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

Conditions

• Relapsed or Refractory Diffuse Large B-cell Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Tinostamustinein — DRUG
  Tinostamustine80-120mg IV Q3W (dose to be determined in part 1) for 6 cycles
• Pembrolizumab — DRUG
  Pembrolizumab 200mg IV Q3W until disease progression or unacceptable toxicities (max. 2 years)
• Rituximab — DRUG
  Rituximab 375 mg/m2 IV Q3W for 6 cycles

Study Details

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

Key Dates

Start date

Sep 30, 2018

Status verified

Feb 2020

Primary completion

Mar 31, 2020

Completion

Jan 31, 2021

Study Design

Enrollment

0 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Other: Safety Run in & Main Efficacy Part
  Part 1 (safety run-in) aims to evaluate the maximum tolerated dose (MTD) of tinostamustinein combination with pembrolizumab (200mg Q3W) and rituximab (375mg/m2 Q3W). The dose of tinostamustineestablished to be safe and tolerable in this combination will be used in part 2 of the trial (main efficacy part). The aim of part 2 is to detect signals of anti-tumour activity and to further assess the safety of this combination treatment in r/r DLBCL. The study has a strong focus on correlative research in order to identify mechanisms of response and resistance to pembrolizumab and the pembrolizumab/R-tinostamustinecombination.

Primary Outcome Measure

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 2.3 years ]