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

Lung Cancer Clinical Trial

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02763761
• Other study ID #: CA209-601
• Status: Withdrawn
• Phase: Phase 2
• Start date: August 16, 2016
• Est. completion date: March 31, 2017

Study information

• Verified date: October 2018
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 31, 2017
• Est. primary completion date: March 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Diarrhea
• Lung Cancer
• Melanoma
• Renal Cell Carcinoma

Intervention

Drug:
• Infliximab + Prednisone
Prednisone dose will be decreased every 3 days for 18 days
• Methylprednisolone + Prednisone
Prednisone dose will be decreased every 4 days for 40 days

Locations

Country	Name	City	State
United States	Local Institution	Albuquerque	New Mexico
United States	University of Michigan	Ann Arbor	Michigan
United States	Winship Cancer Institute, Emory University	Atlanta	Georgia
United States	University of Colorado Cancer Center	Aurora	Colorado
United States	University of California Los Angeles	Los Angeles	California
United States	University of Louisville	Louisville	Kentucky
United States	Atlantic Health System	Morristown	New Jersey
United States	NYU Langone Medical Center	New York	New York
United States	Huntsman Cancer Institute at The University of Utah	Salt Lake City	Utah
United States	H Lee Moffitt Cancer Center and Research Institute	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Number of days to improvement to less than grade 1 diarrhea		Randomization up to 12 weeks
Secondary	Quality of life as measured by European Quality of Life-5 Dimensions Questionnaire (EQ-5D)		Up to 12 weeks
Secondary	Number of hospitalizations		Up to 12 weeks
Secondary	Duration of hospitalizations		Up to 12 weeks
Secondary	Number of patients with adverse events (AEs)		Up to 12 weeks
Secondary	Number of patients with AEs related to steroid use		Up to 12 weeks
Secondary	Number of patients with Gastrointestinal (GI) specific AEs		Up to 12 weeks

External Links

•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form