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Search / Trial NCT05445778

Mirvetuximab Soravtansine With Bevacizumab Versus Bevacizumab as Maintenance in Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer

Launched by ABBVIE · Jun 30, 2022

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Platinum Sensitive Folate Receptor Alpha Expression Antibody Drug Conjugate Cancer Ovarian Neoplasma Recurrent Platinum Sensitive High Grade Ovarian Adc Adult

ClinConnect Summary

The GLORIOSA clinical trial is studying a new treatment approach for patients with certain types of ovarian, fallopian tube, or peritoneal cancer who have responded well to previous platinum-based chemotherapy. The trial is comparing a medication called mirvetuximab soravtansine, combined with another drug called bevacizumab, to bevacizumab alone, to see if the combination is safer and more effective for maintaining health after initial treatment. This study is currently looking for participants aged 18 and older who have specific types of cancer that show a high level of a protein called folate receptor-alpha.

To be eligible, participants must have had a good response to their last treatment and meet certain health criteria. They will need to provide a sample of their tumor for testing and undergo some routine health checks. If chosen for the trial, participants can expect regular visits for treatment and monitoring, which includes scans and blood tests to track their progress. It’s important to note that this trial is specifically for patients who have already been treated with platinum-based chemotherapy and are considered "platinum-sensitive," meaning their cancer hasn’t progressed for more than six months after their last treatment.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • 1. Adult women \>/=18 years old
  • 2. Confirmed diagnosis of high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer
  • 3. Confirmed high FRα expression by regulatory-agency approved Ventana FOLR1 (FOLR1-2.1)
  • 4. Relapsed disease after frontline (first-line) platinum-based chemotherapy and must be plantinum-sensitive
  • 5. Willing and able to sign the informed consent form (ICF) and adhere to protocol requirements
  • 6. Negative pregnancy test and willing to use highly effective contraceptive method(s) while on study medication and for at least 7 months after the last dose of MIRV and 6 months after the last dose of bevacizumab
  • Exclusion Criteria:
  • 1. Endometrioid, clear cell, mucinous, or sarconmatous histology; mixed tumors containing any of the above or low grade/borderline ovarian tumor
  • 2. More than one line of prior chemotherapy before current/planned triplet therapy
  • 3. PD (progressive disease) while on or following platinum-based therapy
  • 4. Prior or whole-pelvis or wide-field radiotherapy
  • 5. \> Grade 1 peripheral neuropathy
  • 6. History of or concurrent ocular disorders
  • 7. Grade 4 thromboembolic events
  • 8. Not appropriate for bevacizumab treatment
  • 9. Requiring use of folate-containing supplements
  • 10. Prior hypersensitivity to monoclonal antibodies
  • 11. Pregnant or breatfeeding women
  • 12. Received prior MIRV or other FRα-targeting agents
  • 13. Untreated or symptomatic central nervous system metastases
  • 14. History of other malignancy within 3 years prior to signing study consent

About Abbvie

AbbVie is a global biopharmaceutical company dedicated to developing innovative therapies that address complex health challenges. Founded in 2013 as a spin-off from Abbott Laboratories, AbbVie focuses on key therapeutic areas, including immunology, oncology, neuroscience, and virology. The company is committed to advancing scientific research and delivering groundbreaking treatments that enhance patient outcomes and quality of life. With a robust pipeline and a strong emphasis on collaboration, AbbVie strives to transform the future of medicine through its commitment to clinical excellence and patient-centered approaches.

Locations

Columbus, Ohio, United States

Charlottesville, Virginia, United States

Lyon, , France

Seattle, Washington, United States

New Orleans, Louisiana, United States

Chicago, Illinois, United States

Valencia, , Spain

Cork, , Ireland

Dublin, , Ireland

Baltimore, Maryland, United States

Palo Alto, California, United States

Boston, Massachusetts, United States

New York, New York, United States

Miami, Florida, United States

Omaha, Nebraska, United States

Cincinnati, Ohio, United States

Fort Lauderdale, Florida, United States

Sarasota, Florida, United States

Iowa City, Iowa, United States

Westwood, Kansas, United States

Lexington, Kentucky, United States

Atlanta, Georgia, United States

Jacksonville, Florida, United States

Bologna, , Italy

Cheltenham, , United Kingdom

Hamilton, Ontario, Canada

La Jolla, California, United States

Lexington, Kentucky, United States

Westmead, , Australia

Barcelona, , Spain

Paris, , France

New Orleans, Louisiana, United States

Stockholm, , Sweden

Turku, , Finland

Dresden, , Germany

Ottawa, Ontario, Canada

Heidelberg, , Germany

Hamburg, , Germany

Kassel, , Germany

Iowa City, Iowa, United States

Baltimore, Maryland, United States

Seoul, , Korea, Republic Of

Seoul, , Korea, Republic Of

Seoul, , Korea, Republic Of

Melbourne, Victoria, Australia

Stavanger, , Norway

Dijon, , France

Salvador, , Brazil

Málaga, , Spain

Brno, , Czechia

Scarborough, Maine, United States

Tianjin, Tianjin, China

Pavia, , Italy

Fuzhou, , China

Shizuoka, , Japan

Shanghai, Shanghai, China

Catania, , Italy

Baltimore, Maryland, United States

Hangzhou, , China

Honolulu, Hawaii, United States

Rio De Janeiro, , Brazil

Bonheiden, , Belgium

Charleroi, , Belgium

Oulu, , Finland

Dortmund, , Germany

Genova, , Italy

Mobile, Alabama, United States

Chapel Hill, North Carolina, United States

San Juan, , Philippines

Tromsø, , Norway

Toronto, Ontario, Canada

Hangzhou, Zhejiang, China

Zhengzhou, Henan, China

Córdoba, , Spain

Esslingen, , Germany

Hackensack, New Jersey, United States

Milano, , Italy

Porto Alegre, , Brazil

Sutton, Surrey, United Kingdom

Southport, Queensland, Australia

Richmond, Virginia, United States

Teaneck, New Jersey, United States

Concord, California, United States

Milano, , Italy

Seoul, , Korea, Republic Of

Zhengzhou, Henan, China

Athens, , Greece

Beijing, Beijing, China

Goyang, Gyeonggi Do, Korea, Republic Of

Seoul, , Korea, Republic Of

Strasbourg, , France

Fuzhou, Fujian, China

Chicago, Illinois, United States

Seoul, , Korea, Republic Of

Zhengzhou, , China

Wuhan, , China

Athens, , Greece

Lublin, , Poland

Rozzano, , Italy

Durham, North Carolina, United States

Montreal, Quebec, Canada

Jinan, Shandong, China

Firenze, , Italy

Hamburg, , Germany

Bonn, , Germany

Montreal, Quebec, Canada

Seoul, , Korea, Republic Of

Sapporo Shi, , Japan

Chiba Shi, , Japan

Niigata Shi, , Japan

Sendai Shi, , Japan

Harbin, Heilongjiang, China

Seongnam, Gyeonggi Do, Korea, Republic Of

Seoul, , Korea, Republic Of

Clayton, Victoria, Australia

Wuhan, Hubei, China

Changsha, Hunan, China

Caba, , Argentina

Shenyang, Liaoning, China

Oslo, , Norway

Tulsa, Oklahoma, United States

Xian, Shaanxi, China

Seoul, , Korea, Republic Of

Parma, , Italy

Swansea, , United Kingdom

Linyi, Shandong, China

Pittsburgh, Pennsylvania, United States

Ostrava Poruba, , Czechia

Guangzhou, Guangdong, China

Reẖovot, , Israel

Kettering, Ohio, United States

Erlangen, , Germany

Galway, , Ireland

Ramat Gan, , Israel

Roma, , Italy

Jinan, , China

Madrid, , Spain

Sligo, , Ireland

Swansea, Wales, United Kingdom

Gdynia, , Poland

Namur, , Belgium

Kielce, , Poland

Chuo Ku, , Japan

Isehara, , Japan

Jinan, Shandong, China

Waterford, , Ireland

Poznań, , Poland

Prague, , Czechia

Indianapolis, Indiana, United States

Sapporo, , Japan

London, , United Kingdom

Bengbu, Anhui, China

Oklahoma City, Oklahoma, United States

Kurume Shi, Hukuoka, Japan

Genova, , Italy

Maroúsi, , Greece

İzmir, , Turkey

Taiyuan, Shanxi, China

Okayama Shi, , Japan

Prague, , Czechia

Albany, New York, United States

Rosario, , Argentina

Seoul, Jongro Gu, Korea, Republic Of

Caba, , Argentina

Brussel, , Belgium

Koto Ku, , Japan

Marseille, , France

Changchun, , China

Barcelona, Barcelona [Barcelona], Spain

New York, New York, United States

Shanghai, , China

Nagoya Shi, , Japan

Surrey, British Columbia, Canada

Kunming, Yunnan, China

Germantown, Tennessee, United States

Petah Tikva, , Israel

Reno, Nevada, United States

Grand Rapids, Michigan, United States

Fort Myers, Florida, United States

Indianapolis, Indiana, United States

Springfield, Massachusetts, United States

Maplewood, Minnesota, United States

Paramus, New Jersey, United States

Albany, New York, United States

Mineola, New York, United States

New York, New York, United States

New York, New York, United States

Eugene, Oregon, United States

Portland, Oregon, United States

Austin, Texas, United States

Bedford, Texas, United States

Dallas, Texas, United States

Fort Worth, Texas, United States

San Antonio, Texas, United States

Norfolk, Virginia, United States

Calgary, Alberta, Canada

Vancouver, British Columbia, Canada

Ballarat, Victoria, Australia

Brighton, Victoria, Australia

Richmond, Victoria, Australia

Willow Grove, Pennsylvania, United States

Iloilo, , Philippines

Pasig, , Philippines

Quezon City, , Philippines

Subiaco, Western Australia, Australia

Irvine, California, United States

Orange, California, United States

Edmonton, Alberta, Canada

Montreal, Quebec, Canada

Sherbrooke, Quebec, Canada

Haifa, , Israel

Holon, , Israel

Jerusalem, , Israel

Jerusalem, , Israel

Kefar Sava, , Israel

Tel Aviv Yaffo, , Israel

Seongnam, Gyeonggi Do, Korea, Republic Of

Daegu, , Korea, Republic Of

Chengdu, Sichuan, China

Akashi Shi, , Japan

Essen, , Germany

Kingston, Ontario, Canada

Nanning, Guangxi, China

Thessaloníki, , Greece

San Diego, California, United States

Richmond, Virginia, United States

Nový Jicín, , Czechia

Lecco, , Italy

Lucca, , Italy

Meldola, , Italy

Mirano, , Italy

Piacenza, , Italy

Prato, , Italy

Rome, , Italy

Iloilo City, , Philippines

Pasig, , Philippines

Barcelona, , Spain

Coruña, , Spain

Girona, , Spain

Pamplona, , Spain

Fulham, London, United Kingdom

Northwood, , United Kingdom

Southampton, , United Kingdom

Irvine, California, United States

Los Angeles, California, United States

Riverside, California, United States

San Diego, California, United States

San Marcos, California, United States

Chicago, Illinois, United States

Hackensack, New Jersey, United States

Sioux Falls, South Dakota, United States

Bonheiden, , Belgium

Gent, , Belgium

Roeselare, , Belgium

Barcelona, , Spain

Barcelona, , Spain

Coruña, , Spain

Girona, , Spain

Girona, , Spain

Madrid, , Spain

Madrid, , Spain

Pamplona, , Spain

Valencia, , Spain

La Jolla, California, United States

Athens, , Greece

Phoenix, Arizona, United States

Irvine, California, United States

San Diego, California, United States

Sylmar, California, United States

Chicago, Illinois, United States

Lebanon, New Hampshire, United States

Portland, Oregon, United States

Subiaco, , Australia

Brussel, , Belgium

Charleroi, , Belgium

Leuven, , Belgium

Namur, , Belgium

Pasig, Metro Manila, Philippines

San Juan, Metro Manila, Philippines

Barcelona, , Spain

Madrid, , Spain

Bielefeld, , Germany

Jerusalem, , Israel

Pittsburgh, Pennsylvania, United States

Caba, , Argentina

Córdoba, , Argentina

Santa Fe, , Argentina

Barretos, , Brazil

Belo Horizonte, , Brazil

Cuiabá, , Brazil

Fortaleza, , Brazil

Itajaí, , Brazil

Porto Alegre, , Brazil

Recife, , Brazil

Rio De Janeiro, , Brazil

Salvador, , Brazil

São Paulo, , Brazil

São Paulo, , Brazil

São Paulo, , Brazil

Shumen, , Bulgaria

Vratsa, , Bulgaria

Aalborg, , Denmark

Copenhagen, , Denmark

Kuopio, , Finland

Brest, , France

Dijon, , France

Essen, , Germany

Giesen, , Germany

Mainz, , Germany

Munich, , Germany

Cork, , Ireland

Dublin, , Ireland

Jerusalem, , Israel

Ramat Gan, , Israel

Safed, , Israel

Napoli, , Italy

Reggio Emilia, , Italy

Kraków, , Poland

Poznań, , Poland

Siedlce, , Poland

Uppsala, , Sweden

Adana, , Turkey

Adana, , Turkey

Ankara, , Turkey

Ankara, , Turkey

Istanbul, , Turkey

Fulham, London, United Kingdom

Sutton, Surrey, United Kingdom

Manchester, , United Kingdom

Northwood, , United Kingdom

Beijing, , China

Beijing, , China

Bengbu, , China

Chengdu, , China

Guangzhou, , China

Guangzhou, , China

Hangzhou, , China

Jinan, , China

Kunming, , China

Linyi, , China

Naning, , China

Shenyang, , China

Taiyuan, , China

Tianjin, , China

Urumqi, , China

Xian, , China

Zhengzhou, , China

Milan, , Italy

Yahaba, , Japan

Mobile, Alabama, United States

Phoenix, Arizona, United States

Irvine, California, United States

La Jolla, California, United States

Orange, California, United States

Palo Alto, California, United States

San Diego, California, United States

San Diego, California, United States

San Marcos, California, United States

Sylmar, California, United States

Walnut Creek, California, United States

Fort Lauderdale, Florida, United States

Fort Myers, Florida, United States

Jacksonville, Florida, United States

Miami, Florida, United States

Sarasota, Florida, United States

Atlanta, Georgia, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Indianapolis, Indiana, United States

Indianapolis, Indiana, United States

Iowa City, Iowa, United States

Westwood, Kansas, United States

Lexington, Kentucky, United States

Lexington, Kentucky, United States

New Orleans, Louisiana, United States

New Orleans, Louisiana, United States

Scarborough, Maine, United States

Baltimore, Maryland, United States

Manchester, Maryland, United States

Towson, Maryland, United States

Boston, Massachusetts, United States

Springfield, Massachusetts, United States

Grand Rapids, Michigan, United States

Coon Rapids, Minnesota, United States

Omaha, Nebraska, United States

Reno, Nevada, United States

Lebanon, New Hampshire, United States

Hackensack, New Jersey, United States

Paramus, New Jersey, United States

Teaneck, New Jersey, United States

Albany, New York, United States

Albany, New York, United States

Lake Success, New York, United States

New York, New York, United States

New York, New York, United States

Chapel Hill, North Carolina, United States

Durham, North Carolina, United States

Cincinnati, Ohio, United States

Columbus, Ohio, United States

Kettering, Ohio, United States

Oklahoma City, Oklahoma, United States

Tulsa, Oklahoma, United States

Eugene, Oregon, United States

Portland, Oregon, United States

Portland, Oregon, United States

Pittsburgh, Pennsylvania, United States

Pittsburgh, Pennsylvania, United States

Willow Grove, Pennsylvania, United States

Sioux Falls, South Dakota, United States

Germantown, Tennessee, United States

Austin, Texas, United States

Bedford, Texas, United States

Dallas, Texas, United States

Fort Worth, Texas, United States

San Antonio, Texas, United States

Charlottesville, Virginia, United States

Norfolk, Virginia, United States

Richmond, Virginia, United States

Seattle, Washington, United States

Rosario, Santa Fe, Argentina

Buenos Aires, , Argentina

Cordoba, , Argentina

Santa Fe, , Argentina

Westmead, New South Wales, Australia

Southport, Queensland, Australia

Ballarat, Victoria, Australia

Clayton, Victoria, Australia

Malvern, Victoria, Australia

Melbourne, Victoria, Australia

Richmond, Victoria, Australia

Subiaco, Western Australia, Australia

Bonheiden, Antwerpen, Belgium

Bruxelles, Bruxelles Capitale, Belgium

Charleroi, Hainaut, Belgium

Gent, Oost Vlaanderen, Belgium

Leuven, Vlaams Brabant, Belgium

Roeselare, West Vlaanderen, Belgium

Namur, , Belgium

Shumen, , Bulgaria

Vratsa, , Bulgaria

Calgary, Alberta, Canada

Edmonton, Alberta, Canada

Surrey, British Columbia, Canada

Vancouver, British Columbia, Canada

Hamilton, Ontario, Canada

Kingston, Ontario, Canada

Ottawa, Ontario, Canada

Toronto, Ontario, Canada

Montreal, Quebec, Canada

Montreal, Quebec, Canada

Montreal, Quebec, Canada

Sherbrooke, Quebec, Canada

Beijing, Beijing, China

Guangzhou, Guangdong, China

Changsha, Hunan, China

Changchun, Jilin, China

Urumqi, Xinjiang, China

Hangzhou, Zhejiang, China

Brno, Brno Mesto, Czechia

Prague, Ceske Budejovice, Czechia

Nový Jičín, Novy Jicin, Czechia

Ostrava, Ostrava Mesto, Czechia

Marseille, Bouches Du Rhone, France

Dijon, Bourgogne Franche Comte, France

Brest, Finistere, France

Lyon Cedex 08, Rhone, France

Paris, , France

Strasbourg, , France

Esslingen Am Neckar, Baden Wuerttemberg, Germany

Erlangen, Bayern, Germany

Bonn, Nordrhein Westfalen, Germany

Dortmund, Nordrhein Westfalen, Germany

Dresden, Sachsen, Germany

Giessen, , Germany

Hamburg, , Germany

Panorama, Thessaloniki, Greece

Athens, , Greece

Athens, , Greece

Marousi, , Greece

Dublin 8, Dublin, Ireland

Cork, , Ireland

Cork, , Ireland

Dublin, , Ireland

Galway, , Ireland

Sligo, , Ireland

Waterford, , Ireland

Haifa, , Israel

Holon, Hamerkaz, Israel

Kfar Saba, Hamerkaz, Israel

Petah Tikva, Hamerkaz, Israel

Rekhovot, Hamerkaz, Israel

Ramat Gan, Tel Aviv, Israel

Tel Aviv, Tel Aviv, Israel

Jerusalem, , Israel

Jerusalem, , Israel

Safed, , Israel

Florence, Firenze, Italy

Genoa, Genova, Italy

Genoa, Genova, Italy

Rozzano, Lombardia, Italy

Milan, Milano, Italy

Milan, Milano, Italy

Naples, Napoli, Italy

Meldola, Reggio Emilia, Italy

Rome, Roma, Italy

Rome, Roma, Italy

Mirano, Venezia, Italy

Bologna, , Italy

Catania, , Italy

Lecco, , Italy

Lucca, , Italy

Parma, , Italy

Pavia, , Italy

Piacenza, , Italy

Prato, , Italy

Reggio Emilia, , Italy

Nagoya Shi, Aichi, Japan

Chiba Shi, Chiba, Japan

Matsuyama, Ehime, Japan

Kurume Shi, Fukuoka, Japan

Sapporo Shi, Hokkaido, Japan

Sapporo, Hokkaido, Japan

Akashi Shi, Hyogo, Japan

Yahaba, Iwate, Japan

Isehara, Kanagawa, Japan

Sendai Shi, Miyagi, Japan

Niigata Shi, Niigata, Japan

Okayama Shi, Okayama, Japan

Hidaka, Saitama, Japan

Sunto Gun, Shizuoka, Japan

Chuo Ku, Tokyo, Japan

Koto Ku, Tokyo, Japan

Minato Ku, Tokyo, Japan

Shinjuku Ku, Tokyo, Japan

Goyang Si, Gyeonggido, Korea, Republic Of

Seongnam Si, Gyeonggido, Korea, Republic Of

Seongnam, Gyeonggido, Korea, Republic Of

Daegu, Gyeongsangbugdo, Korea, Republic Of

Seoul, Seoul Teugbyeolsi, Korea, Republic Of

Seoul, Seoul Teugbyeolsi, Korea, Republic Of

Seoul, Seoul Teugbyeolsi, Korea, Republic Of

Seoul, Seoul Teugbyeolsi, Korea, Republic Of

Seoul, Seoul Teugbyeolsi, Korea, Republic Of

Seoul, Seoul Teugbyeolsi, Korea, Republic Of

Seoul, Seoul Teugbyeolsi, Korea, Republic Of

Seoul, Seoul Teugbyeolsi, Korea, Republic Of

Pasig, National Capital Region, Philippines

Quezon City, National Capital Region, Philippines

San Juan City, National Capital Region, Philippines

Siedlce, Mazowieckie, Poland

Gdynia, Pomorskie, Poland

A Coruña, A Coruna, Spain

L'hospitalet De Llobregat, Barcelona, Spain

Pamplona, Navarra, Spain

Barcelona, , Spain

Barcelona, , Spain

Girona, , Spain

Madrid, , Spain

Madrid, , Spain

Valencia, , Spain

Ankara, , Turkey

Cheltenham, Gloucestershire, United Kingdom

London, Greater London, United Kingdom

London, Greater London, United Kingdom

Northwood, Greater London, United Kingdom

Southampton, Hampshire, United Kingdom

Sutton, Surrey, United Kingdom

Manchester, , United Kingdom

Swansea, , United Kingdom

Patients applied

0 patients applied

Trial Officials

ABBVIE INC.

Study Director

AbbVie

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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