Study of Efficacy and Safety of NIS793 (With and Without Spartalizumab) in Combination With SOC C… (NCT04390763) | Clinical Trial Compass
TerminatedPhase 2
Study of Efficacy and Safety of NIS793 (With and Without Spartalizumab) in Combination With SOC Chemotherapy in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)
Stopped: The study was early terminated following the NIS793 treatment halt and urgent safety measure issued in July 2023, as the continued evaluation of Standard of Care alone will not support the original purpose of this phase 2 clinical trial.
United States164 participantsStarted 2020-10-16
Plain-language summary
The purpose of this Phase II study is to assess the efficacy and safety of NIS793 with and without spartalizumab in combination with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel in previously untreated mPDAC.
Who can participate
Age range18 Years – 100 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Signed informed consent must be obtained prior to participation in the study.
✓. Male or female ≥ 18 years of age at the time of informed consent.
✓. Participants with histologically or cytologically confirmed treatment-naïve metastatic adenocarcinoma of the pancreas with measurable disease as per RECIST 1.1.
✓. Participants must have a site of disease amenable to biopsy, and be candidate for tumor biopsy according to the treating institution's guidelines. Participants must be willing to undergo a tumor biopsy at screening and during therapy on the study. In the event a new biopsy cannot be safely performed at study entry, an archival sample (collected \<6 months prior) may be substituted following documented discussion with Novartis.
✓. ECOG performance status ≤ 1.
Exclusion criteria
✕. Previous radiotherapy, surgery (with exception of placement of biliary stent, which is allowed), chemotherapy or any other investigational therapy for the treatment of metastatic pancreatic cancer. Participants having received previous chemotherapy in the adjuvant setting.
✕
What they're measuring
1
Safety run-in Part: Number of Participants With Dose-Limiting Toxicities (DLTs)
Timeframe: First cycle of treatment (28 days)
2
Safety run-in Part: Number of Participants With AEs and SAEs During the On-treatment Period
Timeframe: Up to approximately 0.8 years
3
Safety run-in Part: Number of Participants With Dose Reductions and Dose Interruptions of NIS793, Spartalizumab, Gemcitabine and Nab-paclitaxel
Timeframe: Up to approximately 0.7 years
4
Safety run-in Part: Dose Intensity of NIS793 and Spartalizumab
Timeframe: Cycle 1 and Cycle 3. The duration of each cycle was 28 days.
5
Safety run-in Part: Dose Intensity of Gemcitabine and Nab-paclitaxel
Timeframe: Cycle 1 and Cycle 3. The duration of each cycle was 28 days.
6
Randomized Part: Progression-Free Survival (PFS) Per RECIST v1.1 - Bayesian Model
Timeframe: Up to approximately 2 years. Risk changing timepoint=approximately 0.3 years.
7
Randomized Part: Progression-Free Survival (PFS) Per RECIST v1.1 - Kaplan-Meier Curves and Cox Model
. Participants amenable to potentially curative resection.
✕. Participants with a diagnosis of pancreatic neuroendocrine tumors (NETs), acinar, or islet cell tumors.
✕. Having out of range laboratory values as pre-defined in the protocol.
✕. Participants with MSI-H pancreatic adenocarcinoma.
✕. Presence of symptomatic CNS metastases, or CNS metastases that require local CNS directed therapy (such as radiotherapy or surgery), or increasing doses of corticosteroids 2 weeks prior to study entry.
✕. History of severe hypersensitivity reactions to any ingredient of study drug(s) and other mAbs and/or their excipients.
✕. The participant exhibits any of the events outlined in the contra-indications or special warnings and precautions sections of gemcitabine and nab-paclitaxel as per locally approved labels.