Renal Cell CarcinomaPhase 2NCT02763761
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 study testing Infliximab + Prednisone and Methylprednisolone + Prednisone in people with Renal Cell Carcinoma and Melanoma, run by Bristol-Myers Squibb at 10 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma, Melanoma, Lung Cancer
- What is being tested?
- Infliximab + Prednisone and Methylprednisolone + Prednisone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 10 sitesUnited States
- Study dates
- 16 Aug 2016to 31 Mar 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Local Institution
Albuquerque, New Mexico, 87131
University of Michigan
Ann Arbor, Michigan, 48109
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322-1013
University of Colorado Cancer Center
Aurora, Colorado, 80045
University of California Los Angeles
Los Angeles, California, 90024
University of Louisville
Louisville, Kentucky, 40202
Atlantic Health System
Morristown, New Jersey, 07962
NYU Langone Medical Center
New York, New York, 10016
Huntsman Cancer Institute at The University of Utah
Salt Lake City, Utah, 84112
H Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
About this study
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)
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
- Renal Cell Carcinoma, Melanoma, Lung Cancer
- Being tested
- Infliximab + Prednisone, Methylprednisolone + Prednisone
- Medical subject headings
- Carcinoma, Renal Cell, Melanoma, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infliximab + PrednisoneDrug
Prednisone dose will be decreased every 3 days for 18 days
Methylprednisolone + PrednisoneDrug
Prednisone dose will be decreased every 4 days for 40 days
| Study group | Role | What they receive |
|---|---|---|
| Infliximab + Prednisone | Experimental | Infliximab intravenous solution (single dose) + low dose prednisone per oral for 18 days Receives: Drug: Infliximab + Prednisone |
| Methylprednisolone + Prednisone | Experimental | Methylprednisolone intravenous solution (single dose) + high dose prednisone per oral for 40 days Receives: Drug: Methylprednisolone + Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Up to 78 hours
Secondary outcomes (7)
Number of days to improvement to less than grade 1 diarrhea
Measured: Randomization up to 12 weeks
Quality of life as measured by European Quality of Life-5 Dimensions Questionnaire (EQ-5D)
Measured: Up to 12 weeks
Number of hospitalizations
Measured: Up to 12 weeks
Duration of hospitalizations
Measured: Up to 12 weeks
Number of patients with adverse events (AEs)
Measured: Up to 12 weeks
Number of patients with AEs related to steroid use
Measured: Up to 12 weeks
Number of patients with Gastrointestinal (GI) specific AEs
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study start16 Aug 2016
- Primary completion31 Mar 2017 (estimated)
- Study completion31 Mar 2017 (estimated)
Why it stopped: Insufficient enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02763761
- Sponsor's protocol ID
- CA209-601
- Status last verified
- Oct 2018
- First submitted
- 4 May 2016
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02763761
- Acronym / sponsor ID
- CA209-601
- Conditions
- Renal Cell Carcinoma, Melanoma, Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Insufficient enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 16 Aug 2016 (actual)
- Primary completion
- 31 Mar 2017 (estimated)
- Study completion
- 31 Mar 2017 (estimated)
- First posted
- 5 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infliximab + Prednisone | Experimental | Drug: Infliximab + PrednisoneInfliximab intravenous solution (single dose) + low dose prednisone per oral for 18 days |
| Methylprednisolone + Prednisone | Experimental | Drug: Methylprednisolone + PrednisoneMethylprednisolone intravenous solution (single dose) + high dose prednisone per oral for 40 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infliximab + PrednisonePrednisone dose will be decreased every 3 days for 18 days | Drug | Infliximab + Prednisone |
| Methylprednisolone + PrednisonePrednisone dose will be decreased every 4 days for 40 days | Drug | Methylprednisolone + Prednisone |
Primary outcome
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
Time frame: 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
Time frame: Up to 78 hours
7 secondary outcomes
Number of days to improvement to less than grade 1 diarrhea
Time frame: Randomization up to 12 weeks
Quality of life as measured by European Quality of Life-5 Dimensions Questionnaire (EQ-5D)
Time frame: Up to 12 weeks
Number of hospitalizations
Time frame: Up to 12 weeks
Duration of hospitalizations
Time frame: Up to 12 weeks
Number of patients with adverse events (AEs)
Time frame: Up to 12 weeks
Number of patients with AEs related to steroid use
Time frame: Up to 12 weeks
Number of patients with Gastrointestinal (GI) specific AEs
Time frame: Up to 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Infliximab + Prednisone and Methylprednisolone + Prednisone in people with Renal Cell Carcinoma and Melanoma, run by Bristol-Myers Squibb at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Up to 78 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2018.