Study of Mirvetuximab Soravtansine and Bevacizumab for Maintenance in Adults with Recurrent Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

3 1 1 1

What is this study about?

This clinical trial is focused on studying the treatment of platinum-sensitive epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer. These are types of cancers that affect the female reproductive system and are sensitive to platinum-based chemotherapy. The study will use a combination of two medications: mirvetuximab soravtansine and bevacizumab. Mirvetuximab soravtansine, also known by its code name IMGN853, is an antibody-drug conjugate, which means it is a targeted therapy designed to bind to specific cancer cells. Bevacizumab is a medication that inhibits the growth of blood vessels that supply nutrients to tumors, helping to slow or stop their growth.

The purpose of this study is to compare the effectiveness of the combination of mirvetuximab soravtansine and bevacizumab with bevacizumab alone in maintaining the health of patients who have not shown disease progression after receiving platinum-based chemotherapy. Patients will be randomly assigned to receive either the combination treatment or bevacizumab alone. The study will monitor the patients over a period to assess how long they remain free from cancer progression. This is known as progression-free survival, which is a measure of how long patients live without the cancer getting worse.

Participants in the study will receive the treatments as an infusion, which means the medication is delivered directly into the bloodstream through a vein. The study will also involve regular check-ups and assessments to monitor the patients’ health and any side effects they may experience. The trial aims to provide valuable information on whether the combination of mirvetuximab soravtansine and bevacizumab offers better outcomes for patients compared to bevacizumab alone. This research could potentially lead to improved treatment options for individuals with these types of cancers.

1 Joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including age, previous treatments, and health status.

A consent form is signed to confirm understanding and agreement to participate in the study.

2 Initial assessment

An initial assessment is conducted, which includes imaging tests like CT or MRI scans and blood tests to measure CA-125 levels.

This assessment occurs between 3 to 8 weeks after the last dose of previous chemotherapy.

3 Randomization

Participants are randomly assigned to one of two groups: one receiving mirvetuximab soravtansine with bevacizumab, and the other receiving bevacizumab alone.

This step must occur no later than 8 weeks after the last chemotherapy dose.

4 Treatment phase

For those in the combination group, mirvetuximab soravtansine and bevacizumab are administered through intravenous infusion.

The frequency and dosage are determined by the study protocol and monitored by healthcare professionals.

5 Monitoring and follow-up

Regular follow-up visits are scheduled to monitor health status, side effects, and treatment effectiveness.

These visits include physical exams, blood tests, and imaging studies as needed.

6 Completion of treatment

Upon completion of the treatment phase, a final assessment is conducted to evaluate the overall response to the treatment.

Participants may continue to be monitored for long-term outcomes and any delayed side effects.

Who Can Join the Study?

  • Patients must be at least 18 years old.
  • Patients must have received or be receiving specific chemotherapy drugs like paclitaxel, gemcitabine, or pegylated liposomal doxorubicin along with platinum-based therapy.
  • Patients must have shown a response to treatment, such as complete response (CR), partial response (PR), or stable disease (SD), after completing the therapy.
  • Patients must be randomized into the study within 8 weeks after their last dose of the platinum-based therapy.
  • Patients must have either measurable disease, elevated CA-125 levels, or no evidence of disease as determined by medical tests.
  • Patients must have recovered from any side effects of previous treatments, except for hair loss.
  • Patients must have completed any major surgery at least 4 weeks before starting the study treatment and have recovered from it.
  • Patients must have adequate blood, liver, and kidney function as defined by specific medical tests.
  • Patients must be willing to sign a consent form and follow the study requirements.
  • Females who can have children must agree to use effective birth control methods during the study and for at least 3 months after the last dose.
  • Females who can have children must have a negative pregnancy test before starting the therapy.
  • Patients must have a performance status of 0 or 1, which means they are fully active or have some restrictions but can still do light work.
  • Patients must have a confirmed diagnosis of high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer.
  • Patients must provide a tumor sample for testing or undergo a procedure to obtain a new biopsy to confirm high levels of a specific protein (FRα).
  • Patients must have had prior BRCA testing, which checks for specific genetic mutations, and have received certain treatments if they tested positive.
  • Patients’ disease must have returned after one line of platinum-based chemotherapy and must be sensitive to platinum, meaning it took more than 6 months for the disease to progress after the last dose.
  • Patients must be suitable for, currently on, or have completed platinum-based triplet therapy in the second line of treatment.
  • Patients must have received between 4 to 8 cycles of platinum-based triplet therapy, including at least 3 cycles with bevacizumab, unless stopped due to side effects.
  • In cases of certain surgeries, patients may have received fewer cycles of bevacizumab if given with the last cycles of platinum-based therapy.

Who Cannot Join the Study?

  • Patients who do not have platinum-sensitive cancers. This means the cancer should respond well to treatments that contain a metal called platinum.
  • Patients who do not have epithelial ovarian, fallopian tube, or primary peritoneal cancers. These are specific types of cancers that affect the ovaries, the tubes connecting the ovaries to the uterus, or the lining of the abdomen.
  • Patients who are not female, as the study is only for female participants.
  • Patients who are not considered part of a vulnerable population. This term refers to groups of people who might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Institut De Cancerologie Strasbourg Europe STRASBOURG, Alsace France
Diagnostic & Therapeutic Center Of Athens Hygeia Single Member S.A. Athens Greece
Orszagos Onkologiai Intezet Budapest Hungary
Ospedale San Raffaele S.r.l. Milan Italy
Alessandro Manzoni Hospital Lecco Italy
Nemocnice AGEL Novy Jicin a.s. Novy Jicin Czechia
Azienda USL Toscana Centro Prato Italy
Azienda Unita Sanitaria Locale Toscana Nord Ovest Lucca Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Klinikum Dortmund gGmbH Dortmund Germany
Grand Hopital De Charleroi Charleroi Belgium
Bon Secours Hospital Cork Cork Ireland
University Hospital Waterford Waterford Ireland
Wielkopolskie Centrum Onkologii Im. Marii Sklodowskiej-Curie Poznan Poland
Klinikum Esslingen GmbH Esslingen Am Neckar Germany
Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o. Siedlce Poland
Grand Hopital De Charleroi Charleroi Belgium
Mammazentrum Hamburg MVZ GbR Hamburg Germany
Jagiellońskie Centrum Innowacji Sp. z o.o. Cracow Poland
University Of Debrecen Debrecen Hungary
Universitaetsklinikum Erlangen AöR Erlangen Germany
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Ente Ospedaliero Ospedali Galliera Di Genova Genoa Italy
Alexandra Hospital Athens Greece
Charite Universitaetsmedizin Berlin KöR Berlin Germany
University Hospital Galway Galway Ireland
IRCCS Ospedale Policlinico San Martino Genoa Italy
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Klinikum Kassel GmbH Kassel Germany
Fakultni Nemocnice U Sv Anny V Brne Brno-Stred Czechia
Hospital Universitari De Girona Doctor Josep Trueta Girona Spain
Justus-Liebig-Universitaet Giessen Giessen Germany
Complex Oncological Center – Shumen EOOD Shumen Bulgaria
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach Kielce Poland
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
St. Luke’s Hospital S.A. Thessaloniki Greece
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer Barcelona Spain
Azienda Unita Sanitaria Locale Di Piacenza Piacenza Italy
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Algemeen Ziekenhuis Delta Roeselare Belgium
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Namur Belgium
AZ Sint-Lucas & Volkskliniek Gent Belgium
Azienda Ulss 3 Serenissima Venice Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
University Hospital Ostrava Ostrava Czechia
Beaumont Hospital Dublin Ireland
Hospital Universitario Virgen De La Victoria Malaga Spain
Hymiwtqho Mjvrusgm Svouzl Milan Italy
Imfwpkqy Rxvjoymmv Pmp Lx Sxllbz Dbk Tpjrbe Dqqn Aiscfyk Isib Ssclny Meldola Italy
Utxpnpmvck Mixqywu Cigloz Hqfaqeuykfgjugbqs Hamburg Germany
Ucxkodktoeamotfxoazif Eikjs Ayw Essen Germany
Coja Uvrqqmrhiv Hmxxnupo Cork Ireland
Scqmlbpw Ptbpblrag Snx z oawi Gdynia Poland
Ipqc Gsjxp Filothei Greece
Czmtjmavo Uqswqncvnwgajp Srrkbknua Woluwe-Saint-Lambert Belgium
Cjx Denwc Bwlztcrdz Hdkvyoi Ffjrggmc Mmpczmmin Dijon France
Ohpmlybadrxj Svvalilfnwhyucgbn Bielefeld Germany
Aswoopfzpp Ppbgnmoq Hizvkbfc Dl Mdapuaoyb Marseille France
Akfsqhq Oovgrtzoreq Pch Lscsmtnlfirvbhyox Cwjqdlfyev Catania Italy
Gddfibkpiqmmothtz Vuaxrjzix Pixo Afjmhz Egijwelu Owrzum Kjbwzl Gyor Hungary
Kkbbhchd dxm Ukcrvrdvsszb Mqqexgeg Aaq Munich Germany
Abzyfoy Urn Idbup Dz Rognrz Exibdt Reggio Emilia Italy
Aryjafr Utzjq Svrcruwju Lulrcc Dd Bgeliav Bologna Italy
Aprwxpo Ofeysuatjiz Uurldvgmleugz Pjycw Parma Italy
Cbvjlc Lyvh Bheliu Lyon France
Uwctowmvbr Dymmc Swwxf Dh Rucr Lt Srzoaans Rome Italy
Igmimgtb Cizjlo Dqjfxxiavqwtaejox L'hospitalet De Llobregat Spain
Fxudhubdg Pygv Lq Iripadmxzmveb Bywgbhnfd Dxn Hnafzawv Uewxtfcikcieu Lz Phm Madrid Spain
Ishufg Bonheiden Belgium
Kynaszlc Ejacxgvgmlvlqcfzglpvreku Hsxsarkvrkmackcif Essen Germany
Hzkkwbvm Vcrg dcedxqjv Barcelona Spain
Hiokvrsp Upmipniyeimte dx A Ccslyd A Coruna Galicia Spain
Hxrxrdtx Uvatvlrhgesbrf Suoghpwwpe &iqjwnz Hlhtxuj dl Hpcfimqejcq STRASBOURG, Alsace France
Iuatixtp Cahfg Paris France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
31.08.2023
Bulgaria Bulgaria
Not recruiting
31.08.2023
Czechia Czechia
Not recruiting
31.08.2023
France France
Not recruiting
31.08.2023
Germany Germany
Not recruiting
31.08.2023
Greece Greece
Not recruiting
31.08.2023
Hungary Hungary
Not yet recruiting
31.08.2023
Ireland Ireland
Not recruiting
31.08.2023
Italy Italy
Not recruiting
31.08.2023
Poland Poland
Not recruiting
31.08.2023
Spain Spain
Not recruiting
31.08.2023

Trial locations

Mirvetuximab Soravtansine is an experimental medication being studied for its potential to treat certain types of cancer. It is designed to target and bind to specific cancer cells, delivering a toxic substance directly to them to help destroy the cancer cells while minimizing damage to healthy cells. In this trial, it is being tested in combination with another medication to see if it can help prevent the cancer from coming back or getting worse.

Bevacizumab is a medication used to treat various types of cancer. It works by blocking a protein that helps cancer cells grow new blood vessels, which are needed for tumors to grow and spread. By inhibiting this protein, bevacizumab can help slow down or stop the growth of cancer. In this trial, it is used both alone and in combination with another medication to see how effective it is in maintaining the health of patients with certain types of ovarian and related cancers.

Platinum-sensitive epithelial ovarian cancer – This type of cancer originates in the epithelial cells of the ovaries and is characterized by its responsiveness to platinum-based chemotherapy. It often recurs after initial treatment but tends to respond well to subsequent rounds of platinum-based drugs. The disease progresses as cancer cells grow and spread within the ovaries and potentially to other areas of the pelvis and abdomen. Symptoms may include abdominal bloating, pelvic pain, and changes in bowel habits. The progression is typically monitored through imaging and tumor marker tests.

Platinum-sensitive fallopian tube cancer – This cancer arises in the epithelial cells lining the fallopian tubes and shares similarities with ovarian cancer in terms of treatment response. It is termed “platinum-sensitive” because it responds to platinum-based chemotherapy, especially after a period of remission. The disease can spread to nearby organs and tissues, leading to symptoms such as pelvic pain and abnormal vaginal bleeding. Monitoring involves regular imaging and clinical evaluations to assess the extent of disease spread.

Platinum-sensitive primary peritoneal cancer – This cancer develops in the peritoneum, a thin layer of tissue lining the abdomen, and is closely related to ovarian cancer. It is considered platinum-sensitive when it responds to platinum-based chemotherapy after initial treatment. The cancer can spread throughout the abdominal cavity, causing symptoms like abdominal pain and swelling. Disease progression is tracked through imaging studies and clinical assessments to evaluate the response to treatment.

Trial ID:
2022-501606-35-01
Protocol code:
IMGN853-0421
NCT ID:
NCT05445778
Trial Phase:
Human Pharmacology (Phase I) – Other

Other Trials to Consider

  • Phase 3 Study of LY4170156 (Sofetabart Mipitecan) with drug combination in platinum‑resistant and platinum‑sensitive ovarian cancer patients

    Recruiting

    3 1 1 1
    Austria Belgium Czechia Denmark France Germany +9
  • Comparing AZD5335 with Mirvetuximab Soravtansine or a drug combination in patients with platinum-resistant ovarian cancer

    Recruiting

    3 1 1 1
    Belgium Czechia Denmark France Germany Greece +4