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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04935359 | Study of Efficacy and Safety of NIS793 in Combination With Standard of Care (SOC) Chemotherapy in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) - daNIS-2 | PHASE3 | COMPLETED | 511 | — | — | Sep 30, 2021 | Aug 13, 2024 | May 19, 2026 | 113 | United States, Australia +25 |
A dose-limiting toxicity (DLT) was defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurred within the first cycle (i.e., 28 days or 4 weeks) of the treatment with NIS793 in combination with gemcitabine/nab-paclitaxel. The National Cancer Institute Common Terminology Criteria for Adverse events (NCI CTCAE) version 5 was used for all grading.
Overall Survival (OS) was defined as the time from date of randomization/start of treatment to date of death due to any cause. If a patient was not known to have died, survival was censored at the date of last known date patient alive.
| Arm | Type | Description |
|---|---|---|
| Safety run-in part: NIS793 plus (Gemcitabine and Nab-paclitaxel) | EXPERIMENTAL | Participants received a combination of NIS793, Gemcitabine and Nab-paclitaxel : * NIS793 at 2100 mg (Days 1 and 15) * Gemcitabine at 1000 mg/m² (Days 1, 8 and 15) * Nab-paclitaxel at 125 mg/m² (Days 1, 8 and 15) Note: As of 7-Jul-2023, treatment with NIS793/placebo was stopped. Study participants were allowed to continue with standard of care (SoC) chemotherapy (gemcitabine+ nab-paclitaxel) per investigator assessment. |
| Randomized part (Arm A): NIS793 plus (Gemcitabine and Nab-paclitaxel) | EXPERIMENTAL | Participants received a combination of NIS793, gemcitabine and nab-paclitaxel: * NIS793 at 2100 mg (Days 1 and 15) assuming this was the confirmed RP3D in the safety run-in part or NIS793 at 2100 mg on Day 1 if dose level -1 was the confirmed RP3D in the safety run-in * Gemcitabine at 1000 mg/m² (Days 1, 8 and 15) * Nab-paclitaxel at 125 mg/m² (Days 1, 8 and 15) Note: As of 7-Jul-2023, treatment with NIS793/placebo was stopped. Study participants were allowed to continue with standard of care (SoC) chemotherapy (gemcitabine+ nab-paclitaxel) per investigator assessment. |
| Randomized part (Arm B): Placebo plus (Gemcitabine and Nab-paclitaxel) | PLACEBO_COMPARATOR | Participants received a combination of placebo, gemcitabine and nab-paclitaxel: * Placebo for NIS793 (Days 1 and 15) * Gemcitabine at 1000 mg/m² (Days 1, 8 and 15) * Nab-paclitaxel at 125 mg/m² (Days 1, 8 and 15) Note: As of 7-Jul-2023, treatment with NIS793/placebo was stopped. Study participants were allowed to continue with standard of care (SoC) chemotherapy (gemcitabine+ nab-paclitaxel) per investigator assessment. |
| Name | Type | Description |
|---|---|---|
| NIS793 | DRUG | Concentrate for solution infusion (Liquid in Vial) |
| Nab-paclitaxel | DRUG | Per locally approved formulation |
| Gemcitabine | DRUG | Per locally approved formulation |
| Placebo | DRUG | Dextrose 5% in water (D5W) solution for infusion |
Key Inclusion Criteria: Applicable for both Safety run-in and Randomized part * Participants aged ≥18 years with histologically or cytologically confirmed (based on local assessment and per local guidelines) mPDAC eligible for treatment in the first line setting and not amenable for potentially cu...