Search Cancer Clinical Trials
Recruiting
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 untreated mPDAC.
- Metastatic Pancreatic Ductal Adenocarcinoma
- NIS793
- Spartalizumab
- gemcitabine
- nab-paclitaxel
Phase 2
Interventional
Primary Outcome:
- Incidence of DLTs during the Safety Run-in
- Incidence and severity of treatment emergent Adverse Events and Serious Adverse Events in Safety Run-in
- Dose interruptions/reductions in Safety Run-in
- Dose intensity in Safety Run-in
- Progression-free survival in Randomized part
Secondary Outcome:
- Incidence and severity of Adverse Events and Serious Adverse Events in Randomized part
- Overall response rate per RECIST 1.1 in Randomized part
- Duration of response per RECIST 1.1 in Randomized part
- Time to Progression per RECIST 1.1 in Randomized part
- Overall Survival per RECIST 1.1 in Randomized part
- CD8 and PD-L1 expression in Randomized part
- Antidrug antibodies (ADA) (anti-NIS793 and anti-spartalizumab) expression in Randomized part
- Pharmacokinetic (PK) parameter Cmax in Randomized part
- Pharmacokinetic parameter AUClast in Randomized part
- Pharmacokinetic parameter Ctrough
161
October 16, 2020
- Gender: All
- Minimum age: 18 Years
- Maximum age: N/A
- Healthy volunteers: No
Novartis Pharmaceuticals
Novartis
A Phase II, Open Label, Randomized, Parallel Arm Study of NIS793 (With and Without Spartalizumab) in Combination With SOC Chemotherapy Gemcitabine/Nab-paclitaxel, and Gemcitabine/Nab-paclitaxel Alone in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)
NCT04390763
Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.