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A Phase Ib Combination Study of Rituximab, TinostamustinEAnd CHeckpoint Inhibition With Pembrolizumab in Relapsed/Refractory DLBCL

NCT04279938 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2020-02-21

No results posted yet for this study

Summary

Safety run-in (part 1): Relapsed or refractory B-cell Non-Hodgkin lymphoma (NHL)

Main study (part 2): Relapsed or refractory diffuse large B-cell lymphoma

Conditions

Interventions

DRUG

Tinostamustinein

Tinostamustine80-120mg IV Q3W (dose to be determined in part 1) for 6 cycles

DRUG

Pembrolizumab

Pembrolizumab 200mg IV Q3W until disease progression or unacceptable toxicities (max. 2 years)

DRUG

Rituximab

Rituximab 375 mg/m2 IV Q3W for 6 cycles

Sponsors & Collaborators

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • Mundipharma-EDO GmbH

    collaborator INDUSTRY

  • Royal Marsden NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Professor David Cunningham · The Royal Marsden Hospital NHS Foundation Trust

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-30
Primary Completion
2020-03-31
Completion
2021-01-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04279938 on ClinicalTrials.gov