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Protocol # 20-607

Status

Recruiting

Description

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.

Condition

  • Metastatic Pancreatic Ductal Adenocarcinoma

Interventions

  • NIS793
  • Spartalizumab
  • gemcitabine
  • nab-paclitaxel

Phase

Phase 2

Study Type

Interventional

Further Study Details

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

Enrollment

161

Study Start Date

October 16, 2020

Eligibility

  • Gender:     All
  • Minimum age:     18 Years
  • Maximum age:     N/A
  • Healthy volunteers:     No

Sponsors

Novartis Pharmaceuticals

Source

Novartis

Official title

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)

Clinicaltrials.gov Identifier

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.