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New hope for rare ovarian tumors: targeted drugs under study

NCT ID NCT04931342

Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 11, 2026 · Updated 3 times

Summary

This phase 2 trial is testing several targeted drugs in people with rare types of ovarian cancer that have come back or not gone away. The drugs are chosen based on specific biomarkers in each patient's tumor. The goal is to see if these treatments can shrink or control the cancer. About 176 participants will receive one of four drugs: ipatasertib, cobimetinib, trastuzumab emtansine, or atezolizumab.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Ipatasertib, Cobimetinib, Trastuzumab Emtansine, Atezolizumab
What this could lead to
If successful, this could provide effective treatment options for people with rare ovarian cancers that have returned or not responded to standard therapy.
What could go wrong
This is an early-phase study with a small number of participants. The drugs may not work for all tumor types, and side effects could limit their use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

176 people

The number who actually took part.

Started

Oct 2021

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Persistent or recurrent EOC that meets the following criteria: Histologically confirmed non-high-grade serous, non-high-grade endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer, including but not limited to low-grade serous ovarian carcinoma, clear cell carcinoma, mucinous carcinoma, carcinosarcoma, undifferentiated carcinoma, seromucinous carcinoma, malignant Brenner tumors, Grades 1 or 2 endometrioid carcinoma, mesonephric-like adenocarcinoma and small cell carcinoma of the ovary, hypercalcemic type (SCCOHT). Disease that is not amenable to curative surgery * Measurable disease (at least one target lesion) according to RECIST v1.1 * Previous treatment with one to four lines of therapy, at least one of which was platinum-based. Hormonal therapy does not count as a line of therapy. * Platinum-resistant disease, defined as disease progression during or within 6 months of last platinum therapy, with the following exception: Participants with primary platinum-refractory disease are excluded. * Submission of a representative tumor specimen that is suitable for next-generation sequencing (NGS) testing and estrogen receptor immunohistochemistry (ER IHC) to determine treatment arm assignment and for central pathology review. * Submission of the local pathology report and, if available, any associated stained slides that supported the local diagnosis of the histology (to be used for central pathology review) * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Adequate hematologic and end-organ function * For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs (if applicable) * In addition to the general inclusion criteria above, participants must meet all of the arm-specific inclusion criteria for the respective arm General Exclusion Criteria: * Pregnant or breastfeeding, or intending to become pregnant or breastfeed during the study * Primary platinum-refractory disease, defined as progression during or within 4 weeks after the last dose of the first-line platinum treatment * Histologic diagnosis of high-grade serous or high-grade endometrioid ovarian, fallopian tube, or primary peritoneal cancer * Current diagnosis of solely borderline epithelial ovarian tumor * Current diagnosis of non-epithelial ovarian tumors * Current diagnosis of synchronous primary endometrial cancer * Prior history of primary endometrial cancer, with the following exception: a prior diagnosis of primary endometrial cancer is permitted if it meets all of the following conditions: Stage IA, no lymphovascular invasion, International Federation of Gynecology and Obstetrics Grade 1 or 2, not a high-grade subtype. * Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures * Symptomatic, untreated, or actively progressing CNS metastases * Severe infection within 4 weeks prior to initiation of study treatment * Treatment with chemotherapy, radiotherapy, antibody therapy or other immunotherapy, gene therapy, vaccine therapy, or investigational therapy within 28 days prior to initiation of study treatment * Treatment with hormonal therapy within 14 days prior to initiation of study treatment * In addition to the general exclusion criteria above, participants can not meet any of the arm-specific exclusion criteria for the respective arm

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Conditions

The condition(s) this trial relates to.

ovarian cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ovarian cancer

Contacts and locations

Locations

  • A.O. U. Consorziale Policlinico di Bari

    Bari, Apulia, 70124, Italy

  • Adana Baskent University Medical Faculty; Oncology

    Adana, 01220, Turkey (Türkiye)

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Baskent Universitesi Ankara Hastanesi; Tıbbi Onkoloji Bölümü

    Ankara, 06490, Turkey (Türkiye)

  • CHU Besançon - Hôpital Jean Minjoz

    Besançon, 25030, France

  • Cabrini Hospital

    Malvern, Victoria, 3144, Australia

  • Centre Eugène Marquis

    Rennes, 35042, France

  • Centre Francois Baclesse

    Caen, 14076, France

  • Centre Leon Berard

    Lyon, 69373, France

  • Groupe Hospitalier Diaconesses

    Paris, 75020, France

  • Gustave Roussy

    Villejuif, 94800, France

  • Gynekologicko-porodnicka klinika

    Prague, 120 00, Czechia

  • Hospital Clinico Universitario Virgen de la Victoria

    Málaga, 29010, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hôpitaux Universitaires de Genève

    Geneva, 1205, Switzerland

  • ICO - Site René Gauducheau

    Saint-Herblain, 44805, France

  • IRCCS S. Raffaele

    Milan, Lombardy, 20132, Italy

  • Institut Claudius Regaud

    Toulouse, 31059, France

  • Institutio Catalan De Oncologia

    Barcelona, 08908, Spain

  • Istituto Tumori Napoli

    Naples, Campania, 80131, Italy

  • Kliniken Essen-Mitte Evang. Huyssens-Stiftung, Klinik für Gynäkologie und gynäkologische Onkologie

    Essen, 45136, Germany

  • Koc University Medical Faculty; Department of Gynecology & Obstetrics

    Istanbul, 34010, Turkey (Türkiye)

  • LLC Medscan

    Moskva, Moscow Oblast, 119421, Russia

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204, United States

  • McGill University Health Centre - Glen Site

    Montreal, Quebec, H4A 3J1, Canada

  • Ohio State University

    Columbus, Ohio, 43210, United States

  • Policlinico Universitario Agostino Gemelli

    Rome, Lazio, 00168, Italy

  • Princess Margaret Cancer Center

    Toronto, Ontario, M5G 1Z5, Canada

  • Samsung Medical Center

    Seoul, (0)6351, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722, South Korea

  • Texas Oncology - Gulf Coast

    The Woodlands, Texas, 77380, United States

  • UCSF Helen Diller Family CCC

    San Francisco, California, 94158, United States

  • University College London Hospitals NHS Foundation Trust - University College Hospital

    London, NW1 2PG, United Kingdom

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104, United States

  • University of Washington - Seattle Cancer Care Alliance

    Seattle, Washington, 98109, United States

  • Universitätsklinikum Mannheim

    Mannheim, 68167, Germany

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63108, United States

  • Western General Hospital

    Edinburgh, EH4 2XU, United Kingdom

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