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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-004631-24 | EudraCT Number |
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Business objectives have changed.
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The purpose of this Phase 1 study is to evaluate the safety and tolerability of CC-96673 in adult participants with Relapsed or Refractory Non-Hodgkin's Lymphoma (R/R NHL).
The study will be conducted in 2 parts: Part A, monotherapy dose escalation and Part B, monotherapy dose expansion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Administration of CC-96673 | Experimental | CC-96673 will be administered on a once weekly (Q1W) or once every 2 weeks (Q2W) schedule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CC-96673 | Drug | IV Infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events (AEs) | An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a pre-existing condition) should be considered an AE. | From enrollment until at least 28 days after completion of study treatment |
| Dose-limiting toxicity (DLT) | Number of participants with a DLT | Up to approximately 18 months |
| Maximum tolerated dose (MTD) | Is defined as the dose level that can be given such that the estimated DLT probability is closest to approximately 30%. | Up to approximately 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) | Is defined as the percent of participants whose best response is CR or PR | Up to 2 years after study treatment |
| Time to response (TTR) | Is defined as the time from the first dose of CC-96673 to tumor response |
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Inclusion Criteria:
Participants must satisfy the following criteria to be enrolled in the study:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 104 | Minneapolis | Minnesota | 55455 | United States | ||
| Local Institution - 103 |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
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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/
See Plan Description
See Plan Description
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| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| Up to 2 years after study treatment |
| Duration of response (DOR) | Is defined as the time from tumor response to progression/death | Up to 2 years after study treatment |
| Progression free survival (PFS) | Is defined as the time from the first dose of CC-96673 to the first occurrence of disease progression or death from any cause | Up to 2 years after study treatment |
| Pharmacokinetics - Cmax | Maximum observed serum concentration of drug | Up to 24 Months |
| Pharmacokinetics - AUC | Area under the serum concentration-time curve | Up to 24 Months |
| Pharmacokinetics - tmax | Time of maximum observed serum concentration | Up to 24 Months |
| Incidence of laboratory-reported positive responses of anti-CC-96673 antibodies | Up to 24 Months |
| Omaha |
| Nebraska |
| 68198-6840 |
| United States |
| Local Institution - 101 | Houston | Texas | 77030 | United States |
| Local Institution - 102 | Seattle | Washington | 98124 | United States |
| Local Institution - 201 | Toronto | Ontario | M5G 2M9 | Canada |
| Local Institution - 202 | Montreal | Quebec | H3T 1E2 | Canada |
| Local Institution - UNK-5 | Angers | 49933 | France |
| Local Institution - 303 | Lille | 59037 | France |
| Local Institution - 302 | Montpellier | 34295 | France |
| Hopital Lyon Sud | Pierre-Bénite | 69310 | France |
| Local Institution - 401 | Madrid | 28027 | Spain |
| Local Institution - 403 | Málaga | 29010 | Spain |
| Local Institution - 402 | Salamanca | 37007 | Spain |
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |