Clinical trials: Tertiary Lymphoid Structures (TLS)
Chronic Graft Versus Host Disease
Tissue Immune Landscape of Graft Versus Host Disease After Allogeneic Stem Cell Transplantation (TIL-GVHD)
Graft versus Host Disease (GVHD) is frequent after allogeneic stem cell transplantation (alloSCT). GVHD occurs following 2 patterns : acute GVHD (aGVHD) or chronic GVHD (cGVHD).
- Trial name
- TIL-GVHD (NCT06247150)
- Testing
- Additional blood sample, cGVHD target tissue biopsy
- Where
- France
- Volunteers
- 70 people
- Sponsor
- University Hospital, Bordeaux
Adult Soft Tissue Sarcoma, Non Small Cell Lung Cancer
Targeting MDMD and PD1 in Tumors With Tertiary Lymphoid Structures
Phase II, multicenter, open-label, multi-cohort proof-of-concept study designed to evaluate the safety and efficacy of Ezabenlimab combined with BI 907828 in patients with unresectable, locally advanced or metastatic solid tumors.
- Conditions
- Adult Soft Tissue Sarcoma, Non Small Cell Lung Cancer, Triple Negative Breast Cancer, Colorectal Cancer
- Trial name
- EMPIRE (NCT06084689)
- Testing
- Ezabenlimab + BI907828
- Where
- 6 sites in France
- Sponsor
- Institut Bergonié
Metastatic Cancer Lung, Advanced Lung Cancer
Targeting PD-L1 and TIGIT in Tumors With Tertiary Lymphoid Structures
This study encompasses multicenter open-label, phase II trials. Patients will be dispatched into 2 cohorts: Cohort A: Patients naïve from systemic treatment will be randomized according to two treatment modalities: atezolizumab +…
- Conditions
- Metastatic Cancer Lung, Advanced Lung Cancer, CBNPC Cancer
- Trial name
- INDIGO (NCT06713798)
- Testing
- Atezolizumab 1200 mg IV, Tiragolumab 600 mg IV
- Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
Resectable Sarcoma
Neoadjuvant Chemotherapy and Retifanlimab in Patients With Selected Sarcomas (TORNADO)
Multicenter, prospective, open-labeled, 2-arm, non-comparative randomized phase II trial to assess the antitumor activity of retifanlimab (INCMGA00012) in association with neoadjuvant chemotherapy
- Trial name
- TORNADO (NCT04968106)
- Testing
- Doxorubicin, Ifosfamide, INCMGA00012
- Where
- 3 sites in France
- Volunteers
- 66 people
- Sponsor
- Institut Bergonié
Nasopharyngeal Cancinoma (NPC)
Tertiary Lymphoid Structures in Nasopharyngeal Carcinoma
This study aims to conduct a prospective cohort study to validate the prognostic performance of Tertiary Lymphoid Structures (TLSs) as a predictive marker in pathological tissue sections for nasopharyngeal carcinoma (NPC).
- Trial name
- NCT06770699
- Where
- China
- Volunteers
- 260 people
- Sponsor
- Jiangxi Provincial Cancer Hospital
Prostate Cancer
Heterogeneity of Tertiary Lymphoid Structures Predicts Distinct Malignancy and Immune Microenvironment in Prostate Cancer: a Retrospective Cohort Study
The aim of this study was to reveal the predictive value of spatial heterogeneity and maturity difference of tertiary lymphoid structure in pathological sections of prostate cancer patients for clinical features and prognosis.
- Trial name
- NCT06484127
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Fudan University
Colorectal Cancer Not MSI-H or MMR-deficient, GIST
A Phase I/II Study of Regorafenib Plus Avelumab in Solid Tumors
Assessment of the efficacy and safety of Regorafenib and Avelumab in patients with advanced or metastatic solid tumors (ten cohorts), once the Recommanded Phase II Dose (RP2D) has been determined (phase I trial).
- Conditions
- Colorectal Cancer Not MSI-H or MMR-deficient, GIST, Oesophageal or Gastric Carcinoma, Biliary Tract Cancer
- Trial name
- REGOMUNE (NCT03475953)
- Testing
- Phase 1 : Regorafenib, Phase 1 : Avelumab, Phase 2 : Regorafenib
- Where
- 7 sites in France
- Volunteers
- 747 people
- Sponsor
- Institut Bergonié
Locally Advanced Gastric Cancer, Tumor Immune Microenvironment
Machine Learning Model Guided by TLS Predicts Survival and Immune Features in Gastric Cancer
This study aims to develop and validate a machine learning model that uses information from tertiary lymphoid structures (TLSs)-specialized immune-related cell clusters found near tumors-to predict survival outcomes and immune…
- Conditions
- Locally Advanced Gastric Cancer, Tumor Immune Microenvironment, Tertiary Lymphoid Structures (TLS)
- Trial name
- NCT06979817
- Testing
- TLS-Informed Machine Learning Prognostic Model
- Volunteers
- 1,200 people
- Sponsor
- Qun Zhao
Cancer
Study Evaluating Pembrolizumab +/- Olaparib in TLS Positive Selected Resectable STS Followed by Adjuvant Pembrolizumab
Soft tissue sarcomas represent a subtype of cancer that is both rare and very heterogeneous. When they are organized, their current treatment is essentially based on tumor resection surgery, +/- associated with treatment by…
- Trial name
- NeoSarc (NCT06116578)
- Testing
- Pembrolizumab, Pembrolizumab and Olaparib, Pembrolizumab adjuvant
- Where
- France
- Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
Metastatic Non-Clear Cell Renal Cell Carcinoma, Metastatic Renal Medullary Carcinomas
MANTIS-RCC: Toripalimab-Axitinib Induction in TLS-Positive Advanced Non-Clear Cell and Renal Medullary Carcinomas
This Phase II study will evaluate toripalimab plus axitinib in adults with previously untreated, synchronous metastatic non-clear cell renal cell carcinoma and renal medullary carcinomas whose primary kidney tumor remains in…
- Trial name
- MANTIS-RCC (NCT07816770)
- Testing
- Toripalimab, Axitinib, Deferred Cytoreductive Nephrectomy
- Volunteers
- 30 people
- Sponsor
- Fudan University
Muscle-Invasive Bladder Carcinoma, Urothelial Carcinoma (UC)
Immune-Stromal Landscape in Muscle-Invasive Bladder Cancer
Bladder cancer is a significant global health issue. When the cancer spreads into the muscle layer of the bladder (muscle-invasive bladder cancer), a common treatment is the surgical removal of the bladder (radical cystectomy).
- Conditions
- Muscle-Invasive Bladder Carcinoma, Urothelial Carcinoma (UC), Bladder Cancer, Muscle-Invasive Urothelial Bladder Carcinoma
- Trial name
- NCT07525349
- Volunteers
- 100 people
- Sponsor
- Assiut University
Metastatic Clear Cell Renal Cell Carcinoma, Advanced Clear Cell Renal Cell Carcinoma
TACTIC-RCC: Toripalimab Plus Axitinib Induction With Selective Deferred Cytoreductive Nephrectomy in TLS-Positive Advanced Clear Cell Renal Cell Carcinoma
This prospective, open-label, single-arm Phase 2 study is evaluating toripalimab plus axitinib as induction therapy for adults with newly diagnosed metastatic clear cell renal cell carcinoma whose primary kidney tumor remains in…
- Trial name
- TACTIC-RCC (NCT07776717)
- Testing
- Toripalimab, Axitinib, Deferred Cytoreductive Nephrectomy
- Volunteers
- 30 people
- Sponsor
- Fudan University
Soft Tissue Sarcoma Adult, Advanced Cancer
Combination of Nivolumab Plus Relatlimab in Patients With Advanced or Metastatic Soft-tissue Sarcoma: a Proof-of-concept Randomized Phase II Study
This is a multicenter study assessing the efficacy of nivolumab in association with relatlimab.
- Trial name
- CONGRATS (NCT04095208)
- Testing
- Association of Nivolumab + Relatlimab, Nivolumab
- Where
- 5 sites in France
- Volunteers
- 68 people
- Sponsor
- Institut Bergonié
Epithelial High Grade Serous Ovarian Cancer
Elements of Adaptive Immunity in Epithelial Ovarian Cancer
The study seeks to evaluate the presence and correlation with clinical outcome of several components of adaptive immunity (TILs, TLS, plasma cells and PD-L1 expression) in tumor specimens of patients with EOC treated with…
- Trial name
- NCT07528911
- Testing
- Assessment of elements of adaptive immunity in tumor biopsies
- Where
- Greece
- Volunteers
- 687 people
- Sponsor
- Hellenic Cooperative Oncology Group
Advanced Soft-tissue Sarcoma, Metastatic Soft-tissue Sarcoma
Bintrafusp Alfa and Doxorubicin Hydrochloride in Treating Patients With Advanced Sarcoma
This study encompasses two multicenter, prospective, open-labeled, 2-arm, non-comparative randomized phase II trials to assess the antitumor activity of bintrafusp alfa in association with doxorubicin
- Trial name
- TRUST (NCT04874311)
- Testing
- Bintrafusp alfa, Doxorubicin
- Where
- 6 sites in France
- Volunteers
- 80 people
- Sponsor
- Institut Bergonié
Renal Cell Carcinoma (RCC)
Tertiary Lymphoid Structures Related Genes Predicting Prognosis in Clear Cell Renal Cell Carcinoma: a Retrospective Cohort Study
The purpose of this research was to uncover the prognostic significance of tertiary lymphoid structures related genes from ccRCC patients with respect to clinical characteristics and outcomes.
- Trial name
- NCT06883565
- Where
- China
- Volunteers
- 232 people
- Sponsor
- Ding-Wei Ye
Hepatocellular Carcinoma, Immunotherapy
Study on the Classification of Comprehensive Treatment Effect of Hepatocellular Carcinoma
Through a retrospective study of patients who underwent comprehensive treatment for hepatocellular carcinoma at the Second Affiliated Hospital of Zhejiang University, we explored the risk factors related to the sensitivity of…
- Trial name
- NCT06542796
- Testing
- Immunotherapy combined with targeted therapy, Standard treatment plan
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Advanced Solid Tumor, Advanced Colorectal Carcinoma
Combining Epigenetic And Immune Therapy to Beat Cancer.
Umbrella study structure to independently and simultaneously assess the effects of the association of durvalumab and tazemetostat in multiple solid tumors.
- Conditions
- Advanced Solid Tumor, Advanced Colorectal Carcinoma, Advanced Soft-tissue Sarcoma, Advanced Pancreatic Adenocarcinoma
- Trial name
- CAIRE (NCT04705818)
- Testing
- Durvalumab, Tazemetostat
- Where
- 3 sites in France
- Volunteers
- 164 people
- Sponsor
- Institut Bergonié
Advanced Solid Tumor
MEDI5752 in Patients With Mature Tertiary Lymphoid Structures Solid Tumors.
Multicentric, prospective, multi-indication, single-treatment arm, open-label phase II trial assessing the efficacy of MEDI5752
- Trial name
- TAYLOR (NCT05888857)
- Testing
- MEDI5752
- Where
- France
- Volunteers
- 102 people
- Sponsor
- Institut Bergonié
Breast Neoplasms
Study Of Capecitabine Combined With Camrelizumab For Non-pCR TNBC With TLS After Neoadjuvant Chemoterapy
This study aims to evaluate the efficacy and safety of camrelizumab in combination with capecitabine compared to placebo in combination with capecitabine as adjuvant therapy for patients with triple-negative breast cancer (TNBC)…
- Trial name
- NCT06313463
- Testing
- Carrellizumab + Capecitabine
- Where
- China
- Volunteers
- 375 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University