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A Study of CC-90010 in Combination With Temozolomide With or Without Radiation Therapy in Participants With Newly Diagnosed Glioblastoma

Primary Purpose

Glioblastoma

Status

Active

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

CC-90010

Temozolomide

Radiotherapy

About this trial

This is an interventional treatment trial for Glioblastoma focused on measuring CC-90010, Temozolomide, Glioblastoma, NEWLY DIAGNOSED, Radiation therapy, Safety, Tolerability, MTD and RP2D

Eligibility Criteria

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

Inclusion Criteria:

Primary isocitrate dehydrogenase (IDH)-wild type newly diagnosed World Health Organization (WHO) Grade IV Glioblastoma
O6-methylguanine-DNA methyltransferase (MGMT) promoter methylation status must be available prior to randomization
Karnofsky performance status of ≥70

Exclusion Criteria:

Indeterminate MGMT promoter methylation status
Biopsy only of glioblastoma (GBM) at surgery, defined as < 20% resection of enhancing tumor
Any known metastatic extracranial or leptomeningeal disease

Other protocol-defined inclusion/exclusion criteria apply

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Other

Arm Label

Part A

Part B - CC-90010 + Temozolomide (TMZ) + Radiotherapy (RT)

Part B - Standard TMZ + RT

Arm Description

Control

Outcomes

Primary Outcome Measures

Incidence of adverse events (AEs) using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0

Parts A and B

Incidence of serious adverse events (SAEs) using the NCI CTCAE v5.0

Parts A and B

Incidence of dose-limiting toxicities (DLTs)

Part A

Maximum Tolerated Dose (MTD) of CC-90010 in combination with Temozolomide (TMZ)

Part A

MTD of CC-90010 in combination with TMZ and Radiation Therapy (RT)

Part A

Recommended Phase 2 Dose (RP2D) of CC-90010 in combination with TMZ

Part A

RP2D of CC-90010 in combination with TMZ and RT

Part A

Median Progression-free survival (PFS) in Arm A vs Arm B

Part B

Hazard ratio for PFS in Arm A vs Arm B

Part B

Secondary Outcome Measures

Progression-free survival (PFS) defined as the time from the first dose of CC-90010 to the first occurrence of disease progression or death from any cause

Parts A and B

Overall survival (OS) measured as the time from the first dose of CC-90010 to death due to any cause and will be analyzed in a manner similar to that described for PFS

Parts A and B

Duration of therapy (DoT) in Arm A vs Arm B

Part B

Response by Response Assessment in Neuro-Oncology (RANO) criteria

Parts A and B

Pharmacokinetics - Maximum observed plasma concentration (Cmax)

Parts A and B

Pharmacokinetics - Area under the plasma concentration time-curve (AUC)

Parts A and B

Pharmacokinetics - Time to maximum plasma concentration (Tmax)

Parts A and B

Full Information

NCT ID

NCT04324840

First Posted

March 25, 2020

Last Updated

May 2, 2023

Sponsor

Celgene

1. Study Identification

Unique Protocol Identification Number

NCT04324840

Brief Title

A Study of CC-90010 in Combination With Temozolomide With or Without Radiation Therapy in Participants With Newly Diagnosed Glioblastoma

Official Title

A Phase 1b, Open-label, Dose-Finding Study of CC-90010 in Combination With Temozolomide With or Without Radiation Therapy in Subjects With Newly Diagnosed Glioblastoma

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

July 10, 2020 (Actual)

Primary Completion Date

September 12, 2023 (Anticipated)

Study Completion Date

March 5, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Celgene

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to determine the safety and tolerability of CC-90010 when combined with standard of care treatment, temozolomide (TMZ) with or without radiotherapy (RT) in the newly diagnosed WHO Grade IV glioblastoma (ndGBM).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glioblastoma

Keywords

CC-90010, Temozolomide, Glioblastoma, NEWLY DIAGNOSED, Radiation therapy, Safety, Tolerability, MTD and RP2D

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

194 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Part A

Arm Type

Experimental

Arm Title

Part B - CC-90010 + Temozolomide (TMZ) + Radiotherapy (RT)

Arm Type

Experimental

Arm Title

Part B - Standard TMZ + RT

Arm Type

Other

Arm Description

Control

Intervention Type

Drug

Intervention Name(s)

CC-90010

Intervention Description

Specified dose on specified days

Intervention Type

Drug

Intervention Name(s)

Temozolomide

Intervention Description

Specified dose on specified days

Intervention Type

Radiation

Intervention Name(s)

Radiotherapy

Intervention Description

Specified dose on specified days

Primary Outcome Measure Information:

Title

Incidence of adverse events (AEs) using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0

Description

Parts A and B

Time Frame

Up to 3 years

Title

Incidence of serious adverse events (SAEs) using the NCI CTCAE v5.0

Description

Parts A and B

Time Frame

Up to 3 years

Title

Incidence of dose-limiting toxicities (DLTs)

Description

Part A

Time Frame

Up to 3 years

Title

Maximum Tolerated Dose (MTD) of CC-90010 in combination with Temozolomide (TMZ)

Description

Part A

Time Frame

Up to 3 years

Title

MTD of CC-90010 in combination with TMZ and Radiation Therapy (RT)

Description

Part A

Time Frame

Up to 3 years

Title

Recommended Phase 2 Dose (RP2D) of CC-90010 in combination with TMZ

Description

Part A

Time Frame

Up to 3 years

Title

RP2D of CC-90010 in combination with TMZ and RT

Description

Part A

Time Frame

Up to 3 years

Title

Median Progression-free survival (PFS) in Arm A vs Arm B

Description

Part B

Time Frame

Up to 12 months

Title

Hazard ratio for PFS in Arm A vs Arm B

Description

Part B

Time Frame

Up to 12 months

Secondary Outcome Measure Information:

Title

Progression-free survival (PFS) defined as the time from the first dose of CC-90010 to the first occurrence of disease progression or death from any cause

Description

Parts A and B

Time Frame

Up to 5 years

Title

Overall survival (OS) measured as the time from the first dose of CC-90010 to death due to any cause and will be analyzed in a manner similar to that described for PFS

Description

Parts A and B

Time Frame

Up to 5 years

Title

Duration of therapy (DoT) in Arm A vs Arm B

Description

Part B

Time Frame

Up to 5 years

Title

Response by Response Assessment in Neuro-Oncology (RANO) criteria

Description

Parts A and B

Time Frame

Up to 5 years

Title

Pharmacokinetics - Maximum observed plasma concentration (Cmax)

Description

Parts A and B

Time Frame

Up to 2 years

Title

Pharmacokinetics - Area under the plasma concentration time-curve (AUC)

Description

Parts A and B

Time Frame

Up to 2 years

Title

Pharmacokinetics - Time to maximum plasma concentration (Tmax)

Description

Parts A and B

Time Frame

Up to 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Primary isocitrate dehydrogenase (IDH)-wild type newly diagnosed World Health Organization (WHO) Grade IV Glioblastoma O6-methylguanine-DNA methyltransferase (MGMT) promoter methylation status must be available prior to randomization Karnofsky performance status of ≥70 Exclusion Criteria: Indeterminate MGMT promoter methylation status Biopsy only of glioblastoma (GBM) at surgery, defined as < 20% resection of enhancing tumor Any known metastatic extracranial or leptomeningeal disease Other protocol-defined inclusion/exclusion criteria apply

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

Local Institution - 800

City

New York

State/Province

New York

ZIP/Postal Code

10075

Country

United States

Facility Name

Local Institution - 503

City

Aalborg

ZIP/Postal Code

9100

Country

Denmark

Facility Name

Local Institution - 501

City

Copenhagen

ZIP/Postal Code

2100

Country

Denmark

Facility Name

Local Institution - 500

City

Odense

ZIP/Postal Code

5000

Country

Denmark

Facility Name

Local Institution - 201

City

Milano

ZIP/Postal Code

20132

Country

Italy

Facility Name

Local Institution - 202

City

Milan

ZIP/Postal Code

20089

Country

Italy

Facility Name

Local Institution - 204

City

Padova

ZIP/Postal Code

35128

Country

Italy

Facility Name

Local Institution - 200

City

Verona

ZIP/Postal Code

37126

Country

Italy

Facility Name

Local Institution - 408

City

Leiden

State/Province

Zuid-Holland

ZIP/Postal Code

2333 ZA

Country

Netherlands

Facility Name

Local Institution - 405

City

Amsterdam

ZIP/Postal Code

1066 CX

Country

Netherlands

Facility Name

Local Institution - 400

City

Rotterdam

ZIP/Postal Code

3015 GD

Country

Netherlands

Facility Name

Local Institution - 401

City

Utrecht

ZIP/Postal Code

3584 CX

Country

Netherlands

Facility Name

Local Institution - 600

City

Oslo

ZIP/Postal Code

0424

Country

Norway

Facility Name

Local Institution - 311

City

A Coruna

ZIP/Postal Code

15006

Country

Spain

Facility Name

Local Institution - 306

City

Barcelona

ZIP/Postal Code

08003

Country

Spain

Facility Name

Local Institution - 302

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Local Institution - 303

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

Local Institution - 307

City

Hospitalet de Llobregat, Barcelona

ZIP/Postal Code

08907

Country

Spain

Facility Name

Local Institution - 304

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Name

Local Institution - 301

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Local Institution - 300

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Local Institution - 310

City

Pamplona

ZIP/Postal Code

31008

Country

Spain

Facility Name

Local Institution - 309

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

Facility Name

Local Institution - 305

City

Valencia

ZIP/Postal Code

46026

Country

Spain

Facility Name

Local Institution - 312

City

Vigo

ZIP/Postal Code

36312

Country

Spain

Facility Name

Local Institution - 702

City

Goteborg

ZIP/Postal Code

41345

Country

Sweden

Facility Name

Local Institution - 701

City

Lund

ZIP/Postal Code

222 41

Country

Sweden

Facility Name

Local Institution - 700

City

Solna

ZIP/Postal Code

171 64

Country

Sweden

Facility Name

Local Institution - 703

City

Uppsala

ZIP/Postal Code

75185

Country

Sweden

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Information relating to our policy on data sharing and the process for requesting data can be found at the following link: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing URL

https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

Links:

URL

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Description

BMS Clinical Trial Information

URL

https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

Description

FDA Safety Alerts and Recalls

URL

http://www.BMSStudyConnect.com

Description

BMS Clinical Trial Patient Recruiting

Learn more about this trial

A Study of CC-90010 in Combination With Temozolomide With or Without Radiation Therapy in Participants With Newly Diagnosed Glioblastoma

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A Study of CC-90010 in Combination With Temozolomide With or Without Radiation Therapy in Participants With Newly Diagnosed Glioblastoma

Glioblastoma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial