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

Bristol-Myers Squibb (BMS)

Status and phase: Withdrawn; Phase 2

Conditions: Melanoma; Lung Cancer; Renal Cell Carcinoma

Treatments: Drug: Methylprednisolone + Prednisone; Drug: Infliximab + Prednisone

Study type: Interventional

Funder types: Industry

Identifiers

NCT02763761

CA209-601

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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/exclusion criteria could apply

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Infliximab + Prednisone

Experimental group

Description:

Infliximab intravenous solution (single dose) + low dose prednisone per oral for 18 days

Treatment:

Drug: Infliximab + Prednisone

Methylprednisolone + Prednisone

Experimental group

Description:

Methylprednisolone intravenous solution (single dose) + high dose prednisone per oral for 40 days

Treatment:

Drug: Methylprednisolone + Prednisone