Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Uterine Cervical Neoplasms

Recurrence

Disease Attributes

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

a single center, single-arm, open label, interventional study

TILs

He Yinyan

Prospective, single center, single-arm, open label, interventional study evaluating adoptive cell therapy (ACT) with autologous tumor infiltrating lymphocytes (TIL) infusion followed by IL-2 after a non-myeloablative (NMA) lymphodepletion preparative regimen for the treatment of patients with recurrent, metastatic cervical carcinoma.

TILs for Treatment of Metastatic or Recurrent Cervical Cancer

An Exploratory Clinical Study of TILs Treatment for Metastatic or Recurrent Cervical Cancer

Safety and tolerability of TILs, as determined by the rate of Dose Limiting Toxicities (DLTs)

To evaluate the efficacy of TILs in patients with recurrent, metastatic cervical carcinoma based on the objective response rate (ORR) as assessed by the Independent Review Committee (IRC) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

To evaluate the efficacy parameters of TILs in patients with recurrent, metastatic cervical carcinoma by assessing duration of response (DOR) as assessed by the IRC per RECIST v1.1

To evaluate the efficacy parameters of TILs in patients with recurrent, metastatic cervical carcinoma by assessing progression-free survival (PFS) as assessed by the IRC per RECIST v1.1

To evaluate overall survival (OS) in patients with recurrent, metastatic cervical carcinoma

To evaluate the efficacy of TILs in patients with recurrent, metastatic cervical carcinoma by assessing disease control rate (DCR) as assessed by the Investigator per RECIST v1.1

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai OriginCell Therapeutics Co., Ltd.

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Anti-Infective Agents

Nivolumab

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Aldesleukin

Ipilimumab

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Antimetabolites

Anti-HIV Agents

Anti-Retroviral Agents

Antiviral Agents

Tumor-infiltrating lymphocytes grown ex-vivo from resected from cancer tissue and reapplied to the patient via an intravenous infusion.

Autologous tumor-infiltrating lymphocytes

One treatment with ipilimumab (3 mg/kg) prior to tumor resection.

4 doses of nivolumab. Starting 2 days prior to TIL infusion and every 2 weeks hereafter.

2 MIE s.c. injection, after TIL infusion and continuing for 2 weeks

proleukin

Fludara

Anders H Kverneland, MD

Inge Marie Svane, MD, Prof.

This study will perform tumor-infiltrating lymphocyte (TIL)-based adoptive T-cell therapy in combination with checkpoint inhibition on cancer patients across all cancer diagnoses.

Adoptive cell therapy (ACT) is a personalized form of immunotherapy, where lymphocytes isolated from the patient's own tumor tissue are expanded 1000-fold ex-vivo and then infused back into the patient. The lymphocytes are then able to recognize and attack remaining cancer cells. This approach has shown remarkable clinical results in several trials conducted worldwide for patients with advanced melanoma - some with durable remissions. Promising clinical results were obtained in smaller trials where patients with disparate solid tumors were treated with tumor-infiltrating lymphocytes (TILs). At Center for Cancer Immune Therapy (CCIT) at Herlev Hospital, there are currently clinical trials undergoing in ovarian and renal cancer, and internationally ACT is being tested in an increasing number of cancer diagnoses, some trials are even recruiting patients across cancer types. Studies have shown that a high intratumoral infiltration with TILs in is correlated to the general clinical outcome of the disease in virtually all solid tumors, and thus clinical trials with TIL-based ACT to different cancer diagnoses have been undertaken.

To support the TIL-mediated tumor elimination, in classical ACT protocols patients go through a highly specialized treatment regime before and after TIL infusion. This regime includes lymphodepletion with 7 days non-myeloablative chemotherapy, to provide an immunological window of opportunity for the infused TILs, and concomitant immune stimulation with interleukin-2 (IL-2). Checkpoint inhibition to support the anti-tumor activity of TILs is currently under extensive investigation in several other trials worldwide. Thus, lymphodepletion and IL-2 stimulation are well-established as supportive therapy and already an integrated part of current ACT protocols and while checkpoint inhibition is a new addition at CCIT; internationally other centers have ongoing comparable trials.

Drug-based immunotherapy in the form of checkpoint inhibitors (anti-PD-1 and anti-CTLA-4) has yielded impressive clinical results across tumor histologies. Recent results indicate that the effect of immunotherapy relies not so much on the cancer diagnoses but rather on the genomic and immunologic features of the individual patient's cancer disease. Both ACT and checkpoint inhibition work by tipping the immunological balance in favor of activation and away from suppression or avoidance by the cancer cells. Scientific evidence now show that administering anti-CTLA-4 and PD-1 could provide a benefit in the ACT setting, and several ongoing clinical trials are testing combinations of ACT and checkpoint inhibition. To synergistically maximize the immunological potential, we wish to combine ACT with an anti-CTLA-4 antibody (Ipilimumab) prior to tumor resection and an anti-PD-1 antibody (Nivolumab) in combination with TIL infusion.

Patients will be treated with one dose of Ipilimumab 14 days before undergoing surgery to harvest tumor material for TIL production. Patients is admitted on day -8 in order to undergo lymphodepleting chemotherapy with cyclophosphamide and fludara starting day -7. On day -2 patients will start treatment with Nivolumab every 2 weeks for a total of 4 doses to increase the activity of the infused TIL product.

Available evidence indicates that ACT is a safe and feasible treatment option in an increasing number of solid tumors, and that it should be tested in all cancer patients regardless of their cancer diagnosis.

Adoptive Cell Therapy Across Cancer Diagnoses

Determine the safety of the administration of TIL therapy including checkpoint inhibitors, lymphodepleting chemotherapy and Interleukin-2 for patients with cancer by reporting adverse events according to CTCAE v. 4.0.

Clinical response in progression-free survival to treatment according to RECIST 1.1

Clinical response in terms of overall survival.

Flow cytometry-based immunological evaluation of peripheral blood

Inge Marie Svane

M.D. Professor

Immune System Diseases

Rare Diseases

Carcinoma

Carcinoma, Transitional Cell

Hypersensitivity

Urinary Bladder Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Transitional Cell Carcinoma

Bladder cancer (BC) is a heterogeneous malignancy with dismal outcome.Despite treatment, the 5-year overall survival rates for MIBC are \<50%, with many patients unresponsive or inapt, necessitating biomarkers to select those most likely to respond or fit for treatment

In this study was assessed the associations among most frequently mutated genes and with clinicopathological features, as well as the prognostic significance of the presence of mutations in the top mutated and DNA Damage response (DDR) mutated genes in terms of Overall Survival (OS). Moreover, overall tumor-infiltrating lymphocytes (TILs) density was measured, analyzed immunohistochemically the expression of PD-L1, the four MMR proteins (MLH1, MSH2, MSH6 and PMS2) and tumor or stromal CD8+ cytotoxic T lymphocyte infiltrates and assessed their association with each other, top mutated genes and available clinicopathological parameters together with their role in prognosis.

Prognostic Biomarkers in Patients With Urothelial Carcinoma

Investigation of Prognostic Biomarkers in Patients With Urothelial Carcinoma Treated With Platinum Regimens

Hellenic Cooperative Oncology Group

Glioma

Glioblastoma

Astrocytoma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Neuroepithelioma

1x10\^9-5x10\^10 of autologous TILs will be adoptive transfer to patients.

The autologous TILs will be intravenous infused into patients.

Tumor Infiltrating Lymphocytes (TIL)

Na Kuang

Chunyan Li, academician

The study is to evaluate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy for patients with maligant glioblastoma multiforme. Autologous TiLs should be given by intravenous infusion after 5 days of lymphodepletion treatment.

The Safety Study of Autologous TILs Therapy for Patients With Glioblastoma Multiforme.

The Safety and Efficacy Study of Autologous Tumor-infiltrating Lymphocyte (TILs) Therapy Combined With Conventional Chemotherapy for Patients With Advanced Stage of Glioblastoma Multiforme.

The primary outcome measure of this clinical trial is accessed by the safety of the TILs product. The safety profile for TILs is characterized by its incidence of the adverse events.

PFS is defined as the duration of time from start of treatment to time of progression. All patients will be followed for a minimum of 2 years.

Hebei Senlang Biotechnology Inc., Ltd.

Gland and Hormone Related Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Ascites

Fallopian Tube Neoplasms

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Endocrine System Diseases

Gonadal Disorders

Fallopian Tube Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Participants will receive the following interventions because they are enrolled in the study: blood sample collection

* at diagnosis, before chemotherapy (pre-CT)
* after chemotherapy (post-ct)

Intervention : Collection of two blood samples (5mL)

* before chemotherapy (pre-CT), at diagnosis, up to 1 month after enrollment
* and then, after chemotherapy (post-CT), up to 3 months after enrollment

Participants will receive the following interventions because they are enrolled in the study: blood sample collection

* at diagnosis, before chemotherapy (pre-CT)
* after chemotherapy (post-ct) Collection of two blood samples (5mL),
* before chemotherapy (pre-CT), at diagnosis, up to 1 month after enrollment
* and then, after chemotherapy (post-CT), up to 3 months after enrollment

Blood sample collection

Marie Vanseymortier

Delphine Hudry, MD

Fabrice Narducci, MD

Cyril Abdeddaim, MD

Annick Chevalier, MD

Eric Leblanc, MD

Emilie Kaczmarek, MD

Alfred Bassil, MD

Charlotte Bellier, MD

This is a monocenter, interventional, non-randomized study among women patients with an ovarian or tubal cancer who will receive a surgery or adjuvant chemotherapy treatment, or a neo-adjuvant chemotherapy then surgery +/- adjuvant chemotherapy. The planned interventions are collection of biological samples at different times. The study will aim to describe the immunological profile at diagnosis in terms of phenotypic : PBMCs (peripheral blood, mononuclear cells) in peripheral blood, TILs (tumor-infiltrating lymphocytes) in ascites and in carcinomatosis.

Participants will receive the following interventions because they are enrolled in the study: blood sample collection

* at diagnosis, before chemotherapy (pre-CT)
* after chemotherapy (post-ct)

Two additional blood samples will be collected in each patient : one at diagnosis and one at the end of chemotherapy.

The aim of this study is to describe the immunological profile at diagnosis in terms of phenotypic : PBMC in peripheral blood, TILs in ascites and in carcinomatosis, in patients treated for peritoneal carcinomatosis of ovarian or tubal origin. The treatment has to be a surgery and an adjuvant chemotherapy, or a neo-adjuvant chemotherapy followed by a surgery +/- adjuvant chemotherapy.

Other objectives of the study include:

* Evaluate the association between the immunological profile at diagnosis and the characteristics of the disease at diagnosis (histological type, extension)
* Evaluate the prognostic value of the immunological profile at diagnosis in terms of clinical response to neoadjuvant chemotherapy (for patients with interval surgery)
* Evaluate the polarization of the immune response induced by chemotherapy, describing the phenotypic changes in the different types of samples (blood, +/- ascites, +/- carcinomatosis) after chemotherapy in comparison with samples at diagnostic
* Evaluate the association between these immunological phenotypic changes and the clinical response to chemotherapy in patients receiving neoadjuvant chemotherapy
* Collect biological material for peritoneal carcinomatosis for subsequent biological analyzes

Phenotypic Characterization Tumor-infiltrating Lymphocytes at Diagnosis and After Chemotherapy in Ovarian Cancer

Phenotypic Characterization Tumor-infiltrating Lymphocytes at Diagnosis and After Chemotherapy in Advanced High-grade Serous Ovarian Cancer in Blood, Ascites, Peritoneal Biopsy

For each sample taken (blood / ascites / peritoneal carcinomatosis fragment), before chemotherapy, the lymphocyte populations will be counted by flow cytometry (CMF). For this, 4 panels of 32 markers will be used to identify 5 populations of lymphocytes: Thelper, B lymphocytes, TREG, TFH, TCD8, and immuno checkpoint

For each sample taken (blood / ascites / peritoneal carcinomatosis fragment), at the end of chemotherapy, the lymphocyte populations will be counted by flow cytometry (CMF). For this, 4 panels of 32 markers will be used to identify 5 populations of lymphocytes: Thelper, B lymphocytes, TREG, TFH, TCD8, and immuno checkpoint

To check if there is an extension to the pleura (FIGO-IV) or not (FIGO-IIIC)

In patients receiving neo-adjuvant chemotherapy, clinical response to chemotherapy defined by a partial or complete radiological response (assessed on the thoraco-abdominopelvic CT scan), associated with a decrease in CA125 and a disappearance of ascites in case of ascites at inclusion

Rate of patients with no residual disease on excised tissue regarding the assessment of histological response to chemotherapy

Time between the diagnosis and the progression of the disease or the death of the patient, whatever the cause

Time between diagnosis and death, whatever the cause

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
TILs for Treatment of Metastatic or Recurrent Cervical Cancer	NCT04674488	TILs, Metastati...	TILs	18 Years - 70 Years	Shanghai OriginCell Therapeutics Co., Ltd.
Adoptive Cell Therapy Across Cancer Diagnoses	NCT03296137	Cancer	Autologous tumo... Ipilimumab Nivolumab proleukin Cyclophosphamid... Fludara	18 Years - 70 Years	Herlev Hospital
Adoptive Cell Therapy Across Cancer Diagnoses	NCT03296137	Cancer	Autologous tumo... Ipilimumab Nivolumab proleukin Cyclophosphamid... Fludara	18 Years - 70 Years	Herlev Hospital
Prognostic Biomarkers in Patients With Urothelial Carcinoma	NCT04872036	Bladder Cancer		18 Years -	Hellenic Cooperative Oncology Group
The Safety Study of Autologous TILs Therapy for Patients With Glioblastoma Multiforme.	NCT05333588	Glioblastoma Mu...	Tumor Infiltrat...	18 Years - 80 Years	Hebei Senlang Biotechnology Inc., Ltd.
Prognostic Biomarkers in Patients With Urothelial Carcinoma	NCT04872036	Bladder Cancer		18 Years -	Hellenic Cooperative Oncology Group
Phenotypic Characterization Tumor-infiltrating Lymphocytes at Diagnosis and After Chemotherapy in Ovarian Cancer	NCT03922776	Ovarian Cancer ... Fallopian Tube ... Fallopian Tube ... Ovarian Cancer ...	Blood sample co...	18 Years -	Centre Oscar Lambret

Spots Global Cancer Trial Database for tils

Every month we try and update this database with for tils cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for tils

Every month we try and update this database with for tils cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for tils cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.