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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05927571




Registration number
NCT05927571
Ethics application status
Date submitted
22/06/2023
Date registered
3/07/2023

Titles & IDs
Public title
A Study Evaluating the Safety, Pharmacokinetics, and Activity of the Combination of Cevostamab and Elranatamab in Participants With Relapsed or Refractory Multiple Myeloma (R/R MM)
Scientific title
An Open-Label, Multicenter, Phase Ib Trial Evaluating the Safety, Pharmacokinetics, and Activity of the Combination of Cevostamab and Elranatamab in Patients With Relapsed or Refractory Multiple Myeloma
Secondary ID [1] 0 0
2023-504657-13-00
Secondary ID [2] 0 0
GO43979
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsed or Refractory Multiple Myeloma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Cevostamab
Treatment: Drugs - Elranatamab
Treatment: Drugs - Tocilizumab

Experimental: Safety Lead-In Cohort - Participants will receive cevostamab, intravenously (IV), in combination with elranatamab, subcutaneously (SC), with step-up dosing of each drug in pre-phase following which they will receive elranatamab, at the assigned dose as a SC injection until disease progression or unacceptable toxicity. Participants will also receive cevostamab at the assigned dose as IV infusion until disease progression or unacceptable toxicity or up to 1 year on treatment, whichever occurs first.

Experimental: Dose Expansion Cohort - Participants will receive cevostamab, IV, in combination with elranatamab, SC, with step-up dosing of each drug in pre-phase following which they will receive elranatamab, at the assigned dose as a SC injection until disease progression or unacceptable toxicity. Participants will also receive cevostamab at the assigned dose as IV infusion until disease progression or unacceptable toxicity or up to 1 year on treatment, whichever occurs first.


Treatment: Drugs: Cevostamab
Cevostamab solution for infusion will be administered as IV as specified in each treatment arm.

Treatment: Drugs: Elranatamab
Elranatamab solution for injection will be administered SC as specified in each treatment arm.

Treatment: Drugs: Tocilizumab
Tocilizumab will be used as rescue medication for participants who experience a cytokine release syndrome (CRS) event.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Adverse Events (AEs)
Timepoint [1] 0 0
From signing of informed consent up to end of study (EOS) (approximately 36 months)
Secondary outcome [1] 0 0
Objective Response Rate (ORR) as Determined by the Investigator per International Myeloma Working Group (IMWG) Criteria
Timepoint [1] 0 0
Up to approximately 36 months
Secondary outcome [2] 0 0
Complete Response (CR)/ Stringent Complete Response (sCR) Rate as Determined by the Investigator per IMWG Criteria
Timepoint [2] 0 0
Up to approximately 36 months
Secondary outcome [3] 0 0
Rate of Very Good Partial Response (VGPR) or Better, as Determined by the Investigator per IMWG Criteria
Timepoint [3] 0 0
Up to approximately 36 months
Secondary outcome [4] 0 0
Progression-Free Survival as Determined by the Investigator per IMWG Criteria
Timepoint [4] 0 0
Up to approximately 36 months
Secondary outcome [5] 0 0
Duration of Response (DOR) as Determined by the Investigator (for Participants who Achieve a Response of Partial Response (PR) or Better)
Timepoint [5] 0 0
Up to approximately 36 months
Secondary outcome [6] 0 0
Time to First Response (for Participants who Achieve a Response of PR or Better)
Timepoint [6] 0 0
Up to approximately 36 months
Secondary outcome [7] 0 0
Time to Best Response (for Participants who Achieve a Response of PR or Better)
Timepoint [7] 0 0
Up to approximately 36 months
Secondary outcome [8] 0 0
Overall Survival (OS)
Timepoint [8] 0 0
Up to approximately 36 months
Secondary outcome [9] 0 0
Serum Concentration of Cevostamab at Specified Timepoints
Timepoint [9] 0 0
Up to approximately 36 months
Secondary outcome [10] 0 0
Serum Concentration of Elranatamab at Specified Timepoints
Timepoint [10] 0 0
Up to approximately 36 months
Secondary outcome [11] 0 0
Number of Participants with Anti-Drug Antibody (ADA) Against Cevostamab
Timepoint [11] 0 0
Up to approximately 36 months
Secondary outcome [12] 0 0
Number of Participants with ADA Against Elranatamab
Timepoint [12] 0 0
Up to approximately 36 months

Eligibility
Key inclusion criteria
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Diagnosis of R/R MM per IMWG criteria
* For female participants of childbearing potential: agreement to remain abstinent or use contraception
* For male participants: agreement to remain abstinent or use a condom
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior treatment with cevostamab or another agent targeting fragment crystallizable receptor-like 5 (FcRH5)
* Prior treatment with elranatamab
* Prior allogeneic stem cell transplantation (SCT)
* Absolute plasma cell count exceeding 500 per milliliter (mL) or 5% of the peripheral blood white cells
* Diagnosis of Waldenström macroglobulinemia or polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, skin changes (POEMS) syndrome
* Participants with known history of amyloidosis
* History of autoimmune disease
* History of confirmed progressive multifocal leukoencephalopathy
* Peripheral motor polyneuropathy of prespecified grade
* Known or suspected chronic cytomegalovirus (CMV) and/or Epstein-Barr virus (EBV) infection
* Known history of hemophagocytic lymphohistiocytosis (HLH) or macrophage activation syndrome (MAS)
* Acute or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
* Human immunodeficiency virus (HIV) seropositivity
* History of central nervous system (CNS) myeloma disease
* Significant cardiovascular disease

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/08/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/07/2026
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Alfred Hospital - Prahan
Recruitment postcode(s) [1] 0 0
3181 - Prahan
Recruitment outside Australia
Country [1] 0 0
Israel
State/province [1] 0 0
Haifa
Country [2] 0 0
Israel
State/province [2] 0 0
Ramat Gan
Country [3] 0 0
Israel
State/province [3] 0 0
Tel Aviv-Yafo
Country [4] 0 0
Korea, Republic of
State/province [4] 0 0
Seocho
Country [5] 0 0
Korea, Republic of
State/province [5] 0 0
Seoul

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Genentech, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
GO43979 https://forpatients.roche.com/
Address 0 0
Country 0 0
Phone 0 0
888-662-6728 (U.S. Only)
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05927571