Pembrolizumab and Epacadostat in Patients With Thymic Carcinoma

NCT02364076 | Unknown Phase 2 Results DMC FDA Drug

• 1 other identifier: 2014-1315
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

This is a non-randomized clinical trial in patients with thymic carcinomas who failed prior systemic therapy. All subjects will receive pembrolizumab and epacadostat treatment in three week cycles until unacceptable toxicity, death, progressive disease or withdrawal.

Conditions

Thymic Carcinoma; Thymus Neoplasms; Thymus Cancer

Keywords

Pembrolizumab; Epacadostat

Outcome Measures

Primary Outcomes (1)

• Response Rate

  To measure response of all the participants to the drug at the end of the study.

  24 months

Secondary Outcomes (3)

• Progression-free Survival

  24 months

• Overall Survival

  24 months

• Number of Participants With New-Onset Severe Adverse Events

  24 months

Study Arms (1)

Pembrolizumab and Epacadostat

EXPERIMENTAL

Pembrolizumab 200 mg intravenously every 3 weeks Epacadostat 100mg by mouth taken daily

Drug: Pembrolizumab; Drug: Epacadostat

Interventions

Pembrolizumab DRUG

Administration of 200 mg MK-3475 once every 3 weeks

Also known as: Keytruda, MK-3475

Pembrolizumab and Epacadostat

Epacadostat DRUG

100mg taken by mouth twice daily

Also known as: INCB024360

Pembrolizumab and Epacadostat

Eligibility Criteria

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

You may qualify if:

• Histologic confirmation of thymic carcinoma (WHO Classification, See Appendix 12.1)
• Advanced disease (Masaoka staging, See Appendix 12.2) not amenable to curative treatment.
• At least 1 prior line of chemotherapy.
• Progression of disease must be documented prior to study entry.
• Absence of any autoimmune syndrome typically associated with thymomas but not thymic carcinomas (myasthenia gravis, pure red cell aplasia, etc.).
• Be willing and able to provide written informed consent/assent for the trial.
• Be at least 18 years of age on day of signing informed consent.
• Have measurable disease based on RECIST 1.1.
• Have provided tissue from an archival tissue sample or newly obtained core or excisional biopsy of a tumor lesion.
• Have a performance status of 0 or 1 on the ECOG Performance Scale (See Appendix 12.3).
• Demonstrate adequate organ function
• Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
• Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication (Reference Section 5.7.2). Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \> 1 year.
• Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.

You may not qualify if:

• Has disease which is amenable to radical treatment with surgery or radiation or a combination of treatments.
• Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment.
• Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
• Has had a prior monoclonal antibody within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
• Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
• Note: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.
• Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
• Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
• Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment.
• Has an active automimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjorgen's syndrome will not be excluded from the study.
• Has evidence of interstitial lung disease
• Has a history of non-infectious pneumonitis that required steroids, or has a history of active pneumonitis.
• Has an active infection requiring systemic therapy.
• Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
• Has known hypersensitivity to pembrolizumab (MK-3475) or its formulation.

Sponsors & Collaborators

• Georgetown University: lead
• Merck Sharp & Dohme LLC: collaborator
• Incyte Corporation: collaborator

Study Sites (1)

Georgetown Lombardi Comprehensive Cancer Center

Washington D.C., District of Columbia, 20007, United States

Location

Related Publications (2)

• He Y, Ramesh A, Gusev Y, Bhuvaneshwar K, Giaccone G. Molecular predictors of response to pembrolizumab in thymic carcinoma. Cell Rep Med. 2021 Sep 3;2(9):100392. doi: 10.1016/j.xcrm.2021.100392. eCollection 2021 Sep 21.

  PMID: 34622229 DERIVED

• Giaccone G, Kim C, Thompson J, McGuire C, Kallakury B, Chahine JJ, Manning M, Mogg R, Blumenschein WM, Tan MT, Subramaniam DS, Liu SV, Kaplan IM, McCutcheon JN. Pembrolizumab in patients with thymic carcinoma: a single-arm, single-centre, phase 2 study. Lancet Oncol. 2018 Mar;19(3):347-355. doi: 10.1016/S1470-2045(18)30062-7. Epub 2018 Jan 26.

  PMID: 29395863 DERIVED

MeSH Terms

Conditions

Thymoma; Thymus Neoplasms

Interventions

pembrolizumab; epacadostat

Condition Hierarchy (Ancestors)

Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lymphatic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Dr Giuseppe Giaccone
• Organization: Georgetown University Medical Center -Lomabardi Comprehensive Cancer Center

gg496@georgetown.edu

202-687-7072

Study Officials

• Giuseppe Giaccone, MD PhD

  Georgetown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2015
• First Posted: February 16, 2015
• Study Start: March 1, 2015
• Primary Completion: June 1, 2019
• Study Completion: December 1, 2021
• Last Updated: December 13, 2019
• Results First Posted: December 13, 2019

Record last verified: 2018-11

Locations

US (1)