- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02166905
DEC-205/NY-ESO-1 Fusion Protein CDX-1401, Poly ICLC, and IDO1 Inhibitor INCB024360 in Treating Patients With Ovarian, Fallopian Tube, or Primary Peritoneal Cancer in Remission
A Phase I/IIb Study of DEC205mAb-NY-ESO-1 Fusion Protein (CDX-1401) Given With Adjuvant Poly-ICLC in Combination With INCB024360 for Patients in Remission With Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma Whose Tumors Express NY-ESO-1 or LAGE-1 Antigen
Study Overview
Status
Detailed Description
PRIMARY OBJECTIVES:
I. To determine the safety of fixed doses of DEC205mAb-NY-ESO-1 fusion protein (DEC-205/NY-ESO-1 fusion protein CDX-1401) with adjuvant poly-ICLC given as a vaccine in combination with INCB024360 (IDO1 inhibitor INCB024360). (Phase I) II. To evaluate toxicity as defined by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. (Phase I) III. To determine the progression free survival (PFS) (primary endpoint) using standard immune-related response criteria (irRC) criteria. (Phase IIb)
SECONDARY OBJECTIVES:
I. To determine the effectiveness of INCB024360 on enhancing vaccine efficacy by assessing cancer-testis antigen (NY-ESO-1) specific cellular and humoral immunity.
II. To determine the effectiveness of Sirolimus on enhancing vaccine efficacy by assessing NY-ESO-1 specific cellular and humoral immunity (Exploratory Cohort ONLY) III. Peripheral blood NY-ESO-1 specific cluster of differentiation (CD)8+ and CD4+ T cells. (Exploratory Cohort ONLY) IV. Peripheral blood NY-ESO-1 specific antibodies.(Exploratory Cohort ONLY) V. Peripheral blood frequency of CD4+CD25+forkhead box P3 (FOXP3)+ regulatory T cells. (Exploratory Cohort ONLY) VI. Pharmacokinetics of INCB02360 in relation to T cell frequency and function in correlation with PFS. (Exploratory Cohort ONLY)
OUTLINE:
PHASE I:
Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401 via intracutaneous injection on day 1, poly ICLC subcutaneously (SC) on days 1 and 2, and IDO1 inhibitor INCB024360 orally (PO) twice daily (BID) on days 1-28. Treatment repeats every 28 days for up to 5 courses in the absence of disease progression or unacceptable toxicity. Patients receive IDO1 inhibitor INCB024360 for up to 7 courses.
PHASE IIb: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401 and poly ICLC as in Phase I.
ARM II: Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401, poly ICLC, and IDO1 inhibitor INCB024360 as in Phase I.
After completion of study treatment, patients are followed up for 30 days and then at 3, 6, and 12 months.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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New York
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Buffalo, New York, United States, 14263
- Roswell Park Cancer Institute
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Eligible patients will be women with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma after chemotherapy with no evidence of disease or minimal residual disease for primary or recurrent disease; this may or may not be measurable; these patients would normally enter a period of observation after standard management
- Any human leukocyte antigen (HLA) type; (historic HLA typing is permitted)
- Tumor expression of NY-ESO-1 or LAGE-1 by immunohistochemistry (IHC) and/or reverse transcriptase polymerase chain reaction (RTPCR)
- Life expectancy > 6 months
- Absolute neutrophil count (ANC) >= 1,000/uL
- Platelets (PLT) >= 100,000/uL
- Hemoglobin (Hgb) >= 8 g/dL
- Total bilirubin =< 1.5 x upper limit of normal (ULN)
- Serum aspartate aminotransferase (serum glutamic oxaloacetic transaminase [SGOT]/AST) or serum alanine aminotransferase (serum glutamate pyruvate transaminase [SGPT]/ALT) =< 3 x ULN
- Serum creatinine =< 2 x ULN
- Have been informed of other treatment options
- Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
- The ability to swallow and retain oral medication
- Patients of child-bearing potential must agree to use acceptable contraceptive methods (e.g., double barrier) during treatment
- Patients may have received previous NY-ESO-1 vaccine therapy; patients who received maintenance paclitaxel or bevacizumab are eligible for enrollment provided they have discontinued therapy (at least 4 weeks for prior taxane or prior bevacizumab) prior to randomization and recovered from toxicities to less than grade 2
Exclusion Criteria:
- Metastatic disease to the central nervous system for which other therapeutic options, including radiotherapy, may be available
- Other serious illnesses (e.g., serious infections requiring antibiotics, bleeding disorders)
- History of severe autoimmune disorders requiring use of steroids or other immunosuppressives
- Concomitant systemic treatment with chronic use (based on the investigator's judgment) of corticosteroids, anti-histamine or non-steroidal anti-inflammatory drugs, and other platelet inhibitory agents
- Chemotherapy, radiation therapy, or immunotherapy within 4 weeks prior to first dosing of study drug (6 weeks for nitrosoureas); concomitant hormonal therapies for breast cancers are allowed
- Subjects being treated with a monoamine oxidase inhibitor (MAOI), or drug which has significant MAOI activity (e.g., Meperidine, linezolid, methylene blue) within 3 weeks prior to screening
- Subjects who are currently receiving therapy with a potent cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducer or inhibitor (e.g. clarithromycin, telithromycin, nefazodone, itraconazole, ketoconazole, atazanavir)
- Use of UDP glucuronosyltransferase 1 family, polypeptide A9 (UGT1A9) inhibitor including: diclofenac, imipramine, and ketoconazole
- Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dosing of study drug
- Known hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
- Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study
- Lack of availability of a patient for immunological and clinical follow-up assessment
- Evidence of current drug or alcohol abuse or psychiatric impairment, which in the Investigator's opinion will prevent completion of the protocol therapy or follow-up
- Pregnant or nursing female patients
- Unwilling or unable to follow protocol requirements
- Any condition which in the Investigator's opinion deems the patient an unsuitable candidate to receive study drug (i.e., any significant medical illness or abnormal laboratory finding that would, in the investigator's judgment, increase the patient's risk by participating in this study)
- Known hypersensitivity to any of the study drugs that will be given to the participant
- Additional exclusion criteria for exploratory cohort ONLY: Known pulmonary hypertension
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm I (CDX-1401, poly ICLC)
Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401 and poly ICLC as in Phase I.
|
Correlative studies
Correlative studies
Given via intracutaneous injection
Other Names:
Given SC
Other Names:
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Experimental: Arm II (CDX-1401, poly ICLC, IDO1 inhibitor INCB024360)
Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401, poly ICLC, and IDO1 inhibitor INCB024360 as in Phase I.
|
Correlative studies
Correlative studies
Given via intracutaneous injection
Other Names:
Given SC
Other Names:
Given PO
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To Determine the Safety and Evaluate Toxicity of Fixed Doses for Phase I Patients
Time Frame: 28 days
|
To determine the safety of fixed doses of DEC205mAb-NY-ESO-1 fusion protein with adjuvant poly-ICLC given as a vaccine in combination with INCB024360 300mg, number of Participants with Dose Limiting Toxicities is reported
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28 days
|
Progression Free Survival (PFS) Based on Immune Related Response Criteria (irRC) for Phase II Patients
Time Frame: Up to 6 months
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Percentage of Participants with Progression Free Survival Using irRC Criteria for Phase II Patients are reported.
irRC criteria disease progression is defined as at least 25% increase in tumor burden compared with nadir (at any single time point) in two consecutive observations at least 4 weeks apart.
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Up to 6 months
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To Evaluate Toxicity as Defined by NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
Time Frame: Up to 12 months
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All patients enrolled in this study will be eligible for the analysis of toxicity.
The toxicity rate will be estimated using a one-sided, 95%, exact binomial confidence interval (Clopper-Pearson).
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Up to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Antibody Titers
Time Frame: Up to 12 months
|
Due to the PI leaving the institute, these biomarker data were not generated and are therefore not available to be analyzed.
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Up to 12 months
|
Frequency of Memory T Cell Populations
Time Frame: Up to 12 months
|
Due to the PI leaving the institute, these biomarker data were not generated and are therefore not available to be analyzed.
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Up to 12 months
|
NY-ESO-1 Specific CD8+ and CD4+ Frequency and Function
Time Frame: Up to 12 months
|
Due to the PI leaving the institute, these biomarker data were not generated and are therefore not available to be analyzed.
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Up to 12 months
|
T Cell Receptor (TCR) Avidity
Time Frame: Up to 12 months
|
Due to the PI leaving the institute, these biomarker data were not generated and are therefore not available to be analyzed.
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Up to 12 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- I 248613 (Other Identifier: Roswell Park Cancer Institute)
- P30CA016056 (U.S. NIH Grant/Contract)
- NCI-2014-00771 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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