Health TrialsbyHealthPanel

Phase II Study of Second- Line Pembrolizumab Plus GVD for Relapsed or Refractory Hodgkin Lymphoma

ConditionsHodgkin LymphomaRelapsed 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 volunteers

Qualifiers

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

Disqualifiers

Received more than 1 prior treatment (combined modality therapy represents 1 treatment) for Hodgkin Lymphoma

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • pembrolizumab

    Drug

    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)

  • gemcitabine

    Drug

    1000mg/m\^2 Days 1 and 8 of each 3 week cycle IV infusion 2-4 cycles

  • vinorelbine

    Drug

    20mg/m\^2 Days 1 and 8 of each 3 week cycle IV infusion 2-4 cycles

  • liposomal doxorubicin

    Drug

    15mg/m\^2 Days 1 and 8 of each 3 week cycle IV infusion 2-4 cycles

  • Stem cell mobilization and collection

    Procedure/Surgery

    Stem cell mobilization and collection will be performed as per standard MSKCC guidelines after 2-4 cycles of pembrolizumab-GVD.

Treatment groups

257 Participants
are divided into 6 treatment groups

6

Treatment groups

See 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 3)Experimental treatment 5 interventions
Group F: Involved-site radiation therapy (ISRT) (PART 3)Experimental treatment 5 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 years

Secondary 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 years

Other outcomes

Sponsors 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
Apply now