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

Part of paid clinical trials in Duarte, California.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT03618550
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Aug 1, 2018
Status verified
Apr 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
257 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Safety Window and DLT definition (Part 1)
    Initially, 6 patients will be treated on the safety portion of the study and observed for dose limiting toxicities (DLTs). If 1 or fewer patients experience dose\[1\]limiting toxicity (DLT), enrollment onto the study will proceed according to a phase II, Simon 2- stage design.
  • Experimental: Safety monitoring beyond after completion of safety window (PART 1)
    During the phase II portion of the study, patients will continue to be monitored for DLTs, adverse events, and events of interest throughout treatment with pembrolizumab-GVD, ASCT (part 1, if applicable), and 100 days following the last dose of pembrolizumab. Total planned enrollment is 39 patients
  • Experimental: Autologous Stem Cell Transplant (ASCT) (PARTS 1 and 3)
    Stem cell mobilization and collection will be performed as per institutional guidelines after 2-4 cycles of pembrolizumab-GVD.
  • Experimental: Pembrolizumab maintenance (PART 2)
    In part 2 of the study, patients who achieve complete response after 4 cycles of pembrolizumab\[1\]GVD will receive single-agent pembrolizumab for 13 cycles, which will begin 3-5 weeks after cycle 4 of pembrolizumab-GVD.
  • Experimental: Pembrolizumab maintenance, third-line therapy, and HDT/ASCT (PART 3)
    In part 3 of the study, patients who achieve complete response after 2 cycles of pembrolizumab\[1\]GVD will be randomized to either consolidation with autologous stem cell transplant (after an additional optional 1-2 cycles of pembro-GVD) or 2 cycles of pembro-GVD followed by single agent pembrolizumab maintenance for 13 cycles.
  • Experimental: Involved-site radiation therapy (ISRT) (PART 3)
    Patients with limited sites of disease prior to initiation of pembro-GVD are eligible to receive ISRT prior to ASCT with pembrolizumab maintenance.

Primary Outcome Measure

Complete response rate (part 1) [ Time Frame: 2 years ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
City of Hope Cancer Center (Data Collection Only)DuarteCalifornia91010
Matthew Mei, MD
626-275-8064
Stanford University Medical CenterStanfordCalifornia94305-5408
Ranjana Advani, MD
650-498-6000
University of MiamiMiamiFlorida33136
Craig Moskowitz, MD
305-243-5302
Memorial Sloan Kettering Basking RidgeBasking RidgeNew Jersey07920
Alison Moskowitz, MD
212-639-4839
Memorial Sloan Kettering MonmouthMiddletownNew Jersey07748
Alison Moskowitz, MD
212-639-4839
Memorial Sloan Kettering BergenMontvaleNew Jersey07645
Alison Moskowitz, MD
212-639-4839
Memorial Sloan Kettering Cancer Center @ CommackCommackNew York11725
Alison Moskowitz, MD
212-639-4839
Memorial Sloan Kettering WestchesterHarrisonNew York10604
Alison Moskowitz, MD
212-639-4839
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Alison Moskowitz, MD
212-639-4839
Heiko Schoder, MD
212-639-2079
Alison Moskowitz, MD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering NassauUniondaleNew York11553
Alison Moskowitz, MD
212-639-4839

Find similar trials in Duarte, CA

By research site
City of Hope Cancer Center (Data Collection Only)· Duarte, CAStanford University Medical Center· Stanford, CAUniversity of Miami· Miami, FLMemorial Sloan Kettering Basking Ridge· Basking Ridge, NJMemorial Sloan Kettering Monmouth· Middletown, NJMemorial Sloan Kettering Bergen· Montvale, NJ

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