Pembrolizumab With Chemotherapy in Front Line Advanced Ovarian, Primary Peritoneal and Fallopian Tube Cancer

Last updated: March 23, 2023
Sponsor: National Cancer Institute, Naples
Overall Status: Active - Recruiting

Phase

2

Condition

Vaginal Cancer

Fallopian Tube Cancer

Ovarian Cancer

Treatment

N/A

Clinical Study ID

NCT03410784
MITO28 / MaNGO ov4
2016-003926-18
  • Ages > 18
  • Female

Study Summary

This study is designed to assess the therapeutic efficacy and toxicity of the combination chemotherapy Paclitaxel and Carboplatin with Pembrolizumab in patients with advanced ovarian cancer. The main objective is to test whether the therapeutic intervention benefits the patient evaluating the number of subjects who are progression-free after 18 months from the beginning of the first line treatment.

Eligibility Criteria

Inclusion

Inclusion Criteria: In order to be eligible for participation in this trial, the subject must:

  • Have a histologically confirmed diagnosis of advanced (FIGO stage IIIB, IIIC, IV)epithelial ovarian, primary peritoneal or fallopian tube cancer.
  • Have evidence of residual tumor after debulking surgery OR be non-eligible neither forprimary surgery nor for neoadjuvant chemotherapy followed by interval debulkingsurgery
  • 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 tumor samples available for biomarker analysis.
  • Have a performance status of 0 or 1 on the ECOG Performance Scale.
  • Female subject of childbearing potential should have a negative urine or serumpregnancy within 72 hours prior to receiving the first dose of study medication. Ifthe urine test is positive or cannot be confirmed as negative, a serum pregnancy testwill be required.
  • Female subjects of childbearing potential should be willing to use 2 methods of birthcontrol or be surgically sterile, or abstain from heterosexual activity for the courseof the study through 120 days after the last dose of study medication. Subjects ofchildbearing potential are those who have not been surgically sterilized or have notbeen free from menses for > 1 year.
  • Must be not eligible to receive Bevacizumab in combination with carboplatin andpaclitaxel, due to contraindication, patient refusal or investigator choice
  • Demonstrate adequate organ function

Exclusion

Exclusion Criteria: The subject must be excluded from participating in the trial if the subject:

  • Is currently participating and receiving study therapy or has participated in a studyof an investigational agent or investigational device and received study therapy orused an investigational device within 4 weeks of the first dose of treatment.
  • Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or anyother form of immunosuppressive therapy within 7 days prior to the first dose of trialtreatment.
  • 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 studyDay 1 or who has not recovered (Grade 0 or 1 at baseline) from adverse events due toagents administered more than 4 weeks earlier.
  • Has had prior chemotherapy, targeted small molecule therapy, or radiation therapywithin 2 weeks prior to study Day 1 or who has not recovered (Grade 0 or 1 atbaseline) from adverse events due to a previously administered agent. Note: Subjects with Grade 1 or 2 neuropathy are an exception to this criterion and mayqualify for the study. Note: If subject received major surgery, they must have recovered adequately from thetoxicity 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 or squamous cell carcinoma of theskin that has undergone potentially curative therapy or in situ cervical cancer.
  • Has known active central nervous system (CNS) metastases and/or carcinomatousmeningitis. Subjects with previously treated brain metastases may participate providedthey are stable (without evidence of progression by imaging for at least four weeksprior to the first dose of trial treatment and any neurologic symptoms have returnedto baseline), have no evidence of new or enlarging brain metastases, and are not usingsteroids for at least 28 days prior to trial treatment. This exception does notinclude carcinomatous meningitis which is excluded regardless of clinical stability.
  • Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressivedrugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroidreplacement therapy for adrenal or pituitary insufficiency, etc.) is not considered aform of systemic treatment.
  • Has a history of (non-infectious) pneumonitis that required steroids or currentpneumonitis.
  • Has an active infection requiring systemic therapy.
  • Has a history or current evidence of any condition, therapy, or laboratory abnormalitythat might confound the results of the trial, interfere with the subject'sparticipation for the full duration of the trial, or is not in the best interest ofthe subject to participate, in the opinion of the treating investigator.
  • Has known psychiatric or substance abuse disorders that would interfere withcooperation with the requirements of the trial.
  • Is pregnant or breastfeeding, or expecting to conceive children within the projectedduration of the trial, starting with the pre-screening or screening visit through 120days after the last dose of trial treatment.
  • Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or otherco-inhibitory T-cell receptor (e.g. CTLA-4, OX-40, CD137) or drug specificallytargeting T-cell co-stimulation or checkpoint pathways
  • 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).
  • Has received a live vaccine within 30 days of planned start of study therapy. Note:Seasonal influenza vaccines for injection are generally inactivated flu vaccines andare allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are liveattenuated vaccines, and are not allowed.

Study Design

Total Participants: 72
Study Start date:
April 01, 2018
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • Ospedale Generale Regionale "F. Miulli "

    Acquaviva delle Fonti,
    Italy

    Active - Recruiting

  • Istituto Tumori Giovanni Paolo II

    Bari,
    Italy

    Active - Recruiting

  • Spedali Civili - Università di Brescia

    Brescia,
    Italy

    Active - Recruiting

  • Ospedale Senatore Antonio Perrino

    Brindisi,
    Italy

    Active - Recruiting

  • Fondazione del Piemonte per l'Oncologia

    Candiolo,
    Italy

    Active - Recruiting

  • Istituto Nazionale Tumori

    MIlano,
    Italy

    Active - Recruiting

  • Istituto Romagnolo per lo Studio e la Cura dei Tumori

    Meldola,
    Italy

    Active - Recruiting

  • AOU Policlinico Federico II

    Napoli,
    Italy

    Active - Recruiting

  • AOU Università degli studi della Campania "Luigi Vanvitelli"

    Napoli,
    Italy

    Active - Recruiting

  • Istituto Nazionale dei Tumori

    Napoli,
    Italy

    Active - Recruiting

  • Ospedale Silvestrini

    Perugia,
    Italy

    Active - Recruiting

  • Ospedale S. Giovanni Calibita Fatebenefratelli

    Roma,
    Italy

    Active - Recruiting

  • Policlinico Universitario Gemelli Università Cattolica del Sacro Cuore

    Roma,
    Italy

    Site Not Available

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