Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma, Large B-Cell, Diffuse

Lymphoma

Lymphoma, T-Cell

Lymphoma, T-Cell, Peripheral

Hodgkin Disease

Lymphoma, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Lymphosarcoma

Peripheral T-cell Lymphoma

Hodgkin Lymphoma

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Pembrolizumab 200mg IV every 3 weeks up to 8 cycles

Philippe Armand, MD, PhD

This phase II study is designed to determine the clinical efficacy of PD-1 blockade, using the anti-PD-1 monoclonal antibody pembrolizumab (MK-3475), administered as consolidation therapy after autologous stem cell transplant (ASCT), in patients with relapsed or refractory (R/R) Diffuse Large B Cell Lymphoma (DLBCL), classical Hodgkin Lymphoma (cHL) or peripheral T-cell lymphoma (PTCL) in 1st remission.

Pembrolizumab is an antibody drug that blocks a molecule called PD-1. PD-1 is a receptor molecule on the surface of immune cells that can be used to turn off the immune response. Some cancers use this as a way to turn off the immune response against them. Blocking PD-1 with pembrolizumabmay restore an effective immune attack against the lymphoma cells.

On this study, patients who undergo ASCT for R/R cHL, DLBCL or PTCL in 1st remission will receive pembrolizumab at a dose of 200mg intravenously every 3 weeks for up to 8 cycles, beginning within a few weeks of ASCT.

Pembrolizumab After ASCT for Hodgkin Lymphoma, DLBCL and T-NHL

A Phase 2 Study of Pembrolizumab (MK-3475) After Autologous Stem Cell Transplantation in Patients With Relapsed/Refractory Classical Hodgkin Lymphoma and, Diffuse Large B Cell Lymphoma and T- Cell Non-Hodgkin Lymphoma

Survival probability of patients alive 18 months from ASCT stratified by PET status before transplantation, time-to-event. Patients categorized by complete metabolic response (complete response by PET scan, assessed using the Lugano 2014 criteria), partial response (assessed using Lugano 2014 criteria) prior to transplantation.

Progression-free survival probability of patients alive and disease-free 18 months from ASCT stratified by PET status before transplantation, time-to-event

Number of patients who complete the planned treatment

Level of MRD detected by PCR (if feasible) before and after pembrolizumab

Proportion of patients alive and disease-free 18 months from autologous stem cell transplantation (ASCT). Progression criteria are per Lugano 2014 criteria. All patients receiving any amount of protocol treatment. Patients who have progressed or lost to follow-up prior to 18 months are counted as failures; only patients followed and progression-free for at least 18 months are counted as successes.

Survival probability of patients alive 18 months from ASCT, time-to-event

Number of patients who relapse within 18 months from autologous stem cell transplantation.

Number of patients who experienced at least a grade 2 toxicity with "definite," "probable," or "possible" attribute to study treatment, according to the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

In patients with measurable disease after ASCT, rate of objective response after treatment. Response was assessed using the Lugano 2014 criteria.

Progression-free survival probability of patients who are alive and without progression 18 months from ASCT, time-to-event

Merck Sharp & Dohme LLC

Dana-Farber Cancer Institute

Principal Investigator

Pembrolizumab 200mg IV every 3 weeks up to 8 cycles

Pembrolizumab: Anti-PD-1 monoclonal antibody

Diffuse Large B Cell Lymphoma

Classical Hodgkin Lymphoma

Peripheral T Cell Lymphoma

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

ECOG Performance Score

Progression-free Survival After ASCT

Overall Survival

Patients who have been followed for at least 18 months or have relapsed prior to 18 months post ASCT

Relapse

Safety and Tolerability Assessed by CTCAE v4 Grade 2 and Above Toxicity Related to Study Treatment

Response Rate to Pembrolizumab

Progression-free Survival

Diffuse Large B Cell Lymphoma patients who were PET-CR before transplantation

Diffuse Large B Cell Lymphoma, PET-CR

Diffuse Large B Cell Lymphoma patients who were not PET-CR before transplantation

Diffuse Large B Cell Lymphoma, PET-NCR

Classical Hodgkin Lymphoma patients who were PET-CR before transplantation

Classical Hodgkin Lymphoma - PET-CR

Classical Hodgkin Lymphoma patients who were not PET-CR before transplantation

Classical Hodgkin Lymphoma - PET-NCR

Peripheral T Cell patients who were PET-CR before transplantation

Peripheral T Cell - PET-CR

Peripheral T Cell patients who were not PET-CR before transplantation

Peripheral T Cell - PET-NCR

Overall Survival After ASCT by PET Status

Progression-free Survival After ASCT by PET Status

Completion Rate

Minimal Residual Disease

Overall Study

Cemiplimab

Patients will receive IS-RT with a dose of 20 Gy. Involved-site radiotherapy will be carried out on the basis of 3D imaging as described in the protocol

Involved-site radiotherapy (IS-RT)

Clinical Trial Management

The primary objective is to estimate the efficacy of experimental treatment with the anti-PD-1 antibody cemiplimab (REGN2810) in combination with simultaneous or subsequent radiotherapy (RT) in early-stage favorable classical Hodgkin lymphoma (cHL).

Secondary objectives are to assess the safety and feasibility of the 2 experimental strategies.

Anti-PD-1 Antibody Treatment With Cemiplimab and Radiotherapy in Early-stage Classical Hodgkin Lymphoma

Anti-PD-1 Antibody Treatment With Cemiplimab and Radiotherapy in Early-stage Favorable Classical Hodgkin Lymphoma (CARHL) - A Randomized Phase II Trial

All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ).

-FA12 module complements the core EORTC QLQ-C30 questionnaire regarding fatigue. Each item can be scored in four dimension on a scale from 1 to 4 with higher scores indicating worse symptoms.

Scores range from 0 to 100. A high scale score represents a higher response level.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Pembrolizumab After ASCT for Hodgkin Lymphoma, DLBCL and T-NHL	NCT02362997	Hodgkin Lymphom... Diffuse Large B... Peripheral T-Ce...	Pembrolizumab	18 Years -	Dana-Farber Cancer Institute
Anti-PD-1 Antibody Treatment With Cemiplimab and Radiotherapy in Early-stage Classical Hodgkin Lymphoma	NCT04373083	Hodgkin Lymphom...	Cemiplimab Involved-site r...	18 Years - 75 Years	Regeneron Pharmaceuticals

Spots Global Cancer Trial Database for classical hodgkin lymphoma (chl)