Melanoma Stage IV Clinical Trial
Official title:
Phase II Study of Infliximab for the 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 cancer. The main questions this study aims to answer are: - How many patients treated with infliximab experience steroid-free disease resolution after 7 weeks? - How many patients treated with steroids experience steroid-free disease resolution after 7 weeks?
This is a phase II, randomized, signal-detection trial to evaluate the efficacy and safety of the drugs infliximab, methylprednisolone, and prednisone to manage the side of effect of colitis caused by immune checkpoint inhibitors (ICIs) that target a protein called CTLA-4. An example of one of these ICIs is ipilimumab, which has been approved by the FDA to treat metastatic melanoma. The names of the treatments involved in this study are: - Infliximab - Methylprednisolone - Prednisone The FDA has approved infliximab, methylprednisolone, and prednisone to treat many conditions affecting the immune system, including colitis. Participants will receive a CTLA-4 inhibitor, like ipilimumab, and any other cancer treatments as part of their regular care for stage III/IV skin cancer at the discretion of treating oncologist. Participants who enroll in this study will undergo one or more flexible sigmoidoscopies or colonoscopies as part of their clinical care. The first of these procedures would occur at the time of study enrollment, and the second may occur after several weeks of treatment at the discretion of the study doctor. During these procedures, biopsies will be collected for clinical purposes as well as for research purposes. Blood will also be collected for research at the time of enrollment and at the time of study completion. Any extra samples for research would only be collected if it is safe for the participant. Participants will also complete weekly follow-ups either over the phone or in-person that may last about 10 minutes. During these visits, participants will be asked about any new symptoms or changes in their health, their medications, and their GI symptoms. Blood for research may be collected at one or more of these visits if it coincides with a scheduled clinical blood draw. Participants are expected to be on study treatment for approximately 7 weeks. Once participants complete the study treatment, the study team will review their medical records every 6 months for any changes in their health. It is expected that about 42 people will take part in this research study. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04330430 -
Neo-adjuvant T-VEC + Nivolumab Combination Therapy for Resectable Early Metastatic (Stage IIIB/C/D-IV M1a) Melanoma With Injectable Disease
|
Phase 2 | |
Withdrawn |
NCT04007588 -
A Phase II Trial of Neoadjuvant Treatment With PD-1 Inhibition (Nivolumab) With or Without IDO Inhibition (BMS-986205) and With or Without CTLA-4 Inhibition (Ipilimumab) in Resectable Stage III or IV Melanoma
|
Phase 2 | |
Recruiting |
NCT05171374 -
pRospective Evaluation of Clinical Outcomes in Patients With metAsTatIŃ melanOma Treated With dabrafeNib and trAmetinib in reaL practicE
|
||
Completed |
NCT03620019 -
Denosumab + PD-1 in Subjects With Stage III/ IV Melanoma
|
Phase 2 | |
Recruiting |
NCT04562129 -
IL2 With Ipilimumab Followed by Nivolumab in Stage 3 or 4 Melanoma Patients
|
Phase 2 | |
Recruiting |
NCT04990726 -
Immune Related Toxicity and Symptom Burden in Chronic Cancer Survivors With Melanoma Receiving Adjuvant Immunotherapy With Immune Checkpoint Inhibitors
|
||
Recruiting |
NCT05970497 -
A Study Assessing KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors
|
Phase 1 | |
Recruiting |
NCT05370807 -
A Clinical Trial of Regorafenib in Patients With Pretreated Advanced Melanoma
|
Phase 2 | |
Recruiting |
NCT04045691 -
Binimetinib Plus Encorafenib Real Life Investigation of Next Generation Melanoma Treatment
|
||
Not yet recruiting |
NCT05068453 -
Study of Oncolytic Virus in Combination With HX-008 and Radiotherapy in Melanoma Patients With Liver Metastasis
|
Phase 1 | |
Not yet recruiting |
NCT05070221 -
Study of Oncolytic Virus in Combination With HX-008 and Axitinib in Melanoma Patients With Liver Metastasis
|
Phase 1 | |
Recruiting |
NCT03353402 -
Fecal Microbiota Transplantation (FMT) in Metastatic Melanoma Patients Who Failed Immunotherapy
|
Phase 1 | |
Recruiting |
NCT04513028 -
Beta Glucan's Effect on Pembrolizumab Immunologic Response in Stage III-IV Melanoma
|
N/A | |
Recruiting |
NCT05598853 -
Intrathecal Double Checkpoint Inhibition
|
Phase 1 | |
Recruiting |
NCT04521075 -
A Phase Ib Trial to Evaluate the Safety and Efficacy of FMT and Nivolumab in Subjects With Metastatic or Inoperable Melanoma, MSI-H, dMMR or NSCLC
|
Phase 1/Phase 2 | |
Recruiting |
NCT06425926 -
Safety and Tolerability Study of GIM-531 in Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Completed |
NCT03153085 -
A Study of Combination With TBI-1401(HF10) and Ipilimumab in Japanese Patients With Unresectable or Metastatic Melanoma
|
Phase 2 | |
Recruiting |
NCT04741997 -
Adjuvant Therapy Based on Pathologic Response After Neoadjuvant Encorafenib Binimetinib in Melanoma
|
Early Phase 1 | |
Recruiting |
NCT03991130 -
High Dose IL-2 in Combination With Anti-PD-1 to Overcome Anti-PD-1 Resistance in Metastatic Melanoma and Renal Cell Carcinoma
|
Phase 2 | |
Active, not recruiting |
NCT04526899 -
Trial With BNT111 and Cemiplimab in Combination or as Single Agents in Patients With Anti-PD-1-refractory/Relapsed, Unresectable Stage III or IV Melanoma
|
Phase 2 |