Retifanlimab (INCMGA00012) and Telotristat Ethyl for the Treatment of Advanced Neuroendocrine Tumors and Carcinoid Syndrome

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT04776876
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Retifanlimab — BIOLOGICAL
    Given IV
  • Telotristat Ethyl — DRUG
    Given PO

Study Details

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.

Key Dates

Start date
Mar 1, 2021
Status verified
Sep 2021
Primary completion
Sep 2, 2021
Completion
Sep 2, 2021

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (retifanlimab, telotristat ethyl)
    Patients receive retifanlimab IV over 30-60 minutes on day 1 and telotristat ethyl PO TID on days 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Overall best response rate (partial response or complete response) [ Time Frame: Up to 2 years ]

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