Epacadostat and Vaccine Therapy in Treating Patients With Stage III-IV Melanoma

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Brief Title

Epacadostat and Vaccine Therapy in Treating Patients With Stage III-IV Melanoma

Official Title

A Phase II Pilot Trial of an Indoleamine 2,3, Dioxygenase-1 (IDO1) Inhibitor (INCB024360) Plus a Multipeptide Melanoma Vaccine (MELITAC 12.1) in Patients With Advanced Melanoma

Brief Summary

      This pilot phase II trial studies how well epacadostat and vaccine therapy work in treating
      patients with stage III-IV melanoma. Epacadostat may stop the growth of tumor cells by
      blocking some of the enzymes needed for cell growth. Vaccines made from peptides and antigens
      may help the body build an effective immune response to kill tumor cells. Giving epacadostat
      with vaccine therapy may be an effective treatment for advanced melanoma.
    

Detailed Description

      PRIMARY OBJECTIVES:

      I. To determine the extent to which a regimen of INCB024360 (epacadostat) that normalizes
      serum kynurenine (Kyn)/ tryptophan (Trp) ratios alters the tumor microenvironment of
      melanoma, including determining the number and character of tumor-infiltrating lymphocytes as
      determined by examination of serial biopsies with immunohistochemistry (IHC) and gene
      signatures.

      II. To determine the extent to which continued INCB024360 treatment plus the addition of the
      multipeptide melanoma vaccine, MELITAC 12.1 (MELITAC 12.1 peptide vaccine), further alters
      the tumor microenvironment of melanoma, including determining the number and character of
      tumor-infiltrating lymphocytes as determined by serial biopsies evaluating IHC and gene
      signatures.

      SECONDARY OBJECTIVES:

      I. To determine whether a regimen of INCB024360 that normalizes serum Kyn/Trp ratios plus
      MELITAC 12.1 vaccine changes the level or character of the vaccine-induced clusters of
      differentiation (CD) 8+ and CD4+ T-cell immune responses as measured in peripheral blood, as
      compared to prior published experience.

      II. To evaluate the extent to which INCB024360 plus MELITAC 12.1 vaccine alters the number
      and character of peripheral blood mononuclear cell (PBMC) populations, including T and
      natural killer (NK) cells, as evaluated by multiparameter flow cytometry.

      III. To evaluate the extent to which INCB024360 plus MELITAC 12.1 vaccine alters the PBMC
      transcriptome.

      IV. To assess the safety and tolerability of INCB024360 plus MELITAC 12.1 vaccine.

      V. To obtain preliminary data on the tumor response rate of INCB024360 plus MELITAC 12.1
      vaccine by objective response rate (ORR), time to tumor progression, and overall survival.

      VI. To associate any observed changes with the expression of IDO1 protein by IHC in tumor or
      tumor-infiltrating cells.

      OUTLINE:

      Patients receive epacadostat orally (PO) twice daily (BID) on days 1-98 and receive MELITAC
      12.1 peptide vaccine intradermally (ID)/subcutaneously (SC) on days 21, 28, 35, 56, 77, and
      98. Treatment with epacadostat may repeat every 98 days for up to 3 additional courses in the
      absence of disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed up for 1 year.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Changes in the Concentration and Number of CD8+ Cells Infiltrating Tumor by IHC by Normalization of Kyn/Trp Ratios.

Secondary Outcome

 Change in PBMC Transcriptome_v2

Condition

Mucosal Melanoma

Intervention

Epacadostat

Study Arms / Comparison Groups

 Treatment (epacadostat, MELITAC 12.1)
Description:  Patients receive epacadostat PO BID on days 1-98 and receive MELITAC 12.1 peptide vaccine ID/SC on days 21, 28, 35, 56, 77, and 98 for up to 3 additional courses in the absence of disease progression or unacceptable toxicity.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

11

Start Date

September 13, 2013

Completion Date

May 18, 2017

Primary Completion Date

October 31, 2016

Eligibility Criteria

        Inclusion Criteria:

          -  Patients must have malignant melanoma validated by histology or cytology; patients may
             have had primary cutaneous, mucosal, or ocular melanoma or metastasis from an unknown
             primary site

               -  NOTE: patients must have measurable disease, defined as at least 1 lesion that
                  can be accurately measured in at least 1 dimension (longest diameter to be
                  recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm with
                  conventional chest x-ray or as >= 10 mm with spiral computed tomography (CT)
                  scan, magnetic resonance imaging (MRI), or calipers by clinical exam

          -  Unresectable stage III or IV validated by clinical criteria (including recurrent
             melanoma), or patients with multiple skin/soft tissue metastases of melanoma that may
             be resectable but are judged to have a future recurrence risk exceeding 70% (e.g.,
             large adenopathy, distant skin metastases or multiple in-transit melanoma metastases);
             tumor deemed amenable to biopsy (excisional, incisional, or core, with at least 100
             mm^3 tumor volume per biopsy date) and fine-needle aspiration (FNA) biopsy

               -  NOTE: optimally, patients will have tumor approachable for three serial biopsies
                  during the trial; for patients with only one or two tumors approachable for
                  biopsy, available tumor blocks from prior biopsies can serve as the pretreatment
                  sample, but only if formalin-fixed tumor tissue is available and adequate to
                  provide at least 20 unstained slides with sufficient tumor for analysis

               -  NOTE: patients with unresectable advanced stage III or IV melanoma (including
                  recurrent melanoma) are only eligible if they have failed at least one other
                  first-line systemic therapy (other than adjuvant therapy); exceptions to this
                  requirement are those patients who have refused and/or are ineligible for other
                  systemic therapies

               -  NOTE: v-raf murine sarcoma viral oncogene homolog B inhibitor (BRAFi) should be
                  considered for all 'unresectable" or metastatic melanoma with BRAFV600E mutation;
                  for low burden in-transit disease patients may enter trial without prior systemic
                  therapy

                    -  Stage IV no evidence of disease (NED) is excluded by this criterion

          -  Patients may have had prior systemic therapy without constraint on the number of prior
             treatment regimens except:

               -  Patients may not have had > 450 mg/m^2 doxorubicin

               -  Patients may not have had > 3000 centigray (cGy) to fields encompassing the
                  entire pelvis

          -  Patients must not be on any other systemic therapy within the following intervals
             before study enrollment:

               -  1 week after stereotactic radiosurgery of the brain or comparable technology

               -  4 weeks after cytotoxic chemotherapy or external beam radiation therapy

               -  6 weeks after chemotherapy regimens including BCNU (carmustine) or mitomycin C

               -  Patients who experience melanoma progression (by Response Evaluation Criteria in
                  Solid Tumors [RECIST] 1.1 criteria) while on or after treatment with programmed
                  cell death 1 (PD-1) or PD ligand-1 (PDL-1) antibody may enroll on this study

                    -  NOTE: Patients must be off PD-1/PDL- antibody for at least 2 weeks to assess
                       for delayed toxicity before being enrolled and receiving INCB024360;
                       patients who are enrolled 2 weeks and up to 6 weeks after the last dose of
                       PD-/PDL-1 antibody will enroll in cohort B and receive 100 mg BID of
                       INCB024360; patients enrolled beyond the 6 week period after failing
                       anti-PD-1/PDL-1 will be enrolled in cohort A; cohort A patients will receive
                       300 mg BID of INCB024360; patients must not have active grade 2 autoimmune
                       toxicities attributed to these antibodies at study entry

               -  8 weeks after ipilimumab, other cytotoxic T-lymphocyte-associated protein 4
                  (CTLA-4) antibody or other immunologically active antibody

                    -  NOTE: Patients receiving prior CTLA-4, anti-PD1 antibody or other
                       immunologic therapy must show evidence of normal pituitary function at
                       baseline and must not have active grade 2 autoimmune toxicities attributed
                       to these antibodies at study entry

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (Karnofsky >= 70%)

          -  Life expectancy of at least 6 months

          -  Leukocytes >= 3,000/mcL

          -  Absolute neutrophil count >= 1,500/mcL

          -  Platelets >= 75,000/mcL

          -  Hemoglobin > 9 g/dL

          -  Total bilirubin < 1.5 x institutional upper limit of normal (bilirubin < 3 ×
             institutional upper limit of normal for Gilbert's syndrome)

          -  Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
             [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])
             up to 2.5 times upper limit normal (ULN)

          -  Creatinine < 1.5 x institutional upper limit of normal OR

          -  Creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above
             institutional normal

          -  Prothrombin time (PT), international normalized ratio (INR) =< 1.5 x institutional ULN
             unless patient is therapeutically anticoagulated; if on anticoagulants, PT/INR need to
             be within appropriate anticoagulation limits for the clinical indication; patients who
             are receiving anticoagulants may participate in the trial if their anticoagulation can
             be stopped safely for several days at the time of each biopsy

          -  Thyroid-stimulating hormone (TSH) up to 4 times ULN if thyroxine (T4) is normal

          -  T4 within normal limits; if abnormal and patient is receiving thyroid replacement
             therapy, the thyroid medication may be adjusted and the T4 may be re-tested

          -  Patients must express human leukocyte antigen (HLA) -A1+, -A2+, or -A3+ (80% of
             patients)

          -  Lactate dehydrogenase (LDH) < 5 × upper limits of normal

               -  (NOTE: these criteria will select against patients with bulky disease and will
                  select for patients with less disease and earlier disease)

          -  Participants must not have had prior autoimmune disorders requiring cytotoxic or
             immunosuppressive therapy, or autoimmune disorders with visceral involvement;
             participants must not have an active or inactive autoimmune disorders (e.g.,
             rheumatoid arthritis, moderate or severe psoriasis, multiple sclerosis, inflammatory
             bowel disease, etc.); participants who are receiving therapy for an autoimmune or
             inflammatory disease requiring these therapies are also excluded

          -  The following will not be exclusionary:

               -  Resolved ipilimumab associated inflammatory disease

               -  The presence of laboratory evidence of autoimmune disease (e.g., positive
                  antinuclear antibody [ANA] titer) without associated symptoms

               -  Subjects with vitiligo, thyroiditis, or atopic dermatitis, but otherwise not
                  meeting this criterion may be enrolled; individual cases can be discussed with
                  the sponsor

          -  Not likely curable with surgery alone

          -  Not currently receiving therapy

          -  Females of childbearing potential must have a negative pregnancy test within 48 hours
             before initiating protocol therapy

               -  NOTE: women of child-bearing potential and men must agree to use adequate
                  contraception (hormonal or barrier method of birth control or abstinence) before
                  study entry and for the duration of study participation; should a woman become
                  pregnant or suspect she is pregnant while she or her partner is participating in
                  this study, she should inform her treating physician immediately; men treated or
                  enrolled on this protocol must also agree to use adequate contraception before
                  the study, for the duration of study participation, and 4 months after completing
                  INCB024360 and MELITAC 12.1 administration

               -  NOTE: subjects are considered not of child bearing potential if they are
                  surgically sterile, have undergone a hysterectomy, bilateral tubal ligation, or
                  bilateral oophorectomy, or are postmenopausal; menopause is the age associated
                  with complete cessation of menstrual cycles and menses, and implies the loss of
                  reproductive potential; by a practical definition, the term assumes menopause
                  after 1 year without menses with an appropriate clinical profile at the
                  appropriate age

          -  Ability to understand and willingness to sign a written informed consent document

        Exclusion Criteria:

          -  Patients who have had cytotoxic chemotherapy, radiotherapy, interferon (IFN),
             immunosuppressive therapy, or steroids within 4 weeks (6 weeks for nitrosoureas or
             mitomycin C) before entering the study or those who have not recovered from adverse
             events (AEs) due to agents administered more than 4 weeks earlier

          -  Ipilimumab or other immunologically active therapy within 8 weeks of enrollment; NOTE:
             patients who experience melanoma progression (by RECIST 1.1 criteria) while on or
             after treatment with PD-1 or PDL-1 antibody may enroll on this study

          -  Active immunosuppressive therapy, including concurrent systemic immunosuppressive
             therapy or steroid therapy with more than 7 consecutive days of steroids within the
             prior 4 weeks

               -  The use of prednisone or equivalent < 0.125 mg/kg/day (absolute maximum of 10
                  mg/day) as replacement therapy is permitted

               -  Inhaled corticosteroids are permitted

          -  Cardiovascular disease that meets one of the following: congestive heart failure (New
             York Heart Association class III or IV), active angina pectoris, or recent myocardial
             infarction or acute coronary syndrome (within the last 6 months)

          -  History of peripheral vascular disease (PVD) that has required surgical or
             percutaneous intervention or documented PVD that requires medical management with
             medications such as acetylsalicylic acid (ASA) + clopidogrel; patients with diabetes
             that is not well controlled are excluded from participation; not well controlled is
             defined as a hemoglobin (Hgb) A1C of greater than 7.5%

          -  Current or history of systemic autoimmune disease requiring systemic therapy,
             including significant autoimmunity associated with prior ipilimumab therapy or therapy
             with antibodies to PD-1 or PD-L1

          -  Cirrhosis, chronic hepatitis C virus positivity, or chronic hepatitis B infection;
             subjects who may not tolerate immune-mediated hepatitis due to compromised hepatic
             reserve also excluded from participation including: subjects with extensive liver
             metastasis (as judged by the investigator); subjects who drink more than two standard
             alcoholic beverages per day on a regular basis; subjects who consume more than 2 grams
             of acetaminophen per day on a regular basis

               -  A positive hepatitis B serology indicative of previous immunization (i.e.,
                  hepatitis B surface antibody [HBsAb]-positive and hepatitis B core antibody
                  [HBcAb]-negative), or a fully resolved acute hepatitis B infection is not an
                  exclusion criterion

          -  Patients who are receiving any other investigational agents for melanoma

          -  Patients who have had a grade one or grade two gastrointestinal adverse event during
             or after receiving anti-CTLA-4, anti-PD1 or anti-PD, without a colonoscopy verifying
             complete resolution of the adverse event

          -  Patients who have experienced bowel perforation, neurologic involvement, Guillain
             Barré syndrome, Myasthenia Gravis, Steven Johnson syndrome and other intractable
             events or grade 4 non-laboratory toxicity

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements

          -  Pregnancy, nursing, or unwilling to take adequate birth control during therapy

               -  NOTE: pregnant women are excluded from this study; breastfeeding should be
                  discontinued if the mother is treated with INCB024360 and MELITAC 12.1

          -  Known human immunodeficiency virus (HIV) or other history of immunodeficiency disorder

               -  NOTE: HIV-positive patients taking combination antiretroviral therapy are
                  ineligible

          -  Extensive active brain disease, including symptomatic brain metastases or the presence
             of leptomeningeal disease

               -  Patients with brain metastasis, after definitive therapy with surgery or
                  stereotactic radiation and stable off steroids for > 4 weeks, are eligible

          -  Any malignancy that has not been in complete remission for at least 3 years

               -  NOTE: patients with cured basal or squamous cell skin cancer are not excluded;
                  patients with a history of excised in situ cancers, including breast, cervical,
                  colon, superficial bladder, prostate or other body system are not excluded; study
                  entry will be allowed at the discretion of the Principal Investigator

               -  NOTE: recurrence of the in situ cancer or tumor at the time of study entry would
                  be exclusionary

          -  Monoamine oxidase (MAO) inhibitor use within the past 3 weeks or prior evidence of
             serotonin syndrome

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to INCB024360, MELITAC 12.1, or other vaccine components

          -  Prior organ allograft or allogeneic transplantation, if the transplanted tissue is
             still in place

          -  Medical or psychiatric illness that would, in the opinion of the investigator,
             preclude participation in the study or the ability of patients to provide informed
             consent for themselves

          -  History of pulmonary disease such as emphysema or chronic obstructive pulmonary
             disease (COPD), (forced expiratory volume in one second [FEV1] > 60% of predicted for
             height and age); pulmonary function tests (PFTs) are required in patients with
             prolonged smoking history or symptoms of respiratory dysfunction

          -  Use of any UDP glucuronosyltransferase 1 family, polypeptide A9 (UGT1A9) inhibitor
             including: acitretin, amitriptyline, androsterone, cyclosporine, dasatinib,
             diclofenac, diflunisal, efavirenz, erlotinib, estradiol (17-beta), flutamide,
             geftinib, gemfibrozil, glycyrrhetinic acid, glycyrrhizin, imatinib, imipramine,
             ketoconazole, lineoleic acid, mefenamic acid, mycophenolic acid, niflumic acid,
             nilotinib, phenobarbital, phenylbutazone, phenytoin, probenecid propofol, quinidine,
             ritonavir, Sorafenib, sulfinpyrazone, valproic acid and verapamil from screening
             through follow-up period

          -  Low-dose Coumadin (1 mg) is acceptable; however, doses that increase INR are not
             permitted; if an alternative to Coumadin-based anticoagulants cannot be used, the INR
             should be monitored weekly after initiation of therapy and upon discontinuation of
             INCB024360, until INR normalization
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Craig Slingluff, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01961115

Organization ID

CITN-04

Secondary IDs

NCI-2013-01605

Responsible Party

Principal Investigator

Study Sponsor

Fred Hutchinson Cancer Research Center

Collaborators

 Incyte Corporation

Study Sponsor

Craig Slingluff, Principal Investigator, Cancer Immunotherapy Trials Network


Verification Date

May 2018