An Open-label, Randomized, Multicenter, Phase II Study of MDX-060 in Combination With Gemcitabine, MDX060 in Combination With Dexamethasone, and Gemcitabine Monotherapy in Patients With Relapsed or Refractory Hodgkin's Disease
Overview
- Phase
- Phase 2
- Intervention
- MDX-060
- Conditions
- Hodgkin's Disease
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 74
- Locations
- 17
- Primary Endpoint
- Overall response rate
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
This study is designed to determine the objective response rate in patients with relapsed or refractory Hodgkin's disease treated with MDX-060 in combination with gemcitabine or gemcitabine alone.
Detailed Description
Secondary objectives include: * to characterize progression-free survival * to characterize time to progression * to determine response duration * to characterize the effect of study drug on health-related quality of life * to explore the correlation of positron emission tomography (PET) scan results with objective responses observed with conventional imaging in this patient population * to characterize the immunogenicity response of MDX-060 * to characterize the safety of MDX-060, and * to characterize the pharmacokinetic profile of MDX-060
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of Hodgkin's disease \[HD\] (excluding HIV-associated HD)
- •Patients must have read, understood, and provided written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization after the nature of the study has been fully explained
- •Patients must have failed or relapsed following second line (i.e., salvage) chemotherapy or relapsed or failed following autologous stem cell transplant
- •ECOG Performance Status of 0-2
- •Patients must have bi-measurable disease
- •At least 4 weeks since the last chemotherapy or radiation therapy with clinical evidence of recovery from any toxicity associated with such treatment
- •Life expectancy 12 weeks or greater
- •Screening laboratory values must be met
- •Patients on corticosteroids must be tapered off the medication 2 weeks prior to study drug administration and remain off corticosteroids until study completion.
Exclusion Criteria
- •Previous treatment with any anti-CD30 antibody
- •History of allogeneic transplant
- •Any tumor lesion 10cm or greater in diameter
- •Any other malignancy, excluding basal or squamous cell carcinoma of the skin, or cervical carcinoma in situ. Any cancer from which the patient has been disease free for at least 5 years is permissible.
- •Any significant active or chronic infection
- •Apparent active or latent tuberculosis (TB) infection
- •Patients who are pregnant or nursing
- •Any underlying medical condition which, in the investigator's opinion, will make the administration of the study drug hazardous or obscure the interpretation of adverse events
- •Concomitant chemotherapy, steroids, investigational agents, other anti-HD biologics, or radiation therapy
Arms & Interventions
MDX-060 plus standard of care
MDX-060 in combination with gemcitabine
Intervention: MDX-060
Standard of care
Gemcitabine
Intervention: MDX-060
Outcomes
Primary Outcomes
Overall response rate
Time Frame: Day 50/57
Secondary Outcomes
- Progression-free survival(Day 50/57)