Melanoma Clinical Trial
Official title:
Treatment of Immune Checkpoint Inhibitor-Related Colitis With Infliximab or Vedolizumab: A Randomized Trial
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients who receive any type of immune checkpoint inhibitor (ICI) therapy - Patients with peak grade >= 2 immune-related diarrhea and/or colitis (according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 within 45 days prior to initiation of study treatment (infliximab/ vedolizumab) - Patients with ability to understand and willingness to sign informed consent - Patients with genitourinary cancer or melanoma or non-small cell lung cancer - No concern for active concomitant GI infection for immune-related diarrhea and/or colitis work up at the time of protocol therapy initiation as confirmed by stool tests or as per the treating physician based on clinical presentation - Patient who has been cleared for enrollment by Infectious Diseases consultant or treating physician if positive infection workup or screening tests (e.g. lifelong positive T-spot due to BCG inoculation, chronic colonization) prior to initiation of diarrhea/colitis treatment Exclusion Criteria: - Patients younger than 18 years of age - Patients with persistent gastrointestinal infection confirmed with positive testing despite completing 5 days of antibiotics - Patients are on concurrent immunosuppressive therapies other than what will be given for colitis - Patients with preexisting activehistory of inflammatory bowel disease and/or radiation enterocolitis with active disease status at the time of study treatment initiation - Pregnant and breastfeeding women, and - Women of child-bearing potential who have positive urine or serum pregnancy test or refuse to do pregnancy test unless last menstrual cycle was > 1 year prior to consent and/ or clear documentation states that patient is peri- or post-menopausal or there was recent supporting objective evidence of 'no pregnancy' status (e.g. blood or imaging) within 30 days prior to initiation of study treatment - Patients who develop concurrent non-GI toxicity at the time of study treatment initiation |
Country | Name | City | State |
---|---|---|---|
United States | M D Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Endoscopic remission (Mayo Clinic sub-score 0-1) of immune-related diarrhea/colitis | Will be compared between the two treatment arms. | At 4 and 8 weeks after initiation of infliximab or vedolizumab treatment | |
Other | Histological remission (resolution of active inflammation) of immune-related diarrhea/colitis | Will be compared between the two treatment arms. | At 8 weeks after initiation of infliximab or vedolizumab treatment | |
Other | Time duration to achieve clinical remission/response | Will be estimated using the method of Kaplan and Meier. Comparisons of the time-to-event endpoint by important subgroups will be made using the log-rank tests. | From initiation of infliximab or vedolizumab treatment to clinical remission/response or last follow-up, assessed up to 3 months | |
Other | Overall survival | Will be estimated using the method of Kaplan and Meier. | From the initiation of infliximab or vedolizumab treatment till death or last follow-up, assessed up to 3 months | |
Other | Change in levels of cytokines in tissue/blood/stool samples | Will be compared using 2-sample t-test. | Baseline up to 3 months after infliximab or vedolizumab treatment | |
Other | Change in frequencies of immune cells in tissue/blood/stool samples | Will be compared using 2-sample t-test. | Baseline up to 3 months after infliximab or vedolizumab treatment | |
Primary | Clinical remission/response rate of immune-mediated colitis (IMC) | The difference of the remission rate between standard of care (infliximab + corticosteroid) and the treatment with vedolizumab + corticosteroid will be calculated along with the 95% confidence interval. | At 2 weeks after initiation of infliximab or vedolizumab with corticosteroid taper | |
Primary | Treatment-related adverse events | Will follow standard reporting guidelines for adverse events. Safety data will be summarized by category, severity and frequency. | Within 3 months after initiation of infliximab or vedolizumab | |
Secondary | Clinical remission/response rate of IMC | Will be estimated and compared between the two treatment arms using chi-square test. | At 4 weeks after initiation of infliximab or vedolizumab with corticosteroid taper | |
Secondary | Complete weaning of corticosteroid | Will be estimated and compared between the two treatment arms using chi-square test. | Within 4 weeks after infliximab or vedolizumab initiation without rebound of IMC | |
Secondary | Recurrent immune-related diarrhea/colitis | Will be estimated and compared between the two treatment arms using chi-square test. | Within 3 months after corticosteroid taper |
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