 50% in both arms. Of patients analyzed, most (8/11) who received SOC + IO developed multifunctional CD4+/CD8+ T-cell responses to cascade antigens MUC1 and/or brachyury, compared to 1/8 who received SOC alone (P = .020). We detected post-treatment changes in immune parameters that were distinct to the SOC and SOC + IO treatment arms. Accrual closed after an unplanned analysis predicted a low likelihood of meeting the primary endpoint.
conclusionsSOC + IO generated multifunctional MUC1- and brachyury-specific CD4+/CD8+ T cells despite concurrent chemotherapy. Although a tumor-directed immune response is necessary for T-cell-mediated antitumor activity, it was not sufficient to improve PFS. Adding agents that increase the number and function of effector cells may be required for clinical benefit.
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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.