Phase 1
Completed N=306
A Phase 1 Study of Nivolumab (BMS-936558) in Subjects With Advanced or Recurrent Malignancies
Metastatic Castration-resistant Prostrate Cancer · Renal Cell Carcinoma · Melanoma · Non-Small Cell Lung Cancer
Source: ClinicalTrials.gov NCT00730639 ↗
Enrolled (actual)
306
Serious AEs
52.0%
Results posted
Apr 2016
Primary outcomePrimary: Number of Participants With Severe Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs — 9; 8; 37; 26 participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Severe Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs |
9; 8; 37; 26; 79; 13 | — |
| PRIMARY Number of Participants With Abnormal Serum Chemistry Laboratory Values |
8; 7; 21; 11; 38; 0 | — |
| PRIMARY Number of Participants With Abnormal Hematology Laboratory Values |
12; 12; 58; 46; 101; 0 | — |
| SECONDARY Immunogenicity Assessment |
6; 2; 7; 2; 4; 1 | — |
| SECONDARY Objective Response Rate |
0; 0; 0; 22.2; 23.8; 16.7 | — |
| SECONDARY Duration of Tumor Response |
NA; NA; NA; NA; 19.1; NA | — |
| SECONDARY Geometric Mean Maximum Serum Concentration (Cmax) |
1.9; 7.0; 19.6; 61.3; 191.2; 3.7 | — |
| SECONDARY Median Time of Maximum Serum Concentration (Tmax) |
1.1; 1.2; 1.2; 2.1; 3.9; 8.0 | — |
| SECONDARY Geometric Mean Area Under the Curve (AUC[TAU]) in One Dosing Interval Observed Post-Single Dose |
279.4; 954.7; 3589.6; 8785.8; 31095.1; 1101.4 | — |
| SECONDARY Geometric Mean Total Body Clearance of Drug From Serum (CLT) |
8.3; 6.9; 8.0; 10.3; 8.5 | — |
| SECONDARY Mean Effective Half-life (T-HALFeff) |
622; 555; 636; 661; 595 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00730639). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.