Diseases and Conditions Researched
Malignant Melanoma
What is the purpose of this trial?
The purpose of this study is to determine the safety and tolerability of treatment with BMS-936558 (MDX-1106) in combination with Ipilimumab (BMS-734016) when given at the same time or as a sequenced regimen in subjects with unresectable Stage III or Stage IV malignant melanoma (MEL)
Participation Guidelines
Age: 18 Years and older
Gender: Both
Click here for
detailed participation information for this trial.
|
Sponsors:
|
Bristol-Myers Squibb; Medarex; Ono Pharma USA Inc |
| Dates: |
December 1, 2009 |
| Last Updated: |
April 12, 2013 |
| Study HIC#: |
0908005564 |
| Clinicaltrials.gov ID: |
NCT01024231
|
Condition
Malignant Melanoma
Trial Phase
Phase 1
Trial Purpose
The purpose of this study is to determine the safety and tolerability of treatment with BMS-936558 (MDX-1106) in combination with Ipilimumab (BMS-734016) when given at the same time or as a sequenced regimen in subjects with unresectable Stage III or Stage IV malignant melanoma (MEL)
Participation Guidelines
Age: 18 Years and older
Gender: Both
Eligibility Criteria
For additional information, please contact the BMS oncology clinical trial information
service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit
www.BMSStudyConnect.com for more information on clinical trial participation.
Inclusion Criteria:
- Histologic diagnosis of malignant melanoma (MEL)
- Measurable unresectable Stage III or IV MEL
- ECOG performance status score of 0 or 1
- Life expectancy = 4 months
- For those enrolled in amendment 5 and later, tumor tissue (archival or recent
acquisition) must be available
- For Cohorts 1-5, subjects may have been treated with up to 3 prior systemic standard
treatments for metastatic melanoma not including any post-incisional adjuvant
therapy. Subjects may be treatment naïve. All metastatic melanoma regardless of
primary site of disease will be allowed
- For Cohorts 6- 7, subjects may have been treated with up to 3 prior systemic standard
treatments for metastatic melanoma; this does not include any post-incisional
adjuvant therapy. Specifically, subjects must have received = 3 doses of Ipilimumab
therapy and the last dose having been administered within 4-12 weeks of initiation of
study treatment
Exclusion Criteria:
- History of severe hypersensitivity reactions to other mAbs
- Prior malignancy active within the previous 2 years except for localized cancers
that are considered to have been cured and in the opinion of the investigator present
a low risk for recurrence
- Active autoimmune disease or a history of known or suspected autoimmune disease
- History of recently active diverticulitis or symptomatic peptic ulcer disease and
history of adrenal insufficiency
- Regular narcotic analgesia
- Active, untreated central nervous system metastasis
- For subjects enrolled in Cohorts 1-5, prior therapy with an anti-PD-1, anti-PD-L1,
anti-PD-L2, anti-CD137 or anti-CTLA-4 antibody
- For subjects enrolled in Cohorts 6-7, prior therapy with an anti-PD-1, anti-PD-L1,
anti-PD-L2, or anti-CD137 antibodies
- Any non-oncology vaccine therapy used for prevention of infectious disease
- Concomitant therapy with any other anti-cancer therapy, concurrent medical conditions
requiring use of immunosuppressive medications or use of other investigational drugs
- Positive tests for human immunodeficiency virus (HIV), acquired immunodeficiency
syndrome (AIDS), hepatitis B, hepatitis C
- Subjects weighing = 125 kg are excluded from Cohort 5
- Subjects in Cohorts 6 and 7 must have received Ipilimumab monotherapy immediately
prior to study entry, but must not have received that Ipilimumab as part of a
clinical trial
Links
|
Sponsors:
|
Bristol-Myers Squibb; Medarex; Ono Pharma USA Inc |
| Dates: |
December 1, 2009 |
| Last Updated: |
April 12, 2013 |
| Study HIC#: |
0908005564 |
| Clinicaltrials.gov ID: |
NCT01024231
|