A Phase 1 Study of Nivolumab (BMS-936558) in Subjects With Advanced or Recurrent Malignancies (MDX1106-03)

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 1

Conditions

Non-small Cell Lung Cancer

Metastatic Melanoma

Metastatic Castration-resistant Prostrate Cancer

Renal Cell Carcinoma

Treatments

Biological: BMS-936558 (MDX-1106)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00730639

CA209-003

MDX1106-03 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to determine the safety and effectiveness of MDX-1106 in patients with certain types of cancer. Another purpose is to determine how MDX-1106 is absorbed and distributed within the body, and how it's eventually eliminated.

Enrollment

395 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

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-PD-L2, 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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

395 participants in 5 patient groups

Melanoma - BMS-936558 (MDX-1106)

Experimental group

Treatment:

Biological: BMS-936558 (MDX-1106)

RCC - BMS-936558 (MDX-1106)

Experimental group

Treatment:

Biological: BMS-936558 (MDX-1106)

mCRPC - BMS-936558 (MDX-1106)

Experimental group

Treatment:

Biological: BMS-936558 (MDX-1106)

NSCLC - BMS-936558 (MDX-1106)

Experimental group

Treatment:

Biological: BMS-936558 (MDX-1106)

CRC - BMS-936558 (MDX-1106)

Experimental group

Treatment:

Biological: BMS-936558 (MDX-1106)

Trial contacts and locations

13

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