Clinical trial NCT02763761: 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
Official title: 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)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Renal Cell Carcinoma
Melanoma
Lung Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2016-05-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
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
timeFrame: Up to 78 hours
measure: Improvement in management of persistent grade 2 diarrhea as measured by proportion of responders to less than or equal to grade 1
timeFrame: Up to 78 hours
Secondary outcomes:
measure: Number of days to improvement to less than grade 1 diarrhea
timeFrame: Randomization up to 12 weeks
measure: Quality of life as measured by European Quality of Life-5 Dimensions Questionnaire (EQ-5D)
timeFrame: Up to 12 weeks
measure: Number of hospitalizations
timeFrame: Up to 12 weeks
measure: Duration of hospitalizations
timeFrame: Up to 12 weeks
measure: Number of patients with adverse events (AEs)
timeFrame: Up to 12 weeks
measure: Number of patients with AEs related to steroid use
timeFrame: Up to 12 weeks
measure: Number of patients with Gastrointestinal (GI) specific AEs
timeFrame: Up to 12 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
city: Aurora
country: United States
facility: University of Colorado Cancer Center
state: Colorado
city: Tampa
country: United States
facility: H Lee Moffitt Cancer Center and Research Institute
state: Florida
city: Atlanta
country: United States
facility: Winship Cancer Institute, Emory University
state: Georgia
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Morristown
country: United States
facility: Atlantic Health System
state: New Jersey
city: Albuquerque
country: United States
facility: Local Institution
state: New Mexico
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute at The University of Utah
state: Utah
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: