NCT01982487

Brief Summary

This partially randomized phase I/IIb trial studies the side effects vaccine therapy and indoleamine 2,3-dioxygenase (IDO1) inhibitor 4-amino-1,2,5-oxadizaole-3-carboximidamide (INCB024360) and to see how well they work in treating patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in remission. Vaccines made from gene-modified virus may help the body build an effective immune response to kill tumor cells. IDO1 inhibitor INCB024360 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving vaccine therapy with IDO1 inhibitor INCB024360 may be an effective treatment for epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Status
withdrawn

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Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 13, 2013

Completed
18 days until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Last Updated

December 18, 2013

Status Verified

December 1, 2013

Enrollment Period

3.8 years

First QC Date

November 6, 2013

Last Update Submit

December 17, 2013

Conditions

Recurrent Fallopian Tube CancerRecurrent Ovarian Epithelial CancerRecurrent Primary Peritoneal Cavity CancerStage IA Fallopian Tube CancerStage IA Ovarian Epithelial CancerStage IA Primary Peritoneal Cavity CancerStage IB Fallopian Tube CancerStage IB Ovarian Epithelial CancerStage IB Primary Peritoneal Cavity CancerStage IC Fallopian Tube CancerStage IC Ovarian Epithelial CancerStage IC Primary Peritoneal Cavity CancerStage IIA Fallopian Tube CancerStage IIA Ovarian Epithelial CancerStage IIA Primary Peritoneal Cavity CancerStage IIB Fallopian Tube CancerStage IIB Ovarian Epithelial CancerStage IIB Primary Peritoneal Cavity CancerStage IIC Fallopian Tube CancerStage IIC Ovarian Epithelial CancerStage IIC Primary Peritoneal Cavity CancerStage IIIA Fallopian Tube CancerStage IIIA Ovarian Epithelial CancerStage IIIA Primary Peritoneal Cavity CancerStage IIIB Fallopian Tube CancerStage IIIB Ovarian Epithelial CancerStage IIIB Primary Peritoneal Cavity CancerStage IIIC Fallopian Tube CancerStage IIIC Ovarian Epithelial CancerStage IIIC Primary Peritoneal Cavity CancerStage IV Fallopian Tube CancerStage IV Ovarian Epithelial CancerStage IV Primary Peritoneal Cavity Cancer

Outcome Measures

Primary Outcomes (2)

  • Maximum tolerated dose of IDO1 inhibitor INCB024360, determined by incidence of dose limiting toxicities graded according to the NCI CTCAE version 4.0 (Phase I)

    28 days

  • PFS (Phase IIb)

    The primary analysis will be carried forth using a Cox proportional hazards model with factors corresponding to treatment combination, IDO1 inhibitor INCB024360 (yes/no) and ALVAC(2)-NY-ESO-1 (M)/TRICOM vaccine (yes/no), a continuous covariate adjustment for the length of the treatment free interval and a blocking factor.

    Up to 15 years

Secondary Outcomes (2)

  • Immunological response

    Up to 12 months

  • Toxicity rate, graded according to NCI CTCAE version 4.0

    Up to 12 months

Study Arms (4)

Arm A (no treatment)

NO INTERVENTION

Patients receive no treatment.

Arm B (IDO1 inhibitor INCB024360)

EXPERIMENTAL

Patients receive IDO1 inhibitor INCB024360 PO BID on days 1-28.

Drug: IDO1 inhibitor INCB024360Other: laboratory biomarker analysisOther: pharmacological study

Arm C (vaccine, IDO1 inhibitor INCB024360)

EXPERIMENTAL

Patients receive ALVAC(2)-NY-ESO-1 (M)/TRICOM vaccine SC on day 1 and IDO1 inhibitor INCB024360 PO BID on days 1-28.

Biological: ALVAC(2)-NY-ESO-1 (M)/TRICOM vaccineDrug: IDO1 inhibitor INCB024360Other: laboratory biomarker analysisOther: pharmacological study

Arm D (vaccine)

EXPERIMENTAL

Patients receive ALVAC(2)-NY-ESO-1 (M)/TRICOM vaccine SC on day 1.

Biological: ALVAC(2)-NY-ESO-1 (M)/TRICOM vaccineOther: laboratory biomarker analysisOther: pharmacological study

Interventions

ALVAC(2)-NY-ESO-1 (M)/TRICOM vaccineBIOLOGICAL

Given SC

Also known as: vCP2292
Arm C (vaccine, IDO1 inhibitor INCB024360)Arm D (vaccine)
IDO1 inhibitor INCB024360DRUG

Given PO

Also known as: INCB024360, indoleamine-2,3-dioxygenase inhibitor INCB024360
Arm B (IDO1 inhibitor INCB024360)Arm C (vaccine, IDO1 inhibitor INCB024360)
laboratory biomarker analysisOTHER

Correlative studies

Arm B (IDO1 inhibitor INCB024360)Arm C (vaccine, IDO1 inhibitor INCB024360)Arm D (vaccine)
pharmacological studyOTHER

Correlative studies

Also known as: pharmacological studies
Arm B (IDO1 inhibitor INCB024360)Arm C (vaccine, IDO1 inhibitor INCB024360)Arm D (vaccine)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma and no evidence of disease or no measurable disease after 1st or 2nd line therapy; 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 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
  • +4 more criteria

You may not qualify if:

  • 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 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Fallopian Tube NeoplasmsCarcinoma, Ovarian Epithelial

Interventions

epacadostat

Condition Hierarchy (Ancestors)

Genital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFallopian Tube DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeOvarian NeoplasmsEndocrine Gland NeoplasmsOvarian DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • Kunle Odunsi

    Roswell Park Cancer Institute

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2013

First Posted

November 13, 2013

Study Start

December 1, 2013

Primary Completion

September 1, 2017

Last Updated

December 18, 2013

Record last verified: 2013-12