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Pembrolizumab With Chemotherapy in Front Line Advanced Ovarian, Primary Peritoneal and Fallopian Tube Cancer (MITO28MaNGOov4)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03410784
Recruitment Status : Not yet recruiting
First Posted : January 25, 2018
Last Update Posted : April 12, 2018
Sponsor:
Collaborator:
Mario Negri Institute for Pharmacological Research
Information provided by (Responsible Party):
National Cancer Institute, Naples

Brief 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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: Pembrolizumab Drug: Paclitaxel Drug: Carboplatin Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : April 2018
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
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
Drug: Pembrolizumab
Pembrolizumab 200 mg i.v. on Day 1 every 3 weeks up to 22 cycles

Drug: Paclitaxel
Paclitaxel 175 mg/m2 i.v. on Day 1 every 3 weeks up to 6 cycles

Drug: Carboplatin
Carboplatin (AUC 5) i.v. on Day 1 every 3 weeks for up to 6 cycles




Primary Outcome Measures :
  1. Proportion of patients free from progression [ Time Frame: 18 months from beginning of first line treatment ]

Secondary Outcome Measures :
  1. progression free survival [ Time Frame: 3 years ]
  2. overall survival [ Time Frame: 5 years ]
  3. number of patients with complete and partial responses [ Time Frame: 18 months ]
  4. worst grade toxicity per patient [ Time Frame: evaluated every 3 weeks up to 18 months ]
    according to Common Toxicity Criteria for Adverse Events v. 4.03

  5. changes in patient-reported outcome (PRO) scores of disease-related symptoms from baseline [ Time Frame: up to 18 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 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:

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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03410784


Contacts
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Contact: Francesco Perrone, M.D., Ph.D. +39 081 5903571 f.perrone@istitutotumori.na.it
Contact: Gennaro Daniele, M.D., Ph.D. +39 081 5903383 g.daniele@istitutotumori.na.it

Locations
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Italy
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
MIlano, 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
Sponsors and Collaborators
National Cancer Institute, Naples
Mario Negri Institute for Pharmacological Research
Investigators
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Principal Investigator: Sandro Pignata, M.D., Ph.D. National Cancer Institute, Naples
Principal Investigator: Nicoletta Colombo, M.D. European Institute of Oncology
Principal Investigator: 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"
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Responsible Party: National Cancer Institute, Naples
ClinicalTrials.gov Identifier: NCT03410784    
Other Study ID Numbers: MITO28 / MaNGO ov4
2016-003926-18 ( EudraCT Number )
First Posted: January 25, 2018    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Cancer Institute, Naples:
PD-L1 Expression
prognostic factors
predictive factors
Patient reported outcomes
Additional relevant MeSH terms:
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Fallopian Tube Neoplasms
Neoplasms by Site
Neoplasms
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Fallopian Tube Diseases
Paclitaxel
Carboplatin
Pembrolizumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological