Clinical trial · Interventional
Assessment Study to Evaluate Specific Immune Response in Locally Advanced Cervix Cancer After Radio-chemotherapy
Assessment Study to Evaluate Specific Immune Response in Locally Advanced Cervix Cancer After Radio-chemotherapy (IMMUVIX)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): insufficient recruitment
Summary
Brief summary (as posted)
Perspectives: * To set-up another clinical trial with this specific phenotype as the main stratification factor. Therefore a more aggressive or a more specific systemic treatment (with or without an immunomodulator) could be proposed to those selected patients in the field of personalized medicine. * To evaluate the use of the smear as a surrogate non-invasive technique to biopsy for immunomonitoring. * To use the CTC/PD-L1 assay as a liquid biopsy in future clinical trials for stratification and monitoring of cancer patients undergoing immune checkpoint treatments. This specific subset of CTCs might represent metastatic cells with a high potential to escape T cell-mediated lysis and might therefore be the actual targets of immunotherapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin injection | Drug | Cisplatin | ALIAS |
| radiotherapy | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cisplatin
- description
- Weekly cisplatin (40 mg/m²) will be administered during radiotherapy. At least 3 cycles of cisplatin should be performed according to the hematological and renal functions but not mandatory.
- interventionNames
- Drug: Cisplatin injection
- Combination Product: radiotherapy
Primary outcomes (1)
- measure
- Expression of CD8+CD39+PD1+ lymphocytes infiltrate on cervix biopsies
- timeFrame
- through study completion, an average of 1 year disease free survival
- description
- Cervix biopsies analysis
Secondary outcomes (1)
- measure
- Effect on 1-year DFS of other putative biomarkers (CD73, CD39, PD1 and Tim3) on the non-regulatory CD4+ and CD8+ lymphocytes
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years. * HPV-positive cervical cancer proven\* by biopsy. * All FIGO stages cervical cancers which are the matter for radio-chemotherapy and exclusive brachytherapy indications. * ECOG performance status ≤2. * Ability to give informed consent. * Patients must be affiliated to a Social Security System. * Patient information and written informed consent form signed. Exclusion Criteria: * Adenocarcinoma of cervix. * Known autoimmune disorder. * History of HIV and/ or hepatitis infection. * History of pelvic radiation or radio-chemotherapy. * Recurrent or metastatic cervical cancer. * Contra-indication for cisplatin. * Patient pregnant and/or breastfeeding. * History of other malignancy within the previous 5 years (except for appropriately treated melanoma skin carcinoma). * Patients with psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
References
Publications (40)
- BACKGROUNDFerlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015 Mar 1;136(5):E359-86. doi: 10.1002/ijc.29210. Epub 2014 Oct 9. PMID 25220842
- BACKGROUNDDe Vuyst H, Clifford G, Li N, Franceschi S. HPV infection in Europe. Eur J Cancer. 2009 Oct;45(15):2632-9. doi: 10.1016/j.ejca.2009.07.019. Epub 2009 Aug 24. PMID 19709878
- BACKGROUNDzur Hausen H. Papillomavirus infections--a major cause of human cancers. Biochim Biophys Acta. 1996 Oct 9;1288(2):F55-78. doi: 10.1016/0304-419x(96)00020-0. PMID 8876633
- BACKGROUNDMauch P, Constine L, Greenberger J, Knospe W, Sullivan J, Liesveld JL, Deeg HJ. Hematopoietic stem cell compartment: acute and late effects of radiation therapy and chemotherapy. Int J Radiat Oncol Biol Phys. 1995 Mar 30;31(5):1319-39. doi: 10.1016/0360-3016(94)00430-S. PMID 7713791
- BACKGROUNDMell LK, Tiryaki H, Ahn KH, Mundt AJ, Roeske JC, Aydogan B. Dosimetric comparison of bone marrow-sparing intensity-modulated radiotherapy versus conventional techniques for treatment of cervical cancer. Int J Radiat Oncol Biol Phys. 2008 Aug 1;71(5):1504-10. doi: 10.1016/j.ijrobp.2008.04.046. PMID 18640499
- BACKGROUNDKobayashi A, Weinberg V, Darragh T, Smith-McCune K. Evolving immunosuppressive microenvironment during human cervical carcinogenesis. Mucosal Immunol. 2008 Sep;1(5):412-20. doi: 10.1038/mi.2008.33. Epub 2008 Jul 2. PMID 19079205
- BACKGROUNDJordanova ES, Gorter A, Ayachi O, Prins F, Durrant LG, Kenter GG, van der Burg SH, Fleuren GJ. Human leukocyte antigen class I, MHC class I chain-related molecule A, and CD8+/regulatory T-cell ratio: which variable determines survival of cervical cancer patients? Clin Cancer Res. 2008 Apr 1;14(7):2028-35. doi: 10.1158/1078-0432.CCR-07-4554.