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

NCT02588443 | Completed Phase 1 DMC

• 1 other identifier: UPCC 20214
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Number of Adverse Events

  2 years

Study Arms (2)

Arm1

EXPERIMENTAL

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 will include nab-paclitaxel 125mg/m2 and gemcitabine 1000mg/m2 on days 1,8 and 15 of a 28 day cycle along with RO7009789 0.2mg/kg on day 3 of each cycle. Four cycles of adjuvant therapy will be given. All medications are administered intravenously.

Drug: RO70097890; Drug: nab-paclitaxel; Drug: gemcitabine

Arm2

EXPERIMENTAL

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 and will then have their disease surgically resected. Patients will receive four cycles of these same medications in an adjuvant fashion after recovering from surgical resection. A cycle will consist of nab-paclitaxel (125mg/m²), gemcitabine (1000mg/m²) given on days 1,8 and 15 of a 28 day cycle along with RO7009789 0.2mg/kg on day 3 of each cycle.

Drug: RO70097890; Drug: nab-paclitaxel; Drug: gemcitabine

Interventions

RO70097890 DRUG

Arm1; Arm2

nab-paclitaxel DRUG

Arm1; Arm2

gemcitabine DRUG

Arm1; Arm2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

130-nm albumin-bound paclitaxel; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Robert Vonderheide, MD, DPhil

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2015
• First Posted: October 27, 2015
• Study Start: October 1, 2015
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: September 6, 2022

Record last verified: 2022-09

Locations

US (1)