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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

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ClinicalTrials.gov Identifier: NCT02588443
Recruitment Status : Completed
First Posted : October 27, 2015
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: RO70097890 Drug: nab-paclitaxel Drug: gemcitabine Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: Phase I 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
Actual Study Start Date : October 2015
Actual Primary Completion Date : November 2018
Actual Study Completion Date : November 2018


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 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
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 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



Primary Outcome Measures :
  1. Number of Adverse Events [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02588443


Locations
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United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
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Principal Investigator: Robert Vonderheide, MD, DPhil Abramson Cancer Center of the University of Pennsylvania

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Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02588443     History of Changes
Other Study ID Numbers: UPCC 20214
First Posted: October 27, 2015    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019

Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Gemcitabine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs