Ph1b study of bispecifics with lenalidomide in relapsed/refractory FL
Research type
Research Study
Full title
A PHASE IB, OPEN-LABEL, NON-RANDOMIZED, MULTICENTER STUDY EVALUATING THE SAFETY, PHARMACOKINETICS, AND EFFICACY OF MOSUNETUZUMAB IN COMBINATION WITH LENALIDOMIDE OR RO7082859 IN COMBINATION WITH LENALIDOMIDE OR RO7082859 IN COMBINATION WITH OBINUTUZUMAB PLUS LENALIDOMIDE IN PATIENTS WITH RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA
IRAS ID
278775
Contact name
Deanna Orsi
Contact email
Sponsor organisation
Hoffmann-La Roche Limited
Eudract number
2019-004291-20
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 9 months, 16 days
Research summary
Given that Follicular lymphoma (FL) remains an incurable disease with currently available therapies and that patients with relapsed or refractory R/R FL that previously failed standard therapies have relatively poor prognosis, new treatments are needed to improve the outcome for multiply relapsed patients. The goals of this Phase Ib study are to assess the safety, efficacy, pharmacokinetics, pharmacodynamics, and immunogenicity of one of the following treatments:
- mosunetuzumab in combination with lenalidomide
- RO7082859 in combination with lenalidomide
- RO7082859 in combination with obinutuzumab plus lenalidomideThis study will enroll patients with R/R FL. This is the first clinical evaluation of the combination of RO7082859 or mosunetuzumab with lenalidomide. While no direct benefits are known at this time, the available data provide a strong rationale for investigating the potential benefit of these combinations in patients with R/R FL.
The study will include an initial dose-escalation phase, comprising of 2 dose-escalation cohorts, designed to determine the recommended Phase II dose (RP2D) of mosunetuzumab and RO7082859 in their respective step-up treatment combinations. The initial dose-escalation phase will be followed by an expansion phase in which the RP2D for mosunetuzumab or RO7082859 will be given. All study drugs will be administered intravenuously.
The proposed study is planned to be conducted in the EU/EEA Member States France and Spain and the UK. A total of 27 female and male patients (age ≥ 18 years) will be enrolled. The total length of the study is expected to be approximately 36 to 48 months, depending upon which treatment is activated. The maximum number of visits patients would attend the hospital could be 55.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
20/EM/0089
Date of REC Opinion
4 May 2020
REC opinion
Favourable Opinion