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

NCT03410784 | Unknown Phase 2

• 2 other identifiers: MITO28 / MaNGO ov42016-003926-18
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 13

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.

Conditions

Ovarian Cancer

Keywords

PD-L1 Expression; prognostic factors; predictive factors; Patient reported outcomes

Outcome Measures

Primary Outcomes (1)

• Proportion of patients free from progression

  18 months from beginning of first line treatment

Secondary Outcomes (5)

• progression free survival

  3 years

• overall survival

  5 years

• number of patients with complete and partial responses

  18 months

• worst grade toxicity per patient

  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

Study Arms (1)

First-line chemotherapy with pembrolizumab

OTHER

* 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; Drug: Paclitaxel; Drug: Carboplatin

Interventions

Pembrolizumab DRUG

Pembrolizumab 200 mg i.v. on Day 1 every 3 weeks up to 22 cycles

First-line chemotherapy with pembrolizumab

Paclitaxel DRUG

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

First-line chemotherapy with pembrolizumab

Carboplatin DRUG

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

First-line chemotherapy with pembrolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Institute, Naples: lead
• Mario Negri Institute for Pharmacological Research: collaborator

Study Sites (13)

Ospedale Generale Regionale "F. Miulli "

Acquaviva delle Fonti, Italy

RECRUITING

Istituto Tumori Giovanni Paolo II

Bari, Italy

RECRUITING

Spedali Civili - Università di Brescia

Brescia, Italy

RECRUITING

Ospedale Senatore Antonio Perrino

Brindisi, Italy

RECRUITING

Fondazione del Piemonte per l'Oncologia

Candiolo, Italy

RECRUITING

Istituto Romagnolo per lo Studio e la Cura dei Tumori

Meldola, Italy

RECRUITING

Istituto Nazionale Tumori

Milan, Italy

RECRUITING

AOU Policlinico Federico II

Napoli, Italy

RECRUITING

AOU Università degli studi della Campania "Luigi Vanvitelli"

Napoli, Italy

RECRUITING

Istituto Nazionale dei Tumori

Napoli, Italy

RECRUITING

Ospedale Silvestrini

Perugia, Italy

RECRUITING

Ospedale S. Giovanni Calibita Fatebenefratelli

Roma, Italy

RECRUITING

Policlinico Universitario Gemelli Università Cattolica del Sacro Cuore

Roma, Italy

NOT YET RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

pembrolizumab; Paclitaxel; Carboplatin

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2018
• First Posted: January 25, 2018
• Study Start: April 1, 2018
• Primary Completion: August 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 24, 2023

Record last verified: 2023-03

Locations

IT (13)