Lung Cancer, Melanoma, Renal Cell Carcinoma
Conditions
Brief summary
The purpose of this study is to compare the effects of Infliximab and oral prednisone versus methylprednisolone and oral prednisone in patients with melanoma, lung cancer, or renal cell carcinoma who have immune related Grade 3-4 diarrhea for up to 3 days or persistent Grade 2 diarrhea for more than 5 days after treatment with Yervoy and/or Opdivo
Interventions
DRUGInfliximab + Prednisone
Prednisone dose will be decreased every 3 days for 18 days
DRUGMethylprednisolone + Prednisone
Prednisone dose will be decreased every 4 days for 40 days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Subjects must have melanoma or lung cancer or renal cell carcinoma and received ipilimumab or nivolumab as a single treatment or in combination * Subject must have NCI common toxicity Grade 3-4 immune-related diarrhea for up to 3 days or persistent Grade 2 diarrhea for more than 5 days * Subjects must be discontinued from ipilimumab or nivolumab as monotherapy or with the combination regimen
Exclusion criteria
* Subjects who received other anti Cytotoxic T-lymphocytic antigen (CTLA-4) (non-ipilimumab) or other anti-Programmed death-1 (PD-1) (non-nivolumab) treatment * Subjects treated with systemic Corticosteroid (CST) within 1 week before randomization and subjects treated with infliximab within 7 weeks before randomization * Subjects with known history of tuberculosis * Subjects with immunosuppressive disease that require use of systemic steroids or immunosuppressive treatment * Subjects allergic to infliximab, inactive components of infliximab, murine proteins and methylprednisolone Other protocol defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in management of immune related grade 3 and 4 diarrhea as measured by proportion of responders to less than or equal to grade 1 | Up to 78 hours |
| Improvement in management of persistent grade 2 diarrhea as measured by proportion of responders to less than or equal to grade 1 | Up to 78 hours |
Secondary
| Measure | Time frame |
|---|---|
| Number of hospitalizations | Up to 12 weeks |
| Duration of hospitalizations | Up to 12 weeks |
| Number of days to improvement to less than grade 1 diarrhea | Randomization up to 12 weeks |
| Number of patients with AEs related to steroid use | Up to 12 weeks |
| Number of patients with Gastrointestinal (GI) specific AEs | Up to 12 weeks |
| Number of patients with adverse events (AEs) | Up to 12 weeks |
| Quality of life as measured by European Quality of Life-5 Dimensions Questionnaire (EQ-5D) | Up to 12 weeks |
Countries
United States
Outcome results
None listed