NCT03618550 · Memorial Sloan Kettering Cancer Center
Phase II Study of Second- Line Pembrolizumab Plus GVD for Relapsed or Refractory Hodgkin Lymphoma
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
pembrolizumab
Age 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)
DRUG
gemcitabine
1000mg/m\^2 Days 1 and 8 of each 3 week cycle IV infusion 2-4 cycles
DRUG
vinorelbine
20mg/m\^2 Days 1 and 8 of each 3 week cycle IV infusion 2-4 cycles
DRUG
liposomal doxorubicin
15mg/m\^2 Days 1 and 8 of each 3 week cycle IV infusion 2-4 cycles
PROCEDURE
Stem cell mobilization and collection
Stem cell mobilization and collection will be performed as per standard MSKCC guidelines after 2-4 cycles of pembrolizumab-GVD.
RADIATION
Involved-site radiation therapy
Involved-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.
Primary outcome measures
Complete response rate (part 1)
Time frame: 2 years
Response to pembrolizumab-GVD will be assessed using the RECIL criteria.
Assess freedom from disease at 5 years (part 3)
Time frame: 5 years
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Histologic diagnosis of classical Hodgkin's lymphoma. Primary refractory or relapsed disease proven by biopsy at enrolling institution.
- Stage I-III Hodgkin lymphoma (part 3)
- Relapse or refractory disease following 1 line of multi-agent chemotherapy (not including pembro-GVD).
- Eligible for HDT/ASCT
- Achieved complete response (Deauville 3 or better) per clinical review following 2 cycles of pembro-GVD
- Be willing and able to provide written informed consent/assent for the trial.
- Be ≥ 18 years of age on day of signing informed consent.
- Have measurable disease based on Lugano 2014 criteria
- Have a performance status of 0 or 1 on the ECOG Performance Scale
- Demonstrate adequate organ function as defined in table below
- Demonstrate adequate organ function as defined in table below. Hematological
- Absolute neutrophil count (ANC) ≥1000 /mcL
- Platelets ≥50,000 / mcL
- Hemoglobin ≥8 g/dL Renal
- Serum creatinine OR ≤1.5 X upper limit of normal (ULN) OR *
Where
- Duarte, California
- Stanford, California
- Miami, Florida
- Basking Ridge, New Jersey
- Middletown, New Jersey
- Montvale, New Jersey
- Commack, New York
- Harrison, New York
- New York, New York
- Uniondale, New York
Collaborators
Merck Sharp & Dohme LLC
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 29, 2026 · Source of record for eligibility and locations