Clinical Trials /

Phase II: Pembrolizumab/Carboplatin/Taxol in Epithelial Ovary Cancer

NCT02766582

Description:

Phase II single arm, open label, nonrandomized study. The aim of our study is to assess the Progression Free Survival (PFS) in suboptimally cytoreduced epithelial ovarian/ primary peritoneal/ fallopian tube cancer patients treated with the novel combination of carboplatin every 21 days (triweekly) /weekly paclitaxel IV with pembrolizumab IV followed by maintenance pembrolizumab IV.

Related Conditions:
  • Fallopian Tube Carcinoma
  • Ovarian Carcinoma
  • Primary Peritoneal Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Phase II: Pembrolizumab/Carboplatin/Taxol in Epithelial Ovary Cancer
  • Official Title: Phase II Open Label Nonrandomized Trial of the Anti PD 1 Therapy Pembrolizumab With First Line Platinum Based Chemotherapy Followed by 12 Months Pembrolizumab Monotherapy for Patients With Stage III/IV Epithelial Ovarian Cancer

Clinical Trial IDs

  • ORG STUDY ID: Uyar 25680 IIT Merck
  • NCT ID: NCT02766582

Conditions

  • Ovarian Cancer

Interventions

DrugSynonymsArms
PembrolizumabKeytrudaChemotherapy combined with pembrolizumab
CarboplatinParaplatinChemotherapy combined with pembrolizumab
PaclitaxelTaxol, OnxolChemotherapy combined with pembrolizumab

Purpose

Phase II single arm, open label, nonrandomized study. The aim of our study is to assess the Progression Free Survival (PFS) in suboptimally cytoreduced epithelial ovarian/ primary peritoneal/ fallopian tube cancer patients treated with the novel combination of carboplatin every 21 days (triweekly) /weekly paclitaxel IV with pembrolizumab IV followed by maintenance pembrolizumab IV.

Detailed Description

      Utilization of combination standard intravenous chemotherapy with intravenous pembrolizumab
      (for 6 cycles) in first line treatment of patients with advanced ovarian cancer post surgery
      with any residual disease. This will be followed by single agent intravenous pembrolizumab
      (every 3 weeks) for 12 additional cycles.
    

Trial Arms

NameTypeDescriptionInterventions
Chemotherapy combined with pembrolizumabExperimentalSingle arm study: Pembrolizumab IV every 21 days (200 mg) Carboplatin IV every 21 days Paclitaxel IV infusion (80 mg/m2) every 21 days for 6 cycles Followed by 12 months pembrolizumab IV every 21 days
  • Pembrolizumab
  • Carboplatin
  • Paclitaxel

Eligibility Criteria

        Inclusion Criteria:

          -  Have advance stage III/IV epithelial ovarian, fallopian tube or primary peritoneal
             cancer

          -  Be willing and able to provide written informed consent/assent for the trial.

          -  Be 18 years of age on day of signing informed consent.

          -  Have measurable/ macroscopic disease based on RECIST 1.1.

          -  Be willing to provide tissue from a newly obtained core or excisional biopsy of a
             tumor lesion. Newly-obtained is defined as a specimen obtained up to 6 weeks (42
             days) prior to initiation of treatment on Day 1. Subjects for whom newly-obtained
             samples cannot be provided (e.g. inaccessible or subject safety concern) may submit
             an archived specimen only upon agreement from the Sponsor.

          -  Have a performance status of 0, 1 or 2 on the ECOG Performance Scale.

          -  Demonstrate adequate organ function

          -  All screening labs should be performed within 10 days of treatment initiation.

          -  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.

          -  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.

        Exclusion Criteria:

          -  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.

          -  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 a known history of active TB (Bacillus Tuberculosis)

          -  Hypersensitivity to pembrolizumab or any of its excipients.

          -  Has had a prior anti-cancer monoclonal antibody (mAb) 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.

        oNote: 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 within the last 3 years, or that is progressing or
             requires active treatment. Exceptions include basal cell carcinoma of the skin or
             squamous cell carcinoma of the skin that has undergone potentially curative therapy
             or in situ cervical cancer.

          -  Has known active central nervous system (CNS) metastases and/or carcinomatous
             meningitis.

          -  Has 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 (eg., thyroxine, insulin, or
             physiologic corticosteroid replacement therapy for adrenal or pituitary
             insufficiency, etc.) is not considered a form of systemic treatment.

          -  Has known history of, or any evidence of active, non-infectious 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.

          -  Patients with medical history or conditions not otherwise previously specified which
             in the opinion of the investigator should exclude participation in this study. The
             investigator should consult the Study Chair.

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

          -  Is pregnant or breastfeeding, or expecting to conceive children within the projected
             duration of the trial, starting with the pre-screening or screening visit through 120
             days after the last dose of trial treatment.

          -  Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.

          -  Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).

          -  Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA
             [qualitative] is detected).

          -  Patients with borderline ovarian tumors, recurrent epithelial ovarian/ primary
             peritoneal cancer/fallopian tube cancer or non-epithelial ovarian cancer are not
             eligible.

          -  Has received a live vaccine within 30 days of planned start of study therapy.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression Free Survival (PFS) of combination platinum based therapy with anti-Programmed Death (PD)-1 therapy followed by maintenance anti-PD-1 therapy in patients with epithelial ovarian cancer (EOC).
Time Frame:24-48 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Overall Survival (OS) of combination platinum based therapy with anti-PD-1 therapy followed by maintenance anti-PD-1 therapy in patient with suboptimally cytoreduced epithelial ovarian cancer.
Time Frame:24-48 months
Safety Issue:
Description:
Measure:Monitor quality of life during combination therapy and single agent maintenance therapy with anti-PD-1 therapy with the Functional Assessment of Cancer Therapy (FACT) surveys at intervals during therapy.
Time Frame:Every 6 months during treatment until 6 months after completion of therapy. 24-28 months
Safety Issue:
Description:Each cycle is 21 days.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Medical College of Wisconsin

Trial Keywords

  • Ovarian
  • platinum
  • pembrolizumab

Last Updated

November 17, 2016