ArticleBMC cancer2025
CombiCoR-Vax trial: study protocol for a phase II, single-arm, multicenter trial of sequential pembrolizumab plus dendritic cell vaccine followed by trifluridine/tipiracil and bevacizumab in refractory microsatellite-stable metastatic colorectal cancer.
Article in BMC cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 2 papers.
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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.
Sequential Immunochemotherapy Treatment with Pembrolizumab Plus Dendritic Cell (DC) Vaccine Followed by Trifluridine/Tipiracil (FTD/TPI) Plus Bevacizumab in Refractory Mismatch-repair-proficient (pMMR) or Microsatellite-stable (MSS) Metastatic Colorectal Cancer (CombiCoR-Vax)
A Clinical Trial Evaluating the Safety, Tolerability, and Preliminary Antitumor Activity of MSH2-/- Tumor Cell Vaccines in Patients With Advanced pMMR Colorectal Cancer.
Who cites it
2 citing papers in PubMed.
- Review
- Key immune cells in the tumor immune microenvironment of colorectal cancer: Roles and research advances (Review).Oncology reports · 2026Review
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.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundMetastatic colorectal cancer (mCRC) remains an incurable disease with a poor prognosis. Recently, the global phase 3 SUNLIGHT study demonstrated that adding bevacizumab to trifluridine/tipiracil (FTD/TPI) in refractory disease significantly improves overall survival (OS). As a result, this combination is set to become the new standard of care for refractory mCRC. Immune checkpoint inhibitors (ICIs), including Pembrolizumab, have shown excellent results in mCRC patients with mismatch-repair deficiency (dMMR) or high microsatellite instability (MSI-H) mCRC. Additionally, recent trials evaluating both concomitant and sequential chemoimmunotherapy in mismatch-repair-proficient (pMMR) and microsatellite-stable (MSS) mCRC have yielded promising outcomes. Dendritic cell (DC) vaccines, though historically limited in effectiveness, show potential when combined with ICIs. Preliminary studies suggest they enhance chemotherapy response while maintaining favorable safety profiles. These evidences support the exploration of immunotherapy and FTD/TPI plus Bevacizumab in pMMR/MSS mCRC patients.
methodsThis is a single-arm, open-label, multicenter, phase 2 clinical trial evaluating the clinical and immunological activity of an innovative approach combining induction immunotherapy (Pembrolizumab plus DC vaccine) followed by maintenance chemotherapy (FTD/TPI plus Bevacizumab) in patients with refractory MSS/pMMR mCRC. The primary endpoint is the objective response rate (ORR). Secondary endpoints include progression-free survival (PFS), safety, and overall survival (OS). DISCUSSION: This study explores a novel sequential immunochemotherapy approach combining a DC-based vaccine with anti-PD-1 immunotherapy and standard chemotherapy in patients with refractory pMMR/MSS mCRC. By integrating cellular immunotherapy without omitting the current standard of care (FTD/TPI plus bevacizumab), the trial aims to enhance treatment efficacy in a setting traditionally resistant to immunological strategies. To the best of our knowledge, this is the only ongoing trial investigating this therapeutic combination in this specific patient population.
trial registrationThis study, acronym CombiCoR-Vax, has been registered on clinicaltrials.gov registry with identifier NCT06522919, on July 9, 2024.
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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.