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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03194867




Registration number
NCT03194867
Ethics application status
Date submitted
19/06/2017
Date registered
21/06/2017

Titles & IDs
Public title
Isatuximab in Combination With Cemiplimab in Relapsed/Refractory Multiple Myeloma (RRMM) Patients
Scientific title
A Phase 1/2 Study to Evaluate Safety, Pharmacokinetics and Efficacy of Isatuximab in Combination With Cemiplimab in Patients With Relapsed/Refractory Multiple Myeloma
Secondary ID [1] 0 0
2017-001431-39
Secondary ID [2] 0 0
TCD14906
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Plasma Cell 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 - Isatuximab SAR650984
Treatment: Drugs - Cemiplimab REGN2810

Experimental: Isatuximab/cemiplimab (Regimen 1) - Isatuximab on Days 1, 8, 15, and 22, then Days 1 and 15 in 28-day cycles up to disease progression.

Cemiplimab on Days 1 and 15 in 28-day cycle up to disease progression.

Experimental: Isatuximab/cemiplimab (Regimen 2) - Isatuximab on Days 1, 8, 15, and 22, then Days 1 and 15 in 28-day cycles up to disease progression.

Cemiplimab on Day 1 in 28-day cycle up to disease progression.

Active comparator: Isatuximab - Isatuximab on Days 1, 8, 15 and 22, then Day 1 and 15 in 28-day cycles up to disease progression.


Treatment: Drugs: Isatuximab SAR650984
Pharmaceutical form: solution for infusion

Route of administration: intravenous

Treatment: Drugs: Cemiplimab REGN2810
Pharmaceutical form: solution for infusion

Route of administration: intravenous
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs)
Timepoint [1] 0 0
Cycle 1 Day 1 to Day 28
Primary outcome [2] 0 0
Phase 1 and Phase 2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Timepoint [2] 0 0
TEAEs were collected from the first dose up to 30 days after the last dose of study treatment, approximately 50 months
Primary outcome [3] 0 0
Phase 2: Percentage of Participants With Overall Response Rate (ORR)
Timepoint [3] 0 0
From Cycle 1 Day 1 up to primary analysis completion date of 9 Oct 2019 i.e., up to approximately 17 months
Secondary outcome [1] 0 0
Phase 2: Percentage of Participants With Clinical Benefit Rate (CBR)
Timepoint [1] 0 0
From Cycle 1 Day 1 up to primary analysis completion date of 9 Oct 2019 i.e., up to approximately 17 months
Secondary outcome [2] 0 0
Phase 2: Duration of Follow-up
Timepoint [2] 0 0
From the date of randomization up to primary analysis completion date of 9 Oct 2019 i.e., up to approximately 17 months
Secondary outcome [3] 0 0
Phase 2: Duration of Response (DOR)
Timepoint [3] 0 0
From Cycle 1 Day 1 up to primary analysis completion date of 9 Oct 2019 i.e., up to approximately 17 months
Secondary outcome [4] 0 0
Phase 2: Time to Response (TTR)
Timepoint [4] 0 0
From Cycle 1 Day 1 up to primary analysis completion date of 9 Oct 2019 i.e., up to approximately 17 months
Secondary outcome [5] 0 0
Phase 2: Progression Free Survival (PFS)
Timepoint [5] 0 0
From Cycle 1 Day 1 up to primary analysis completion date of 9 Oct 2019 i.e., up to approximately 17 months
Secondary outcome [6] 0 0
Phase 2: Overall Survival (OS)
Timepoint [6] 0 0
From Cycle 1 Day 1 up to primary analysis completion date of 9 Oct 2019 i.e., up to approximately 17 months
Secondary outcome [7] 0 0
Phase 1 and 2: Plasma Concentration Observed at the End of IV Infusion (Ceoi) of Isatuximab Alone and in Combination With Cemiplimab
Timepoint [7] 0 0
At end of infusion (EOI) on Cycle 1 Day 1
Secondary outcome [8] 0 0
Phase 1 and 2: Maximum Observed Concentration (Cmax) of Isatuximab Alone and in Combination With Cemiplimab
Timepoint [8] 0 0
At start of infusion (SOI), EOI, EOI+4 hours, 72 hours and 168 hours on Day 1 of Cycle 1
Secondary outcome [9] 0 0
Phase 1 and 2: Time to Reach Cmax (Tmax) of Isatuximab Alone and in Combination With Cemiplimab
Timepoint [9] 0 0
At SOI, EOI, EOI+4 hours, 72 hours and 168 hours on Day 1 of Cycle 1
Secondary outcome [10] 0 0
Phase 1 and 2: Last Concentration Observed Above the Lower Limit of Quantitation (Clast) of Isatuximab Alone and in Combination With Cemiplimab
Timepoint [10] 0 0
At SOI, EOI, EOI+4 hours, 72 hours and 168 hours on Day 1 of Cycle 1
Secondary outcome [11] 0 0
Phase 1 and 2: Time of Clast (Tlast) of Isatuximab Alone and in Combination With Cemiplimab
Timepoint [11] 0 0
At SOI, EOI, EOI+4 hours, 72 hours and 168 hours on Day 1 of Cycle 1
Secondary outcome [12] 0 0
Phase 1 and 2: Area Under the Concentration Versus Time Curve (AUC) From Time Zero to Tlast (AUClast) of Isatuximab Alone and in Combination With Cemiplimab
Timepoint [12] 0 0
At SOI, EOI, EOI+4 hours, 72 hours and 168 hours on Day 1 of Cycle 1
Secondary outcome [13] 0 0
Phase 1 and 2: AUC From Time 0 to Week 1 (AUC1week) of Isatuximab Alone and in Combination With Cemiplimab
Timepoint [13] 0 0
At SOI, EOI, EOI+4 hours, 72 hours and 168 hours on Day 1 of Cycle 1
Secondary outcome [14] 0 0
Phase 1 and 2: Number of Participants With Anti-Drug Antibodies (ADA) to Isatuximab
Timepoint [14] 0 0
From Cycle 1 Day 1 up to primary analysis completion date of 9 Oct 2019 i.e., up to approximately 20 months
Secondary outcome [15] 0 0
Phase 1 and 2: Number of Participants With ADA to Cemiplimab
Timepoint [15] 0 0
From Cycle 1 Day 1 up to primary analysis completion date of 9 Oct 2019 i.e., up to approximately 20 months

Eligibility
Key inclusion criteria
Inclusion criteria:

* Patients must have a known diagnosis of multiple myeloma with evidence of measurable disease, as defined below:

* Serum M-protein =1 g/dL (=0.5 g/dL in case of immunoglobulin A [IgA] disease), AND/OR
* Urine M-protein =200 mg/24 hours, OR
* In the absence of measurable M-protein, serum immunoglobulin free light chain =10 mg/dL, and abnormal serum immunoglobulin kappa lambda free light chain ratio (<0.26 or >1.65).
* Patients must have received prior treatment with an immunomodulatory drug (IMiD) (for =2 cycles or =2 months of treatment) and a proteasome inhibitor (PI) (for =2 cycles or =2 months of treatment).
* Patients must have received at least 3 prior lines of therapy (Note: Induction therapy and stem cell transplant ± maintenance will be considered as one line).
* Patient must have achieved MR or better with any anti-myeloma therapy (ie, primary refractory disease is not eligible).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

* Prior exposure to isatuximab or participated clinical studies with isatuximab.
* Prior exposure to any agent (approved or investigational) that blocks the programmed cell death-1 (PD-1)/PD-L1 pathway.
* Evidence of other immune related disease/conditions.
* History of non-infectious pneumonitis requiring steroids or current pneumonitis; history of the thoracic radiation.
* Has received a live-virus vaccination within 30 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted.
* Has allogenic haemopoietic stem cell (HSC) transplant.
* Prior treatment with idelalisib (a PI3K inhibitor).
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) >2.
* Poor bone marrow reserve.
* Poor organ function.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/02/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
5/04/2023
Sample size
Target
Accrual to date
Final
109
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Investigational Site Number :0360003 - Wollongong
Recruitment hospital [2] 0 0
Investigational Site Number :0360002 - Richmond
Recruitment hospital [3] 0 0
Investigational Site Number :0360001 - West Perth
Recruitment postcode(s) [1] 0 0
2500 - Wollongong
Recruitment postcode(s) [2] 0 0
3121 - Richmond
Recruitment postcode(s) [3] 0 0
6005 - West Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
Kansas
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
Pennsylvania
Country [5] 0 0
Brazil
State/province [5] 0 0
Goiás
Country [6] 0 0
Brazil
State/province [6] 0 0
Rio Grande Do Sul
Country [7] 0 0
Brazil
State/province [7] 0 0
São Paulo
Country [8] 0 0
Canada
State/province [8] 0 0
Quebec
Country [9] 0 0
Czechia
State/province [9] 0 0
Brno
Country [10] 0 0
Czechia
State/province [10] 0 0
Ostrava - Poruba
Country [11] 0 0
Czechia
State/province [11] 0 0
Praha 2
Country [12] 0 0
France
State/province [12] 0 0
Lille
Country [13] 0 0
France
State/province [13] 0 0
Nantes
Country [14] 0 0
France
State/province [14] 0 0
Pierre Benite
Country [15] 0 0
France
State/province [15] 0 0
Villejuif
Country [16] 0 0
Greece
State/province [16] 0 0
Athens
Country [17] 0 0
Hungary
State/province [17] 0 0
Budapest
Country [18] 0 0
Italy
State/province [18] 0 0
Milano
Country [19] 0 0
Italy
State/province [19] 0 0
Brescia
Country [20] 0 0
Italy
State/province [20] 0 0
Torino
Country [21] 0 0
Spain
State/province [21] 0 0
Barcelona [Barcelona]
Country [22] 0 0
Spain
State/province [22] 0 0
Catalunya [Cataluña]
Country [23] 0 0
Spain
State/province [23] 0 0
Valenciana, Comunidad
Country [24] 0 0
Spain
State/province [24] 0 0
Madrid

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
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 Sciences & Operations
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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 patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03194867