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The safety and efficacy of this agent(s), or use in this setting, has not been established or is subject to confirmation. For an agent(s) whose safety and efficacy has not been established or confirmed, future regulatory approval or commercial availability is not guaranteed.
Active Not-enrolling
United States, Australia, Czechia, Italy, Poland, Spain
EXPERIMENTAL: Part A: A+AVD
Brentuximab vedotin (A) plus doxorubicin (+A), vinblastine (V), and dacarbazine (D) administered by intravenous (IV) infusion in participants with advanced stage classical Hodgkin lymphoma (cHL) during each treatment cycle.
DRUG: brentuximab vedotin
1.2 mg/kg by IV infusion
DRUG: doxorubicin
25 mg/m\^2 by IV infusion
DRUG: vinblastine
6 mg/m\^2 by IV infusion
DRUG: dacarbazine
375 mg/m\^2 by IV infusion
DRUG: G-CSF
Granulocyte colony stimulating factor (G-CSF) primary prophylaxis administered 24-36 hours after each dose of A+AVD
EXPERIMENTAL: Part B: AN+AD
Brentuximab vedotin (A) plus nivolumab (N), doxorubicin (+A), and dacarbazine (D) administered separately by IV infusion in participants with Stage II bulky mediastinal disease and Stage III or IV cHL during each treatment cycle.
DRUG: brentuximab vedotin
1.2 mg/kg by IV infusion
DRUG: doxorubicin
25 mg/m\^2 by IV infusion
DRUG: dacarbazine
375 mg/m\^2 by IV infusion
DRUG: nivolumab
240 mg by IV infusion
EXPERIMENTAL: Part C: AN+AD
Brentuximab vedotin (A) plus nivolumab (N), doxorubicin (+A), and dacarbazine (D) administered separately by IV infusion in participants with Stage I or II cHL with non-bulky mediastinal disease during each treatment cycle.
DRUG: brentuximab vedotin
1.2 mg/kg by IV infusion
DRUG: doxorubicin
25 mg/m\^2 by IV infusion
DRUG: dacarbazine
375 mg/m\^2 by IV infusion
DRUG: nivolumab
240 mg by IV infusion
Inclusion Criteria
Febrile Neutropenia (FN) Rate (Part A)
The FN rate is defined as the number of participants who experience treatment-emergent FN.
7.5 months
Complete Response (CR) Rate (Parts B and C)
CR rate at EOT is defined as the percentage of subjects with CR at EOT, according to the Lugano Classification Revised Staging System for malignant lymphoma (Cheson 2014) with the incorporation of LYRIC (Cheson 2016), in subjects with previously untreated cHL.
7.8 months
Primary Refractory Disease Rate (Part A)
The primary refractory disease rate is defined as the percentage of participants with less than complete response or relapse within 3 months of EOT, according to the Lugano Classification Revised Staging System for nodal non-Hodgkin and Hodgkin lymphomas
10.2 months
Complete Response Rate (Part A)
The complete response rate is defined as the percentage of participants with CR at EOT according to the Lugano Classification Revised Staging System for nodal non-Hodgkin and Hodgkin lymphomas (Cheson 2014).
7.2 months
Physician-reported Progression Free Survival (PFS) (Part A)
The physician-reported PFS rate at 2 years is estimated based on Kaplan-Meier methodology.
24 months
Subsequent Anticancer Therapy Utilization Rate (Part A)
Number of participants with subsequent anticancer therapy
33.8 months
Actual Dose Intensity: Brentuximab Vedotin (Part A)
6.5 months
Actual Dose Intensity: Doxorubicin, Vinblastine, Dacarbazine (Part A)
6.5 months
Relative Dose Intensity (Part A)
6.5 months
Rate of Dose Reduction and Delays: Brentuximab Vedotin (Part A)
6.5 months
Rate of Dose Reduction and Delays: Doxorubicin (Part A)
6.5 months
Rate of Dose Reduction and Delays: Vinblastine (Part A)
6.5 months
Rate of Dose Reduction and Delays: Dacarbazine (Part A)
6.5 months
Incidence of Adverse Events (Parts B and C)
8.9 months
Incidence of Laboratory Abnormalities (Parts B and C)
Laboratory values were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE version 4.03).
8.9 months
Overall Response Rate (ORR) at EOT (Parts B and C)
ORR is defined as the proportion of participants with CR or partial response (PR) at EOT according to the Lugano Classification Revised Staging System for malignant lymphoma (Cheson 2014) with the incorporation of LYRIC (Cheson 2016) in subjects with previously untreated cHL.
7.8 months
255
Sponsor: Seagen Inc.
Collaborator: Bristol-Myers Squibb
For more information, call or email the Pfizer Clinical Trial Contact Center:
When calling, please reference this study number: