A Phase II Study of MDX-060 in Subjects With Relapsed or Refractory Hodgkin's Disease

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

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