EUCTR2016-003926-18-IT
Active, not recruiting
Phase 1
A phase II clinical trial of Pembrolizumab in combination with Carboplatin-Paclitaxel in patients with advanced (stage III B-C-IV) ovarian, primary peritoneal and fallopian tube cancer: MITO28/MANGO OV4 study - MITO28/MANGO OV4
Conditionsadvanced (stage III B-C-IV) ovarian, primary peritoneal and fallopian tube cancerMedDRA version: 21.1Level: PTClassification code 10070907Term: Ovarian cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10070908Term: Ovarian cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- advanced (stage III B-C-IV) ovarian, primary peritoneal and fallopian tube cancer
- Sponsor
- ISTITUTO NAZIONALE TUMORI - IRCCS FONDAZIONE PASCALE
- Enrollment
- 72
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosis/Condition for Entry into the Trial
- •Patients must have a histologically confirmed diagnosis of advanced (FIGO IIIB\-CIV) epithelial ovarian, primary peritoneal or fallopian tube cancer. Patients must be
- •not eligible to receive Bevacizumab in combination with carboplatin and paclitaxel,
- •due to contraindication, patient refusal or investigator choice.
- •Subject Inclusion Criteria
- •1\. In order to be eligible for participation in this trial, the subject must:
- •2\. Have a histologically confirmed diagnosis of advanced (FIGO stage IIIB,
- •IIIC, IV) epithelial ovarian, primary peritoneal or fallopian tube cancer.
- •3\. Have evidence of residual tumor after debulking surgery OR be non\-eligible
- •neither for primary surgery nor for neoadjuvant chemotherapy followed by
Exclusion Criteria
- •1\. 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.
- •2\. 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.
- •3\. Has a known history of active TB (Bacillus Tuberculosis)
- •4\. Hypersensitivity to Pembrolizumab or any of its excipients.
- •5\. 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.
- •6\. 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.
- •7\. Subjects with \=Grade 2 neuropathy are an exception to this criterion and may qualify for the study.
- •8\. If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
- •9\. 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.
- •10\. 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
Outcomes
Primary Outcomes
Not specified
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