Know Cancer

or
forgot password

A Phase 1b, Open-label, Multicenter, Multidose, Dose-escalation Study of MDX-1106 in Subjects With Selected Advanced or Recurrent Malignancies


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Metastatic Castration-resistant Prostrate Cancer (mCRPC), Renal Cell Carcinoma (RCC), Metastatic Melanoma (MEL), Non-small Cell Lung Cancer (NSCLC)

Thank you

Trial Information

A Phase 1b, Open-label, Multicenter, Multidose, Dose-escalation Study of MDX-1106 in Subjects With Selected Advanced or Recurrent Malignancies


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:



- Subjects must have mCRPC,RCC, MEL, Non-small-cell lung cancer (NSCLC), or Colorectal
Cancer (CRC), that is advanced (non-resectable), or recurrent and for which no
alternative, curative standard exists

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2

- Must have at least 1 measurable lesion

- Subjects with mCRPC and with only non-measurable bone lesions must have either
progression new lesions or have Prostate-specific antigen (PSA) progression within
the 6-week period before study administration

- At least 1 and up to 5 prior systemic therapies for advanced/recurrent disease

- Prior treated brain or meningeal metastases must be without Magnetic resonance
imaging (MRI) evidence of progression for at least 8 weeks and off immunosuppressive
doses of systemic steroids for at least 2 weeks before study drug administration

- Prior systemic radiation therapy must have been completed at least 4 weeks before
study drug administration. Prior focal radiotherapy completed at least 2 weeks prior
to study drug administration

- Immunosuppressive doses of systemic medications, such as steroids or absorbed topical
steroids must be discontinued at least 2 weeks before study drug administration

- Prior surgery that required general anesthesia must be completed at least 2 weeks
before study drug administration. Surgery requiring local/epidural anesthesia must be
completed at least 72 hours before study drug administration

Exclusion Criteria:

- History of severe hypersensitivity reactions to other Monoclonal antibody (mAb)s

- Subjects with any active autoimmune disease or a documented history of autoimmune
disease, or history of syndrome that required systemic steroids or immunosuppressive
medications, except for subjects with vitiligo or resolved childhood asthma/atopy

- Prior therapy with an anti-Programmed death-1 (PD-1), anti-PD-L1, anti-PDL-2, or
anti- Cytotoxic t-lymphocyte antigen-4 (CTLA-4) antibody (or any other antibody
targeting T cell co-stimulation pathways)

- Known history of Human Immunodeficiency Virus

- Active infection requiring therapy, positive tests for Hepatitis B surface antigen or
Hepatitis C ribonucleic acid (RNA)

- Underlying medical conditions that will make the administration of study drug
hazardous

- Concurrent medical condition requiring the use of immunosuppressive medications, or
immunosuppressive doses of systemic or absorbable topical corticosteroids

- Use of other investigational drugs (drugs not marketed for any indication) within 28
days or at least 5 half-lives (whichever is longer) before study drug administration

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To characterize the safety and tolerability of multiple doses of BMS-936558 (MDX-1106)

Outcome Time Frame:

70 days post last dose of study drug

Safety Issue:

Yes

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA209-003

NCT ID:

NCT00730639

Start Date:

October 2008

Completion Date:

April 2015

Related Keywords:

  • Metastatic Castration-resistant Prostrate Cancer (mCRPC)
  • Renal Cell Carcinoma (RCC)
  • Metastatic Melanoma (MEL)
  • Non-Small Cell Lung Cancer (NSCLC)
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Renal Cell
  • Lung Neoplasms
  • Melanoma

Name

Location

Johns Hopkins UniversityBaltimore, Maryland  21205
Memorial Sloan Kettering Cancer CenterNew York, New York  10021
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Christ HospitalCincinnati, Ohio  45219
Massachusetts General HospitalBoston, Massachusetts  02114-2617
University of Michigan Cancer CenterAnn Arbor, Michigan  48109
H. Lee Moffitt Cancer Center & Research InstituteTampa, Florida  33612
Dana Farber Cancer InstituteBoston, Massachusetts  02115
Yale University School Of MedicineNew Haven, Connecticut  06520
Carolina BioOncology InstituteHuntersville, North Carolina  28078
Sarah Cannon Research InstituteNashville, Tennessee  37203
Vanderbilt-Ingram Cancer CtrNashville, Tennessee  37232
Pinnacle Oncology HematologyScottsdale, Arizona  85258