An Open-label, Uncontrolled, Multicenter Phase II Trial of MK-3475 (Pembrolizumab) in Children and Young Adults with Newly Diagnosed Classical Hodgkin Lymphoma with Inadequate (Slow Early) Response to Frontline chemotherapy (KEYNOTE 667).

Conditions

Classical Hodgkin lymphoma in children and young adults

Brief summary

Objective Response Rate (ORR) in SER Participants By Risk Group (Low, High) as assessed by Blinded Independent Central Review (BICR)

Detailed description

Rate of Positron Emission Tomography (PET) Scan Negativity in SER Participants By Risk Group (Low, High) After AVD (Doxorubicin, vinblastine and dacarbazine) or COPDAC-28 (cyclophosphamide, vincristine, prednisone, and dacarbazine) Chemotherapy, Event-Free Survival (EFS) in SER Participants By Risk Group (Low, High) as Assessed by BICR, Overall Survival (OS) in SER Participants By Risk Group (Low, High), Exposure to Radiotherapy (RT) in SER Participants By Risk Group (Low, High), Rate of PET Scan Negativity In Group 1 Participants After ABVD Induction Therapy, EFS in Rapid Early Responder (RER) Participants By Risk Group (Low, High) as Assessed by Investigator, OS in RER Participants By Risk Group (Low, High), Serum Thymus and Activation-Regulated Chemokine (TARC) Levels in SER Participants By Risk Group (Low, High), Number of SER Participants Experiencing an Adverse Event (AE) By Risk Group (Low, High), Number of SER Participants Discontinuing Study Treatment Due to AEs By Risk Group (Low, High)

Related papers

No related papers found yet.

Interventions

DRUGPREDNISOLONE

DRUGDOXORUBICIN

DRUGVINBLASTINE

DRUGDACARBAZINE

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUGVINCRISTINE

DRUGBLEOMYCIN

DRUGPREDNISONE

DRUGCYCLOPHOSPHAMIDE

DRUGETOPOSIDE

Eligibility

Sex/Gender

All

Age

0 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Objective Response Rate (ORR) in SER Participants By Risk Group (Low, High) as assessed by Blinded Independent Central Review (BICR)	—

Secondary

Measure	Time frame
Rate of Positron Emission Tomography (PET) Scan Negativity in SER Participants By Risk Group (Low, High) After AVD (Doxorubicin, vinblastine and dacarbazine) or COPDAC-28 (cyclophosphamide, vincristine, prednisone, and dacarbazine) Chemotherapy, Event-Free Survival (EFS) in SER Participants By Risk Group (Low, High) as Assessed by BICR, Overall Survival (OS) in SER Participants By Risk Group (Low, High), Exposure to Radiotherapy (RT) in SER Participants By Risk Group (Low, High), Rate of PET Scan Negativity In Group 1 Participants After ABVD Induction Therapy, EFS in Rapid Early Responder (RER) Participants By Risk Group (Low, High) as Assessed by Investigator, OS in RER Participants By Risk Group (Low, High), Serum Thymus and Activation-Regulated Chemokine (TARC) Levels in SER Participants By Risk Group (Low, High), Number of SER Participants Experiencing an Adverse Event (AE) By Risk Group (Low, High), Number of SER Participants Discontinuing Study Treatment Due to AEs By Risk Group	—

Measure

Time frame

Rate of Positron Emission Tomography (PET) Scan Negativity in SER Participants By Risk Group (Low, High) After AVD (Doxorubicin, vinblastine and dacarbazine) or COPDAC-28 (cyclophosphamide, vincristine, prednisone, and dacarbazine) Chemotherapy, Event-Free Survival (EFS) in SER Participants By Risk Group (Low, High) as Assessed by BICR, Overall Survival (OS) in SER Participants By Risk Group (Low, High), Exposure to Radiotherapy (RT) in SER Participants By Risk Group (Low, High), Rate of PET Scan Negativity In Group 1 Participants After ABVD Induction Therapy, EFS in Rapid Early Responder (RER) Participants By Risk Group (Low, High) as Assessed by Investigator, OS in RER Participants By Risk Group (Low, High), Serum Thymus and Activation-Regulated Chemokine (TARC) Levels in SER Participants By Risk Group (Low, High), Number of SER Participants Experiencing an Adverse Event (AE) By Risk Group (Low, High), Number of SER Participants Discontinuing Study Treatment Due to AEs By Risk Group

—

Countries

Czechia, France, Germany, Greece, Italy, Netherlands, Slovakia, Spain

Outcome results

None listed