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Safety Study of SEA-CD40 in Cancer Patients

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ClinicalTrials.gov Identifier: NCT02376699
Recruitment Status : Recruiting
First Posted : March 3, 2015
Last Update Posted : November 2, 2018
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Seattle Genetics, Inc.

Brief Summary:
This study will examine the safety profile of SEA-CD40 given alone and in combination with pembrolizumab. The study will test increasing doses of SEA-CD40 given at least every 3 weeks to small groups of patients. The goal is to find the highest dose of SEA-CD40 that can be given to patients that does not cause unacceptable side effects. Different dose regimens will be evaluated. Different methods of administration may be evaluated. The pharmacokinetics, pharmacodynamic effects, biomarkers of response, and antitumor activity of SEA-CD40 will also be evaluated.

Condition or disease Intervention/treatment Phase
Cancer Carcinoma Carcinoma, Non-Small-Cell Lung Carcinoma, Squamous Cell Hematologic Malignancies Hodgkin Disease Lymphoma Lymphoma, B-Cell Lymphoma, Follicular Lymphoma, Large B-Cell, Diffuse Melanoma Neoplasms Neoplasm Metastasis Neoplasms, Head and Neck Neoplasms, Squamous Cell Non-Small Cell Lung Cancer Non-Small Cell Lung Cancer Metastatic Non-small Cell Carcinoma Squamous Cell Cancer Squamous Cell Carcinoma Squamous Cell Carcinoma of the Head and Neck Squamous Cell Neoplasm Lymphoma, Non-Hodgkin Drug: IV SEA-CD40 monotherapy regimen Drug: Pembrolizumab Drug: SC SEA-CD40 monotherapy regimen Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 410 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-label, Dose-escalation Study of SEA-CD40 in Adult Patients With Advanced Malignancies
Actual Study Start Date : February 2015
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : September 2022


Arm Intervention/treatment
Experimental: IV Monotherapy in Solid Tumors
SEA-CD40 administered IV
Drug: IV SEA-CD40 monotherapy regimen
Given intravenously on Day 1 every 3 weeks; or Days 1 and 8 every 3 weeks for 2 cycles, and then Day 1 every 3 weeks in subsequent cycles. Number of cycles: until progression or unacceptable toxicity develops.
Other Name: SEA-CD40

Experimental: IV Monotherapy in Lymphomas
SEA-CD40 administered IV
Drug: IV SEA-CD40 monotherapy regimen
Given intravenously on Day 1 every 3 weeks; or Days 1 and 8 every 3 weeks for 2 cycles, and then Day 1 every 3 weeks in subsequent cycles. Number of cycles: until progression or unacceptable toxicity develops.
Other Name: SEA-CD40

Experimental: Combination Therapy in Solid Tumors
SEA-CD40 (administered IV) + pembrolizumab
Drug: IV SEA-CD40 monotherapy regimen
Given intravenously on Day 1 every 3 weeks; or Days 1 and 8 every 3 weeks for 2 cycles, and then Day 1 every 3 weeks in subsequent cycles. Number of cycles: until progression or unacceptable toxicity develops.
Other Name: SEA-CD40

Drug: Pembrolizumab
Given intravenously on Day 2 every 3 weeks. Number of cycles: until progression or unacceptable toxicity develops up to a maximum of 35 cycles.
Other Name: Keytruda

Experimental: SC Monotherapy in Solid Tumors
SEA-CD40 administered SC
Drug: SC SEA-CD40 monotherapy regimen
Given subcutaneously on Day 1 every 3 weeks. Number of cycles: until progression or unacceptable toxicity develops.
Other Name: SEA-CD40

Experimental: SC Monotherapy in Lymphomas
SEA-CD40 administered SC
Drug: SC SEA-CD40 monotherapy regimen
Given subcutaneously on Day 1 every 3 weeks. Number of cycles: until progression or unacceptable toxicity develops.
Other Name: SEA-CD40




Primary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: Through up to approximately 6 weeks following last dose ]
  2. Incidence of chemistry and hematology laboratory abnormalities [ Time Frame: Through up to approximately 6 weeks following last dose ]

Secondary Outcome Measures :
  1. Blood concentrations of SEA-CD40 [ Time Frame: Through up to approximately 6 weeks after dosing ]
  2. Incidence of antitherapeutic antibodies against SEA-CD40 [ Time Frame: Through up to approximately 6 weeks after dosing ]
  3. Mean absolute and percent change from baseline over time of selected pharmacodynamic markers [ Time Frame: Through up to approximately 6 weeks after dosing ]
  4. Objective response rate [ Time Frame: Through up to approximately 6 weeks following last dose ]
  5. Disease control rate [ Time Frame: Through up to approximately 6 weeks following last dose ]
  6. Duration of response [ Time Frame: Up to approximately 6 years ]
  7. Progression-free survival [ Time Frame: Up to approximately 6 years ]
  8. Overall survival [ Time Frame: Up to approximately 6 years ]


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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:

  • (Monotherapy - Parts A, B, C, D, G, H, J, and K) -- Histologically confirmed advanced malignancy, either: (a) Metastatic or unresectable solid malignancy; or (b) Classical Hodgkin lymphoma (HL), or diffuse large B-cell lymphoma (DLBCL), or indolent lymphoma (including follicular lymphoma [FL])
  • (Monotherapy - Parts A, B, C, D, G, H, J, and K) -- Relapsed, refractory, or progressive disease, specifically: (a) Solid tumors: Following at least 1 prior systemic therapy, and no further standard therapy is available for the patient's advanced solid tumor at the time of enrollment; or (b) Classical HL: Following at least 2 prior systemic therapies in patients who are not candidates for autologous stem cell transplant (SCT), or following failure of autologous SCT; or (c) DLBCL: Following at least 1 prior systemic therapy; patients must have also received intensive salvage therapy unless they refused or were deemed ineligible; or (d) Indolent lymphoma: Following at least 1 prior chemoimmunotherapy regimen that included an anti-CD20 monoclonal antibody and for which no other more appropriate treatment option exists
  • (Combination Therapy - Part E and Part F) -- Histologically or cytologically confirmed advanced or metastatic solid malignancy for which pembrolizumab treatment is approved. In Part F, other advanced solid tumor indications may be eligible as identified by the Sponsor.
  • Representative baseline tumor tissue sample is available
  • Measurable disease
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate baseline hematologic, renal, and hepatic function
  • Recovery to Grade 1 of any clinically significant toxicity attributed to prior anticancer therapy prior to initiation of study drug administration

Exclusion Criteria:

  • Prior chemotherapy, small molecule inhibitors, and/or other investigational anticancer agents (excluding investigational monoclonal antibodies) within 4 weeks
  • Prior radiotherapy: therapeutic radiotherapy within 4 weeks, or palliative radiotherapy (to non-CNS disease) within 1 week
  • Prior immune-checkpoint inhibitors within 4 weeks (or 8 weeks, if immuno-oncology doublet used as the prior line of therapy)
  • Prior monoclonal antibodies, antibody-drug conjugates, or radioimmunoconjugates within 4 weeks (or 2 weeks if patient experienced disease progression on the prior treatment)
  • Prior T-cell or other cell-based therapies within 12 weeks (or 2 weeks if patient experienced disease progression on the prior treatment)
  • Recent or ongoing serious infections within 2 weeks
  • Known positivity for hepatitis B infection
  • Known active hepatitis C infection
  • Active autoimmune or auto-inflammatory ocular disease within 6 months
  • Known or suspected active organ-threatening autoimmune disease
  • Active central nervous system tumor or metastases
  • Patients with lymphomas: prior allogeneic SCT
  • Patients in Part E or Part F: history of severe immune-mediated adverse reactions or severe hypersensitivity to pembrolizumab

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): NCT02376699


Contacts
Contact: Seattle Genetics Trial Information Support 866-333-7436 clinicaltrials@seagen.com

Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: HOPE Line Patient Referral    205-996-4673    phase1referral@uab.edu   
Principal Investigator: Amitkumar Mehta, MD         
United States, California
Cedars Sinai Medical Center / Samuel Oschin Comprehensive Cancer Institute Recruiting
Los Angeles, California, United States, 90048
Contact: Rosalinda Massie    310-967-4322    Rosalinda.Massie@cshs.org   
Principal Investigator: Monica Mita, MD         
Angeles Clinic and Research Institute, The Recruiting
Santa Monica, California, United States, 90404
Contact: Saba Mukarram    310-231-2181    smukarram@theangelesclinic.org   
Principal Investigator: Monica Mita, MD         
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Patty Nelson    312-942-8004    Patricia_Nelson@rush.edu   
Principal Investigator: Timothy Kuzel, MD         
University of Chicago Recruiting
Chicago, Illinois, United States, 60637-1470
Contact: Erika Pemberton    773-702-1982    epemberton@medicine.bsd.uchicago.edu   
Principal Investigator: Thomas Gajewski, MD, PhD         
United States, Michigan
University of Michigan Comprehensive Cancer Center Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: University of Michigan Cancer Answer Line    800-865-1125      
Principal Investigator: David Smith, MD         
Karmanos Cancer Institute / Wayne State University Recruiting
Detroit, Michigan, United States, 48201
Contact: Christopher Salas    313-576-9816    salasc@karmanos.org   
Principal Investigator: Elisabeth Heath         
United States, Minnesota
Mayo Clinic Minnesota Recruiting
Rochester, Minnesota, United States, 55905
Contact: Janet Lensing    507-284-3137    lensing.janet@mayo.edu   
Principal Investigator: Svetomir Markovic, MD         
United States, Nevada
Comprehensive Cancer Centers of Nevada Recruiting
Las Vegas, Nevada, United States, 89169
Contact: Christine Zades    702-862-1104    christine.zades@usoncology.com   
Principal Investigator: Fadi Braiteh         
United States, New Mexico
University of New Mexico Cancer Center Recruiting
Albuquerque, New Mexico, United States, 87106
Contact: Mollie Geske    505-925-0377    mgeske@nmcca.org   
Principal Investigator: Olivier Rixe         
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Contact: Mohammad Ghalib    718-405-8515    mhghalib@montefiore.org   
Principal Investigator: Sanjay Goel, MD         
United States, North Carolina
UNC Lineberger Comprehensive Cancer Center / University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Jennifer Garbarino    984-974-8662    jennifer_garbarino@med.unc.edu   
Principal Investigator: Juneko Grilley-Olson, MD         
United States, Ohio
Case Western Reserve University / University Hospitals Cleveland Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Cancer Information Services    800-641-2422      
Principal Investigator: David Bajor         
United States, Oregon
Providence Portland Medical Center Recruiting
Portland, Oregon, United States, 97213
Contact: Kim Sutcliffe    503-215-5763    kimberly.sutcliffe@providence.org   
Principal Investigator: Brendan Curti, MD         
United States, Texas
MD Anderson Cancer Center / University of Texas Recruiting
Houston, Texas, United States, 77030-4095
Contact: Deborah Davis    713-792-3850    DLDavis@mdanderson.org   
Principal Investigator: Hun Ju Lee, MD         
United States, Utah
Utah Cancer Specialists Recruiting
Salt Lake City, Utah, United States, 84106
Contact: KaDee Henrie    801-269-0231    khenrie@utahcancer.com   
Principal Investigator: Justin Call, MD         
United States, Washington
Seattle Cancer Care Alliance / University of Washington Recruiting
Seattle, Washington, United States, 98109-1023
Contact: SCCA Phase 1 Program    206-288-7551    Phase1@u.washington.edu   
Principal Investigator: Andrew Coveler, MD         
Sponsors and Collaborators
Seattle Genetics, Inc.
Merck Sharp & Dohme Corp.
Investigators
Study Director: Phoenix Ho, MD Seattle Genetics, Inc.
Study Director: Michael Schmitt, MD, PhD Seattle Genetics, Inc.

Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT02376699     History of Changes
Other Study ID Numbers: SGNS40-001
PN 863 ( Other Identifier: Merck Sharp & Dohme Corp )
First Posted: March 3, 2015    Key Record Dates
Last Update Posted: November 2, 2018
Last Verified: October 31, 2018

Keywords provided by Seattle Genetics, Inc.:
CD40 Antigen
Drug Therapy
Follicular Lymphoma
Hodgkin Disease
Immunotherapy
Indolent Lymphoma
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Non-Hodgkin
Monoclonal Antibody
Neoplasms
Neoplasm Metastasis
Solid tumor

Additional relevant MeSH terms:
Lymphoma
Carcinoma
Lung Neoplasms
Neoplasms
Carcinoma, Non-Small-Cell Lung
Carcinoma, Squamous Cell
Neoplasm Metastasis
Head and Neck Neoplasms
Hodgkin Disease
Lymphoma, Non-Hodgkin
Neoplasms, Squamous Cell
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Follicular
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms, Glandular and Epithelial
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neoplastic Processes
Pathologic Processes
Pembrolizumab