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Safety Study of SEA-CD40 in Cancer Patients

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ClinicalTrials.gov Identifier: NCT02376699
Recruitment Status : Active, not recruiting
First Posted : March 3, 2015
Last Update Posted : December 24, 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 95 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


Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
Cedars Sinai Medical Center / Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California, United States, 90048
Angeles Clinic and Research Institute, The
Santa Monica, California, United States, 90404
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
University of Chicago
Chicago, Illinois, United States, 60637-1470
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
Karmanos Cancer Institute / Wayne State University
Detroit, Michigan, United States, 48201
United States, Minnesota
Mayo Clinic Minnesota
Rochester, Minnesota, United States, 55905
United States, Nevada
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89169
United States, New Mexico
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87106
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
United States, North Carolina
UNC Lineberger Comprehensive Cancer Center / University of North Carolina
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Case Western Reserve University / University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
United States, Oregon
Providence Portland Medical Center
Portland, Oregon, United States, 97213
United States, Texas
MD Anderson Cancer Center / University of Texas
Houston, Texas, United States, 77030-4095
United States, Utah
Utah Cancer Specialists
Salt Lake City, Utah, United States, 84106
United States, Washington
Seattle Cancer Care Alliance / University of Washington
Seattle, Washington, United States, 98109-1023
Sponsors and Collaborators
Seattle Genetics, Inc.
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Phoenix Ho, MD Seattle Genetics, Inc.
Study Director: Michael Schmitt, MD, PhD Seattle Genetics, Inc.

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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: December 24, 2018
Last Verified: December 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:
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Lymphoma
Carcinoma
Lung Neoplasms
Neoplasms
Carcinoma, Non-Small-Cell Lung
Carcinoma, Squamous Cell
Neoplasm Metastasis
Squamous Cell Carcinoma of Head and Neck
Hodgkin Disease
Lymphoma, Non-Hodgkin
Neoplasms, Squamous Cell
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Follicular
Head and Neck Neoplasms
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