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Endometrial CancerPhase 2MITO END-3NCT03503786

Carboplatin, Paclitaxel With or Without Avelumab in Advanced or Recurrent Endometrial Cancer

A Phase 2 study testing Carboplatin, Paclitaxel and Avelumab in people with Endometrial Cancer, run by National Cancer Institute, Naples at 11 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study aims to evaluate the safety and activity of the Avelumab in combination with Carboplatin-Paclitaxel in advanced or recurrent endometrial cancer Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Endometrial Cancer
What is being tested?
Carboplatin, Paclitaxel and Avelumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
125 participants
Where
11 sitesItaly
Study dates
1 Apr 2018to Dec 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female aged at least 18 years on day of signing informed consent
  • ECOG Performance Status of 0-1
  • Patients with newly diagnosed or recurrent endometrial cancer FIGO stage III-IV and histologically-confirmed (any histology except sarcoma and carcinosarcoma)
  • Patients may have received adjuvant treatment (platinum-based cytotoxic chemotherapy and/or radiotherapy). Patients having received prior chemotherapy must have completed their treatment at least 6 months prior to registration for protocol therapy. Patients having received prior radiotherapy must have completed their treatment at least 28 days prior to registration for protocol therapy
  • Have measurable disease based on RECIST v1.1 criteria
  • Availability of tumor samples for biomarker analysis
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  • Endometrial cancer will include all carcinomas, including endometrioid carcinoma, papillary serous carcinoma, clear cell carcinoma
  • Adequate hematological function defined by absolute neutrophil count (ANC) ≥ 1500 × mm3, platelet count ≥ 100,000 × mm3, and hemoglobin ≥ 9 g/dL (may have been transfused)
  • Adequate hepatic function defined by a total bilirubin level ≤ 1.5 × the upper limit of normal (ULN) range and AST and ALT levels ≤ 2.5 × ULN for all subjects (or ≤ 5 x ULN if liver metastases are present)
  • Adequate renal function defined by an estimated creatinine clearance ≥ 50 mL/min according to the Cockcroft-Gault formula or serum creatinine ≤ 1.5 ULN (for local institutional standard method)
  • Alkaline phosphatase < 1.5 x ULN for the institution (if > 1.5 x ULN, then alkaline phosphatase liver fraction must be < 1.5 ULN)
  • Be willing and able to provide written informed consent/assent for the trial
  • Females of childbearing potential must have a negative serum pregnancy test (serum hCG) at screening. Women of childbearing potential are those who have not been surgically sterilized or have not been free from menses for ≥1 year
  • Highly effective contraception for females if the risk of conception exists. (Note: The effects of the trial drug on the developing human fetus are unknown; thus, women of childbearing potential must agree to use 2 highly effective contraception, defined as methods with a failure rate of less than 1 % per year). Highly effective contraception is required at least 28 days prior, throughout and for at least 60 days after Avelumab treatment

Who cannot join

  • Women who are pregnant or lactating
  • Patients with brain metastases, except those meeting the following criteria:
  • Brain metastases that have been treated locally and are clinically stable for at least 2 weeks prior to enrollment
  • No ongoing neurological symptoms that are related to the brain localization of the disease (sequelae that are a consequence of the treatment of the brain metastases are acceptable)
  • patients must be either off steroids or on a stable or decreasing dose of <10mg daily prednisone (or equivalent)
  • Prior Anticancer treatment for advanced disease and/or prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent. Previous hormonal therapy for advanced disease is allowed, but treatment must be discontinued at least 28 days prior to registration for protocol therapy
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  • History of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma)
  • Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v4.03 Grade ≥ 3)
  • Prior organ transplantation, including allogeneic stem cell transplantation
  • Significant acute or chronic infections including, among others:
  • Known history of testing positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
  • Positive test for hepatitis B surface antigen and / or confirmatory hepatitis C RNA (if anti-hepatitis C antibody tested positive)
  • Evidence of interstitial lung disease or active non-infectious pneumonitis.
  • Active infection requiring systemic therapy
  • Known history of active Tuberculosis Bacillus (TB)
  • Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent:
  • Subjects with diabetes type I, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible
  • Subjects requiring hormone replacement with corticosteroids are eligible if the steroids are administered only for the purpose of hormonal replacement and at doses ≤ 10 mg or 10 mg equivalent prednisone per day
  • Administration of steroids through a route known to result in a minimal systemic exposure (topical, intranasal, intro-ocular, or inhalation) are acceptable
  • Persisting toxicity related to prior therapy of Grade >1 NCI-CTCAE v 4.03; however, alopecia and sensory neuropathy Grade ≤ 2 is acceptable
  • Another primary malignancy within the past five years (except for non-melanoma skin cancer and cervical carcinoma in situ).
  • Concurrent treatment with immunosuppressive or investigational agents EXCEPT for the following: a. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); b. Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent; c. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).
  • Active cardiac disease, defined as:
  • Myocardial infarction or unstable angina pectoris within 6 months of the first date of study therapy,
  • History of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation), high-grade atrio-ventricular block, or other cardiac arrhythmias requiring anti-arrhythmic medications (except for atrial fibrillation that is well controlled with antiarrhythmic medication); history of QT interval prolongation.
  • New York Heart Association (NYHA) Class III or greater congestive heart failure, or left ventricular ejection fraction of < 40%.
  • Known alcohol or drug abuse
  • Vaccination within 4 weeks of the first dose of avelumab and while on trial is prohibited except for administration of inactivated vaccines
  • Any psychiatric condition that would prohibit the understanding or rendering of informed consent
  • All other significant diseases (for example, inflammatory bowel disease, uncontrolled asthma), which, in the opinion of the Investigator, All other significant diseases (for example, inflammatory bowel disease, uncontrolled asthma) including recent or active suicidal ideation or behavior, which, in the opinion of the Investigator, may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

Italy11 sites

  • Ospedale Senatore Antonio Perrino

    Brindisi

  • Fondazione del Piemonte per l'Oncologia

    Candiolo

  • Istituto Romagnolo per lo Studio e la Cura dei Tumori

    Meldola

  • IRCCS San Raffaele

    Milan

  • Istituto Nazionale Tumori

    Milan

  • AOU Policlinico Federico II

    Naples

  • AOU Università degli studi della Campania "Luigi Vanvitelli"

    Naples

  • Istituto Nazionale dei Tumori

    Naples

  • Ospedale Silvestrini

    Perugia

  • Ospedale S. Giovanni Calibita Fatebenefratelli

    Roma

  • Policlinico Universitario Gemelli Università Cattolica del Sacro Cuore

    Roma

Other trials in Italy

About this study

Official title: MITO END-3: A Randomized Phase II Trial of Carboplatin+Paclitaxel Compared to Carboplatin+Paclitaxel+Avelumab in Advanced (Stage III-IV) or Recurrent Endometrial Cancer

This study aims to evaluate the safety and activity of the Avelumab in combination with Carboplatin-Paclitaxel in advanced or recurrent endometrial cancer

Keywords
PD-L1 Expression, advanced endometrial cancer, recurrent endometrial cancer, Patient reported outcomes
Medical subject headings
Endometrial Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CarboplatinDrug

    Carboplatin AUC 5 i.v. every 3 weeks for 6 - 8 cycles

  • PaclitaxelDrug

    Paclitaxel 175 mg/m2 i.v. every 3 weeks for 6-8 cycles

  • AvelumabDrug

    Avelumab 10 mg/kg every 3 weeks for 6-8 cycles + Avelumab 10 mg/kg every 14 days until disease progression or unacceptable toxicity

Study groups in NCT03503786
Study groupRoleWhat they receive
ChemotherapyActive comparatorCarboplatin AUC 5+Paclitaxel 175 mg/m2 q 21days for 6-8 cycles and Avelumab
Receives: Drug: Carboplatin; Drug: Paclitaxel
Chemotherapy and avelumabExperimentalCarboplatin AUC 5+ Paclitaxel 175 mg/ m2+Avelumab 10 mg/kg q 21days for 6 -8 cycles + Avelumab 10 mg/kg every 14 days until disease progression or unacceptable toxicity
Receives: Drug: Carboplatin; Drug: Paclitaxel; Drug: Avelumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. progression free survival

    Measured: 18 months from beginning of treatment

Secondary outcomes (5)

  1. overall survival

    Measured: 3 years

  2. number of patients with complete and partial responses

    Measured: 18 months

  3. worst grade toxicity per patient

    according to Common Toxicity Criteria for Adverse Events v. 4.03

    Measured: evaluated every 3 weeks up to 2 years

  4. changes in patient-reported outcome (PRO) scores of quality of life and endometrial cancer disease and treatment related symptoms from baseline

    European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C-30 En-24C QOL questionnaire C-30 En-24

    Measured: up to 2 years

  5. changes in patient-reported outcome (PRO) scores of symptomatic toxicities during treatment

    PRO-CTCAE questionnaire

    Measured: up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2018
  2. Study start1 Apr 2018
  3. Primary completionDec 2023 (estimated)
  4. Study completionDec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Phase 2 randomized with a safety run-in cohort for the experimental arm
Masking
None (open label)
Enrolment
125 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03503786
Sponsor's protocol ID
MITO END-3
Other IDs
2016-004403-31, 2016
Acronym
MITO END-3
Status last verified
Mar 2023
First submitted
6 Apr 2018
Last updated
13 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Pignata S, Scambia G, Schettino C, Arenare L, Pisano C, Lombardi D, De Giorgi U, Andreetta C, Cinieri S, De Angelis C, Priolo D, Casanova C, Rosati M, Greco F, Zafarana E, Schiavetto I, Mammoliti S, Cecere SC, Salutari V, Scalone S, Farolfi A, Di Napoli M, Lorusso D, Gargiulo P, Califano D, Russo D, Spina A, De Cecio R, Chiodini P, Perrone F; MITO investigators. Carboplatin and paclitaxel plus avelumab compared with carboplatin and paclitaxel in advanced or recurrent endometrial cancer (MITO END-3): a multicentre, open-label, randomised, controlled, phase 2 trial. Lancet Oncol. 2023 Mar;24(3):286-296. doi: 10.1016/S1470-2045(23)00016-5. Epub 2023 Feb 14.

    PubMed 37052965

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Carboplatin, Paclitaxel and Avelumab in people with Endometrial Cancer, run by National Cancer Institute, Naples at 11 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

progression free survival (time frame: 18 months from beginning of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03503786, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.

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