Phase II Study of Second- Line Pembrolizumab Plus GVD for Relapsed or Refractory Hodgkin Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center
About this trial
The purpose of this study is to test any good and bad effects of the study drug, pembrolizumab, in combination with GVD in the treatment of Hodgkin lymphoma.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologic diagnosis of classical Hodgkin's lymphoma. Primary refractory or relapsed disease proven by biopsy at enrolling institution.
Be willing and able to provide written informed consent/assent for the trial.
Be ≥ 18 years of age on day of signing informed consent.
PET scan before initiating pembro-GVD have measurable disease based on Lugano 2014 criteria
Disqualifiers
Known pregnancy or breast-feeding.
Breast-feeding should be discontinued prior to treatment initiation.
Medical illness unrelated to Hodgkin's Lymphoma, which, in the opinion of the attending physician and/or principal investigator, makes participation in this study inappropriate.
Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.
Trial design
Design model
Single group
Treatments tested in this trial
pembrolizumab
DrugAge 10-17: 2mg/kg (cap at 200mg), Age ≥ 18: 200 mg (flat) ,Day 1 of each 3 week cycle IV infusion 2-4 cycles (pre-ASCT)
gemcitabine
Drug1000mg/m\^2 Days 1 and 8 of each 3 week cycle IV infusion 2-4 cycles
vinorelbine
Drug20mg/m\^2 Days 1 and 8 of each 3 week cycle IV infusion 2-4 cycles
liposomal doxorubicin
Drug15mg/m\^2 Days 1 and 8 of each 3 week cycle IV infusion 2-4 cycles
Stem cell mobilization and collection
Procedure/SurgeryStem cell mobilization and collection will be performed as per standard MSKCC guidelines after 2-4 cycles of pembrolizumab-GVD.
Involved-site radiation therapy
RadiationInvolved-site radiation therapy (ISRT) Patients with limited sites of disease prior to initiation of pembro-GVD are eligible to receive ISRT prior to ASCT or with pembrolizumab maintenance. n. ISRT to nodal based disease should be delivered in line with the guidelines provided by the International Lymphoma Radiation Oncology Group.
Treatment groups
257 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Safety Window and DLT definition (Part 1)Experimental treatment 5 interventions
Group B: Safety monitoring beyond after completion of safety window (PART 1)Experimental treatment 5 interventions
Group C: Autologous Stem Cell Transplant (ASCT) (PARTS 1 and 3)Experimental treatment 5 interventions
Group D: Pembrolizumab maintenance (PART 2)Experimental treatment 5 interventions
Group E: Pembrolizumab maintenance, third-line therapy, and HDT/ASCT (PART 3A)Experimental treatment 5 interventions
Group F: Involved-site radiation therapy (ISRT) (PART 3B)Experimental treatment 6 interventions
Trial outcomes
Primary outcomes
1
Complete response rate (part 1)
Response to pembrolizumab-GVD will be assessed using the RECIL criteria.
Time frame
2 years2
Assess freedom from disease at 5 years (part 3)
A disease event will be defined as disease relapse after transplant or after maintenance if transplant does not occur, death, or loss to follow-up before the 5-year follow-up period ends.
Time frame
5 yearsSecondary outcomes
1
Evaluate the 2-year PFS rate (part 2)
Only patients who receive the Pembrolizumab maintenance regime will be considered evaluable for 2-year PFS and OS rates.
Time frame
2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Memorial Sloan Kettering Cancer Center
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator
Source ClinicalTrials.gov