drugset / Trial / NCT04407247
Infliximab or Vedolizumab in Treating Immune Checkpoint Inhibitor-Related Colitis in Patients With Genitourinary Cancer or Melanoma
Phase 1/2
Active not recruiting
47 enrolled
M.D. Anderson Cancer Center
National Cancer Institute (NCI) · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
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 the genital and urinary organs (genitourinary) or melanoma. Monoclonal antibodies, such as infliximab or vedolizumab, may help to treat immunotherapy induced colitis/diarrhea. This study may help to identify the optimal treatment strategy for immune checkpoint inhibitor-related colitis in patients with genitourinary cancer or melanoma.
Timeline
- Start
- 2020-07-09
- Primary completion
- 2027-12-31
- Completion
- 2027-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Infliximab | Monoclonal antibody | — | Intravenous |
| Subject | Vedolizumab | Monoclonal antibody | — | Intravenous |