Pembrolizumab With Chemotherapy in Front Line Advanced Ovarian, Primary Peritoneal and Fallopian Tube Cancer
NCT ID: NCT03410784
Last Updated: 2023-03-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
72 participants
INTERVENTIONAL
2018-04-01
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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First-line chemotherapy with pembrolizumab
* Pembrolizumab 200 mg i.v. on Day 1 every 3 weeks for up to 22 cycles
* Paclitaxel 175 mg/m2 on Day 1 every 3 weeks for up to 6 cycles
* Carboplatin (AUC 5) on Day 1 every 3 weeks for up to 6 cycles
Pembrolizumab
Pembrolizumab 200 mg i.v. on Day 1 every 3 weeks up to 22 cycles
Paclitaxel
Paclitaxel 175 mg/m2 i.v. on Day 1 every 3 weeks up to 6 cycles
Carboplatin
Carboplatin (AUC 5) i.v. on Day 1 every 3 weeks for up to 6 cycles
Interventions
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Pembrolizumab
Pembrolizumab 200 mg i.v. on Day 1 every 3 weeks up to 22 cycles
Paclitaxel
Paclitaxel 175 mg/m2 i.v. on Day 1 every 3 weeks up to 6 cycles
Carboplatin
Carboplatin (AUC 5) i.v. on Day 1 every 3 weeks for up to 6 cycles
Eligibility Criteria
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Inclusion Criteria
* 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 for primary surgery nor for neoadjuvant chemotherapy followed by interval debulking surgery
* 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 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. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \> 1 year.
* Must be not eligible to receive Bevacizumab in combination with carboplatin and paclitaxel, due to contraindication, patient refusal or investigator choice
* Demonstrate adequate organ function
Exclusion Criteria
* Is currently participating and receiving study therapy or has participated in a study of an investigational agent or investigational device 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 (Grade 0 or 1 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 (Grade 0 or 1 at baseline) from adverse events due to a previously administered agent.
Note: Subjects with Grade 1 or 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 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. 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 28 days prior to trial treatment. This exception does not include 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 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 a history of (non-infectious) pneumonitis that required steroids or current 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 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 or other co-inhibitory T-cell receptor (e.g. CTLA-4, OX-40, CD137) or drug specifically targeting 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 and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.
18 Years
FEMALE
No
Sponsors
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Mario Negri Institute for Pharmacological Research
OTHER
National Cancer Institute, Naples
OTHER
Responsible Party
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Principal Investigators
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Sandro Pignata, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute, Naples
Nicoletta Colombo, M.D.
Role: PRINCIPAL_INVESTIGATOR
European Institute of Oncology
Francesco Perrone, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute, Naples
Gennaro Daniele, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute, Naples
Ciro Gallo, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Campania Luigi Vanvitelli
Locations
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Ospedale Generale Regionale "F. Miulli "
Acquaviva delle Fonti, , Italy
Istituto Tumori Giovanni Paolo II
Bari, , Italy
Spedali Civili - Università di Brescia
Brescia, , Italy
Ospedale Senatore Antonio Perrino
Brindisi, , Italy
Fondazione del Piemonte per l'Oncologia
Candiolo, , Italy
Istituto Romagnolo per lo Studio e la Cura dei Tumori
Meldola, , Italy
Istituto Nazionale Tumori
Milan, , Italy
AOU Policlinico Federico II
Napoli, , Italy
AOU Università degli studi della Campania "Luigi Vanvitelli"
Napoli, , Italy
Istituto Nazionale dei Tumori
Napoli, , Italy
Ospedale Silvestrini
Perugia, , Italy
Ospedale S. Giovanni Calibita Fatebenefratelli
Roma, , Italy
Policlinico Universitario Gemelli Università Cattolica del Sacro Cuore
Roma, , Italy
Countries
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Central Contacts
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Other Identifiers
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2016-003926-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MITO28 / MaNGO ov4
Identifier Type: -
Identifier Source: org_study_id
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