Retifanlimab (INCMGA00012) and Telotristat Ethyl for the Treatment of Advanced Neuroendocrine Tum… (NCT04776876) | Clinical Trial Compass
WithdrawnPhase 2
Retifanlimab (INCMGA00012) and Telotristat Ethyl for the Treatment of Advanced Neuroendocrine Tumors and Carcinoid Syndrome
Stopped: The study will not be opening. Support was withdrawn.
0Started 2021-03-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Grade 1, 2, or 3 (or described as low grade, intermediate grade, well differentiated, or moderately differentiated) neuroendocrine tumor, according to reviewing pathologist or documented interpretation of report by the investigator
* Progressive disease over the preceding 12 months
* Prior therapy with any number of anticancer therapies, but a somatostatin analogue (such as octreotide, lanreotide, or pasireotide) must be one of the prior therapies
* Carcinoid syndrome, as documented by the investigator
* Patients using a somatostatin analogue for symptom control must be on stable doses for 56 days prior to enrollment
* Signed informed consent form
* Age \>= 18 years
* Ability to comply with the study protocol, in the investigator's judgment
* Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1
* Previously irradiated lesions can be considered as measurable disease only if progressive disease has been unequivocally documented at that site since radiation
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Absolute neutrophil count \>= 1,500/mm\^3 without granulocyte colony-stimulating factor support (obtained within 28 days prior to initiation of study treatment)
* Lymphocyte count \>= 500/mm\^3 (obtained within 28 days prior to initiation of study treatment)
* Platelet count \>= 100,000/mm\^3 without transfusion (obtained within 28 days prior to initiation of study treatment)
* W…
What they're measuring
1
Overall best response rate (partial response or complete response)