A Phase 1B Study of Canakinumab, Spartalizumab, Nab-paclitaxel, and Gemcitabine in Metastatic Pancreatic Cancer (PC) Patients

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Pancreatic Cancer Action Network
Study ID
NCT04581343
Phase
PHASE1
Status
Completed

Conditions

  • Metastatic Pancreatic Ductal Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This study combines canakinumab (ACZ885), a high-affinity human anti-interleukin-1β (IL-1β) monoclonal antibody (mAb), and spartalizumab (PDR001), a mAb directed against human Programmed Death-1 (PD-1), with the chemotherapy combination of gemcitabine and nab-paclitaxel. This study will confirm for this 4-drug combination the tolerable doses, the acceptable safety profile, and the dose to be used for a Phase II combination treatment regimen.

Key Dates

Start date
Nov 2, 2020
Status verified
Apr 2025
Primary completion
Nov 2, 2022
Completion
Feb 27, 2023

Study Design

Enrollment
10 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Canakinumab, spartalizumab, nab-paclitaxel and gemcitabine
    Spartalizumab (PDR001),IV infusion, 400 mg, D1 of each 28-day cycle; Canakinumab (ACZ885), s.c. injection, 250 mg, Day 1 of each 28- day cycle; Gemcitabine, IV Infusion, 1000 mg/m2, Days 1, 8, 15 of each 28-day cycle; Nab-paclitaxel, IV Infusion, 125 mg/m2, Days 1, 8, 15 of each 28-day cycle.

Primary Outcome Measure

The Incidence of DLTs in the First 56 Days (8 Weeks) of Dosing to Determine Tolerable Phase 2/3 Dose of Canakinumab, Spartalizumab, Nab-paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Cancer. [ Time Frame: Assess the incidence of dose limiting toxicities (DLT) in the first 56 days (8 weeks) of dosing ]

Locations (2)

FacilityCityStateZIPSite coordinators
Dana Farber Cancer InstituteBostonMassachusetts02215-
New York UniversityNew YorkNew York10016-

Find similar trials in Boston, MA

By research site
Dana Farber Cancer Institute· Boston, MANew York University· New York, NY

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