Clinical trials: IrAE, open to volunteers
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
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-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
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
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
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
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
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
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
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
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
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
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
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
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 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
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
Cytokine Release Syndrome, Neoplasms
Continuous Temperature Monitoring (CTM) for Cytokine Release Syndrome (CRS), an Immune-Related Adverse Event
Background: Drugs or cell therapies to treat cancer can sometimes cause cytokine release syndrome (CRS). That is, the body makes too many cytokines after treatment. Cytokines are proteins that play a role in the immune system.
- Conditions
- Cytokine Release Syndrome, Neoplasms, Lymphoma, Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Trial name
- NCT07499128
- Testing
- TempTraq, VitalTraq
- Where
- United States
- Volunteers
- 136 people
- Sponsor
- National Cancer Institute (NCI)
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