A Study of Cabiralizumab Given With Nivolumab With and Without Chemotherapy in Patients With Advanced Pancreatic Cancer

Conditions

• Advanced Pancreatic Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Cabiralizumab — BIOLOGICAL
  specified dose on specified days
• Nab-paclitaxel — DRUG
  specified does on specified days
• Onivyde — DRUG
  specified dose on specified days
• Nivolumab — BIOLOGICAL
  specified dose on specified days
• Fluorouracil — DRUG
  specified dose on specified days
• Gemcitabine — DRUG
  specified dose on specified days
• Oxaliplatin — DRUG
  specified dose on specified day
• Leucovorin — DRUG
  Specified dose on specified days
• Irinotecan Hydrochloride — DRUG
  Specified dose on specified days

Study Details

The purpose of this study is to determine whether an investigational immuno-therapy, cabiralizumab in combination with nivolumab, with or without chemotherapy, is effective for the treatment of advanced pancreatic cancer.

Key Dates

Start date

Dec 18, 2017

Status verified

Jul 2024

Primary completion

Jun 1, 2023

Completion

Jun 1, 2023

Study Design

Enrollment

205 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm A
  Investigator choice of chemotherapy: Gemcitabine/Nab-Paclitaxel (Abraxane®) or 5-Fluorouracil/Leucovorin/Irinotecan Liposome (ONIVYDE)
• Experimental: Arm B
  Cabiralizumab Q2W + Nivolumab Q4W
• Experimental: Arm C
  Cabiralizumab Q2W + Nivolumab Q4W and Gemcitabine + Nab-Paclitaxel (Abraxane®) D1, 8 and 15 Q4W
• Experimental: Arm D
  Cabiralizumab Q2W + Nivolumab Q4W and Oxaliplatin/5-Flurouracil/Leucovorin (FOLFOX) Q2W

Primary Outcome Measure

Progression Free Survival (PFS) by BICR [ Time Frame: From randomization date to the date of first objectively documented disease progression or death (up to approximately 65 months) ]

Locations (19)

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