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Safety Study of SEA-CD40 in Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02376699
Recruitment Status : Recruiting
First Posted : March 3, 2015
Last Update Posted : October 19, 2020
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Seagen Inc.

Brief Summary:
This study is being done to find out if SEA-CD40 is safe and effective when given alone, in combination with pembrolizumab, and in combination with pembrolizumab, gemcitabine, and nab-paclitaxel. 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 Pancreatic Adenocarcinoma Drug: Intravenous (IV) SEA-CD40 Drug: Pembrolizumab Drug: Subcutaneous (SC) SEA-CD40 Drug: Gemcitabine Drug: Nab-paclitaxel Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 470 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 28, 2015
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : February 28, 2022


Arm Intervention/treatment
Experimental: IV Monotherapy in Solid Tumors
SEA-CD40 administered IV
Drug: Intravenous (IV) SEA-CD40
Given intravenously; schedule is cohort-specific.
Other Name: SEA-CD40

Experimental: IV Monotherapy in Lymphomas
SEA-CD40 administered IV
Drug: Intravenous (IV) SEA-CD40
Given intravenously; schedule is cohort-specific.
Other Name: SEA-CD40

Experimental: Combination Therapy in Solid Tumors
SEA-CD40 (administered IV) + pembrolizumab
Drug: Intravenous (IV) SEA-CD40
Given intravenously; schedule is cohort-specific.
Other Name: SEA-CD40

Drug: Pembrolizumab
Given intravenously; schedule is cohort-specific.
Other Name: Keytruda

Experimental: SC Monotherapy in Solid Tumors
SEA-CD40 administered SC
Drug: Subcutaneous (SC) SEA-CD40
Given subcutaneously on Day 1 every 3 weeks
Other Name: SEA-CD40

Experimental: SC Monotherapy in Lymphomas
SEA-CD40 administered SC
Drug: Subcutaneous (SC) SEA-CD40
Given subcutaneously on Day 1 every 3 weeks
Other Name: SEA-CD40

Experimental: Combination Therapy in Pancreatic Cancer
SEA-CD40 (administered IV) + pembrolizumab + gemcitabine + nab-paclitaxel
Drug: Intravenous (IV) SEA-CD40
Given intravenously; schedule is cohort-specific.
Other Name: SEA-CD40

Drug: Pembrolizumab
Given intravenously; schedule is cohort-specific.
Other Name: Keytruda

Drug: Gemcitabine
1000 mg/m^2 given intravenously on Day 1, 8, and 15 of each 28-day cycle
Other Name: Gemzar

Drug: Nab-paclitaxel
125 mg/m^2 given intravenously on Day 1, 8, and 15 of each 28-day cycle
Other Name: Abraxane




Primary Outcome Measures :
  1. Incidence of adverse events (Parts A-K) [ Time Frame: Through 6 weeks following last dose, up to an average of 6 months ]
  2. Incidence of laboratory abnormalities (Parts A-K) [ Time Frame: Through 6 weeks following last dose, up to an average of 6 months ]
  3. Objective response rate (ORR) per RECIST according to investigator assessment in the efficacy-evaluable population (Part L) [ Time Frame: Through 6 weeks following last dose, up to an average of 6 months ]

Secondary Outcome Measures :
  1. Incidence of adverse events (Part L) [ Time Frame: Through 6 weeks following last dose, up to an average of 6 months ]
  2. ORR per iRECIST (Part L) [ Time Frame: Through 6 weeks following last dose, up to an average of 6 months ]
  3. ORR (Parts A-K) [ Time Frame: Through 6 weeks following last dose, up to an average of 6 months ]
  4. Disease control rate (All Parts) [ Time Frame: Through 6 weeks following last dose, up to an average of 6 months ]
  5. Duration of response (All Parts) [ Time Frame: Up to approximately 6 years ]
  6. Progression-free survival (All Parts) [ Time Frame: Up to approximately 6 years ]
  7. Overall survival (All Parts) [ Time Frame: Up to approximately 6 years ]
  8. Cmax (maximum observed concentration) [ Time Frame: Through 6 weeks following last dose, up to an average of 6 months ]
  9. Tmax (time of maximum observed concentration) [ Time Frame: Through 6 weeks following last dose, up to an average of 6 months ]
  10. AUClast (AUC from time 0 to last quantifiable timepoint) [ Time Frame: Through 6 weeks following last dose, up to an average of 6 months ]
  11. AUCinf (AUC from time 0 to infinity) [ Time Frame: Through 6 weeks following last dose, up to an average of 6 months ]
  12. Apparent total clearance [ Time Frame: Through 6 weeks following last dose, up to an average of 6 months ]
  13. T1/2 (apparent terminal elimination half-life) [ Time Frame: Through 6 weeks following last dose, up to an average of 6 months ]
  14. Incidence of antitherapeutic antibodies against SEA-CD40 [ Time Frame: Through 6 weeks following last dose, up to an average of 6 months ]
  15. Blood concentrations of SEA-CD40 [ Time Frame: Through 6 weeks following last dose, up to an average of 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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.
  • (Pancreatic Cancer Cohort - Part L) - Histologically or cytologically confirmed metastatic exocrine ductal adenocarcinoma of the pancreas not amenable to curative therapy. Patients must not have received any prior systemic therapy for metastatic disease; patients who have received prior therapy for non-metastatic pancreatic adenocarcinoma are eligible if therapy was fully completed more than 4 months before start of study treatment.
  • Representative baseline tumor tissue sample is available (Parts A-K)
  • 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:

  • Parts A-K

    1. Prior chemotherapy, small molecule inhibitors, and/or other investigational anticancer agents (excluding investigational monoclonal antibodies) within 4 weeks
    2. Prior radiotherapy: therapeutic radiotherapy within 4 weeks, or palliative radiotherapy (to non-CNS disease) within 1 week
    3. Prior immune-checkpoint inhibitors within 4 weeks (or 8 weeks, if immuno-oncology doublet used as the prior line of therapy)
    4. Prior monoclonal antibodies, antibody-drug conjugates, or radioimmunoconjugates within 4 weeks (or 2 weeks if patient experienced disease progression on the prior treatment)
    5. Prior T-cell or other cell-based therapies within 12 weeks (or 2 weeks if patient experienced disease progression on the prior treatment)
  • Part L

    1. History of radiation pneumonitis
    2. Neuropathy Grade 2 or higher
    3. Has received prior therapy with an anti-PD-1, anti-PDL1, or anti-PD-L2 agent, with an agent directed to another stimulatory or co-inhibitory T-cell receptor
    4. Has had allogenic tissue/solid organ transplant
  • All Parts

    1. Recent or ongoing serious infections within 2 weeks
    2. Known positivity for hepatitis B infection
    3. Known active hepatitis C infection
    4. Active autoimmune or auto-inflammatory ocular disease within 6 months
    5. Known or suspected active organ-threatening autoimmune disease
    6. Active central nervous system tumor or metastases
  • Patients with lymphomas: prior allogeneic SCT
  • Patients in Part E, F, or L: 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
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Contact: Seattle Genetics Trial Information Support 866-333-7436 clinicaltrials@seagen.com

Locations
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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35249
Contact: HOPE Line Patient Referral    205-996-4673    phase1referral@uab.edu   
Principal Investigator: Olumide Gbolahan, MD         
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Christiana Ansong    312-563-4101    Christiana_Ansong@rush.edu   
Principal Investigator: Ashiq Masood, MD         
University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637-1470
Contact: Belen Martinez-Caro Aguado    773-834-2895    bmartinezcaroa@medicine.bsd.uchicago.edu   
Principal Investigator: Hedy Kindler, 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: Mark Zalupski, MD         
Karmanos Cancer Institute / Wayne State University Recruiting
Detroit, Michigan, United States, 48201
Contact: Victoria LaBush    313-576-8711    labushv@karmanos.org   
Principal Investigator: Elisabeth Heath         
United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Chelsea McCabe    551-996-4725    Chelsea.McCabe@hackensackmeridian.org   
Principal Investigator: Martin Gutierrez         
United States, New Mexico
University of New Mexico Cancer Center Recruiting
Albuquerque, New Mexico, United States, 87106
Contact: Mollie Dedig       MDedig@nmcca.org   
Principal Investigator: Emrullah Yilmaz         
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 Inbox    800-641-2422      
Principal Investigator: David Bajor         
United States, Oregon
Providence Portland Medical Center Recruiting
Portland, Oregon, United States, 97213
Contact: Andrea Burt    503-215-5696    Andrea.Burt@providence.org   
Contact: Mary McCormick    503-215-5696    Mary.McCormick@Providence.org   
Principal Investigator: Gina Vaccaro, MD         
United States, Texas
MD Anderson Cancer Center / University of Texas Recruiting
Houston, Texas, United States, 77030-4095
Contact: Rabia Khan    713-745-4667    RKhan@mdanderson.org   
Principal Investigator: Sarina Piha-Paul, 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
Seagen Inc.
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Michael Schmitt, MD, PhD Seagen Inc.
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Responsible Party: Seagen Inc.
ClinicalTrials.gov Identifier: NCT02376699    
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: October 19, 2020
Last Verified: October 2020
Keywords provided by Seagen 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
Hematologic Neoplasms
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