Clinical trials: Immune-related Adverse Events, open to volunteers
Immune-Related Adverse Events
Rituximab for Treatment of Checkpoint Inhibitor Induced Immune-related Adverse Events
The goal of this clinical trial is to investigate the safety of rituximab for management of immune-related adverse events in malignant melanoma patients.
- Trial name
- RiTOX (NCT07694414)
- Testing
- Rituximab (RTX)
- Where
- Denmark
- Volunteers
- 25 people
- Sponsor
- Inge Marie Svane
Solid Tumor Cancer, Immune-Related Adverse Events
Cancer Nutrition Study - A Study of Dietary Interventions in Cancer Patients Treated With Immune Checkpoint Inhibitors
The goal of this clinical trial is to learn whether changing the diet can help improve gut health and support recovery from immune-related side effects caused by immune checkpoint inhibitor (ICI) cancer treatment in adults with…
- Trial name
- CaNS (NCT07804225)
- Testing
- High-Fermented Food Diet, HI-MAIZE 260 Resistant Starch
- Volunteers
- 50 people
- Sponsor
- Thomas Jefferson University
Immune-mediated Hepatitis, Immune-related Adverse Event
Mycophenolate Mofetil w/ Prednisone for Immune Related Hepatitis From Checkpoint Inhibitor Therapy
This phase II study evaluates whether early treatment with mycophenolate mofetil (MMF) plus prednisone improves liver inflammation caused by immune checkpoint inhibitors.
- Trial name
- NCT07663422
- Testing
- Mycophenolate Mofetil plus prednisone
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- Fox Chase Cancer Center
Immune Checkpoint Inhibitor-related Rash, Immune-related Adverse Events
Wucao Anfu Formula as Adjunctive Treatment for Immune Checkpoint Inhibitor-Related Rash
Immune checkpoint inhibitors have improved outcomes for patients with cancer, but immune checkpoint inhibitor-related skin rash is a common adverse event that may affect quality of life and continuation of anticancer therapy.
- Trial name
- NCT07821424
- Testing
- Wucao Anfu Formula, Standard management
- Volunteers
- 72 people
- Sponsor
- First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
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
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
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
Immune-Related Adverse Events
Study on Biomarkers of Immune-Related Adverse Events
1. To identify biomarkers of immune-related adverse events; 2. To develop a predictive model for immune-related adverse events.
- Trial name
- NCT07527585
- Volunteers
- 440 people
- Sponsor
- Huazhong University of Science and Technology
Immune-Related Adverse Events
Immune-Related Adverse Events After Cancer Immunotherapy and Safety of Treatment Rechallenge
This observational study aims to comprehensively characterize immune-related adverse events (irAEs) occurring during immune checkpoint inhibitor (ICI) therapy in cancer patients and to evaluate the safety and clinical outcomes of…
- Trial name
- NCT07453342
- Testing
- Immune Checkpoint Inhibitors
- Where
- China
- Volunteers
- 500 people
- Sponsor
- Peking Union Medical College Hospital
Inflammatory Arthritis, Immune-related Adverse Event
Early Adalimumab Induction for Immune Checkpoint Inhibitor Associated Inflammatory Arthritis
This study will examine the effectiveness of administering adalimumab as a treatment for patients in the early stages of steroid-dependent immune checkpoint Inhibitor associated inflammatory arthritis (ir-IA).
- Trial name
- NCT06037811
- Testing
- Adalimumab, Prednisone
- Where
- Canada
- Volunteers
- 30 people
- Sponsor
- Tom Appleton
Pathological Complete Remission, Objective Response Rate
Adebrelimab Combined With Chemotherapy for the Esophageal Squamous Cell Carcinoma
This study is a prospective, single-arm, phase II exploratory clinical trial. The primary endpoint of this study is to evaluate the pathological complete response (pCR) rate after surgery and to assess the safety of neoadjuvant…
- Conditions
- Pathological Complete Remission, Objective Response Rate, Immune-related Adverse Events, Quality of Life
- Trial name
- NCT07430579
- Testing
- adebrelimab combined with chemotherapy
- Where
- China
- Volunteers
- 25 people
- Sponsor
- The Second Hospital of Shandong University
Solid Tumor, Immune-Related Adverse Events
Longitudinal Cohort Study of Immune-Related Adverse Events in Solid Tumor Patients Treated With Immune Checkpoint Inhibitors
Immune checkpoint inhibitors (ICIs) have transformed the treatment of solid tumors but are associated with immune-related adverse events (irAEs) that can affect virtually any organ system.
- Conditions
- Solid Tumor, Immune-Related Adverse Events, Immunotherapy Toxicity
- Trial name
- NCT07357636
- Where
- 6 sites in China
- Volunteers
- 940 people
- Sponsor
- Shantou University Medical College
Immune-Related Adverse Events, Lupus Erythematosus, Systemic
Interferon Signature in Anti-CTLA-4 and Anti-PD-1/PD-L1-Treated Cancer Patients Compared With Systemic Autoimmune Disease Patients
This study aims to identify a way to predict the side effects that some people with cancer experience when receiving immunotherapy.
- Conditions
- Immune-Related Adverse Events, Lupus Erythematosus, Systemic, Sjogren Syndrome, Systemic Sclerosis (SSc)
- Trial name
- INTER-AUTENTIC (NCT07249060)
- Testing
- Immune Checkpoint Inhibitors
- Where
- Spain
- Volunteers
- 300 people
- Sponsor
- Hospital Universitario Araba
Immune Related Adverse Events, Immune-Mediated Hepatitis
Management of Immune Checkpoint Inhibition-related Hepatitis Using Low-dose Corticosteroids
This study evaluates the effectiveness of low-dose corticosteroids in managing grade 2-3 immune-related hepatitis in cancer patients treated with immune checkpoint inhibitors.
- Conditions
- Immune Related Adverse Events, Immune-Mediated Hepatitis, Cancer
- Trial name
- MIRA-HEP (NCT07167251)
- Testing
- Low-dose corticosteroids for immune-related hepatitis grade 3, Low-dose corticosteroids for immune-related hepatitis grade 2
- Where
- 2 sites in Switzerland, United Kingdom
- Volunteers
- 63 people
- Sponsor
- University Hospital, Basel, Switzerland
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
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
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
Safety Issues, Dengue
Safety, Virological and Immunological Assessment of the Controlled Dengue Human Infection Model in Dengue-Immune Participants in Thailand (DHIT-Immune)
rDEN2Δ30-7169 is a dengue challenge strain that previously reports its viremia induction effect in participants with minimal symptoms in US flavivirus naïve participants.
- Conditions
- Safety Issues, Dengue, Viremia, Immune-related Adverse Event
- Trial name
- DHIT-Immune (NCT06908018)
- Testing
- rDEN2Δ30-7169
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Mahidol University
Immune-related Adverse Event, Dietary Habits
Food Intervention to Reduce Immunotherapy ToXicity
The FORX (Food intervention to Reduce immunotherapy toXicity) trial will assess whether supplementing dietary fiber intake by providing weekly boxes containing 30 different plants to patients with solid tumors starting immune…
- Trial name
- FORX01 (NCT05832606)
- Testing
- Food box containing 30 different plants
- Where
- Belgium
- Volunteers
- 60 people
- Sponsor
- Universitair Ziekenhuis Brussel
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