Status:
COMPLETED
A Study of CDX-1140 (CD40) as Monotherapy or in Combination in Patients With Advanced Malignancies
Lead Sponsor:
Celldex Therapeutics
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Melanoma
Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a study to determine the maximum tolerated dose (MTD) for CDX-1140 (CD40 antibody), either alone or in combination with CDX-301 (FLT3L), pembrolizumab, or chemotherapy and to further evaluate ...
Detailed Description
This study will determine the MTD of CDX-1140 while also evaluating the safety, tolerability and efficacy of CDX-1140 alone (Part 1) or in combination with CDX-301 (Part 2), pembrolizumab (Part 3), or...
Eligibility Criteria
Inclusion
- Key
- Recurrent, locally advanced or metastatic melanoma (including mucosal and/or ocular), bladder/urothelial, non-small cell lung cancer, pancreatic adenocarcinoma, breast, colorectal, gastric, esophageal, renal cell, hepatic, ovarian fallopian or primary peritoneal carcinoma, head and neck, and cholangiocarcinoma. Additional tumor types (except primary CNS tumors) may be enrolled after discussion with, and approval from, the medical monitor.
- Must have received all standard of care therapies (approved or unapproved) as deemed appropriate by the treating physician. Patients who refuse standard therapy are excluded from the study.
- If of childbearing potential (male or female), agrees to practice an effective form of contraception during study treatment and for at least 3 months following last treatment
- Willingness to undergo a pre-treatment and on-treatment biopsy, if required.
- Additional Inclusion Criteria for Part 1:
- Advanced diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma, or indolent B-cell lymphoma are also eligible.
- Lymphoma patients must have received ≥ 1 prior systemic therapy
- Additional Inclusion Criteria for Part 3:
- Patients must have documented progression while receiving anti-PD-1 or anti-PD-L1 based regimens for FDA approved indications
- Patients cannot have received more than one anti-PD-1 or anti-PD-L1 based regimen
- Additional Inclusion Criteria for Part 4:
- 1\. Patients must have metastatic pancreatic adenocarcinoma, and have not received previous treatment in a metastatic setting
- Key
Exclusion
- History of severe hypersensitivity reactions to other monoclonal antibodies.
- Previous treatment with any anti-CD40 antibody or with FLT3L.
- Inadequate washout period from prior therapy as defined in the Protocol.
- Major surgery within 4 weeks prior to study treatment.
- Use of immunosuppressive medications within 4 weeks or systemic corticosteroids within 2 weeks prior to study treatment.
- Other prior malignancy, except for adequately treated basal or squamous cell skin cancer or in situ cancers. For all other cancers, the patient must be disease-free for at least 3 years to be allowed to enroll.
- Active, untreated central nervous system metastases.
- Active autoimmune disease or documented history of autoimmune disease.
- History of (non-infectious) pneumonitis or has current pneumonitis.
- Active infection requiring systemic therapy, known infection of HIV, Hepatitis B, or Hepatitis C.
- Additional Exclusion Criteria for lymphoma patients in Part 1:
- Prior allogenic stem cell transplantation
- Patients who have received autologous stem cell transplant ≤ 12 weeks prior to the first dose of study drug.
- There are additional criteria your study doctor will review with you to confirm your eligibility for the study.
Key Trial Info
Start Date :
December 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 13 2022
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT03329950
Start Date
December 1 2017
End Date
September 13 2022
Last Update
March 28 2024
Active Locations (11)
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1
HonorHealth Research Insititute
Scottsdale, Arizona, United States, 85258
2
Northside Hospital, Inc.
Atlanta, Georgia, United States, 30342
3
Georgia Cancer Center at Augusta University
Augusta, Georgia, United States, 30912
4
Oncology Hematology West, PC dba Nebraska Cancer Specialists
Omaha, Nebraska, United States, 68130