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Ovarian CancerPhase 3NItCHE-MITO33NCT04679064

Trial on NIraparib-TSR-042 (Dostarlimab) vs Physician's Choice CHEmotherapy in Recurrent, Ovarian, Fallopian Tube or Primary Peritoneal Cancer Patients Not Candidate for Platinum Retreatment

A Phase 3 study testing Niraparib, Dostarlimab and Pegylated liposomal doxorubicin in people with Ovarian Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 8 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Randomized phase 3 trial evaluating niraparib plus dostarlimab vs chemotherapy at physician's choice in the treatment of recurrent ovarian, fallopian tube or primary peritoneal cancer patients for which platinum is not an option Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
Niraparib, Dostarlimab and Pegylated liposomal doxorubicin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
427 participants
Where
8 sitesItaly
Study dates
1 Dec 2020to 1 Jan 2025
Phase
Phase 3
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

  • Participant must have recurrent ovarian, Fallopian tube or primary peritoneal cancer not candidate for platinum retreatment; and in particular
  • platinum resistant patients (platinum-free interval 1-6 months from last dose of platinum)
  • patients for which platinum is contraindicated because of previous allergic reactions or residual toxicity (i.e nephrotoxicity or neurotoxicity)
  • patients not able( in physician's opinion) to receive further platinum or not willing (in patients' opinion) to receive further platinum
  • Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
  • Participants must have measurable disease or evaluable based on RECIST 1.1 (patients with only CA 125 increase without evidence of disease are not included).
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  • Participant must be ≥ 18 years of age
  • Participant must have adequate organ function
  • Participant receiving corticosteroids may continue as long as their dose is stable for least 4 weeks prior to initiating protocol therapy.
  • Participant must agree to not donate blood during the study or for 90 days after the last dose of study treatment.
  • Participants must agree 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.
  • Female participant has a negative urine or serum pregnancy test within 7 days prior to taking study treatment if of childbearing potential and agrees to abstain from activities that could result in pregnancy from screening through 180 days after the last dose of study treatment, or is of nonchildbearing potential.
  • Participant must agree to not breastfeed during the study or for 180 days after the last dose of study treatment.
  • Participant must be able to understand the study procedures and agree to participate in the study by providing written informed consent

Who cannot join

  • Participant must not be simultaneously enrolled in any interventional clinical trial
  • Participants have received >2 previous CHT lines (previous treatment with parp inhibitors and/or anti check point inhibitors is allowed providing that at least 6 months from last treatment are intercurred)
  • Participant must not have had major surgery ≤ 3 weeks prior to initiating protocol therapy and participant must have recovered from any surgical effects.
  • Participant must not have received investigational therapy ≤ 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is shorter, prior initiating protocol therapy.
  • Participant has had radiation therapy encompassing >20% of the bone marrow within 2 weeks; or any radiation therapy within 1 week prior to Day 1 of protocol therapy.
  • Participant must not have a known hypersensitivity to niraparib and dostarlimab components or excipients.
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  • Participant must not have received a transfusion (platelets or red blood cells) ≤ 4 weeks prior to initiating protocol therapy.
  • Participant must not have received colony-stimulating factors (eg, granulocyte colony-stimulating factor, granulocyte macrophage colony-stimulating factor, or recombinant erythropoietin) within 4 weeks prior initiating protocol therapy.
  • Participant has had any known Grade 3 or 4 anemia, neutropenia or thrombocytopenia due to prior chemotherapy that persisted > 4 weeks and was related to the most recent treatment.
  • Participant must not have any known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)
  • Participant must not have a serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 90 days) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent
  • Participant must not have had diagnosis, detection, or treatment of another type of cancer ≤ 3 years prior to initiating protocol therapy (except basal or squamous cell carcinoma of the skin and cervical cancer that has been definitively treated)
  • Participant must not have known, symptomatic brain or leptomeningeal metastases
  • Patient experienced ≥ Grade 3 immune-related AE with prior immunotherapy, with the exception of non-clinically significant lab abnormalities.
  • Participant has a diagnosis of immunodeficiency or has received systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to initiating protocol therapy.
  • Participant has a known history of human immunodeficiency virus (type 1 or 2 antibodies).
  • Participant has known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [qualitative] is detected).
  • Participant has an active autoimmune disease that has required systemic treatment in the past 2 years (ie, 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.
  • Participant must not have a history of interstitial lung disease.
  • 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 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 are live attenuated vaccines, and are not allowed.

Trial locations and contacts

8 sites in 1 country.

Domenica Lorusso, MD contact

0630158545 ext. 0630158545

domenica.lorusso@policlinicogemelli.it

Serena Giolitto, MSc contact

0630158545 ext. 0630158545

serena.giolitto@policlinicogemelli.it

8 sites in 1 country

Italy8 sites, 8 recruiting

  • Azienda Ospedaliera Spedali Civili

    Brescia

    Recruiting

  • Istituto Tumori della Romagna IRST IRCCS

    Meldola

    Recruiting

  • IEO-Istituto Europeo di Oncologia

    Milan

    Recruiting

  • IRCCS Ospedale San Raffaele

    Milan

    Recruiting

  • Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

    Naples

    Recruiting

  • Nuovo Ospedale degli Infermi

    Ponderano

    Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Rome, 00168

    Domenica Lorusso, MD, 0630158545 ext. 0630158545, domenica.lorusso@policlinicogemelli.it

    Serena Giolitto, MSc, 0630158545 ext. 0630158545, serena.giolitto@policlinicogemelli.it

    Recruiting

  • Istituti fisioterapici Ospitalieri - Istituto Tumori Regina Elena

    Rome

    Recruiting

Other trials in Italy

About this study

Official title: Randomized Phase III Trial on NIraparib-TSR-042 (Dostarlimab) vs Physician's Choice CHEmotherapy in Recurrent, Ovarian, Fallopian Tube or Primary Peritoneal Cancer Patients Not Candidate for Platinum Retreatment: NItCHE Trial (MITO 33)

Randomized phase 3 trial evaluating niraparib plus dostarlimab vs chemotherapy at physician's choice in the treatment of recurrent ovarian, fallopian tube or primary peritoneal cancer patients for which platinum is not an option

Read the detailed description

Randomized phase 3 trial evaluating niraparib plus dostarlimab vs chemotherapy at physician's choice in the treatment of recurrent ovarian, fallopian tube or primary peritoneal cancer patients for which platinum is not an option.

The patients must have received no more than 2 previous chemotherapy lines. Stratification factors will include HRD status, previous treatment with parp and anti PD-1/PDL-1 inhibitors, Bevacizumab treatment and PDL1 expression.

Patients will continue to receive niraparib until disease progression (determined using RECIST v.1.1 criteria and clinical criteria), unacceptable toxicity, death, withdrawal of consent, or lost to follow-up, whichever comes first. Patients will continue to receive dostarlimab for a maximum of 2 years, or until disease progression (determined using RECIST v1.1 criteria and clinical criteria), unacceptable toxicity, death, withdrawal of consent, lost to follow-up, whichever may come first. Dose interruption and/or reduction may be implemented at any time for any grade toxicity considered intolerable by the patient.

Conditions
Ovarian Cancer
Being tested
Niraparib, Dostarlimab, Pegylated liposomal doxorubicin, Paclitaxel, Gemcitabine
Medical subject headings
Ovarian Neoplasms

What participants receive

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

  • NiraparibDrug

    Also called Zejula

    PARP-inihibitor

  • DostarlimabDrug

    Also called TSR-042

    PD-1 inihibitor

  • Pegylated liposomal doxorubicinDrug

    Chemotherapy drug

  • PaclitaxelDrug

    Chemotherapy drug

  • GemcitabineDrug

    Chemotherapy drug

  • TopotecanDrug

    Chemotherapy drug

  • BevacizumabDrug

    Also called Avastin

    Chemotherapy drug

Study groups in NCT04679064
Study groupRoleWhat they receive
Phisician's choice of standard chemotherapyActive comparatorChemotherapy at physician's choice between Pegylated Liposomal Doxorubicin 40 mg/mq iv q 28 Weekly Paclitaxel 80 mg/mq d 1,8,15 q 28 Gemcitabine 1000 mg/mq d 1,8,15 q 28 Topotecan 1.25 mg/mq day 1-5 q 21 +/- Bevacizumab at defined scehedule
Receives: Drug: Pegylated liposomal doxorubicin; Drug: Paclitaxel; Drug: Gemcitabine; Drug: Topotecan; Drug: Bevacizumab
Niraparib+DostarlimabExperimentalDostarlimab 500 mg q 3W for the fist 4 cycles, 1000 mg q 6W thereafter + Niraparib 300 mg or 200 mg if platelet count <150,000 /μL and/or body weight <77kg QD po q 28
Receives: Drug: Niraparib; Drug: Dostarlimab

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 tfrom the date of randomization to the date of death by any cause

    Measured: 4 years

Secondary outcomes (13)

  1. Progression free survival

    the length of time from the date of randomization to the earlier date of assessment of progression or death by any cause in the absence of progression.

    Measured: 4 years

  2. Time to first subsequent therapy

    The length of the time interval from the date of randomization to earliest date of fist subsequent therapy or death

    Measured: 4 years

  3. Response rate

    the percentage of patients with CR or PR, as assessed by RECIST (Response Evaluation Criteria on Solid Tumor) v.1.1 criteria evaluated by the investigator.

    Measured: 4 years

  4. Number and type of adverse events

    Safety and tolerability of patients receiving chemotherapy or dostarlimab plus niraparib evaluated according to CTCAE vers 5.0.

    Measured: 4 years

  5. Patient-reported outcomes for physical well-being

    quality of life of patients, in terms of physical well-being, evaluated using EORTC (European Organization for Research and Treatment of Cancer) QLQ C30 (Quality of life Questionnaires C30). "1" is the minimum score and is the better outcome, "4" is the maximum score and is the worse outcome.

    Measured: 4 years

  6. Patient-reported outcomes for physical well-being

    quality of life of patients, in terms of physical well-being, evaluated using EORTC (European Organization for Research and Treatment of Cancer) QLQ OV28 (Quality of life Questionnaires OV28). "1" is the minimum score and is the better outcome, "4" is the maximum score and is the worse outcome.

    Measured: 4 years

  7. Patient-reported outcomes for physical well-being

    quality of life of patients, in terms of physical well-being, evaluated using EQ-5DL (EURO-QOL). "0" is the minimum score and is the worse outcome, "100" is the maximum score and is the better outcome.

    Measured: 4 years

  8. Patient-reported outcomes for social/family well-being

    quality of life of patients, in terms of social/family well-being, evaluated using EORTC (European Organization for Research and Treatment of Cancer) QLQ C30 (Quality of life Questionnaires C30). "1" is the minimum score and is the better outcome, "4" is the maximum score and is the worse outcome.

    Measured: 4 years

  9. Patient-reported outcomes for social/family well-being

    quality of life of patients, in terms of social/family well-being, evaluated using EORTC (European Organization for Research and Treatment of Cancer) QLQ OV28 (Quality of life Questionnaires OV28). "1" is the minimum score and is the better outcome, "4" is the maximum score and is the worse outcome.

    Measured: 4 years

  10. Patient-reported outcomes for social/family well-being

    quality of life of patients, in terms of social/family well-being, evaluated using EORTC (European Organization for Research and Treatment of Cancer) EQ-5DL (EURO-QOL). "0" is the minimum score and is the worse outcome, "100" is the maximum score and is the better outcome.

    Measured: 4 years

  11. Patient-reported outcomes for emotional well-being

    quality of life of patients, in terms of emotional well-being, evaluated using EORTC (European Organization for Research and Treatment of Cancer) QLQ C30 (Quality of life Questionnaires C30). "1" is the minimum score and is the better outcome, "4" is the maximum score and is the worse outcome.

    Measured: 4 years

  12. Patient-reported outcomes for emotional well-being

    quality of life of patients, in terms of emotional well-being, evaluated using EORTC (European Organization for Research and Treatment of Cancer) QLQ OV28 (Quality of life Questionnaires OV28). "1" is the minimum score and is the better outcome, "4" is the maximum score and is the worse outcome.

    Measured: 4 years

  13. Patient-reported outcomes for emotional well-being

    quality of life of patients, in terms of emotional well-being, evaluated using EORTC (European Organization for Research and Treatment of Cancer) EQ-5DL (EURO-QOL). "0" is the minimum score and is the worse outcome, "100" is the maximum score and is the better outcome.

    Measured: 4 years

Timeline

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

  1. First posted22 Dec 2020
  2. Study start1 Dec 2020
  3. Primary completion1 Jan 2025 (estimated)
  4. Study completion1 Jan 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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
427 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04679064
Sponsor's protocol ID
3392
Acronym
NItCHE-MITO33
Status last verified
Sep 2020
First submitted
5 Oct 2020
Last updated
27 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Musacchio L, Salutari V, Pignata S, Braicu E, Cibula D, Colombo N, Frenel JS, Zagouri F, Carbone V, Ghizzoni V, Giolitto S, Giudice E, Perri MT, Ricci C, Scambia G, Lorusso D. Randomized phase III trial on niraparib-TSR-042 (dostarlimab) versus physician's choice chemotherapy in recurrent ovarian, fallopian tube, or primary peritoneal cancer patients not candidate for platinum retreatment: NItCHE trial (MITO 33). Int J Gynecol Cancer. 2021 Oct;31(10):1369-1373. doi: 10.1136/ijgc-2021-002593.

    PubMed 34607820

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Niraparib, Dostarlimab and Pegylated liposomal doxorubicin in people with Ovarian Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 8 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 15 inclusion and 21 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 27 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 (0630158545 ext. 0630158545, 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: 4 years). 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 NCT04679064, 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 27 Aug 2021.

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