A Study of CDX-1401 in Patients With Malignancies Known to Express NY-ESO-1
A Phase I/II, Open-Label, Dose-Escalation Study of CDX-1401 in Patients With Malignancies Known to Express NY-ESO-1
1 other identifier
interventional
70
1 country
7
Brief Summary
The main purpose of this study is to examine the safety and tolerability of CDX-1401 when given in combination with an immune stimulant (resiquimod) to patients with advanced cancers that are known to express the NY-ESO-1 protein.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2009
Longer than P75 for phase_1
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 28, 2009
CompletedFirst Posted
Study publicly available on registry
July 30, 2009
CompletedStudy Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedJune 27, 2016
June 1, 2016
2.8 years
July 28, 2009
June 22, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Occurrence of adverse events (side effects)
12 weeks (1 cycle of study treatment)
Secondary Outcomes (1)
Objective response rate (CR/PR), disease control rate (CR/PR/SD) and time to progression, based on disease-appropriate response criteria.
12 week intervals
Interventions
CDX-1401 is administered as an injection into the skin every 2 weeks for 4 doses. It is given in combination with Resiquimod and/or poly-ICLC. Resiquimod is administered as a topical gel applied to the skin or given as an injection under the skin, and poly-ICLC is given as an injection under the skin. Depending on the treatment group assignment, either one or both of the immune stimulants will be given on the day of and the day after CDX-1401 administrations. This treatment may be repeated every 12 weeks.
Eligibility Criteria
You may qualify if:
- Among other criteria, patients must meet all of the following conditions to be eligible to be in the study:
- years of age or older.
- Have a cancer type that is known to express NY-ESO-1, including (but not limited to) cancer of the bladder, breast, ovary, non-small cell lung cancer, myeloma, sarcoma or melanoma.
- Have cancer that has progressed after any therapies with curative potential or approved salvage therapies (if such therapies exist).
- Have evaluable or measurable tumors.
- Have adequate blood, bone marrow, liver and kidney function as determined by laboratory tests.
- Have a sample of tumor tissue available for NY-ESO-1 testing at a central laboratory.
- If of childbearing potential (male or female), agree to practice an effective form of contraception during study treatment.
You may not qualify if:
- Among other criteria, patients who meet any of the following conditions are NOT eligible to be in the study:
- Are receiving treatment with immunosuppressive or immunomodulatory agents, including any systemic steroid (inhaled or topically applied steroids are permitted).
- Has a known infection with HIV, HBV or HCV, or any other active infection requiring systemic antibiotic treatment.
- Has active central nervous system tumors.
- Any underlying medical condition that in the Principal Investigator's opinion will make the administration of study drug hazardous or otherwise interfere with the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Yale Comprehensive Cancer Center
New Haven, Connecticut, 06519-1717, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, 33140, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10017, United States
Weill Cornell Cancer Center
New York, New York, 10065, United States
Carolina BioOncology Institute, PLLC
Huntersville, North Carolina, 28078, United States
Providence Portland Cancer Center
Portland, Oregon, 97213, United States
Related Publications (1)
Dhodapkar MV, Sznol M, Zhao B, Wang D, Carvajal RD, Keohan ML, Chuang E, Sanborn RE, Lutzky J, Powderly J, Kluger H, Tejwani S, Green J, Ramakrishna V, Crocker A, Vitale L, Yellin M, Davis T, Keler T. Induction of antigen-specific immunity with a vaccine targeting NY-ESO-1 to the dendritic cell receptor DEC-205. Sci Transl Med. 2014 Apr 16;6(232):232ra51. doi: 10.1126/scitranslmed.3008068.
PMID: 24739759RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2009
First Posted
July 30, 2009
Study Start
September 1, 2009
Primary Completion
June 1, 2012
Study Completion
February 1, 2014
Last Updated
June 27, 2016
Record last verified: 2016-06