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Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-08-07
257
Participants Needed
10
Research Sites
N/A
Total Duration
Researchers are studying the effects of the drug pembrolizumab combined with a chemotherapy regimen called GVD in treating patients with relapsed or refractory Hodgkin lymphoma. This Phase II study aims to evaluate the safety and effectiveness of this combination, including monitoring for any dose-limiting toxicities. The trial is sponsored by Memorial Sloan Kettering Cancer Center and involves patients who have classical Hodgkin lymphoma that has either returned or not responded to previous treatment. Participants will first undergo a safety phase where six patients receive pembrolizumab-GVD to check for toxicities. If this phase is successful, the study continues with additional patients receiving pembrolizumab-GVD treatment cycles, followed by stem cell mobilization and collection. Depending on their response, patients may receive further pembrolizumab alone or be randomized to receive autologous stem cell transplant ASCT or pembrolizumab maintenance therapy. Some patients with limited disease may also receive involved-site radiation therapy ISRT. Throughout the study, participants will be closely monitored for adverse events, toxicities, and treatment response. Assessments include PET scans and lab tests to ensure organ function and disease status. The primary outcomes focus on complete response rates and long-term disease freedom, with monitoring continuing up to five years. The total duration and follow-up depend on the treatment phase and patient response.
CONDITIONS
Phase II Study of Second- Line Pembrolizumab Plus GVD for Relapsed or Refractory Hodgkin Lymphoma
A
Alison Moskowitz, MD
H
Heiko Schoder, MD
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Memorial Sloan Kettering Cancer Center
Lead Sponsor
Merck Sharp & Dohme LLC
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Pembrolizumab + GVD Combination | Standard GVD Salvage Chemotherapy |
|---|---|---|
| What it is | A combination regimen of pembrolizumab (PD-1 inhibitor immunotherapy) with gemcitabine, vinorelbine, and liposomal doxorubicin (GVD) chemotherapy, used as second-line therapy in adults with relapsed or refractory classical Hodgkin lymphoma, followed by autologous stem cell transplant and pembrolizumab maintenance in some cases. | Standard GVD chemotherapy (gemcitabine, vinorelbine, liposomal doxorubicin) given as second-line salvage therapy for relapsed or refractory classical Hodgkin lymphoma before autologous stem cell transplant. This regimen is established as a common current-care option in this setting. |
| Role in trial | Studied as the investigational second-line regimen for adults with relapsed or refractory Hodgkin lymphoma prior to autologous transplantation. | Serves as the established standard salvage therapy for eligible relapsed or refractory patients before transplant outside trials. |
| Why it is used | To increase the rate of complete response to second-line therapy and facilitate successful autologous stem cell transplant by combining immunotherapy (pembrolizumab) with established cytotoxic agents in patients with relapsed or refractory disease. | Given to induce remission as second-line salvage in preparation for autologous stem cell transplant in relapsed or refractory classical Hodgkin lymphoma. |
| How it is given | Pembrolizumab given IV (2 mg/kg in pediatric, 200 mg flat in adults) on day 1 of each 3-week cycle, with gemcitabine, vinorelbine, and liposomal doxorubicin administered IV on days 1 and 8 per cycle for 2–4 cycles. Autologous stem cell mobilization and collection after combination, with pembrolizumab maintenance in responders. | Gemcitabine (1000 mg/m²), vinorelbine (20 mg/m²), and liposomal doxorubicin (15 mg/m²) given IV on days 1 and 8 of every 3-week cycle for 2–4 cycles, followed by standard stem cell collection and autologous transplant in responders. |
| Evidence status | Early-phase trial evidence supports promising efficacy for pembrolizumab plus GVD with high complete response rates in the relapsed/refractory setting, but results are not yet definitive or practice-changing. | Extensive retrospective and prospective evidence, as summarized in reviews and consensus guidelines, supports GVD as an established salvage option with documented remission rates prior to transplant. |
| Important limitations | The regimen has only early-phase trial data with no randomized comparison and longer-term outcomes—such as post-transplant survival and late toxicity—remain uncertain. Toxicity profile reflects both immunotherapy and multi-agent chemotherapy, with potential additive adverse effects. | GVD, while effective, has known hematologic and non-hematologic toxicity, sometimes limits on stem cell mobilization, and lacks randomized trial data against other salvage regimens. Response and survival rates can differ by patient risk factors. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Duration of initial treatment cycles
Initial 6 patients receive pembrolizumab-GVD treatment and are observed for dose limiting toxicities to ensure safety.
Regular visits during treatment cycles
Duration - Up to approximately 12 weeks
Participants receive 2 to 4 cycles of pembrolizumab combined with gemcitabine, vinorelbine, and liposomal doxorubicin chemotherapy. Stem cell mobilization and collection occurs after these cycles.
Multiple treatment visits during cycles
Duration - Up to several years depending on response and treatment phase
Patients who achieve complete response may receive additional pembrolizumab maintenance therapy or autologous stem cell transplant, and some may receive involved-site radiation therapy. Monitoring continues for adverse events and disease status.
Regular follow-up visits including assessments for up to 5 years
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
6
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Alison J Moskowitz, Gunjan Shah, Heiko Schöder...
https://pubmed.ncbi.nlm.nih.gov/34170745/Sirui Ma, Michael A Spinner
https://pubmed.ncbi.nlm.nih.gov/41698326/Memorial Sloan Kettering Cancer Center
Lead Sponsor
Merck Sharp & Dohme LLC
Collaborating Sponsor
