Overview

This trial is active, not recruiting.

Conditions metastatic castration-resistant prostrate cancer (mcrpc), renal cell carcinoma (rcc), metastatic melanoma (mel), non-small cell lung cancer (nsclc)
Treatments bms-936558 (mdx-1106)
Phase phase 1
Sponsor Bristol-Myers Squibb
Collaborator Ono Pharmaceutical Co. Ltd
Start date January 2009
End date February 2013
Trial size 311 participants
Trial identifier NCT00730639, CA209-003, MDX1106-03

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
bms-936558 (mdx-1106) BMS-936558
Solution, Intravenous, 0.1 mg/kg - 10 mg/kg, Every 2 weeks, 3 years depending on response
(Experimental)
bms-936558 (mdx-1106) BMS-936558
Solution, Intravenous, 1 - 10 mg/kg, Every 2 weeks, 3 years depending on response
(Experimental)
bms-936558 (mdx-1106) BMS-936558
Solution, Intravenous, 10 mg/kg, Every 2 weeks, 3 years depending on response
(Experimental)
bms-936558 (mdx-1106) BMS-936558
Solution, Intravenous, 1 - 10 mg/kg, Every 2 weeks, 3 years depending on response
(Experimental)
bms-936558 (mdx-1106) BMS-936558
Solution, Intravenous, 10 mg/kg, Every 2 weeks, 3 years depending on response

Primary Outcomes

Measure
To characterize the safety and tolerability of multiple doses of BMS-936558 (MDX-1106)
time frame: 70 days post last dose of study drug

Secondary Outcomes

Measure
Immunogenicity of multiple doses of BMS-936558
time frame: up to 12 eight (8) week cycles
Pharmacokinetic (PK) profile of multiple doses of BMS-936558
time frame: Samples collection for PK analysis through Cycle 3 (first 24 weeks) of study therapy.
Assess the efficacy of BMS-936558 (MDX-1106) as monotherapy
time frame: Every 8 weeks throughout study participation.
The dose response relationship in melanoma and in NSCLC
time frame: 56 of each cycle (up to cycle 18) and if available including off-study and follow-up visits (approximately up to 46 weeks)
Measures of humoral and cellular immune responses to tumor antigens and recall responses to non-tumor antigens such as T cell reactivity against melanoma peptides
time frame: Day 1 of each cycle (up to cycle 18) and if available including off-study and follow-up visits (approximately up to 46 weeks)

Eligibility Criteria

Male or female participants at least 18 years old.

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-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

Additional Information

Official title A Phase 1b, Open-label, Multicenter, Multidose, Dose-escalation Study of MDX-1106 in Subjects With Selected Advanced or Recurrent Malignancies
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.