Keytruda® will be compared to Adcetris® in this study to find out how effective and safe Keytruda is in treating a cancer called Hodgkin lymphoma.

Phase 1

• Conditions: Relapsed or refractory classical Hodgkin lymphoma; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2015-005053-12-FR
• Lead Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-22
• Last Update Posted: 28 November 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

– =18 years of age
– Relapsed or refractory classical Hodgkin lymphoma
– Measurable disease on spiral computed tomography (CT)
– Evaluable core or excisional lymph node biopsy
– Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
– Adequate organ function (laboratory studies)
– Negative pregnancy/lactation
– Adequate contraception (males and females)
Refer to the protocol for more detail on each inclusion criterion.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 210
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90

Exclusion Criteria

– Previous brentuximab vedotin
– Current study of an investigational agent
– Immunosuppressed
– Monoclonal antibody (mAB) within 4 weeks prior to first dose
– Allogeneic hematopoietic stem cell transplantation =5 years
– Known additional malignancy
– Active autoimmune disease, non-infectious pneumonitis, or central nervous system (CNS) metastases
– Known psychiatric or substance abuse disorders
– Prior therapy with antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
– anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD30, anti-CD137, or CTLA?4 antibody
– HIV, hepatitis B (HBV), or hepatitis C (HCV)
– live vaccine within 30 days prior to first dose
Refer to the protocol for more detail on each exclusion criterion.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified