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

NCT02166905 | Completed Phase 1 Results DMC

• 3 other identifiers: I 248613NCI-2014-00771P30CA016056
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This partially randomized phase I/IIb trial studies the side effects and best dose of IDO1 inhibitor INCB024360 in combination with DEC-205/NY-ESO-1 fusion protein CDX-1401 and poly ICLC and to see how well they work in treating patients with ovarian, fallopian tube, or primary peritoneal cancer who no longer have evidence of disease. Antigens (such as cancer/testis antigen \[NY-ESO-1\] protein) are found on many cancer cells. Vaccines made from NY-ESO-1 protein may cause the immune system to produce immune cells and antibodies that may help locate the NY-ESO-1 and/or cancer/testis antigen 2 (LAGE-1) antigens on cancer cells. By finding them, the immune system may then work to control or eliminate the remaining cancer cells. INCB024360 is an inhibitor of an enzyme called indoleamine 2,3 dioxygenase (IDO). This enzyme is produced by tumor cells to disable immune cells, and limit the efficacy of immune attack. Giving DEC-205/NY-ESO-1 fusion protein CDX-1401 with poly ICLC and IDO1 inhibitor INCB024360 may generate stronger and more long lasting anti-cancer immune responses in patients with ovarian, fallopian tube, and primary peritoneal cancer in remission.

Conditions

Fallopian Tube Carcinoma; Ovarian Carcinoma; Primary Peritoneal Carcinoma

Outcome Measures

Primary Outcomes (3)

• To Determine the Safety and Evaluate Toxicity of Fixed Doses for Phase I Patients

  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

  28 days

• Progression Free Survival (PFS) Based on Immune Related Response Criteria (irRC) for Phase II Patients

  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.

  Up to 6 months

• To Evaluate Toxicity as Defined by NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.

  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).

  Up to 12 months

Secondary Outcomes (4)

• Antibody Titers

  Up to 12 months

• Frequency of Memory T Cell Populations

  Up to 12 months

• NY-ESO-1 Specific CD8+ and CD4+ Frequency and Function

  Up to 12 months

• T Cell Receptor (TCR) Avidity

  Up to 12 months

Study Arms (2)

Arm I (CDX-1401, poly ICLC)

EXPERIMENTAL

Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401 and poly ICLC as in Phase I.

Biological: DEC-205/NY-ESO-1 Fusion Protein CDX-1401; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study; Drug: Poly ICLC

Arm II (CDX-1401, poly ICLC, IDO1 inhibitor INCB024360)

EXPERIMENTAL

Patients receive DEC-205/NY-ESO-1 fusion protein CDX-1401, poly ICLC, and IDO1 inhibitor INCB024360 as in Phase I.

Biological: DEC-205/NY-ESO-1 Fusion Protein CDX-1401; Drug: Epacadostat; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study; Drug: Poly ICLC

Interventions

DEC-205/NY-ESO-1 Fusion Protein CDX-1401 BIOLOGICAL

Given via intracutaneous injection

Also known as: CDX-1401

Arm I (CDX-1401, poly ICLC); Arm II (CDX-1401, poly ICLC, IDO1 inhibitor INCB024360)

Epacadostat DRUG

Given PO

Also known as: INCB 024360, INCB024360

Arm II (CDX-1401, poly ICLC, IDO1 inhibitor INCB024360)

Laboratory Biomarker Analysis OTHER

Correlative studies

Arm I (CDX-1401, poly ICLC); Arm II (CDX-1401, poly ICLC, IDO1 inhibitor INCB024360)

Pharmacological Study OTHER

Correlative studies

Arm I (CDX-1401, poly ICLC); Arm II (CDX-1401, poly ICLC, IDO1 inhibitor INCB024360)

Poly ICLC DRUG

Given SC

Also known as: Hiltonol, Poly I:Poly C with Poly-L-Lysine Stabilizer, poly-ICLC, PolyI:PolyC with Poly-L-Lysine Stabilizer, Polyinosinic-Polycytidylic Acid Stabilized with Polylysine and Carboxymethylcellulose, Polyriboinosinic-Polyribocytidylic Acid-Polylysine Carboxymethylcellulose, Stabilized Polyriboinosinic/Polyribocytidylic Acid

Arm I (CDX-1401, poly ICLC); Arm II (CDX-1401, poly ICLC, IDO1 inhibitor INCB024360)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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 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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• National Cancer Institute (NCI): collaborator
• Celldex Therapeutics: collaborator
• Incyte Corporation: collaborator

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Ovarian Neoplasms

Interventions

epacadostat; poly ICLC

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders

Results Point of Contact

• Title: Katy Wang
• Organization: Roswell Park Comprehensive Cancer Center

chong.wang@roswellpark.org

716-845-2300

Study Officials

• Emese Zsiros, MD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: April 21, 2014
• First Posted: June 18, 2014
• Study Start: October 10, 2014
• Primary Completion: August 20, 2020
• Study Completion: August 20, 2020
• Last Updated: February 24, 2023
• Results First Posted: February 24, 2023

Record last verified: 2023-01

Locations

US (1)