Clinical trials: IrAE, active
Non-Small Cell Lung Cancer
A Perioperative Comprehensive Diagnosis and Treatment System for Lung Cancer in the Era of Neoadjuvant Immunotherapy
The goal of this study is to develop and refine an integrated minimally invasive care pathway for resectable lung cancer in the immunotherapy era, establishing a novel precision perioperative immunotherapy paradigm encompassing…
- Trial name
- NCT07119190
- Volunteers
- 350 people
- Sponsor
- Peking University People's Hospital
Advanced Malignant Solid Neoplasm, Hematopoietic and Lymphatic System Neoplasm
Siltuximab for the Prevention of Severe Immune-Related Adverse Events During Immune Checkpoint Inhibitor Rechallenge in Patients With Advanced Cancer, CIRES Trial
This phase II trial studies how well giving siltuximab during the reintroduction (rechallenge) of immune checkpoint inhibitor (ICI) therapy works in preventing severe immune-related adverse events (irAEs) in patients with cancer…
- Trial name
- NCT06470971
- Testing
- Anti-PD-L1 Monoclonal Antibody, Anti-PD1 Monoclonal Antibody, Biopsy
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Yuanquan Yang
Arthritis, Arthropathy
Radiation to Treat Joint Damage Caused by Cancer Immunotherapy
This study will prospectively investigate the feasibility and safety of administering LDRT in patients with immunotherapy-induced inflammatory arthritis.
- Trial name
- NCT07478679
- Testing
- Low dose radiation therapy
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Chicago
Immune-related Adverse Event, Neoadjuvant Therapy
Exploring the Treatment Duration of PD-1 Neoadjuvant Therapy in Stage II-III dMMR Rectal Cancer
This study aims to explore the optimal number of cycles of PD-1 monotherapy required at minimum, under the premise of ensuring pathological complete response (pCR) among patients with dMMR/MSI-H rectal cancer.
- Conditions
- Immune-related Adverse Event, Neoadjuvant Therapy, dMMR Colorectal Cancer
- Trial name
- NCT06613165
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Xijing Hospital
Immunotherapy, Immune Checkpoint Inhibitors
Identification of Predictive Biomarkers for Immune-Related Adverse Events (irAEs) in Patients Undergoing Immune CheckPoint Inhibitors (ICPI) Treatment
In the last decades, cancer treatment was based on surgery, radiotherapy and chemotherapy. Recently, treatments have largely evolved, first with targeted therapies (notably tyrosin kinase inhibitors, TKI) and then with immune…
- Conditions
- Immunotherapy, Immune Checkpoint Inhibitors, Immune-related Adverse Event, Predictive Biomarkers
- Trial name
- Ibe2i-TIPCI (NCT05813418)
- Testing
- blood retriewal
- Where
- France
- Volunteers
- 150 people
- Sponsor
- Centre Hospitalier Universitaire, Amiens
Atherosclerosis, Melanoma
Statins to Prevent Immune Checkpoint Inhibitor-induced PRogression of AtherosLerosis
The goal of this interventional study is to test whether atorvastatin prevents accelerated progression of atherosclerosis in melanoma patients who receive immune checkpoint inhibitor (ICI) therapy.
- Conditions
- Atherosclerosis, Melanoma, Immune-related Adverse Event
- Trial name
- SPIRAL (NCT06785974)
- Testing
- Atorvastatin
- Where
- Netherlands
- Volunteers
- 140 people
- Sponsor
- Erasmus Medical Center
Melanoma Stage III, Melanoma Stage IV
Infliximab for Treatment of Immune Checkpoint Inhibitor Colitis
The goal of this clinical trial is to compare the safety and effectiveness of infliximab compared to steroids for the treatment of immune checkpoint inhibitor-induced colitis (ICI colitis) in patients with stage III/IV skin…
- Conditions
- Melanoma Stage III, Melanoma Stage IV, Skin Cancer Stage III, Skin Cancer Stage IV
- Trial name
- NCT04305145
- Testing
- Infliximab, Methylprednisolone, Prednisone
- Where
- 2 sites in United States
- Volunteers
- 42 people
- Sponsor
- Massachusetts General Hospital
Malignancy, Immune Related Adverse Events
Evaluating Informatics-assisted Immune-related Adverse Event Detection to Improve Registration Onto a Biorepository
Immunotherapies have improved cancer outcomes, but have a unique profile of immune-related adverse events (irAEs). Biorepositories have been established to collect data and samples to help improve our understanding of irAEs…
- Trial name
- NCT06789601
- Testing
- Informatics system for eligibility monitoring, Standard eligibility monitoring
- Where
- 2 sites in United States
- Volunteers
- 100 people
- Sponsor
- Brigham and Women's Hospital
IrAE, Immune-related Adverse Event
Vedolizumab for the Prevention of ICI Related Diarrhea or Colitis in Patients With Cancer
The purpose of this study is to assess the prevention of immune checkpoint inhibitors (ICI) related diarrhea/colitis using vedolizumab in participants with unresectable stage III or metastatic stage IV cancer, starting standard…
- Conditions
- IrAE, Immune-related Adverse Event, Diarrhea, Colitis
- Trial name
- NCT06337695
- Testing
- Vedolizumab
- Where
- 2 sites in Canada
- Volunteers
- 36 people
- Sponsor
- AHS Cancer Control Alberta
Immune-related Adverse Event, Diarrhea
Prophylactic Mesalamine to Prevent Colitis Following Treatment With Ipilimumab/Nivolumab (Ipi/Nivo)
The study team's principal interest is to address the question, "Will prophylactic treatment with mesalamine reduce the incidence and severity of immune-related diarrhea occurring secondarily to treatment with ipi/nivo?"
- Conditions
- Immune-related Adverse Event, Diarrhea, Advanced Melanoma, Advanced Rectal Carcinoma
- Trial name
- IMPACT 1 (NCT05663775)
- Testing
- Mesalamine
- Where
- Canada
- Volunteers
- 20 people
- Sponsor
- AHS Cancer Control Alberta
IrAE, Hematologic Disorder
Golidocitinib for Refractory Immune-related Hematologic Toxicities of Advanced Lung Cancer
This study is a single-arm clinical trial designed to evaluate the safety and efficacy of golidocitinib in patients with refractory, immune-related hematologic toxicity in advanced lung cancer.
- Conditions
- IrAE, Hematologic Disorder, Lung Cancer (Locally Advanced or Metastatic)
- Trial name
- JACKPOT22 (NCT07303881)
- Testing
- golidocitinib
- Where
- China
- Volunteers
- 16 people
- Sponsor
- The First Affiliated Hospital of Guangzhou Medical University
Pneumonitis, Immune-related Adverse Event
Inhaled Budesonide for REcurrence Prevention and Adjuvant THerapy in Checkpoint Inhibitor Pneumonitis
The introduction of immune checkpoint inhibitors (immunotherapy) that stimulate our immune system to recognize and attack cancer cells has been one of the most exciting advances in oncology over the last decade.
- Trial name
- NCT06860542
- Testing
- Arm 2- Budesonide (Pulmicort® Turbuhaler®) + Usual care, Arm 1- Usual care
- Where
- Canada
- Volunteers
- 94 people
- Sponsor
- AHS Cancer Control Alberta
Cancer, Metastatic Cancer
Biomarkers of Immune-Related Toxicity
This is a single-center, correlative pilot study evaluating potential biomarkers predictive of immune-related adverse events associated with immune checkpoint inhibitor therapy.
- Trial name
- NCT03409016
- Testing
- Blood Testing
- Where
- United States
- Volunteers
- 69 people
- Sponsor
- University of Colorado, Denver
Immune-related Adverse Event, Malignant Solid Tumors
The Effect of Serum Ferritin in irAE
This is a prospective clinical study to clarify serum ferritin as a biomarker for the diagnosis, differential diagnosis and prognosis of immune-related adverse event(irAE).
- Conditions
- Immune-related Adverse Event, Malignant Solid Tumors, Acute Leukemia, Serum Ferritin
- Trial name
- NCT06702566
- Testing
- PD-1 and PD-L1 inhibitor, Targeted drugs, chemotherapy drugs
- Where
- China
- Volunteers
- 1,500 people
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
Cancer
A Clinical and Biological Prospective Database of Patients Treated With Anticancer Immunotherapy and Follow up of Their Immune-related Adverse Events irAE
The number of patients affected by cancer and treated with immunotherapy is continuously increasing. With the advent of these new therapies, the investigators observe the emergence of new and unexpected toxicities.
- Trial name
- IMMUCARE-BASE (NCT03989323)
- Testing
- Estimation of the incidence of the irAE
- Where
- 5 sites in France
- Volunteers
- 2,000 people
- Sponsor
- Hospices Civils de Lyon
Patients With Advanced Solid Tumors Who Discontinued Treatment Due to irAE
Ivarmacitinib in Advanced Solid Tumors: A Prospective, Two-Cohort, Two-Phase Exploratory Study in Patients Discontinued Due to Immune Intolerance
This study is a Phase II, two-cohort, multicenter, two-stage clinical trial. It plans to enroll 72 subjects with solid tumors who discontinued prior ICI therapy due to irAE.
- Trial name
- NCT07313202
- Testing
- Ivarmacitinib
- Volunteers
- 72 people
- Sponsor
- Fujian Cancer Hospital
Cancer, Immunotherapy
Exploring Physical and Psychological Needs and Quality of Life in Patients With Advanced Cancer Receiving Immunotherapy
During the immune checkpoint inhibitor therapy (ICIT), most of the patients stay at home, but there is lacking of the studies to explore their physical and psychological distress, financial toxicity, care needs, and quality of…
- Conditions
- Cancer, Immunotherapy, IrAE, Distress, Emotional
- Trial name
- NCT06461780
- Where
- Taiwan
- Volunteers
- 200 people
- Sponsor
- Taipei Veterans General Hospital, Taiwan
Melanoma, Immune-related Adverse Event
Thymosin Alpha 1 Combined With Anti-PD-1 Monoclonal Antibody in Elderly Patients With Advanced Melanoma
Primary Objective: To evaluate the effectiveness of Thymosin Alpha-1 combined with PD-1 monoclonal antibody in elderly patients with advanced melanoma .
- Conditions
- Melanoma, Immune-related Adverse Event, Immune Checkpoint Inhibitor
- Trial name
- NCT07644897
- Testing
- Thymosin Alpha 1 and Anti-PD-1 monoclonal antibody
- Where
- 2 sites in China
- Volunteers
- 55 people
- Sponsor
- Sun Yat-sen University
Cancer, Immune Checkpoint Inhibitor
Fast-Track Cardiovascular Assessment for Suspicion of Cardiovascular Events on Immunecheckpoint Inhibitors
Prospective study cohort on patients addressed for suspected cardiovascular event on immune checkpoint inchibitors. Longitudinal prospective single center cohort.
- Conditions
- Cancer, Immune Checkpoint Inhibitor, Cardiovascular Complication, Immune-related Adverse Event
- Trial name
- FAST-TRACK (NCT05799898)
- Testing
- No intervention for research purposes only
- Where
- France
- Volunteers
- 200 people
- Sponsor
- Institut Mutualiste Montsouris
Hepatocellular Carcinoma (HCC), IrAE
The Safety and Efficacy of Ondansetron in Reducing Immune Checkpoint Inhibitor-Related Toxicities
This study is a prospective, randomized, single-center randomized controlled clinical trial to investigate the safety and efficacy of ondansetron in reducing the toxicity associated with immune checkpoint inhibitor treatment.
- Trial name
- NCT07381634
- Testing
- ondansetron
- Where
- China
- Volunteers
- 134 people
- Sponsor
- First Affiliated Hospital of Wenzhou Medical University