Vaccine Therapy and IDO1 Inhibitor INCB024360 in Treating Patients With Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Who Are in Remission
NCT ID: NCT01982487
Last Updated: 2013-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
PHASE1/PHASE2
INTERVENTIONAL
2013-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
I. To determine the safety of fixed doses of the modified canarypox vector (ALVAC\[2\])-cancer/testis antigen 1B (NY-ESO-1) (M)/triad of costimulatory molecules (TRICOM) 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) using standard imaging response (Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1) criteria. (Phase IIb)
SECONDARY OBJECTIVES:
I. To determine the effectiveness of INCB024360 on enhancing vaccine efficacy by assessing NY-ESO-1 specific cellular and humoral immunity in peripheral blood NY-ESO-1 specific CD8+ and CD4+ T cells.
II. To determine the effectiveness of INCB024360 on enhancing vaccine efficacy by assessing NY-ESO-1 specific cellular and humoral immunity in peripheral blood NY-ESO-1 specific antibodies.
III. To determine the effectiveness of INCB024360 on enhancing vaccine efficacy by assessing NY-ESO-1 specific cellular and humoral immunity in peripheral blood frequency of CD4+CD25+FOXP3+ regulatory T cells.
IV. To determine the effectiveness of INCB024360 on enhancing vaccine efficacy by assessing NY-ESO-1 specific cellular and humoral immunity in pharmacokinetics (PK) of IDO in relation to T cell frequency and function in correlation with PFS.
OUTLINE: This is a Phase I study followed by a randomized Phase IIb study.
PHASE I: Patients receive ALVAC(2)-NY-ESO-1 (M)/TRICOM vaccine subcutaneously (SC) on day 1 and IDO1 inhibitor INCB024360 orally (PO) twice daily (BID) on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
PHASE IIb: Patients are randomized to 1 of 4 arms.
ARM A: Patients receive no treatment.
ARM B: Patients receive IDO1 inhibitor INCB024360 PO BID on days 1-28.
ARM C: Patients receive ALVAC(2)-NY-ESO-1 (M)/TRICOM vaccine SC on day 1 and IDO1 inhibitor INCB024360 PO BID on days 1-28.
ARM D: Patients receive ALVAC(2)-NY-ESO-1 (M)/TRICOM vaccine SC on day 1.
In all arms, treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 6 weeks; at 3, 6, and 12 months; and then annually for up to 15 years.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm A (no treatment)
Patients receive no treatment.
No interventions assigned to this group
Arm B (IDO1 inhibitor INCB024360)
Patients receive IDO1 inhibitor INCB024360 PO BID on days 1-28.
IDO1 inhibitor INCB024360
Given PO
laboratory biomarker analysis
Correlative studies
pharmacological study
Correlative studies
Arm C (vaccine, IDO1 inhibitor INCB024360)
Patients receive ALVAC(2)-NY-ESO-1 (M)/TRICOM vaccine SC on day 1 and IDO1 inhibitor INCB024360 PO BID on days 1-28.
ALVAC(2)-NY-ESO-1 (M)/TRICOM vaccine
Given SC
IDO1 inhibitor INCB024360
Given PO
laboratory biomarker analysis
Correlative studies
pharmacological study
Correlative studies
Arm D (vaccine)
Patients receive ALVAC(2)-NY-ESO-1 (M)/TRICOM vaccine SC on day 1.
ALVAC(2)-NY-ESO-1 (M)/TRICOM vaccine
Given SC
laboratory biomarker analysis
Correlative studies
pharmacological study
Correlative studies
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ALVAC(2)-NY-ESO-1 (M)/TRICOM vaccine
Given SC
IDO1 inhibitor INCB024360
Given PO
laboratory biomarker analysis
Correlative studies
pharmacological study
Correlative studies
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Any human leukocyte antigen (HLA) type; historic HLA typing is permitted
* Tumor expression of NY-ESO-1 or cancer/testis antigen 2 (LAGE-1) by immunohistochemistry (IHC) and/or reverse transcription-polymerase chain reaction (RTPCR)
* No allergy to eggs
* Life expectancy \> 6 months
* Hematology and biochemistry laboratory results within the limits normally expected for the patient population, without evidence of major organ failure
* Absolute neutrophil count (ANC) \>= 1,000/uL
* Platelet count (PLT) \>= 75,000/uL
* Hemoglobin (Hgb) \>= 8g/dL
* Total bilirubin =\< 1.5 x upper limit of normal (ULN)
* Serum aspartate aminotransferase (serum glutamic oxalacetic transaminase \[SGOT\]/aspartate aminotransferase \[AST\]) or serum alanine aminotransferase (serum glutamate pyruvate transaminase \[SGPT\]/alanine aminotransferase \[ALT\]) =\< 3 x ULN
* Serum creatinine =\< 2 x ULN
* Prothrombin time (PT)/international normalized ratio (INR) =\< 1.5
* 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) prior to randomization and recovered from toxicities to less than grade 2
Exclusion Criteria
* Other serious illnesses (e.g., serious infections requiring antibiotics, bleeding disorders)
* History of autoimmune disease (e.g. thyroiditis, lupus) except vitiligo
* Concomitant systemic treatment with 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
* Clinically significant heart disease (New York Heart Association \[NYHA\] class III or class IV) within 6 months
* 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 judgement, increase the patient's risk by participating in this study)
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Roswell Park Cancer Institute
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kunle Odunsi
Role: PRINCIPAL_INVESTIGATOR
Roswell Park Cancer Institute
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2013-02080
Identifier Type: REGISTRY
Identifier Source: secondary_id
080913
Identifier Type: -
Identifier Source: secondary_id
SRC1 082013
Identifier Type: -
Identifier Source: secondary_id
IRB 100313
Identifier Type: -
Identifier Source: secondary_id
SRC2 082713
Identifier Type: -
Identifier Source: secondary_id
I 243013
Identifier Type: OTHER
Identifier Source: secondary_id
I 243013
Identifier Type: -
Identifier Source: org_study_id