Study Of Neo-adjuvant RO7009789 Alone Or Neo-adjuvant RO7009789 Plus Nab-Paclitaxel And Gemcitabine Followed By Adjuvant RO7009789 Plus Nab-Paclitaxel And Gemcitabine For Patients With Newly Diagnosed Resectable Pancreatic Carcinoma

Study Overview

Study of Neo-adjuvant RO7009789 Alone or Neo-adjuvant RO7009789 Plus Nab-Paclitaxel and Gemcitabine Followed by Adjuvant RO7009789 Plus Nab-Paclitaxel and Gemcitabine for Patients With Newly Diagnosed Resectable Pancreatic Carcinoma

The main purpose of this study is to learn if adding the investigational drug RO7009789 (anti-CD40) to nab-paclitaxel and gemcitabine both before surgery and after surgery is safe, feasible, and beneficial to patients with pancreatic cancer. This study also intends to look at blood and tissue samples to help doctors better understand the role of the immune system in fighting cancer.

N/A

Pancreatic Cancer

DRUG: RO70097890
DRUG: nab-paclitaxel
DRUG: gemcitabine

UPCC 20214

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2015-10-21	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2022-09-01
First Submitted that Met QC Criteria 2015-10-26	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2022-09-06
First Posted (ACTUAL) 2015-10-27	Results First Posted N/A	Last Verified 2022-09

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Arm1 Arm I provides one dose of RO70097890 as a single agent in the neoadjuvant setting. Patients will recover from any toxicities and will then have their disease surgically resected. After recovery from surgery patients will proceed to adjuvant therapy which	DRUG: RO70097890 DRUG: nab-paclitaxel DRUG: gemcitabine
EXPERIMENTAL: Arm2 Arm II provides one dose of RO7009789 two days after one dose of nab-paclitaxel and one dose of gemcitabine prior to surgery. Nab-paclitaxel and gemcitabine are given on day 1. RO7009789 will be given on day 3. Patients will recover from any toxicities an	DRUG: RO70097890 DRUG: nab-paclitaxel DRUG: gemcitabine

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Arm1

Arm I provides one dose of RO70097890 as a single agent in the neoadjuvant setting. Patients will recover from any toxicities and will then have their disease surgically resected. After recovery from surgery patients will proceed to adjuvant therapy which

DRUG: RO70097890

DRUG: nab-paclitaxel

DRUG: gemcitabine

EXPERIMENTAL: Arm2

Arm II provides one dose of RO7009789 two days after one dose of nab-paclitaxel and one dose of gemcitabine prior to surgery. Nab-paclitaxel and gemcitabine are given on day 1. RO7009789 will be given on day 3. Patients will recover from any toxicities an

DRUG: RO70097890

DRUG: nab-paclitaxel

DRUG: gemcitabine

Primary Outcome Measures	Measure Description	Time Frame
Number of Adverse Events		2 years

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Histological documentation of primary adenocarcinoma of the pancreas
Surgically eligible for tumor resection with curative intent
Age ≥18 years
ECOG PS 0 or 1
Adequate bone marrow function (ANC ≥1,500; Hgb >9; Plt >100)
Adequate renal function (Cr <1.5 ULN)
Total bilirubin ≤1.5 x ULN; and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <2.5 x ULN (values post biliary stenting allowed for eligibility).
Signed, written informed consent

Non ductal adenocarcinomas, neuroendocrine neoplasms, cystic tumors of the pancreas such as cystadenomas, cystadenocarcinomas and solid pseudopapillary neoplasms. In addition, adenocarcinomas arising from duodenum, distal bile duct, and ampulla will also be excluded.
Patients with M1 disease or a history of M1 disease.
Patients with any type of recurrent pancreatic adenocarcinoma
Prior therapy such as chemotherapy or radiation therapy or anti-tumor experimental therapy for pancreatic cancer
Previous treatment with any other compound that targets CD40
Concurrent treatment with any anticancer agent outside of this protocol
Prior allogeneic bone marrow transplant
History of autoimmune disorder, including type 1 diabetes mellitus, pemphigus vulgaris, systemic mastocytosis, systemic lupus erythromatosis, dermatomyositis/polymyositis, rheumatoid arthritis, systemic sclerosis, Sjörgen's syndrome, vasculitis/arteritis, Behcet's syndrome, autoimmune thyroiditis, multiple sclerosis, or uveitis,. (Vitiligo is allowed)
History (within the previous year) of stroke or transient ischemic attack, unstable angina, myocardial infarction, congestive heart failure
History of deep venous thrombosis or migratory thrombophlebitis (Trousseau);
Hereditary or acquired coagulopathies (e.g., hemophilia, von Willebrand disease, or cancer-associated DIC)
Prior allergic reactions attributed to other monoclonal antibodies
Concurrent or planned concurrent treatment with systemic high dose (immunosuppressive) corticosteroids or treatment with systemic corticosteroids within 4 weeks of baseline
Treatment on another therapeutic clinical trial within 4 weeks of enrollment in this trial
Concurrent or planned concurrent treatment with anticoagulants such as Coumadin or heparin, except to maintain patency of in-dwelling catheters
Ongoing or active infection; treatment with systemic antibiotics or antifungals for ongoing or recurrent infection (topical use of antibiotics or antifungals is allowed)
Pregnancy or breast-feeding - female patients must be surgically sterile, be post-menopausal, or must agree to use effective contraception during the period of therapy and for 90 days following the last dose of RO7009789. All female patients with reproductive potential must have a negative pregnancy test prior to enrollment. Women or men of reproductive potential may not participate unless they agree to use an effective contraceptive method. Female patients should not become pregnant while participating in this research study or for 90 days following therapy. Male patients should not father a child while in this research study or for 90 days following therapy.
Other uncontrolled, concurrent illness that would preclude study participation; or, psychiatric illness or social challenges that would entail unreasonable risk or preclude informed consent or compliance with study procedures

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Robert Vonderheide, MD, DPhil, Abramson Cancer Center at Penn Medicine

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record