Clinical trials: Immune Checkpoint Inhibitor-Related Colitis
Immune Related Adverse Events, Colitis
ECP for Immune-related Adverse Events After Checkpoint Inhibitor Treatment
Preliminary data demonstrate that irAEs induced by immune checkpoint blockade can be successfully treated with ECP (Apostolova et al. NEJM 2020).
- Conditions
- Immune Related Adverse Events, Colitis, Hepatitis, Dermatitis
- Trial name
- ECPforIRAE (NCT05414552)
- Testing
- ECP
- Where
- Germany
- Volunteers
- 11 people
- Sponsor
- University of Freiburg
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
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
Colitis, Hepatitis
PHOENIX-ECP- Extracorporeal Photopheresis for Immune-related Colitis and/or Hepatitis in Advanced Melanoma With Inadequate Response to Steroid Exposure
Extracorporeal photopheresis (ECP) is an immunomodulatory therapy in which the photoactivating agent methoxsalen (also known as UVADEX) is used in combination with ultraviolet A (UVA) light.
- Conditions
- Colitis, Hepatitis, Melanoma (Skin Cancer)
- Trial name
- PHOENIX-ECP (NCT07619898)
- Testing
- methoxsalen, Extracorporeal photopheresis (ECP), Vedolizumab
- Volunteers
- 112 people
- Sponsor
- Therakos LLC
Immune-related Colitis
EPIC- Extracorporeal Photopheresis (ECP) for Immune-related Colitis
The photoactivating agent UVADEX (methoxsalen) is used in conjunction with extracorporeal photopheresis (ECP) as an immunomodulatory therapy approved for the treatment of cutaneous T-cell lymphoma.
- Trial name
- EPIC (NCT06646016)
- Testing
- Methoxsalen, Infliximab, Vedolizumab
- Where
- United States
- Sponsor
- Therakos LLC
Colitis, Immune Checkpoint Inhibitor-Related Colitis
Intestinal Biomarker Analysis After ECP for ICI Colitis
It was previously shown that ICI-colitis can be treated with extracorporeal photophoresis. Therefore this retrospective analysis is launched to study the chnages of immune cells in the peripheral blood and intestinal tract in an…
- Trial name
- IBA_ECP (NCT06074874)
- Testing
- Intestinal tissue analysis
- Where
- Germany
- Volunteers
- 20 people
- Sponsor
- University of Freiburg
Immune-Mediated Colitis
Tofacitinib for the Treatment of Refractory Immune-related Colitis from Checkpoint Inhibitor Therapy- TRICK Study
This is a single-arm pilot study evaluating the efficacy and safety of tofacitinib in cancer patients with immune-related colitis from immune checkpoint inhibitor (ICI) therapy.
- Trial name
- NCT04768504
- Testing
- Tofacitinib 10 mg
- Where
- Canada
- Volunteers
- 2 people
- Sponsor
- Khashayar Esfahani
Immune Checkpoint Inhibitor-Related Diarrhea and Colitis
Etrasimod for Immune Checkpoint Inhibitor Diarrhea and Colitis
This is a randomized, double-blind, placebo-controlled, two-arm phase 2 study of etrasimod plus corticosteroids versus placebo plus corticosteroids for the treatment of IMDC CTCAE v5.0 grade ≥ 2 due to ICI therapy alone…
- Trial name
- NCT06521762
- Testing
- Etrasimod, Corticosteroids
- Where
- United States
- Sponsor
- Yale University
Immune-related Colitis, Colitis
A Pilot Study Testing the Safety and Feasibility of Restorative Microbiota Therapy (RMT) in Patients With Refractory Immune-checkpoint Inhibitor-related Colitis
Immune-related colitis from immune checkpoint inhibitors (ICI) is a common adverse effect causing significant morbidity and impairment of quality of life (QoL).
- Trial name
- NCT05726396
- Testing
- RMT
- Where
- 9 sites in United States
- Volunteers
- 20 people
- Sponsor
- University of Minnesota
Colitis, Lung Non-Small Cell Carcinoma
Infliximab or Vedolizumab in Treating Immune Checkpoint Inhibitor-Related Colitis in Patients With Genitourinary Cancer or Melanoma
This phase I/II trial studies the side effects of infliximab and vedolizumab and to see how well they work in treating inflammation of the colon (colitis) caused by immune checkpoint inhibitor therapy in patients with cancer of…
- Conditions
- Colitis, Lung Non-Small Cell Carcinoma, Malignant Genitourinary System Neoplasm, Malignant Solid Neoplasm
- Trial name
- NCT04407247
- Testing
- Infliximab, Vedolizumab
- Where
- United States
- Volunteers
- 47 people
- Sponsor
- M.D. Anderson Cancer Center
Immune Checkpoint Inhibitor-Related Colitis
Early Vedolizumab as First-Line for Immune-Related Colitis Therapy Trial
The goal of this clinical trial is to compare the effectiveness and safety of Vedolizumab with a short course of steroids compared to standard course of steroids for the treatment of immune checkpoint inhibitor colitis (ICI…
- Trial name
- EVITA (NCT06841705)
- Testing
- Vedolizumab 300 MG Injection [Entyvio], Prednisone (and methylprednisolone), Prednisone Taper
- Where
- 2 sites in United States
- Volunteers
- 80 people
- Sponsor
- Shilpa Grover, MD, MPH
Cancer
Treatment of Immune Checkpoint Inhibitor-related Diarrhea and/ or Colitis With Ustekinumab in Cancer Patients
The goal of this clinical research study is to learn if ustekinumab can help to control immune-related diarrhea and/or colitis in cancer patients.
- Trial name
- NCT06807593
- Testing
- Ustekinumab
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- M.D. Anderson Cancer Center