Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03043664 | Study of Pembrolizumab With Lanreotide Depot for Gastroenteropancreatic Neuroendocrine Tumors | PHASE1 | COMPLETED | 22 | — | — | Jul 1, 2017 | Jun 7, 2022 | Jun 29, 2023 | 2 | United States |
ORR is calculated as the number of people with a complete response (CR) or partial response (PR), divided by the total number of people treated. Complete response is defined as disappearance of all target lesions. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. A lower limit of the true ORR will be estimated by the 90% exact lower confidence bound (LCB) for the binomial proportion. A 90% LCB of \< 0.1 will be considered not to be of clinical value. If the 90% LCB is ≥ 0.1, the regimen will be considered efficacious.
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | Keytruda (pembrolizumab) 200 mg intravenous (IV) infusion every 3 weeks and Somatuline Depot (lanreotide) 90 mg subcutaneous (SQ) injection every 3 weeks. |
| Name | Type | Description |
|---|---|---|
| Lanreotide | DRUG | Somatuline depot (lanreotide) 90 mg SQ every 3 weeks |
| Pembrolizumab | DRUG | Keytruda (pembrolizumab) 200 mg IV every 3 weeks |
Inclusion Criteria: 1. Willing and able to provide written informed consent for the trial. 2. At least 18 years of age on day of signing informed consent. 3. Non-resectable, recurrent, or metastatic well- or moderately-differentiated gastroenteropancreatic neuroendocrine tumor (GEP-NETs) with disea...