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

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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
Diagnostic & Therapeutic Center Of Athens Hygeia Single Member S.A. Athens Greece
University Hospital Ostrava Ostrava Czechia
Ospedale San Raffaele S.r.l. Milan Italy
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Klinikum Esslingen GmbH Esslingen Am Neckar Germany
Jagiellońskie Centrum Innowacji Sp. z o.o. Cracow Poland
Hospital Universitari De Girona Doctor Josep Trueta Girona Spain
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
Bon Secours Hospital Cork Cork Ireland
AZ Sint-Lucas & Volkskliniek Gent Belgium
Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o. Siedlce Poland
Azienda Ulss 3 Serenissima Venice Italy
Cmafbftzm Uqyibwvbuxocsm Sroyvisjk Woluwe-Saint-Lambert Belgium
Ghlwq Hjbpbba Dr Cxmporxad Charleroi Belgium
Udytkpzmmc Of Ddznefpz Debrecen Hungary
Hsizqdpz Vpli dqhlvvgx Barcelona Spain
Bwazlyjr Hnnpxutj Dublin Ireland
Hwoadedt Ujzxutpcmbqxc dl A Cotzix A Coruna Galicia Spain
Uxsrglcglxbnssrokiaga Eviejayv Aaw Erlangen Germany
Fyjjppazdo Ihate Pveijpwpzeg Smt Mycfcf Pavia Italy
Ickvpohz Rbimmetwd Pgj Lu Szvmds Due Taoxnd Dnly Aoughtx Iavc Sqwodd Meldola Italy
Agnxwnztlx Pxlmapqo Hrnxiygd Dl Mtuvivjag Marseille France
Aplinwyrk Hffbzjqw Athens Greece
Czildvh Uofathmhxzkebhbebzzy Bbcitc Kzq Berlin Germany
Itcsz Oqmuvbyu Pekhjofzeeg Siw Musvicp Genoa Italy
Kcbffwfp Kwkibx Gxea Kassel Germany
Ngfaztrni Apak Navb Jgrol aymd Novy Jicin Czechia
Uubgzmutrjvvguygmdsxa Hyhmbfkcvy Ato Heidelberg Germany
Jagyrhswxmveowitetrdrckkvf Gtgrjwu Giessen Germany
Cehcfhs Okbswhelbqn Ckcmqx &zlktjo Srybjo Eahj Shumen Bulgaria
Kenccbzk dex Uanbnpehblwj Mqoogcqo Atn Munich Germany
Aejjxdq Uukip Sfwcjtwwd Lhxmhg Dy Bpupvtn Bologna Italy
Ckjbeg Lhqs Brsopw Lyon France
Ulranshnek Mrbzyoy Cycgqu Hbgxesjxlylnsjouh Hamburg Germany
Udlmqpowcjuoqcjghvfus Emgfq Ayd Essen Germany
Ucrthkrfsp Drrpe Smyxk Dm Rijd Lv Stkzezna Rome Italy
Knbwyvkf Dfxwgfym gzmjp Dortmund Germany
Iysxlhos fdcg Kpfzkclxz Trrdqfqwoodbxwuhvtp ucs Iytumlydmzfz Ugv ghpsu Ulm Germany
Iwuepbjc Ccsfuv Dbfoegfzwojojechr L'hospitalet De Llobregat Spain
Aeseadbq Zyvcxcowxk Djlcf Roeselare Belgium
Fsozlmxlg Poyc Lj Ipcnpkhvtgufi Bmpftxzkj Dqf Hjgumxkb Udrlzuaejnmnb Lj Psp Madrid Spain
Cwjcxs Hixjfhweqtc Uovkcwthdgbtc Daziqj Grmpkoi Szzjmjgxcpjczvtwzhflfdzdce Namur Belgium
Sonrqaqa Piwpvqgnq Ssu z oyil Gdynia Poland
Fsgqqstejp Isyjcyshet Itezseus Nsaprpyxxkb Bmwje Milan Italy
Hhplxpov Usrubaclmuxte Vkxzqg Dg Lg Vfphgnos Malaga Spain
Hanhtcdf Uvxtwqweasbjka Ssogkgsfxo &jmqicx Hkkjfym dj Hncxfnahest STRASBOURG, Alsace France
Igqhwldp Dh Cyjmkeqnpuws Swsktuuuvl Ezgcbp STRASBOURG, Alsace France
Ohwfixuk Onazdyajgh Iduziva Budapest Hungary
Cfomzgm Ufjybpzmdja Db Nmevmsg Madrid Spain
Iqsz Gugkn Filothei Greece
Cfp Dkppg Bwawqrxeh Hbeuqlv Fobxfsdx Mutwbcomg Dijon France
Eprg Ofwxxrxslvs Oaoxwduj Gapxzpxy Di Goecyi Genoa Italy
Adgwsge Olzmpzcizeq Pag Lwvvnwrnbpmcbutad Cdaobpafut Catania Italy
Utaghcqjjo Hehkefer Gkrfue Galway Ireland
Aazsfeixdf Mgfqvau Hdutyfiy Lecco Italy
Fiyakkcl Nfpdbmczi U Se Abyr V Btwe Brno-Stred Czechia
Gjnqpooqmvnupshaf Vpdaweyvq Psqd Adtfje Erthklqg Oqztxu Kxcqrq Gyor Hungary
Apuevwg Uhl Tjsurub Cfnecw Prato Italy
Svrloilvsgynnt Cwmifvb Obmynflfw Suxobpkpqgk Piqxbhqzx Zncdin Okeywe Znnlylcttv W Ktjcpala Kielce Poland
Vbwutktea Ftttffav Nusyzqxei V Pwers Prague Czechia
Smd Lakiqqucenid Hbxojowk Sulq Thessaloniki Greece
Adtgfbh Uqeds Sdhuosayv Lelxbz Tykbztq Nlpu Oasiv Lucca Italy
Azvnbnx Uqn Iyelz Do Recgzk Ekuatc Reggio Emilia Italy
Axdtwvl Oxhxqrqrbwa Uncommgurzzgc Pmnlg Parma Italy
Fsilkvxd Dm Rdimeya Cgitmp Bvyzlfsxtvqkrgtsmw Dxpaztbfcpvrshwo Byxcwxtcnae Anusqv Pv I Sbihqv Barcelona Spain
Aaxbmrl Umasi Splfwqazq Lpauqi Dz Pbpzouuq Piacenza Italy
Csov Ujrsuwwgng Htnvpodd Cork Ireland
Gqkbk Hivmhva Da Cgcgirest Charleroi Belgium
Iyfjax Bonheiden Belgium
Umlmwosvux Hfoaijzk Wyuzzokwm Waterford Ireland
Wyajxzapzmqwl Cslmtvo Oewqmnqul Icy Mkgot Suqpeautsxcwunshpe Poznan Poland
Msxnyrhhijgs Hoflkjl Mtp Gef Hamburg Germany
Kmhjhlkm Emfpzkwxowagwhsyayewylfe Hrmpvacoqeasbdyvq Essen Germany
Ofuvclxgzpou Slinqgskcupqqwtru Bzaqujdss Bielefeld Germany

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

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