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

Sponsor
Memorial Sloan Kettering Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT03618550
Collaborator
Merck Sharp & Dohme Corp. (Industry)
64
Enrollment
9
Locations
1
Arm
60
Anticipated Duration (Months)
7.1
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
64 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
This is a phase II study evaluating pembrolizumab plus gemcitabine, vinorelbine, liposomal doxorubicin (GVD) in transplant eligible patients with relapsed or refractory Hodgkin lymphoma following failure of 1-line of multi-agent chemotherapy.This is a phase II study evaluating pembrolizumab plus gemcitabine, vinorelbine, liposomal doxorubicin (GVD) in transplant eligible patients with relapsed or refractory Hodgkin lymphoma following failure of 1-line of multi-agent chemotherapy.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase II Study of Second-line Pembrolizumab Plus GVD for Relapsed or Refractory Hodgkin Lymphoma
Actual Study Start Date :
Aug 1, 2018
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

ArmIntervention/Treatment
Experimental: pembrolizumab plus GVD

Part 1: Patients will receive 2-4 cycles of pembrolizumab plus GVD Part 2: an additional 25 patients will be enrolled onto an expansion cohort. On the expansion, patients who achieve CR to 4 cycles of pembro-GVD will receive 13 cycles of pembrolizumab maintenance (instead of HDT/ASCT).

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.

Outcome Measures

Primary Outcome Measures

  1. complete response rate [2 years]

    Response to pembrolizumab-GVD will be assessed using the RECIL criteria.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Histologic diagnosis of classical Hodgkin's lymphoma.

  • Primary refractory or relapsed disease proven by excisional or core needle biopsy at enrolling institution.

  • Relapse or refractory disease following 1 line of multi-agent chemotherapy.

  • 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.

  • Absolute neutrophil count (ANC) ≥1000 /mcL

  • Platelets ≥50,000 / mcL

  • Hemoglobin ≥8 g/dL

  • Serum creatinine OR ≤1.5 X upper limit of normal (ULN) OR

  • Measured or calculateda creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≥60 mL/min for subject with creatinine levels > 1.5 X institutional ULN

  • 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

  • Hemoglobin-adjusted diffusing capacity for carbon monoxide ≥50% (If unadjusted DLCO is

/= 50% then there is no need to calculate adjusted)

  • Ejection fraction ≥45%

  • Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication.

  • Female subjects of childbearing potential must be willing to use an adequate method of contraception

  • Male subjects of childbearing potential must agree to use an adequate method of contraception.

Exclusion Criteria:
  • Received more than 1 prior treatment (combined modality therapy represents 1 treatment) for Hodgkin Lymphoma

  • Known pregnancy or breast-feeding.

  • 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 (eg., 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 (non-infectious) pneumonitis that required steroids or has current pneumonitis.

  • Has an active infection requiring systemic therapy.

  • 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.)

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1University of MiamiMiamiFloridaUnited States33136
2Memoral Sloan Kettering Basking RidgeBasking RidgeNew JerseyUnited States07920
3Memoral Sloan Kettering MonmouthMiddletownNew JerseyUnited States07748
4Memorial Sloan Kettering BergenMontvaleNew JerseyUnited States07645
5Memorial Sloan Kettering Cancer Center @ CommackCommackNew YorkUnited States11725
6Memoral Sloan Kettering WestchesterHarrisonNew YorkUnited States10604
7Memorial Sloan - Kettering Cancer CenterNew YorkNew YorkUnited States10021
8Memorial Sloan Kettering Cancer CenterNew YorkNew YorkUnited States10065
9Memorial Sloan Kettering NassauUniondaleNew YorkUnited States11553

Sponsors and Collaborators

  • Memorial Sloan Kettering Cancer Center
  • Merck Sharp & Dohme Corp.

Investigators

  • Principal Investigator: Alison Moskowitz, MD, Memorial Sloan Kettering Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT03618550
Other Study ID Numbers:
  • 18-160
First Posted:
Aug 7, 2018
Last Update Posted:
Mar 8, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Memorial Sloan Kettering Cancer Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 8, 2022