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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-003926-18 | EudraCT Number |
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| Name | Class |
|---|---|
| Mario Negri Institute for Pharmacological Research | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First-line chemotherapy with pembrolizumab | Other |
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pembrolizumab | Drug | Pembrolizumab 200 mg i.v. on Day 1 every 3 weeks up to 22 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients free from progression | 18 months from beginning of first line treatment |
| Measure | Description | Time Frame |
|---|---|---|
| progression free survival | 3 years | |
| overall survival | 5 years | |
| number of patients with complete and partial responses |
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Inclusion Criteria:
In order to be eligible for participation in this trial, the subject must:
Exclusion Criteria:
The subject must be excluded from participating in the trial if the subject:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francesco Perrone, M.D., Ph.D. | Contact | +39 081 5903571 | f.perrone@istitutotumori.na.it | |
| Gennaro Daniele, M.D., Ph.D. | Contact | +39 081 5903383 | g.daniele@istitutotumori.na.it |
| Name | Affiliation | Role |
|---|---|---|
| Sandro Pignata, M.D., Ph.D. | National Cancer Institute, Naples | Principal Investigator |
| Nicoletta Colombo, M.D. | European Institute of Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Generale Regionale "F. Miulli " | Recruiting | Acquaviva delle Fonti | Italy | |||
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| Paclitaxel | Drug | Paclitaxel 175 mg/m2 i.v. on Day 1 every 3 weeks up to 6 cycles |
|
| Carboplatin | Drug | Carboplatin (AUC 5) i.v. on Day 1 every 3 weeks for up to 6 cycles |
|
| 18 months |
| worst grade toxicity per patient | according to Common Toxicity Criteria for Adverse Events v. 4.03 | evaluated every 3 weeks up to 18 months |
| changes in patient-reported outcome (PRO) scores of disease-related symptoms from baseline | up to 18 months |
| Francesco Perrone, M.D., Ph.D. |
| National Cancer Institute, Naples |
| Principal Investigator |
| Gennaro Daniele, M.D., Ph.D. | National Cancer Institute, Naples | Principal Investigator |
| Ciro Gallo, M.D. | University of Campania Luigi Vanvitelli | Principal Investigator |
| Istituto Tumori Giovanni Paolo II |
| Recruiting |
| Bari |
| Italy |
| Spedali Civili - Università di Brescia | Recruiting | Brescia | Italy |
| Ospedale Senatore Antonio Perrino | Recruiting | Brindisi | Italy |
| Fondazione del Piemonte per l'Oncologia | Recruiting | Candiolo | Italy |
| Istituto Romagnolo per lo Studio e la Cura dei Tumori | Recruiting | Meldola | Italy |
| Istituto Nazionale Tumori | Recruiting | Milan | Italy |
| AOU Policlinico Federico II | Recruiting | Naples | Italy |
| AOU Università degli studi della Campania "Luigi Vanvitelli" | Recruiting | Naples | Italy |
| Istituto Nazionale dei Tumori | Recruiting | Naples | Italy |
| Ospedale Silvestrini | Recruiting | Perugia | Italy |
| Ospedale S. Giovanni Calibita Fatebenefratelli | Recruiting | Roma | Italy |
| Policlinico Universitario Gemelli Università Cattolica del Sacro Cuore | Not yet recruiting | Roma | Italy |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| C582435 | pembrolizumab |
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
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