Phase 3 Trial of 90Y-Clivatuzumab Tetraxetan & Gemcitabine vs Placebo & Gemcitabine in Metastatic Pancreatic Cancer

NCT01956812 | Terminated Phase 3 DMC

• 1 other identifier: IMMU-107-04
• Study Type: interventional
• Target: 334
• Locations: 8 countries
• Sites: 64

Brief Summary

The is a double-blind, randomized phase 3 study of 90Y-clivatuzumab tetraxetan with low-dose gemcitabine, versus placebo and low-dose gemcitabine in metastatic pancreatic cancer patients who have progressed on at least 2 prior therapies for metastatic cancer (1 of which was a gemcitabine-containing regimen).

Conditions

Metastatic Pancreatic Cancer; Pancreatic Cancer

Keywords

clivatuzumab tetraxetan; 90Y-clivatuzumab tetraxetan; IMMU-107

Outcome Measures

Primary Outcomes (1)

• overall survival

  24 months

Secondary Outcomes (4)

• Overall survival

  3, 6 and 12 months

• Objective tumor response

  24 months

• Progression free survival

  24 months

• Clinical benefit

  24 months

Study Arms (2)

Arm A IMMU-107 and gemcitabine

EXPERIMENTAL

IMMU-107 and low dose gemcitabine

Drug: IMMU-107; Drug: Gemcitabine

Arm B Placebo and low dose gemcitabine

ACTIVE COMPARATOR

Placebo and low dose gemcitabine

Drug: placebo; Drug: Gemcitabine

Interventions

IMMU-107 DRUG

Arm A: gemcitabine 200 mg/m2 administered weekly x 4 and IMMU-107 administered weekly x 3 for multiple cycles

Also known as: 90Y-clivatuzumab tetraxetan

Arm A IMMU-107 and gemcitabine

placebo DRUG

placebo weekly x 3 and gemcitabine 200 mg/m2 weekly x 4 for multiple cycles

Also known as: normal saline

Arm B Placebo and low dose gemcitabine

Gemcitabine DRUG

Gemcitabine, 200 mg/m2, given weekly x 4 in both arms

Also known as: gemcitabine 200 mg/m2

Arm A IMMU-107 and gemcitabine; Arm B Placebo and low dose gemcitabine

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed adenocarcinoma of the pancreas
• Metastatic disease
• Received at least two prior systemic cytotoxic chemotherapy regimens for unresectable, locally advanced or metastatic disease.
• At least one of the prior systemic cytotoxic chemotherapy regimens for unresectable, locally advanced or metastatic disease must have contained gemcitabine and have met the following criteria:
• Completed at least one cycle of the treatment
• Received gemcitabine administered at a minimum dose of 800 mg/m2 per week in the first cycle of treatment
• Progressed while receiving this gemcitabine regimen or within 3 months of completing gemcitabine
• Progression was documented,
• Preferentially radiologically by tumor growth or new lesions, or by
• Clear symptomatic deterioration supported by at least two of the following clinical criteria: ≥ 10% worsening in KPS or ≥ 1 worsening in ECOG; increasing weakness or fatigue; progressive weight loss; new/worsening pain requiring increased pain medication; new/worsening jaundice, nausea, or vomiting; new/worsening ascites or pleural effusions; other physical or laboratory findings consistent with disease progression.
• KPS \>/= 70
• Adequate bone marrow function
• Adequate hepatic function
• Adequate renal function

You may not qualify if:

• CNS metastatic disease
• Bulky disease (any single mass \>10 cm).
• \>Grade 2 nausea or vomiting, and/or signs of intestinal obstruction.
• Prior external beam irradiation to a field that includes more than 30% of the red bone marrow.
• Patients with clinically significant severe cardiorespiratory disease.

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (64)

Banner MD Anderson

Gilbert, Arizona, 85234, United States

Location

City of Hope National Medical Center

Duarte, California, 91010, United States

Location

Pacific Shores Medical Group

Long Beach, California, 90813, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Whittingham Cancer Center

Norwalk, Connecticut, 06856, United States

Location

Michael and Dianne Bienes Comprehensive Cancer Center - Holy Cross Hospital

Fort Lauderdale, Florida, 33308, United States

Location

Baptist Cancer Institute

Jacksonville, Florida, 32207, United States

Location

Cancer Specialists of North Florida

Jacksonville, Florida, 32256, United States

Location

Mountain States Tumor Institute at St. Luke's Regional Medical Center

Boise, Idaho, 83712, United States

Location

Illinois Cancer Specialists

Arlington Heights, Illinois, 60005, United States

Location

Indiana University Health Goshen Center for Cancer Care

Goshen, Indiana, 46526, United States

Location

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Ashland-Bellefonte Cancer Center

Ashland, Kentucky, 41101, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39213, United States

Location

Oncology Hematology West P.C. dba Nebraska Cancer Specialists

Omaha, Nebraska, 68130, United States

Location

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89169, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

New York Presbyterian Hospital/Weill Cornell Medical Center

New York, New York, 10021, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Stony Brook University Medical Center

Stony Brook, New York, 11794-7007, United States

Location

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

University of North Carolina Hospitals, Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599-7510, United States

Location

The Ohio State University - Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

Location

The Pennsylvania State University (Penn State) Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

Location

University of Pennsylvania Abramson Cancer Center

Philadelphia, Pennsylvania, 19104, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

University of Pittsburgh Medical Center/Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Center for Biomedical Research

Knoxville, Tennessee, 37909, United States

Location

University of Tennessee Medical Center, Cancer Institute

Knoxville, Tennessee, 37920, United States

Location

Mary Crowley Medical Research Center

Dallas, Texas, 75251, United States

Location

Oncology Consultants

Houston, Texas, 77030, United States

Location

Texas Oncology - McAllen

McAllen, Texas, 78503, United States

Location

Texas Oncology - Tyler

Tyler, Texas, 75702, United States

Location

Virginia Oncology Associates

Norfolk, Virginia, 23502, United States

Location

University of Washington

Seattle, Washington, 98109, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98111, United States

Location

Krankenhaus der Elisabethinen Linz

Linz, A-4020, Austria

Location

Medical University Vienna

Vienna, 1090, Austria

Location

University Hospital Leuven

Leuven, 3000, Belgium

Location

Cancer Care Manitoba

Winnepeg, Manitoba, R3E 0V9, Canada

Location

Centre Hospitalier Université de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

ICO René Gauducheau

Nantes, Cedex 1, 44093, France

Location

Institut Paoli-Calmettes

Marseille, Cedex 9, 13273, France

Location

Institut Bergonie

Bordeaux, Cedex, 33076, France

Location

Centre Léon Bérard Cancerologie Medicale

Lyon, 69008, France

Location

Institut Paoli-Calmettes

Marseille, 13273, France

Location

CRLC Val D'Aurelle

Montpellier, 34298, France

Location

Hopital Cochin

Paris, 75014, France

Location

Soroka Medical Center

Beersheba, 84101, Israel

Location

Rambam Medical Center

Haifa, 3109601, Israel

Location

Centrum Onkologii Instytut im. M. Sklodowskiej-Curie - Warszawa

Warsaw, 02-781, Poland

Location

Hospital Sant Joan de Reu

Reus, Tarragona, 43204, Spain

Location

Hospital Vall D'Hebrón

Barcelona, 08035, Spain

Location

Hospital Universitario Gregorio Marañón

Madrid, 28007, Spain

Location

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Centro Integral Oncologico Clara Campal

Madrid, 28050, Spain

Location

Hospital Miguel Servet

Zaragoza, 50009, Spain

Location

Related Publications (19)

• Ocean AJ, Pennington KL, Guarino MJ, Sheikh A, Bekaii-Saab T, Serafini AN, Lee D, Sung MW, Gulec SA, Goldsmith SJ, Manzone T, Holt M, O'Neil BH, Hall N, Montero AJ, Kauh J, Gold DV, Horne H, Wegener WA, Goldenberg DM. Fractionated radioimmunotherapy with (90) Y-clivatuzumab tetraxetan and low-dose gemcitabine is active in advanced pancreatic cancer: A phase 1 trial. Cancer. 2012 Nov 15;118(22):5497-506. doi: 10.1002/cncr.27592. Epub 2012 May 8.

  PMID: 22569804 BACKGROUND

• Gulec SA, Cohen SJ, Pennington KL, Zuckier LS, Hauke RJ, Horne H, Wegener WA, Teoh N, Gold DV, Sharkey RM, Goldenberg DM. Treatment of advanced pancreatic carcinoma with 90Y-Clivatuzumab Tetraxetan: a phase I single-dose escalation trial. Clin Cancer Res. 2011 Jun 15;17(12):4091-100. doi: 10.1158/1078-0432.CCR-10-2579. Epub 2011 Apr 28.

  PMID: 21527562 BACKGROUND

• Sharkey RM, Karacay H, Govindan SV, Goldenberg DM. Combination radioimmunotherapy and chemoimmunotherapy involving different or the same targets improves therapy of human pancreatic carcinoma xenograft models. Mol Cancer Ther. 2011 Jun;10(6):1072-81. doi: 10.1158/1535-7163.MCT-11-0115. Epub 2011 Apr 5.

  PMID: 21467164 BACKGROUND

• Tokh M, Bathini V, Saif MW. First-line treatment of metastatic pancreatic cancer. JOP. 2012 Mar 10;13(2):159-62.

  PMID: 22406590 BACKGROUND

• Gold DV, Newsome G, Liu D, Goldenberg DM. Mapping PAM4 (clivatuzumab), a monoclonal antibody in clinical trials for early detection and therapy of pancreatic ductal adenocarcinoma, to MUC5AC mucin. Mol Cancer. 2013 Nov 20;12(1):143. doi: 10.1186/1476-4598-12-143.

  PMID: 24257318 BACKGROUND

• Gold DV, Gaedcke J, Ghadimi BM, Goggins M, Hruban RH, Liu M, Newsome G, Goldenberg DM. PAM4 enzyme immunoassay alone and in combination with CA 19-9 for the detection of pancreatic adenocarcinoma. Cancer. 2013 Feb 1;119(3):522-8. doi: 10.1002/cncr.27762. Epub 2012 Aug 16.

  PMID: 22898932 BACKGROUND

• Gold DV, Goggins M, Modrak DE, Newsome G, Liu M, Shi C, Hruban RH, Goldenberg DM. Detection of early-stage pancreatic adenocarcinoma. Cancer Epidemiol Biomarkers Prev. 2010 Nov;19(11):2786-94. doi: 10.1158/1055-9965.EPI-10-0667. Epub 2010 Sep 1.

  PMID: 20810605 BACKGROUND

• Gold DV, Goldenberg DM, Karacay H, Rossi EA, Chang CH, Cardillo TM, McBride WJ, Sharkey RM. A novel bispecific, trivalent antibody construct for targeting pancreatic carcinoma. Cancer Res. 2008 Jun 15;68(12):4819-26. doi: 10.1158/0008-5472.CAN-08-0232.

  PMID: 18559529 BACKGROUND

• Gold DV, Karanjawala Z, Modrak DE, Goldenberg DM, Hruban RH. PAM4-reactive MUC1 is a biomarker for early pancreatic adenocarcinoma. Clin Cancer Res. 2007 Dec 15;13(24):7380-7. doi: 10.1158/1078-0432.CCR-07-1488.

  PMID: 18094420 BACKGROUND

• Gold DV, Modrak DE, Ying Z, Cardillo TM, Sharkey RM, Goldenberg DM. New MUC1 serum immunoassay differentiates pancreatic cancer from pancreatitis. J Clin Oncol. 2006 Jan 10;24(2):252-8. doi: 10.1200/JCO.2005.02.8282. Epub 2005 Dec 12.

  PMID: 16344318 BACKGROUND

• Gold DV, Modrak DE, Schutsky K, Cardillo TM. Combined 90Yttrium-DOTA-labeled PAM4 antibody radioimmunotherapy and gemcitabine radiosensitization for the treatment of a human pancreatic cancer xenograft. Int J Cancer. 2004 Apr 20;109(4):618-26. doi: 10.1002/ijc.20004.

  PMID: 14991585 BACKGROUND

• Gold DV, Schutsky K, Modrak D, Cardillo TM. Low-dose radioimmunotherapy ((90)Y-PAM4) combined with gemcitabine for the treatment of experimental pancreatic cancer. Clin Cancer Res. 2003 Sep 1;9(10 Pt 2):3929S-37S.

  PMID: 14506191 BACKGROUND

• Cardillo TM, Blumenthal R, Ying Z, Gold DV. Combined gemcitabine and radioimmunotherapy for the treatment of pancreatic cancer. Int J Cancer. 2002 Jan 20;97(3):386-92. doi: 10.1002/ijc.1613.

  PMID: 11774294 BACKGROUND

• Cardillo TM, Ying Z, Gold DV. Therapeutic advantage of (90)yttrium- versus (131)iodine-labeled PAM4 antibody in experimental pancreatic cancer. Clin Cancer Res. 2001 Oct;7(10):3186-92.

  PMID: 11595713 BACKGROUND

• Gold DV, Cardillo T, Goldenberg DM, Sharkey RM. Localization of pancreatic cancer with radiolabeled monoclonal antibody PAM4. Crit Rev Oncol Hematol. 2001 Jul-Aug;39(1-2):147-54. doi: 10.1016/s1040-8428(01)00114-7.

  PMID: 11418312 BACKGROUND

• Gold DV, Cardillo T, Vardi Y, Blumenthal R. Radioimmunotherapy of experimental pancreatic cancer with 131I-labeled monoclonal antibody PAM4. Int J Cancer. 1997 May 16;71(4):660-7. doi: 10.1002/(sici)1097-0215(19970516)71:43.0.co;2-e.

  PMID: 9178823 BACKGROUND

• Mariani G, Molea N, Bacciardi D, Boggi U, Fornaciari G, Campani D, Salvadori PA, Giulianotti PC, Mosca F, Gold DV, et al. Initial tumor targeting, biodistribution, and pharmacokinetic evaluation of the monoclonal antibody PAM4 in patients with pancreatic cancer. Cancer Res. 1995 Dec 1;55(23 Suppl):5911s-5915s.

  PMID: 7493369 BACKGROUND

• Alisauskus R, Wong GY, Gold DV. Initial studies of monoclonal antibody PAM4 targeting to xenografted orthotopic pancreatic cancer. Cancer Res. 1995 Dec 1;55(23 Suppl):5743s-5748s.

  PMID: 7493339 BACKGROUND

• Gold DV, Lew K, Maliniak R, Hernandez M, Cardillo T. Characterization of monoclonal antibody PAM4 reactive with a pancreatic cancer mucin. Int J Cancer. 1994 Apr 15;57(2):204-10. doi: 10.1002/ijc.2910570213.

  PMID: 7512537 BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Saline Solution; 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)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• William Wegener, MD, PhD

  Gilead Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2013
• First Posted: October 8, 2013
• Study Start: December 1, 2013
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: August 16, 2021

Record last verified: 2020-03

Locations

PL (1); US (42); IL (2); FR (7); CA (2); AU (2); BE (1); ES (7)