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Ovarian CancerPhase 2MITO 27NCT04375956

Study on Pembrolizumab in Recurrent, Platinum Resistant, CPS >1 Positive Ovarian, Fallopian Tube and Primary Peritoneal Cancer Patients

A Phase 2 study testing Pembrolizumab in people with Ovarian Cancer and Primary Peritoneal Carcinoma, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site 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 The sponsor has not verified this record for over two years, so it may be out of date.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 is a single arm phase II, multicenter study evaluating Pembrolizumab in recurrent platinum resistant CPS score >1 positive ovarian, Fallopian tube and primary peritoneal cancer patients. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteItaly
Study dates
26 Apr 2021to 15 Jun 2025
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

  • Platinum resistant (platinum free interval 1-6 months from last platinum dose) ovarian, Fallopian tube or primary peritoneal cancer
  • CPS score>1
  • Be willing and able to provide written informed consent/assent for the trial.
  • Be >= 18 years of age on day of signing informed consent.
  • Have measurable disease or evaluable based on RECIST 1.1 (patients with only CA 125 increase without evidence of disease are not included).
  • Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion. Newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on Day 1. Subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen.
  • Have a performance status of 0 or 1 on the ECOG Performance Scale.
  • Demonstrate adequate organ function

Who cannot join

  • Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
  • Has received >2 previous CHT lines
  • 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 (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
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  • 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.
  • Note: Subjects with ≤ Grade 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
  • 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 7 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 has 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 or father 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. 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.
  • Patients should not be breast-feeding during treatment and for 120 days following the end of treatment
  • Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
  • Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
  • Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority. Has received a live vaccine within 30 days of planned start of study therapy.

Trial locations and contacts

1 site in 1 country.

Domenica Lorusso, MD contact

0630157337 ext. 039

domenica.lorusso@policlinicogemelli.it

Serena Giolitto, MSc contact

0630158545 ext. 0630158545

serena.giolitto@policlinicogemelli.it

Italy1 site, 1 recruiting

  • Fondazione Policlinico Universitario A. Gemelli IRCCS

    Rome, 00168

    Recruiting

Other trials in Italy

About this study

Official title: Prospective, Non Randomized, Phase II Study on MK-3475 in Recurrent, Platinum Resistant, CPS >1 Positive Ovarian, Fallopian Tube and Primary Peritoneal Cancer Patients.

This is a single arm phase II, multicenter study evaluating Pembrolizumab in recurrent platinum resistant CPS score >1 positive ovarian, Fallopian tube and primary peritoneal cancer patients.

Read the detailed description

This is a single arm, phase II, multicenter study trial evaluating Pembrolizumab in recurrent platinum resistant CPS score >1 positive ovarian, Fallopian tube and primary peritoneal cancer patients. All the eligible patients will receive Pembrolizumab 200 mg d1 q 21 iv infusion in 30 minutes, until disease progression of disease, unacceptable toxicity or patient's refusal. Pembrolizumab will be administered for a maximum of 2 years.

The primary objective of the study is to assess overall survival (OS) of patients treated with Pembrolizumab single agent.

Being tested
Pembrolizumab
Medical subject headings
Ovarian Neoplasms, Fallopian Tube Neoplasms

What participants receive

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

Study groups in NCT04375956
Study groupRoleWhat they receive
PembrolizumabExperimentalPembrolizumab 200 mg d1 q 21 iv infusion, until disease progression of disease, unacceptable toxicity or patient's refusal. Pembrolizumab will be administered for a maximum of 2 years.
Receives: Drug: Pembrolizumab

What is being measured

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

  1. Overall Survival

    The length of time from the date of the start of treatment to death

    Measured: 44 months

Secondary outcomes (5)

  1. Advers Events

    The safety and tolerability of patients receiving Pembrolizumab will be assessed

    Measured: 44 months

  2. Response Rate

    The response rate will be assessed by RECIST 1.1 criteria

    Measured: 44 months

  3. Progression Free Survival

    The length of time from the start of treatment to the disease progression

    Measured: 44 months

  4. Quality of life: physical impact of disease

    Patient-reported outcomes of patients receiving pembrolizumab will be assessed utilizing the disease-related symptoms - physical (DRS-P) subscale of the National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy (NCCNFACT) FACT-Ovarian Symptom Index 18 (FOSI-18) Changes and using Euro-Quality of Life 5D (eEQ-5D) tool

    Measured: 44 months

  5. Quality of life: emotional impact of disease

    Patient-reported outcomes of patients receiving pembrolizumab will be assessed utilizing the disease-related symptoms - physical (DRS-P) subscale of the National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy (NCCNFACT) FACT-Ovarian Symptom Index 18 (FOSI-18) Changes and using Euro-Quality of Life 5D (eEQ-5D) tool

    Measured: 44 months

Timeline

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

  1. First posted6 May 2020
  2. Study start26 Apr 2021
  3. Primary completion15 Jun 2025 (estimated)
  4. Study completion15 Jun 2025 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04375956
Sponsor's protocol ID
3094
Acronym
MITO 27
Status last verified
Aug 2021
First submitted
13 Apr 2020
Last updated
20 Dec 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pembrolizumab in people with Ovarian Cancer and Primary Peritoneal Carcinoma, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site 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 8 inclusion and 23 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 20 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Contact Domenica Lorusso, MD (0630157337 ext. 039, domenica.lorusso@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: 44 months). 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 NCT04375956.

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 20 Dec 2021.

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