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A Study to Assess the Effect of CC-95251 in Participants With Acute Myeloid Leukemia and Myelodysplastic Syndromes

Primary Purpose

Leukemia, Myeloid, Acute, Myelodysplastic Syndromes

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
CC-95251
Azacitidine
Venetoclax
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia, Myeloid, Acute focused on measuring Myelodysplastic Syndromes, Acute Myeloid Leukemia, AML, MDS, Hematologic Cancers, Leukemia, Anti-SIRPa antibody, CC-95251

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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 SIRPα 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

Sites / Locations

  • UCLA Hematology/Oncology - Westwood (Building 200 Suite 120)Recruiting
  • Stanford Cancer Center-HematologyRecruiting
  • University of Miami Hospital and Clinics, Sylvester Cancer CenterRecruiting
  • University of Maryland
  • UT Southwestern-Harold C. Simmons Cancer Center
  • The University Of Texas MD Anderson Cancer CenterRecruiting
  • Local Institution - 0027Recruiting
  • Local Institution - 0006Recruiting
  • Local Institution - 0005Recruiting
  • Local Institution - 0037Recruiting
  • Local Institution - 0019Recruiting
  • Local Institution - 0011Recruiting
  • Local Institution - 0010Recruiting
  • Local Institution - 0038Recruiting
  • Institut Paoli-CalmettesRecruiting
  • Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu-hematologyRecruiting
  • Hopital Du Haut-LevequeRecruiting
  • Institut Claudius RegaudRecruiting
  • Gustave Roussy-DITEPRecruiting
  • Local Institution - 0018Recruiting
  • Local Institution - 0026Recruiting
  • Local Institution - 0017Recruiting
  • Local Institution - 0025Recruiting
  • Local Institution - 0013Recruiting
  • Local Institution - 0032Recruiting
  • Local Institution - 0039Recruiting
  • Local Institution - 0036Recruiting
  • Local Institution - 0035Recruiting
  • Local Institution - 0028Recruiting
  • Local Institution - 0021Recruiting
  • Local Institution - 0015Recruiting
  • Local Institution - 0014Recruiting
  • Local Institution - 0044Recruiting
  • Local Institution - 0050Recruiting
  • Local Institution - 0048

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

CC-95251 monotherapy

CC-95251 + azacitidine

CC-95251 + azacitidine + venetoclax

Arm Description

Outcomes

Primary Outcome Measures

Number of participants with a Dose-limiting toxicity (DLT)
Incidence of adverse events (AEs)

Secondary Outcome Measures

Complete remission rate (CRR) for acute myeloid leukemia (AML) according to the modified European Leukemia Net (ELN) response criteria
Overall response rate (ORR) for AML
CRR for myelodysplastic syndromes (MDS) according to the modified International Working Group (IWG) Response Criteria
ORR for MDS
Duration of remission
Duration of response
Stable disease rate is the rate of MDS participants whose best response is stable disease
Relapse-free survival
Event-free survival
Progression-free survival
Time to remission/response
Transfusion independence
Time to AML transformation for MDS participants
Overall survival (OS) rates at 6 months
OS rates at 12 months
Maximum plasma concentration of drug (Cmax)
Minimum serum concentration (Cmin)
Trough observed serum concentration (Ctrough)
Presence of anti-CC-95251 antibodies (ADAs) using a validated electrochemiluminescence (ECL) assay
Frequency of ADAs using a validated ECL assay

Full Information

First Posted
December 8, 2021
Last Updated
October 11, 2023
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT05168202
Brief Title
A Study to Assess the Effect of CC-95251 in Participants With Acute Myeloid Leukemia and Myelodysplastic Syndromes
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 19, 2022 (Actual)
Primary Completion Date
June 14, 2026 (Anticipated)
Study Completion Date
June 14, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
Keywords
Myelodysplastic Syndromes, Acute Myeloid Leukemia, AML, MDS, Hematologic Cancers, Leukemia, Anti-SIRPa antibody, CC-95251

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
218 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CC-95251 monotherapy
Arm Type
Experimental
Arm Title
CC-95251 + azacitidine
Arm Type
Experimental
Arm Title
CC-95251 + azacitidine + venetoclax
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
CC-95251
Other Intervention Name(s)
BMS-986351
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Azacitidine
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Venetoclax
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Number of participants with a Dose-limiting toxicity (DLT)
Time Frame
Up to 42 days
Title
Incidence of adverse events (AEs)
Time Frame
Up to 56 days after the last dose of study treatment
Secondary Outcome Measure Information:
Title
Complete remission rate (CRR) for acute myeloid leukemia (AML) according to the modified European Leukemia Net (ELN) response criteria
Time Frame
Up to 2 years after end of treatment
Title
Overall response rate (ORR) for AML
Time Frame
Up to 2 years after end of treatment
Title
CRR for myelodysplastic syndromes (MDS) according to the modified International Working Group (IWG) Response Criteria
Time Frame
Up to 2 years after end of treatment
Title
ORR for MDS
Time Frame
Up to 2 years after end of treatment
Title
Duration of remission
Time Frame
Up to 2 years after end of treatment
Title
Duration of response
Time Frame
Up to 2 years after end of treatment
Title
Stable disease rate is the rate of MDS participants whose best response is stable disease
Time Frame
Up to 2 years after end of treatment
Title
Relapse-free survival
Time Frame
Up to 2 years after end of treatment
Title
Event-free survival
Time Frame
Up to 2 years after end of treatment
Title
Progression-free survival
Time Frame
Up to 2 years after end of treatment
Title
Time to remission/response
Time Frame
Up to 2 years after end of treatment
Title
Transfusion independence
Time Frame
Up to 2 years after end of treatment
Title
Time to AML transformation for MDS participants
Time Frame
Up to 2 years after end of treatment
Title
Overall survival (OS) rates at 6 months
Time Frame
Up to 2 years after end of treatment
Title
OS rates at 12 months
Time Frame
Up to 2 years after end of treatment
Title
Maximum plasma concentration of drug (Cmax)
Time Frame
Up to 8 weeks post-dose of CC-95251
Title
Minimum serum concentration (Cmin)
Time Frame
Up to 8 weeks post-dose of CC-95251
Title
Trough observed serum concentration (Ctrough)
Time Frame
Up to 8 weeks post-dose of CC-95251
Title
Presence of anti-CC-95251 antibodies (ADAs) using a validated electrochemiluminescence (ECL) assay
Time Frame
Up to 8 weeks post-dose of CC-95251
Title
Frequency of ADAs using a validated ECL assay
Time Frame
Up to 8 weeks post-dose of CC-95251

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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) 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 SIRPα 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BMS Study Connect Contact Center http://www.bmsstudyconnect.com/
Phone
855-907-3286
Email
Clinical.Trials@bms.com
First Name & Middle Initial & Last Name or Official Title & Degree
First line of the email MUST contain the NCT# and Site #.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
UCLA Hematology/Oncology - Westwood (Building 200 Suite 120)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steven Tsai, Site 0030
Phone
626-862-5788
Facility Name
Stanford Cancer Center-Hematology
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabriel Mannis, Site 0031
Phone
650-498-6000
Facility Name
University of Miami Hospital and Clinics, Sylvester Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Justin Watts, Site 0047
Phone
404-272-0609
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SANDRINE NIYONGERE, Site 0049
Phone
410-328-9166
Facility Name
UT Southwestern-Harold C. Simmons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Individual Site Status
Withdrawn
Facility Name
The University Of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naval Daver, Site 0001
Phone
713-794-4392
Facility Name
Local Institution - 0027
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0027
Facility Name
Local Institution - 0006
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0006
Facility Name
Local Institution - 0005
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0005
Facility Name
Local Institution - 0037
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0037
Facility Name
Local Institution - 0019
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0019
Facility Name
Local Institution - 0011
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0011
Facility Name
Local Institution - 0010
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0010
Facility Name
Local Institution - 0038
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0038
Facility Name
Institut Paoli-Calmettes
City
Marseille
ZIP/Postal Code
13273
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylvain Garciaz, Site 0040
Phone
0491223333
Facility Name
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu-hematology
City
Nantes
ZIP/Postal Code
44000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre Peterlin, Site 0029
Phone
33240083271
Facility Name
Hopital Du Haut-Leveque
City
Pessac
ZIP/Postal Code
33600
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
arnaud Pigneux, Site 0020
Phone
+33670528816
Facility Name
Institut Claudius Regaud
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Recher, Site 0023
Phone
33531156355
Facility Name
Gustave Roussy-DITEP
City
Villejuif
ZIP/Postal Code
94805
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephane De Botton, Site 0041
Phone
+33 1 42 11 40 79
Facility Name
Local Institution - 0018
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0018
Facility Name
Local Institution - 0026
City
Milan
ZIP/Postal Code
20162
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0026
Facility Name
Local Institution - 0017
City
Rozzano
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0017
Facility Name
Local Institution - 0025
City
Bergen
ZIP/Postal Code
5021
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0025
Facility Name
Local Institution - 0013
City
Oslo
ZIP/Postal Code
N-0027
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0013
Facility Name
Local Institution - 0032
City
Badalona
State/Province
Barcelona [Barcelona]
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0032
Facility Name
Local Institution - 0039
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0039
Facility Name
Local Institution - 0036
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0036
Facility Name
Local Institution - 0035
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0035
Facility Name
Local Institution - 0028
City
Santander
ZIP/Postal Code
39008
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0028
Facility Name
Local Institution - 0021
City
Gothenburg
ZIP/Postal Code
413 45
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0021
Facility Name
Local Institution - 0015
City
Lund
ZIP/Postal Code
22185
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0015
Facility Name
Local Institution - 0014
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0014
Facility Name
Local Institution - 0044
City
Edinburgh
State/Province
Midlothian
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0044
Facility Name
Local Institution - 0050
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0050
Facility Name
Local Institution - 0048
City
Oxford
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
Individual Site Status
Withdrawn

12. IPD Sharing Statement

Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/us/en/home.html
Description
BMS Clinical Trial Patient Recruiting
URL
http://www.fda.gov/safety/medwatch/safetyinformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

A Study to Assess the Effect of CC-95251 in Participants With Acute Myeloid Leukemia and Myelodysplastic Syndromes

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