Clinical trial · Interventional
An Investigational Study of Infliximab With Prednisone or Methylprednisolone Versus Prednisone Combination Treatment in Immune Related or Severe Diarrhea in Patients Treated With Yervoy and/or Opdivo
A Phase 2, Randomized, Open-Label Study of Infliximab and Lower Exposure Corticosteroids vs Methylprednisolone and Higher Exposure Oral Corticosteroids for the Management of Immune-Related Severe or Persistent Diarrhea in Patients Treated With Yervoy (Ipilimumab) and/or Opdivo (Nivolumab)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Insufficient enrollment
Summary
Brief summary (as posted)
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
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Infliximab + Prednisone | Drug | — | UNRESOLVED |
| Methylprednisolone + Prednisone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Infliximab + Prednisone
- description
- Infliximab intravenous solution (single dose) + low dose prednisone per oral for 18 days
- interventionNames
- Drug: Infliximab + Prednisone
- type
- EXPERIMENTAL
- label
- Methylprednisolone + Prednisone
- description
- Methylprednisolone intravenous solution (single dose) + high dose prednisone per oral for 40 days
- interventionNames
- Drug: Methylprednisolone + Prednisone
Primary outcomes (2)
- measure
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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/exclusion criteria could apply
References
Publications (0)
Data not yet available