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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05168202




Registration number
NCT05168202
Ethics application status
Date submitted
8/12/2021
Date registered
23/12/2021
Date last updated
2/04/2024

Titles & IDs
Public title
A Study to Assess the Effect of CC-95251 in Participants With Acute Myeloid Leukemia and Myelodysplastic Syndromes
Scientific title
A Phase 1, Open-label, Dose Finding Study of CC-95251 Alone and in Combination With Antineoplastic Agents in Subjects With Acute Myeloid Leukemia and Myelodysplastic Syndromes
Secondary ID [1] 0 0
2021-002799-38
Secondary ID [2] 0 0
CA059-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Leukemia, Myeloid, Acute 0 0
Myelodysplastic Syndromes 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma
Blood 0 0 0 0
Haematological diseases
Blood 0 0 0 0
Other blood disorders
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CC-95251
Treatment: Drugs - Azacitidine
Treatment: Drugs - Venetoclax

Experimental: CC-95251 monotherapy -

Experimental: CC-95251 + azacitidine -

Experimental: CC-95251 + azacitidine + venetoclax -


Treatment: Drugs: CC-95251
Specified dose on specified days

Treatment: Drugs: Azacitidine
Specified dose on specified days

Treatment: Drugs: Venetoclax
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with a Dose-limiting toxicity (DLT)
Timepoint [1] 0 0
Up to 42 days
Primary outcome [2] 0 0
Incidence of adverse events (AEs)
Timepoint [2] 0 0
Up to 56 days after the last dose of study treatment
Secondary outcome [1] 0 0
Complete remission rate (CRR) for acute myeloid leukemia (AML) according to the modified European Leukemia Net (ELN) response criteria
Timepoint [1] 0 0
Up to 2 years after end of treatment
Secondary outcome [2] 0 0
Overall response rate (ORR) for AML
Timepoint [2] 0 0
Up to 2 years after end of treatment
Secondary outcome [3] 0 0
CRR for myelodysplastic syndromes (MDS) according to the modified International Working Group (IWG) Response Criteria
Timepoint [3] 0 0
Up to 2 years after end of treatment
Secondary outcome [4] 0 0
ORR for MDS
Timepoint [4] 0 0
Up to 2 years after end of treatment
Secondary outcome [5] 0 0
Duration of remission
Timepoint [5] 0 0
Up to 2 years after end of treatment
Secondary outcome [6] 0 0
Duration of response
Timepoint [6] 0 0
Up to 2 years after end of treatment
Secondary outcome [7] 0 0
Stable disease rate is the rate of MDS participants whose best response is stable disease
Timepoint [7] 0 0
Up to 2 years after end of treatment
Secondary outcome [8] 0 0
Relapse-free survival
Timepoint [8] 0 0
Up to 2 years after end of treatment
Secondary outcome [9] 0 0
Event-free survival
Timepoint [9] 0 0
Up to 2 years after end of treatment
Secondary outcome [10] 0 0
Progression-free survival
Timepoint [10] 0 0
Up to 2 years after end of treatment
Secondary outcome [11] 0 0
Time to remission/response
Timepoint [11] 0 0
Up to 2 years after end of treatment
Secondary outcome [12] 0 0
Transfusion independence
Timepoint [12] 0 0
Up to 2 years after end of treatment
Secondary outcome [13] 0 0
Time to AML transformation for MDS participants
Timepoint [13] 0 0
Up to 2 years after end of treatment
Secondary outcome [14] 0 0
Overall survival (OS) rates at 6 months
Timepoint [14] 0 0
Up to 2 years after end of treatment
Secondary outcome [15] 0 0
OS rates at 12 months
Timepoint [15] 0 0
Up to 2 years after end of treatment
Secondary outcome [16] 0 0
Maximum plasma concentration of drug (Cmax)
Timepoint [16] 0 0
Up to 8 weeks post-dose of CC-95251
Secondary outcome [17] 0 0
Minimum serum concentration (Cmin)
Timepoint [17] 0 0
Up to 8 weeks post-dose of CC-95251
Secondary outcome [18] 0 0
Trough observed serum concentration (Ctrough)
Timepoint [18] 0 0
Up to 8 weeks post-dose of CC-95251
Secondary outcome [19] 0 0
Presence of anti-CC-95251 antibodies (ADAs) using a validated electrochemiluminescence (ECL) assay
Timepoint [19] 0 0
Up to 8 weeks post-dose of CC-95251
Secondary outcome [20] 0 0
Frequency of ADAs using a validated ECL assay
Timepoint [20] 0 0
Up to 8 weeks post-dose of CC-95251

Eligibility
Key inclusion criteria
• Eastern Cooperative Oncology Group Performance Status of 0 to 2

For Parts A & B:

- Relapsed or refractory (R/R) acute myeloid leukemia (AML) as defined by the 2016 WHO
Classification

- R/R myelodysplastic syndromes (MDS) as defined by the 2016 WHO Classification with
intermediate, high or very high risk by Revised International Prognostic Scoring
System (IPSS-R)

For Part C:

• Treatment-naïve (TN) (ie, previously untreated) MDS as defined by the 2016 WHO
Classification with intermediate, high or very high risk by IPSS-R

For Part D:

• TN AML as defined by the 2016 WHO Classification, including secondary AML and
therapy-related AML in participants who are ineligible (IE) for intensive chemotherapy (IC)
and allogeneic hematopoietic stem cell transplant (HSCT)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Acute promyelocytic leukemia

- Immediately life-threatening, severe complications of leukemia such as
disseminated/uncontrolled infection, uncontrolled bleeding, and/or uncontrolled
disseminated intravascular coagulation

- Participants who have received prior treatment with a CD47 or SIRPa targeting agent

- Participant is on chronic systemic immunosuppressive therapy or corticosteroids

- Prior systemic cancer-directed treatments or investigational modalities = 5 half-lives
or 4 weeks prior to starting study treatment, whichever is shorter (relapsed or
refractory participants only).

- Any condition including, active or uncontrolled infection, or the presence of
laboratory abnormalities, which places the participant at unacceptable risk if he/she
were to participate in the study

- Pregnant or nursing participants.

Other protocol-defined inclusion/exclusion criteria apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/01/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
14/06/2026
Actual
Sample size
Target
218
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Local Institution - 0027 - Wollongong
Recruitment hospital [2] 0 0
Local Institution - 0006 - Clayton
Recruitment hospital [3] 0 0
Local Institution - 0005 - Heidelberg
Recruitment hospital [4] 0 0
Local Institution - 0037 - Melbourne
Recruitment postcode(s) [1] 0 0
2500 - Wollongong
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
3084 - Heidelberg
Recruitment postcode(s) [4] 0 0
3065 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Texas
Country [4] 0 0
Canada
State/province [4] 0 0
Alberta
Country [5] 0 0
Canada
State/province [5] 0 0
British Columbia
Country [6] 0 0
Canada
State/province [6] 0 0
Ontario
Country [7] 0 0
Canada
State/province [7] 0 0
Quebec
Country [8] 0 0
France
State/province [8] 0 0
Marseille
Country [9] 0 0
France
State/province [9] 0 0
Nantes
Country [10] 0 0
France
State/province [10] 0 0
Pessac
Country [11] 0 0
France
State/province [11] 0 0
Toulouse
Country [12] 0 0
France
State/province [12] 0 0
Villejuif
Country [13] 0 0
Italy
State/province [13] 0 0
Meldola
Country [14] 0 0
Italy
State/province [14] 0 0
Milan
Country [15] 0 0
Italy
State/province [15] 0 0
Rozzano
Country [16] 0 0
Norway
State/province [16] 0 0
Bergen
Country [17] 0 0
Norway
State/province [17] 0 0
Oslo
Country [18] 0 0
Spain
State/province [18] 0 0
Barcelona [Barcelona]
Country [19] 0 0
Spain
State/province [19] 0 0
Barcelona
Country [20] 0 0
Spain
State/province [20] 0 0
Madrid
Country [21] 0 0
Spain
State/province [21] 0 0
Salamanca
Country [22] 0 0
Spain
State/province [22] 0 0
Santander
Country [23] 0 0
Sweden
State/province [23] 0 0
Gothenburg
Country [24] 0 0
Sweden
State/province [24] 0 0
Lund
Country [25] 0 0
Sweden
State/province [25] 0 0
Stockholm
Country [26] 0 0
United Kingdom
State/province [26] 0 0
Midlothian
Country [27] 0 0
United Kingdom
State/province [27] 0 0
Oxfordshire

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the safety, tolerability, and preliminary clinical
activity of CC-95251 alone and in combination with antineoplastic agents in participants with
relapsed or refractory acute myeloid leukemia and relapsed or refractory and treatment-naive
higher risk melodysplastic syndromes.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05168202
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05168202