- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01982487
Vaccine Therapy and IDO1 Inhibitor INCB024360 in Treating Patients With Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Who Are in Remission
A Phase I/IIb Study of Recombinant ALVAC(2)-NY-ESO-1 (M)/TRICOM 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
Conditions
- Stage IV Ovarian Epithelial Cancer
- Recurrent Ovarian Epithelial Cancer
- Recurrent Primary Peritoneal Cavity Cancer
- Stage IV Primary Peritoneal Cavity Cancer
- Recurrent Fallopian Tube Cancer
- Stage IIA Fallopian Tube Cancer
- Stage IIB Fallopian Tube Cancer
- Stage IIC Fallopian Tube Cancer
- Stage IIIA Fallopian Tube Cancer
- Stage IIIB Fallopian Tube Cancer
- Stage IIIC Fallopian Tube Cancer
- Stage IV Fallopian Tube Cancer
- Stage IIIA Ovarian Epithelial Cancer
- Stage IIIB Ovarian Epithelial Cancer
- Stage IIIC Ovarian Epithelial Cancer
- Stage IIA Ovarian Epithelial Cancer
- Stage IIB Ovarian Epithelial Cancer
- Stage IIC Ovarian Epithelial Cancer
- Stage IIIA Primary Peritoneal Cavity Cancer
- Stage IIIB Primary Peritoneal Cavity Cancer
- Stage IIIC Primary Peritoneal Cavity Cancer
- Stage IIA Primary Peritoneal Cavity Cancer
- Stage IIB Primary Peritoneal Cavity Cancer
- Stage IIC Primary Peritoneal Cavity Cancer
- Stage IA Fallopian Tube Cancer
- Stage IB Fallopian Tube Cancer
- Stage IC Fallopian Tube Cancer
- Stage IA Ovarian Epithelial Cancer
- Stage IB Ovarian Epithelial Cancer
- Stage IC Ovarian Epithelial Cancer
- Stage IA Primary Peritoneal Cavity Cancer
- Stage IB Primary Peritoneal Cavity Cancer
- Stage IC Primary Peritoneal Cavity Cancer
Detailed Description
PRIMARY OBJECTIVES:
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.
Study Type
Phase
- Phase 2
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
- 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:
- 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)
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 |
---|---|
No Intervention: Arm A (no treatment)
Patients receive no treatment.
|
|
Experimental: Arm B (IDO1 inhibitor INCB024360)
Patients receive IDO1 inhibitor INCB024360 PO BID on days 1-28.
|
Correlative studies
Correlative studies
Other Names:
Given PO
Other Names:
|
Experimental: 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.
|
Correlative studies
Correlative studies
Other Names:
Given SC
Other Names:
Given PO
Other Names:
|
Experimental: Arm D (vaccine)
Patients receive ALVAC(2)-NY-ESO-1 (M)/TRICOM vaccine SC on day 1.
|
Correlative studies
Correlative studies
Other Names:
Given SC
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
Time Frame: 28 days
|
28 days
|
|
PFS (Phase IIb)
Time Frame: Up to 15 years
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immunological response
Time Frame: Up to 12 months
|
Immunological parameters (antibody titres, NY-ESO-1 specific CD8+ and CD4+ frequency and function, frequency of memory T cell populations, TCR avidity, secondary recall response) will be analyzed in a straightforward analysis-of-covariance (ANCOVA) fashion modeling post-treatment levels as a function of pre-treatment levels with factors corresponding to IDO1 inhibitor INCB024360 (yes/no) and ALVAC(2)-NY-ESO-1 (M)/TRICOM vaccine (yes/no).
|
Up to 12 months
|
Toxicity rate, graded according to NCI CTCAE version 4.0
Time Frame: Up to 12 months
|
The toxicity rate will be estimated using a one-sided, 95%, exact binomial confidence interval (Clopper-Pearson).
The lower one sided limit will be used.
|
Up to 12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kunle Odunsi, Roswell Park Cancer Institute
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Peritoneal Diseases
- Genital Neoplasms, Female
- Endocrine System Diseases
- Disease Attributes
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Fallopian Tube Diseases
- Abdominal Neoplasms
- Ovarian Neoplasms
- Recurrence
- Fallopian Tube Neoplasms
- Peritoneal Neoplasms
- Carcinoma, Ovarian Epithelial
Other Study ID Numbers
- I 243013 (Other Identifier: Roswell Park Cancer Institute)
- P30CA016056 (U.S. NIH Grant/Contract)
- NCI-2013-02080 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- 080913
- SRC1 082013
- IRB 100313
- SRC2 082713
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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