Clinical Trials /

A Study of Pembrolizumab in Patients With Neuroendocrine Tumors

NCT02939651

Description:

The purpose of this research study is to test if pembrolizumab is safe and effective for treating patients with metastatic high-grade neuroendocrine tumors who have failed platinum based chemotherapy.The study drug, pembrolizumab has been FDA approved for treating a type of skin cancer called melanoma and for metastatic non-small cell lung cancer. However, it is not approved for treatment of metastatic high-grade neuroendocrine tumors.

Related Conditions:
  • Neuroendocrine Tumor
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of Pembrolizumab in Patients With Neuroendocrine Tumors
  • Official Title: A Phase 2, Open-label Study of Pembrolizumab Monotherapy in Patients With Metastatic High Grade Neuroendocrine Tumors

Clinical Trial IDs

  • ORG STUDY ID: GI-087
  • NCT ID: NCT02939651

Conditions

  • Neuroendocrine Tumors

Interventions

DrugSynonymsArms
PembrolizumabKeytruda, MK-3475Pembrolizumab

Purpose

The purpose of this research study is to test if pembrolizumab is safe and effective for treating patients with metastatic high-grade neuroendocrine tumors who have failed platinum based chemotherapy.The study drug, pembrolizumab has been FDA approved for treating a type of skin cancer called melanoma and for metastatic non-small cell lung cancer. However, it is not approved for treatment of metastatic high-grade neuroendocrine tumors.

Trial Arms

NameTypeDescriptionInterventions
PembrolizumabExperimentalMonotherapy with PD-1 antibody pembrolizumab
  • Pembrolizumab

Eligibility Criteria

        Inclusion Criteria:

          1. Patients must have histologically or cytologically confirmed metastatic, high grade
             NET (Ki67 >20%), excluding any high grade NETs of large or small cell type of
             lung/thymus origin and merkel cell carcinoma

          2. Patients must have measurable disease, defined as at least one lesion that can be
             accurately measured in at least one dimension in accordance with RECIST criteria v.
             1.1 as described in detail in section 12.0

          3. Has received prior therapy with at least 1 platinum-containing regimen

          4. Age > 18 years.

          5. ECOG performance status 0 or 1

          6. Patients must have normal organ and marrow function

          7. Female participants of childbearing potential must have a negative serum pregnancy
             within 72 hours prior to receiving the first dose of study medication). They should
             also 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. Note: Abstinence is acceptable if this is the
             usual lifestyle and preferred contraception for the subject.

          8. Male participants must 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
             Note: Abstinence is acceptable if this is the usual lifestyle and preferred
             contraception for the subject.

          9. Ability to understand and willingness to sign a written informed consent and HIPAA
             consent document

        Exclusion Criteria:

          1. 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. This exception does not
             include carcinomatous meningitis which is excluded regardless of clinical stability.

          2. Is currently participating and receiving study therapy or has participated in a study
             of an investigational agent and received study therapy or used an investigational
             device within 4 weeks of the first dose of treatment.

          3. Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form
             of immunosuppressive therapy within 7 days prior to the first dose of trial
             treatment.

          4. Prior anti-cancer therapy with a monoclonal antibody (mAb) within 4 weeks prior to
             study Day 1 or not recovered from adverse events (improved to grade 1 or less) due to
             mAbs administered more than 4 weeks earlier.

          5. Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2
             weeks (12 weeks for measurable sites of CNS disease) prior to study Day 1 or not
             recovered from adverse events (improved to grade 1 or less) due to a previously
             administered agent. Note: Subjects with neuropathy or ≤ Grade 2 alopecia 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.

          6. Known additional malignancy that is progressing or requires active treatment except
             superficial malignancies of the skin and in situ cervical cancer

          7. Has an active autoimmune disease that has required systemic treatment in the past 2
             years (i.e. with use of disease modifying agents, corticosteroids or
             immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or
             physiologic corticosteroid replacement therapy for adrenal or pituitary
             insufficiency, etc.) is not considered a form of systemic treatment.

          8. Has history of (non-infectious) pneumonitis that required steroids, evidence of
             interstitial lung disease or active non-infectious pneumonitis.

          9. Active infection requiring systemic therapy at enrollment.

         10. Has a known history of active TB (Bacillus Tuberculosis)

         11. Hypersensitivity to pembrolizumab or any of its excipients

         12. Has received a live virus vaccine within 30 days of planned start of trial treatment.

         13. Pregnant, breastfeeding, or expecting to conceive or father children within the
             projected duration of the trial, starting with the screening period through 120 days
             after the last dose of trial treatment

         14. Prior therapy with an anti-programmed cell death 1 (PD-1), anti-programmed cell death
             1 ligand (PDL-1), anti-PD-L2, or with an agent directed to another co-inhibitory
             T-cell receptor (e.g. CTLA-4, OX-40, CD137)

         15. Known history of human immunodeficiency virus (HIV)

         16. Known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA
             [qualitative]).

         17. Has known psychiatric or substance abuse disorders that would interfere with
             cooperation with the requirements of the trial

         18. 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective Response Rate (ORR)
Time Frame:Upto 3 years
Safety Issue:
Description:To estimate objective response rate (ORR), using RECIST 1.1, in previously treated metastatic High Grade Neuroendocrine Tumors (HGNET) patients treated with pembrolizumab monotherapy

Secondary Outcome Measures

Measure:Progression free survival (PFS)
Time Frame:Upto 3 years
Safety Issue:
Description:To evaluate progression free survival (PFS) (using RECIST 1.1) in metastatic HGNET patients treated with pembrolizumab monotherapy.
Measure:Overall Survival
Time Frame:Upto 3 years
Safety Issue:
Description:To evaluate overall survival (OS) in metastatic HGNET patients treated with pembrolizumab monotherapy.
Measure:Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Time Frame:Upto 3 years
Safety Issue:
Description:Incidence of toxicity, graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 4.0.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Namrata Vijayvergia

Trial Keywords

  • Metastatic
  • High grade

Last Updated

October 18, 2016