Cervical CancerPhase 2IMMUVIXNCT03255252
Assessment Study to Evaluate Specific Immune Response in Locally Advanced Cervix Cancer After Radio-chemotherapy
A Phase 2 study testing Cisplatin injection and radiotherapy in people with Cervical Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 3 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Cisplatin injection and radiotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 3 sitesFrance
- Study dates
- 15 Jul 2017to 23 Nov 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites
Clinique Beausoleil
Montpellier, 34070
CHRU Montpellier
Montpellier, 34295
Moussin Aurore
Montpellier, 34298
About this study
Official title: Assessment Study to Evaluate Specific Immune Response in Locally Advanced Cervix Cancer After Radio-chemotherapy (IMMUVIX)
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.
Read the detailed description
Cervical cancer is a real worldwide health care issue. High-risk human papillomavirus (HR-HPV) chronic infection is a co-factor in the development of the cervical cancer.
The HR-HPV genome encodes two oncoproteins (E6 and E7) which are required to sustain the malignant phenotype of pre-neoplastic lesions and are considered as foreign antigens recognized by the immune system, Many studies have suggested that local immunologic escape can cause the emergence of HPV-induced cervical cancer Radio-chemotherapy is the gold standard treatment for locally advanced cervical cancer, resulting in 2 year-control rates of about 70 to 85 %. A better and earlier understanding of the reasons for tumor escape may hopefully help to improve these outcomes.
Both radiation and chemotherapy are myelosuppressive treatments, but new treatment modalities such as Intensity-Modulated Radiation Therapy (IMRT) may allow a more rapid hematologic recovery. In addition to this immunosuppressive microenvironment, a significant number of tumor-infiltrating lymphocytes (TILs) are detected in cervical cancer tissue, highlighting interactions between tumor and immune cells.
Another issue is the fact that cancer cells develop different strategies to bypass the immune surveillance, such as a down-regulation of class I human leucocyte antigen (HLA) on tumor cells surface.
Furthermore, there is growing evidence of the importance of immune cells in response to cervical cancer treatment. TILs have been correlated with cervical cancer patients' outcome. More precisely, the location and type of these immune cells seem to be of great importance for the tumor response to treatment.
Receptors with negative regulatory function have been identified on the surface of those T cells, including CTLA4 and PD1 and seem to play a great role in tumor escape to treatment.
The presence of circulating tumor cells (CTCs) was shown to be correlated with a poor patient's prognosis in many cancers. A recent study suggested a potential mechanism of immune escape of these CTCs resulting in metastasis spreading.
The hypothesis of this study is that the frequency of PD1+,CD39+, specific phenotype of the non-regulatory CD4+ and CD8+ T cells among TILs is involved with the lack of response to the treatment and correlates with an early relapse after the treatment (i.e. patients with a very poor prognosis).
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
- Cervical Cancer
- Being tested
- Cisplatin injection, radiotherapy
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cisplatin injectionDrug
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.
radiotherapyCombination product
A total dose of 45Gy in 25 fractions to the PTV is considered standard but simultaneous integrated boost or two steps boost to specific volumes (positive lymph nodes for example) are accepted and left to the investigator's discretion).
| Study group | Role | What they receive |
|---|---|---|
| Cisplatin | Experimental | 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. Receives: Drug: Cisplatin injection; Combination Product: radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression of CD8+CD39+PD1+ lymphocytes infiltrate on cervix biopsies
Cervix biopsies analysis
Measured: through study completion, an average of 1 year disease free survival
Secondary outcomes (1)
Effect on 1-year DFS of other putative biomarkers (CD73, CD39, PD1 and Tim3) on the non-regulatory CD4+ and CD8+ lymphocytes
Cervix biopsies and blood samples analysis
Measured: through study completion, an average of 1 year disease free survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2017
- Study start15 Jul 2017
- Primary completion16 Jun 2022
- Study completion23 Nov 2023
Why it stopped: insufficient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (40)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Institut du Cancer de Montpellier - Val d'AurelleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- radiothérapy with concomittant chemotherapy
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Riou Olivier, MD, Study chair, ICM Val d'Aurelle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03255252
- Sponsor's protocol ID
- ICM-URC 2015/27
- Acronym
- IMMUVIX
- Status last verified
- May 2025
- First submitted
- 10 Aug 2017
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ferlay 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.
PubMed 25220842De 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.
PubMed 19709878zur 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.
PubMed 8876633Mauch 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.
PubMed 7713791Mell 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.
PubMed 18640499Kobayashi 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.
PubMed 19079205Jordanova 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.
PubMed 18381941Hasim A, Abudula M, Aimiduo R, Ma JQ, Jiao Z, Akula G, Wang T, Abudula A. Post-transcriptional and epigenetic regulation of antigen processing machinery (APM) components and HLA-I in cervical cancers from Uighur women. PLoS One. 2012;7(9):e44952. doi: 10.1371/journal.pone.0044952. Epub 2012 Sep 14.
PubMed 23024775Gadducci A, Guerrieri ME, Greco C. Tissue biomarkers as prognostic variables of cervical cancer. Crit Rev Oncol Hematol. 2013 May;86(2):104-29. doi: 10.1016/j.critrevonc.2012.09.003. Epub 2012 Sep 30.
PubMed 23031678Bell MC, Edwards RP, Partridge EE, Kuykendall K, Conner W, Gore H, Turbat-Herrara E, Crowley-Nowick PA. CD8+ T lymphocytes are recruited to neoplastic cervix. J Clin Immunol. 1995 May;15(3):130-6. doi: 10.1007/BF01543104.
PubMed 7559915Yamazawa K, Matsui H, Ishikura H, Seki K, Mitsuhashi A, Sekiya S. Significance of perivascular lymphocytic infiltrates on survival of patients with invasive cervical cancer. J Immunother. 2003 Mar-Apr;26(2):149-55. doi: 10.1097/00002371-200303000-00007.
PubMed 12616106Piersma SJ, Jordanova ES, van Poelgeest MI, Kwappenberg KM, van der Hulst JM, Drijfhout JW, Melief CJ, Kenter GG, Fleuren GJ, Offringa R, van der Burg SH. High number of intraepithelial CD8+ tumor-infiltrating lymphocytes is associated with the absence of lymph node metastases in patients with large early-stage cervical cancer. Cancer Res. 2007 Jan 1;67(1):354-61. doi: 10.1158/0008-5472.CAN-06-3388.
PubMed 17210718de Vos van Steenwijk PJ, Ramwadhdoebe TH, Goedemans R, Doorduijn EM, van Ham JJ, Gorter A, van Hall T, Kuijjer ML, van Poelgeest MI, van der Burg SH, Jordanova ES. Tumor-infiltrating CD14-positive myeloid cells and CD8-positive T-cells prolong survival in patients with cervical carcinoma. Int J Cancer. 2013 Dec 15;133(12):2884-94. doi: 10.1002/ijc.28309. Epub 2013 Jul 5.
PubMed 23740735Sznol M, Chen L. Antagonist antibodies to PD-1 and B7-H1 (PD-L1) in the treatment of advanced human cancer. Clin Cancer Res. 2013 Mar 1;19(5):1021-34. doi: 10.1158/1078-0432.CCR-12-2063.
PubMed 23460533Karim R, Jordanova ES, Piersma SJ, Kenter GG, Chen L, Boer JM, Melief CJ, van der Burg SH. Tumor-expressed B7-H1 and B7-DC in relation to PD-1+ T-cell infiltration and survival of patients with cervical carcinoma. Clin Cancer Res. 2009 Oct 15;15(20):6341-7. doi: 10.1158/1078-0432.CCR-09-1652. Epub 2009 Oct 13.
PubMed 19825956
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment Study to Evaluate Specific Immune Response in Locally Advanced Cervix Cancer After Radio-chemotherapy (IMMUVIX)
- ClinicalTrials.gov ID
- NCT03255252
- Acronym / sponsor ID
- IMMUVIX / ICM-URC 2015/27
- Conditions
- Cervical Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient recruitment
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'AurelleUniversity, hospital or other
- Study start
- 15 Jul 2017 (actual)
- Primary completion
- 16 Jun 2022 (actual)
- Study completion
- 23 Nov 2023 (actual)
- First posted
- 21 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cervical cancer is a real worldwide health care issue. High-risk human papillomavirus (HR-HPV) chronic infection is a co-factor in the development of the cervical cancer.
The HR-HPV genome encodes two oncoproteins (E6 and E7) which are required to sustain the malignant phenotype of pre-neoplastic lesions and are considered as foreign antigens recognized by the immune system, Many studies have suggested that local immunologic escape can cause the emergence of HPV-induced cervical cancer Radio-chemotherapy is the gold standard treatment for locally advanced cervical cancer, resulting in 2 year-control rates of about 70 to 85 %. A better and earlier understanding of the reasons for tumor escape may hopefully help to improve these outcomes.
Both radiation and chemotherapy are myelosuppressive treatments, but new treatment modalities such as Intensity-Modulated Radiation Therapy (IMRT) may allow a more rapid hematologic recovery. In addition to this immunosuppressive microenvironment, a significant number of tumor-infiltrating lymphocytes (TILs) are detected in cervical cancer tissue, highlighting interactions between tumor and immune cells.
Another issue is the fact that cancer cells develop different strategies to bypass the immune surveillance, such as a down-regulation of class I human leucocyte antigen (HLA) on tumor cells surface.
Furthermore, there is growing evidence of the importance of immune cells in response to cervical cancer treatment. TILs have been correlated with cervical cancer patients' outcome. More precisely, the location and type of these immune cells seem to be of great importance for the tumor response to treatment.
Receptors with negative regulatory function have been identified on the surface of those T cells, including CTLA4 and PD1 and seem to play a great role in tumor escape to treatment.
The presence of circulating tumor cells (CTCs) was shown to be correlated with a poor patient's prognosis in many cancers. A recent study suggested a potential mechanism of immune escape of these CTCs resulting in metastasis spreading.
The hypothesis of this study is that the frequency of PD1+,CD39+, specific phenotype of the non-regulatory CD4+ and CD8+ T cells among TILs is involved with the lack of response to the treatment and correlates with an early relapse after the treatment (i.e. patients with a very poor prognosis).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- radiothérapy with concomittant chemotherapy
| Arm | Type | Receives |
|---|---|---|
| Cisplatin | Experimental | Drug: Cisplatin injection, Combination Product: radiotherapyWeekly 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cisplatin injectionWeekly 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. | Drug | Cisplatin |
| radiotherapyA total dose of 45Gy in 25 fractions to the PTV is considered standard but simultaneous integrated boost or two steps boost to specific volumes (positive lymph nodes for example) are accepted and left to the investigator's discretion). | Combination product | Cisplatin |
Primary outcome
Expression of CD8+CD39+PD1+ lymphocytes infiltrate on cervix biopsies
Time frame: through study completion, an average of 1 year disease free survival
Cervix biopsies analysis
1 secondary outcome
Effect on 1-year DFS of other putative biomarkers (CD73, CD39, PD1 and Tim3) on the non-regulatory CD4+ and CD8+ lymphocytes
Time frame: through study completion, an average of 1 year disease free survival
Results and safety
The study was stopped early (reason given: insufficient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Background: PubMed 25220842Ferlay 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.
- Background: PubMed 19709878De 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.
- Background: PubMed 8876633zur 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.
- Background: PubMed 7713791Mauch 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.
- Background: PubMed 18640499Mell 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.
- Background: PubMed 19079205Kobayashi 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.
- Background: PubMed 18381941Jordanova 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.
- Background: PubMed 23024775Hasim A, Abudula M, Aimiduo R, Ma JQ, Jiao Z, Akula G, Wang T, Abudula A. Post-transcriptional and epigenetic regulation of antigen processing machinery (APM) components and HLA-I in cervical cancers from Uighur women. PLoS One. 2012;7(9):e44952. doi: 10.1371/journal.pone.0044952. Epub 2012 Sep 14.
- Background: PubMed 23031678Gadducci A, Guerrieri ME, Greco C. Tissue biomarkers as prognostic variables of cervical cancer. Crit Rev Oncol Hematol. 2013 May;86(2):104-29. doi: 10.1016/j.critrevonc.2012.09.003. Epub 2012 Sep 30.
- Background: PubMed 7559915Bell MC, Edwards RP, Partridge EE, Kuykendall K, Conner W, Gore H, Turbat-Herrara E, Crowley-Nowick PA. CD8+ T lymphocytes are recruited to neoplastic cervix. J Clin Immunol. 1995 May;15(3):130-6. doi: 10.1007/BF01543104.
- Background: PubMed 12616106Yamazawa K, Matsui H, Ishikura H, Seki K, Mitsuhashi A, Sekiya S. Significance of perivascular lymphocytic infiltrates on survival of patients with invasive cervical cancer. J Immunother. 2003 Mar-Apr;26(2):149-55. doi: 10.1097/00002371-200303000-00007.
- Background: PubMed 17210718Piersma SJ, Jordanova ES, van Poelgeest MI, Kwappenberg KM, van der Hulst JM, Drijfhout JW, Melief CJ, Kenter GG, Fleuren GJ, Offringa R, van der Burg SH. High number of intraepithelial CD8+ tumor-infiltrating lymphocytes is associated with the absence of lymph node metastases in patients with large early-stage cervical cancer. Cancer Res. 2007 Jan 1;67(1):354-61. doi: 10.1158/0008-5472.CAN-06-3388.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Riou Olivier, MD study chair
ICM Val d'Aurelle
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cisplatin injection and radiotherapy in people with Cervical Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: insufficient recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expression of CD8+CD39+PD1+ lymphocytes infiltrate on cervix biopsies (time frame: through study completion, an average of 1 year disease free survival). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03255252, which also lists 40 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.