Ignite Creation Date:
2024-05-06 @ 3:50 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04776876
Status:
WITHDRAWN
Last Update Posted:
2021-09-29
First Post:
2021-02-08
Brief Title:
Retifanlimab INCMGA00012 and Telotristat Ethyl for the Treatment of Advanced Neuroendocrine Tumors and Carcinoid Syndrome
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase II Open-Label Single-Arm Study of INCMGA00012 and Telotristat Ethyl in Patients With Advanced Neuroendocrine Tumors and Carcinoid Syndrome
Status:
WITHDRAWN
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study will not be opening Support was withdrawn
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial studies the effect of retifanlimab and telotristat ethyl in treating patients with neuroendocrine tumors that have spread to other places in the body advanced and carcinoid syndrome Retifanlimab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread Telotristat ethyl is a drug used to reduce side effects of carcinoid syndrome Giving retifanlimab and telotristat ethyl may help to control neuroendocrine tumors in patients who also have carcinoid syndrome
Detailed Description:
PRIMARY OBJECTIVE
I To evaluate the efficacy of retifanlimab A12 telotristat ethyl TE
SECONDARY OBJECTIVE
I To evaluate the efficacy of A12 TE
SAFETY OBJECTIVES
I To evaluate the safety of A12 TE II To evaluate the safety of withholding concurrent somatostatin analogue in patients receiving A12 TE
EXPLORATORY BIOMARKER OBJECTIVE
I To identify biomarkers that are predictive of response to A12 TE ie predictive biomarkers are associated with progression to a more severe disease state ie prognostic biomarkers are associated with resistance to A12 TE are associated with susceptibility to developing adverse events can provide evidence of study treatment activity or can increase the knowledge and understanding of disease biology
OUTLINE
Patients receive retifanlimab intravenously IV over 30-60 minutes on day 1 and telotristat ethyl orally PO 3 times daily TID on days 1-28 Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months for 2 years
I To evaluate the efficacy of retifanlimab A12 telotristat ethyl TE
SECONDARY OBJECTIVE
I To evaluate the efficacy of A12 TE
SAFETY OBJECTIVES
I To evaluate the safety of A12 TE II To evaluate the safety of withholding concurrent somatostatin analogue in patients receiving A12 TE
EXPLORATORY BIOMARKER OBJECTIVE
I To identify biomarkers that are predictive of response to A12 TE ie predictive biomarkers are associated with progression to a more severe disease state ie prognostic biomarkers are associated with resistance to A12 TE are associated with susceptibility to developing adverse events can provide evidence of study treatment activity or can increase the knowledge and understanding of disease biology
OUTLINE
Patients receive retifanlimab intravenously IV over 30-60 minutes on day 1 and telotristat ethyl orally PO 3 times daily TID on days 1-28 Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months for 2 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2021-00021 | REGISTRY | None | None |
| 2020-0083 | OTHER | M D Anderson Cancer Center | None |