Trial record 2 of 2 for:
mdx-1106 hcv
Multiple Ascending Dose (Anti-PD-1 HCC)
This study is currently recruiting participants.
Verified May 2013 by Bristol-Myers Squibb
Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01658878
First received: August 3, 2012
Last updated: May 13, 2013
Last verified: May 2013
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Purpose
The purpose of this study is to evaluate the safety, pharmacokinetics, immunoregulatory activity, pharmacodynamics and preliminary anti-tumor activity of BMS-936558 in subjects with advanced hepatocellular carcinoma (HCC)
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatocellular Carcinoma |
Biological: BMS-936558 (Anti-PD-1 antibody) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Dose Escalation Study to Investigate the Safety, Immunoregulatory Activity, Pharmacokinetics, and Preliminary Antitumor Activity of Anti-Programmed-Death-1 (PD-1) Antibody (BMS-936558) in Advanced Hepatocellular Carcinoma in Subjects With or Without Chronic Viral Hepatitis |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- Incidence of worst adverse events [ Time Frame: Up to 100 days after the last dose of BMS-936558 ] [ Designated as safety issue: Yes ]All non-serious adverse events will be collected from Day 1 until 100 days after the subject's last dose of BMS-936558
- Incidence of clinical laboratory test abnormalities including hematology and serum chemistry abnormalities [ Time Frame: Up to Week 214 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Objective response rate and disease control rate [ Time Frame: Up to Week 214 ] [ Designated as safety issue: No ]
- Frequency of subjects with increase in anti-drug antibodies (ADA) levels [ Time Frame: Up to Week 214 ] [ Designated as safety issue: No ]
- Geometric means and coefficients of variation for the pharmacokinetic parameter of serum concentration achieved at the end of the dosing interval (trough concentration, Cmin) [ Time Frame: Up to Week 214 ] [ Designated as safety issue: No ]
- Geometric means and coefficients of variation for the pharmacokinetic parameter of maximum observed serum concentration (Cmax) [ Time Frame: Up to Week 214 ] [ Designated as safety issue: No ]
- Geometric means and coefficients of variation for the pharmacokinetic parameter of serum concentration achieved at the end of the infusion (Ceoinf) [ Time Frame: Up to Week 214 ] [ Designated as safety issue: No ]
- Geometric means and coefficients of variation for the pharmacokinetic parameter of area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] [ Time Frame: Up to Week 214 ] [ Designated as safety issue: No ]
- Geometric means and coefficients of variation for the pharmacokinetic parameter of area under the concentration-time curve in one dosing interval [AUC(TAU)] [ Time Frame: Up to Week 214 ] [ Designated as safety issue: No ]
- Medians, minimum, and maximum for the pharmacokinetic parameter of time to maximum observed concentration (Tmax) [ Time Frame: Up to Week 214 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 72 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Non-infected: BMS-936558 |
Biological: BMS-936558 (Anti-PD-1 antibody)
Solution, Intravenous, 0.3 mg/kg or 1 mg/kg or 3 mg/kg, Every 14 days, 3 doses per each cycle of 42 days, 16 cycles /48 doses depending on response,
|
| Experimental: HCV-infected: BMS-936558 |
Biological: BMS-936558 (Anti-PD-1 antibody)
Solution, Intravenous, 0.3 mg/kg or 1 mg/kg or 3 mg/kg, Every 14 days, 3 doses per each cycle of 42 days, 16 cycles /48 doses depending on response,
|
| Experimental: HBV-infected: BMS-936558 |
Biological: BMS-936558 (Anti-PD-1 antibody)
Solution, Intravenous, 0.1 mg/kg or 0.3 g/kg or 1 mg/kg or 3 mg/kg, Every 14 days, 3 doses per each cycle of 42 days, 16 cycles /48 doses depending on response
|
Detailed Description:
Study Classification: Pharmacokinetics/Pharmacodynamics
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subjects with histological confirmation of advanced hepatocellular carcinoma; subjects must have progressive disease following or be intolerant of at least one line of therapy or refuse sorafenib treatment; subjects must be off sorafenib treatment for at least 28 days prior to first dose
- Child-Pugh score of A
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
Exclusion Criteria:
- Subjects with brain metastasis
- Encephalopathy
- Any prior or current ascites requiring paracentesis for control; any history of clinically meaningful variceal bleeding within the last three months
- Active coinfection with both hepatitis B and C
- Hepatitis D infection in subjects with hepatitis B
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01658878
Contacts
| Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email: | Clinical.Trials@bms.com | |
| Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time. |
Locations
| United States, California | |
| Usc Norris Comprehensive Cancer Center | Recruiting |
| Los Angeles, California, United States, 90033 | |
| Contact: Anthony El-Khoueiry, Site 0008 323-865-3538 | |
| United States, Michigan | |
| University Of Michigan | Recruiting |
| Ann Arbor, Michigan, United States, 48109-5331 | |
| Contact: Theodore Welling, Site 0002 | |
| United States, Oregon | |
| Providence Portland Medical Center | Recruiting |
| Portland, Oregon, United States, 97213 | |
| Contact: Todd Crocenzi, Site 0001 503-215-5696 | |
| Hong Kong | |
| Local Institution | Not yet recruiting |
| Hong Kong, Hong Kong, 8525 | |
| Contact: Site 0005 | |
| Local Institution | Not yet recruiting |
| Shatin, Hong Kong, 8520 | |
| Contact: Site 0006 | |
| Singapore | |
| Local Institution | Recruiting |
| Singapore, Singapore, 308433 | |
| Contact: Site 0007 | |
| Spain | |
| Local Institution | Active, not recruiting |
| Pamplona, Spain, 31192 | |
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
No publications provided
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT01658878 History of Changes |
| Other Study ID Numbers: | CA209-040, 2012-001514-42 |
| Study First Received: | August 3, 2012 |
| Last Updated: | May 13, 2013 |
| Health Authority: | United States: Food and Drug Administration Spain: Agencia Española de Medicamentos y Productos Sanitarios |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Liver Neoplasms Digestive System Neoplasms |
Neoplasms by Site Digestive System Diseases Liver Diseases Antibodies Immunoglobulins Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013