CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 284 enrolled
Drug / intervention
Pamrevlumab + Gemcitabine + Nab-paclitaxel or Pamrevlumab + FOLFIRINOX +1 moredrug
Likely dose
Pamrevlumab via IV infusion on Days 1, 8, 15 of Cycle 1 and Days 1, 15 of subsequent cycles, combined with Gemcitabine (Days 1, 8, 15 of each 28-day cycle) plus Nab-paclitaxel (Days 1, 8, 15) OR Gemcitabine plus Nab-paclitaxel OR FOLFIRINOXAI-extracted
Key inclusion· 9
  • ✓Histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC)
  • ✓Locally advanced pancreatic cancer considered unresectable per NCCN Guidelines as confirmed by central imaging
  • ✓Measurable disease by RECIST 1.1 criteria per central imaging
  • ✓Age ≥18 years
Key exclusion· 10
  • ✕Prior chemotherapy or radiation therapy for pancreatic cancer
  • ✕Previous or concurrent malignancy within 3 years, except non-melanoma skin cancer and in situ carcinomas (excluding in situ breast cancer)
  • ✕Major surgery within 4 weeks prior to informed consent (biliary stents permitted)
  • ✕History of allergy or hypersensitivity to human, humanized or chimeric monoclonal antibodies

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03941093
NCT03941093Phase 3Completed
CompareCT.gov

A Phase 3, Randomized, Double-Blind Study of Pamrevlumab or Placebo in Combination With Either Gemcitabine Plus Nab-paclitaxel or FOLFIRINOX as Neoadjuvant Treatment in Patients With Locally Advanced, Unresectable Pancreatic Cancer

Kyntra Bio·interventional·Posted May 7, 2019·Updated Nov 5, 2024

In Brief

A Phase 3 clinical trial evaluating Pamrevlumab + Gemcitabine + Nab-paclitaxel or Pamrevlumab + FOLFIRINOX and Placebo + Gemcitabine + Nab-paclitaxel or Placebo + FOLFIRINOX for Pancreatic Cancer Non-resectable. Completed, enrolled 284 participants across 90 sites in 12 countries.

Detailed Summary

This is a Phase 3, randomized, double-blind trial to evaluate the efficacy and safety of neoadjuvant treatment with pamrevlumab or placebo in combination with either gemcitabine plus nab-paclitaxel (G/NP) or FOLFIRINOX in the treatment of participants with locally advanced, unresectable pancreatic cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPancreatic Cancer Non-resectable
CountriesAustria, Belgium, Canada, China, France, Germany, Israel, Italy, South Korea, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedMay 7, 2019
Enrollment StartMay 10, 2019
Primary CompletionJun 11, 2024
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 7.2 years ago

Interventions

Pamrevlumab + Gemcitabine + Nab-paclitaxel or Pamrevlumab + FOLFIRINOXdrug

Drug: Pamrevlumab is administered on Days 1, 8 and 15 of Treatment Cycle 1 and on Day 1 and 15 of each subsequent treatment cycle via IV infusion. Drug: Gemcitabine is administered on Days 1, 8 and 15 of each 28 day treatment cycle via IV infusion. Drug: Nab-paclitaxel is administered on Days 1, 8 and 15 of each 28 day treatment cycle via IV infusion. Drug: FOLFIRINOX is a combination of several agents administered on Days 1 and 15 of each 28 day treatment cycle via IV infusion. The specific agents are Oxaliplatin, Folinic Acid, Irinotecan, and Fluorouracil.

Placebo + Gemcitabine + Nab-paclitaxel or Placebo + FOLFIRINOXdrug

Drug: Placebo is administered on Days 1, 8 and 15 of Treatment Cycle 1 and on Day 1 and 15 of each subsequent treatment cycle via IV infusion. Drug: Gemcitabine is administered on Days 1, 8 and 15 of each 28 day treatment cycle via IV infusion. Drug: Nab-paclitaxel is administered on Days 1, 8 and 15 of each 28 day treatment cycle via IV infusion. Drug: FOLFIRINOX is a combination of several agents administered on Days 1 and 15 of each 28 day treatment cycle via IV infusion. The specific agents are Oxaliplatin, Folinic Acid, Irinotecan, and Fluorouracil.