Recruiting

Phase 2

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

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT03618550

Conditions

Hodgkin Lymphoma

Relapsed or Refractory Hodgkin Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

pembrolizumab

gemcitabine

vinorelbine

liposomal doxorubicin

Stem cell mobilization and collection

Study Details

Brief summary:

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.

Conditions

Hodgkin Lymphoma

Relapsed or Refractory Hodgkin Lymphoma

Study ID

NCT03618550

Start date

Aug 1, 2018

Status verified date

Aug, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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
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
Measured or calculated creatinine clearance (eGFR can also be used in place of creatinine) ≥60 mL/min for subject with creatinine levels > 1.5 X institutional ULN Hepatic\*
Serum total bilirubin ≤ 1.5 X ULN OR ≤ 3 X ULN for subjects with liver metastases
AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases Pulmonary
Hemoglobin-adjusted diffusing capacity for carbon monoxide ≥50% (If unadjusted DLCO is >/= 50% then there is no need to calculate adjusted) Cardiac
Ejection fraction ≥45% Coagulation
International normalized ratio (INR) OR prothrombin time (PT), Activated partial thromboplastin time (aPTT): ≤ 1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants

\*Lab values for eligibility should be based upon labs prior to Cycle 1 treatment of Pembro-GVD.

Female subject of childbearing potential should have a negative urine or serum pregnancy within 2 weeks prior to receiving the first dose of study medication. On the day of planned treatment, if a blood pregnancy test has not been performed within the two week window, a stat pregnancy test (urine or blood) should be performed and the results reviewed before treatment is begun.
Female subjects of childbearing potential must be willing to use an adequate method of contraception (see details in section 11.4.3).
Male subjects of childbearing potential must agree to use an adequate method of contraception.(see details in section 11.4.3).
HIV-infected participants must have well-controlled HIV on ART, defined as:

Participants on ART must have a CD4+ T-cell count ≥350 cells/mm3 at the time of screening
Participants on ART must have achieved and maintained virologic suppression defined as confirmed HIV RNA level below 50 copies/mL or the LLOQ (below the limit of detection) using the locally available assay at the time of screening and for at least 12 weeks before screening
It is advised that participants must not have had any AIDS-defining opportunistic infections within the past 12 months.
Participants on ART must have been on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks before study entry (Day 1) and agree to continue ART throughout the study
Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible.

Exclusion Criteria:

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.
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
Has known active HIV, Hepatitis B (e.g., Hepatitis B PCR positive) or Hepatitis C (e.g., HCV RNA \[qualitative\] is detected).
Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed.
Has a history of pneumonitis related to PD-1 blockade that required steroids.
Has an active infection requiring systemic therapy.
Has not adequately recovered from major surgery or has ongoing surgical complications
Has undergone solid organ transplant at any time, or prior allogeneic hematopoietic stem cell transplantation within the last 5 years. (Subjects who have had an allogeneic hematopoietic transplant greater than 5 years ago are eligible as long as there are no symptoms of GVHD.)
Has a history or current evidence of any condition, therapy, or laboratory abnormality or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.

Study Design

Enrollment

257 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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 3A)

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 3B)

Patients with limited sites of disease prior to initiation of pembro-GVD are eligible to receive ISRT prior to ASCT with pembrolizumab maintenance.

Interventions

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)

gemcitabine

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

vinorelbine

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

liposomal doxorubicin

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

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.

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 measure

Complete response rate (part 1) [ Time Frame: 2 years ]
Assess freedom from disease at 5 years (part 3) [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Alison Moskowitz, MD

212-639-4839 moskowia@mskcc.org

Heiko Schoder, MD

212-639-2079

Locations

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Craig Moskowitz, MD

305-243-5302

Memorial Sloan Kettering Basking Ridge

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Alison Moskowitz, MD

212-639-4839

Memorial Sloan Kettering Monmouth

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Alison Moskowitz, MD

212-639-4839

Memorial Sloan Kettering Bergen

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Alison Moskowitz, MD

212-639-4839

Memorial Sloan Kettering Cancer Center @ Commack

Recruiting

Commack, New York, United States, 11725

Contacts

Alison Moskowitz, MD

212-639-4839

Memorial Sloan Kettering Westchester

Recruiting

Harrison, New York, United States, 10604

Contacts

Alison Moskowitz, MD

212-639-4839

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Alison Moskowitz, MD

212-639-4839

Heiko Schoder, MD

212-639-2079

Principal Investigator:

Alison Moskowitz, MD

Memorial Sloan Kettering Nassau

Recruiting

Uniondale, New York, United States, 11553

Contacts

Alison Moskowitz, MD

212-639-4839

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Aug 7, 2026

Last verified

Aug, 2026

Keywords

Pembrolizumab
GVD
18-160

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-08-07.