Study of Nivolumab in Patients With Classical Hodgkin's Lymphoma (Registrational) (CheckMate 205)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Hodgkin Disease

Treatments: Drug: Dacarbazine; Drug: Nivolumab; Drug: Doxorubicin; Drug: Vinblastine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02181738

CA209-205

2014-001509-42 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of Nivolumab in previously treated (cohorts, A, B & C) or newly diagnosed (cohort D) classical Hodgkin Lymphoma participants.

Enrollment: 294 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• Must have received prior high-dose conditioning chemotherapy followed by autologous stem cell transplant (ASCT) as a part of salvage therapy for cHL (cohort A, B & C - enrollment closed)
• Participants may be Brentuximab vedotin- naïve, or may have had prior Brentuximab vedotin treatment (cohort A, B & C - enrollment closed)
• Newly diagnosed and previously untreated classical Hodgkin Lymphoma (cohort D)

Exclusion criteria

• Known central nervous system lymphoma
• Participants with nodular lymphocyte-predominant Hodgkin Lymphoma
• Prior allogeneic stem cell transplantation (SCT)
• Chest radiation ≤ 24 weeks prior to first dose
• Carmustine ≥ 600 mg/m² received as part of the pre-transplant conditioning regimen

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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294 participants in 1 patient group

Nivolumab (Cohort A, B, C and D)

Experimental group

Description:

Cohort (A, B, C): Nivolumab: Specified dose on specified days Cohort (D): Nivolumab: Specified dose on specified days + Doxorubicin: Specified dose on specified days + Vinblastine: Specified dose on specified days + Dacarbazine: Specified dose on specified days

Treatment:

Drug: Nivolumab

Drug: Vinblastine

Drug: Doxorubicin

Drug: Dacarbazine