Current partner codePEPTIDESDE
NCT04931342·Phase 2·INTERVENTIONAL

A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors

Status

Active, not recruiting

Phase

Phase 2

Enrollment

176

Locations

41

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

This study will evaluate the efficacy and safety of multiple biomarker-selected treatments in patients with persistent or recurrent rare epithelial ovarian, fallopian tube, or primary peritoneal tumors. Enrollment will take place in two phases: a preliminary phase followed by a potential expansion phase.

Interventions

Treatment arms and agents.

DRUG

Ipatasertib

Ipatasertib will be administered by mouth once a day on Days 1-21 of each cycle. (Cycle length = 28 days)

DRUG

Cobimetinib

Cobimetinib will be administered by mouth once a day on Days 1-21 of each cycle. (Cycle length=28 days)

DRUG

Trastuzumab Emtansine

Trastuzumab Emtansine will be administered intravenously on Day 1 of each cycle. (Cycle length=21 days)

DRUG

Atezolizumab

Atezolizumab will be administered intravenously on Day 1 of each cycle. (Cycle length=21 days)

DRUG

Bevacizumab

Bevacizumab will be administered intravenously on Day 1 of each cycle. (Cycle length=21 days)

DRUG

Paclitaxel

Paclitaxel will be administered intravenously on Days 1, 8, and 15 of each cycle. (Cycle length=28 days)

DRUG

Giredestrant

Giredestrant will be administered by mouth once a day on Days 1-28 of each cycle (Cycle length=28 days)

DRUG

Abemaciclib

Abemaciclib will be administered by mouth twice a day during each 28-day cycle

DRUG

Inavolisib

Inavolisib will be administered by mouth once a day on Days 1-28 of each 28-day cycle

DRUG

Palbociclib

Palbociclib will be administered by mouth once a day on Days 1-21 of each 28-day cycle

DRUG

Letrozole

Letrozole will be administered by mouth once a day on Days 1-28 of each 28-day cycle

DRUG

Olaparib

Olaparib will be administered by mouth twice a day on Days 1-28 of each 28-day cycle

Timeline

From registration to results.

  1. First posted

    Jun 18, 2021

  2. Study start

    Oct 7, 2021

  3. Primary completion

    Feb 28, 2028

  4. Study completion

    May 30, 2028

  5. Results posted

    Not reported

  6. Registry updated

    Jun 8, 2026

Outcomes

What the study measures.

Primary outcomes

Confirmed Objective Response Rate (ORR)

Time frame · Up to approximately 5 years

Confirmed ORR is defined as the proportion of participants with a confirmed complete response (CR) or partial response (PR) (demonstrated on two consecutive occasions \>=4 weeks apart), as determined by the investigator according to RECIST v1.1.

Secondary outcomes

Duration of Response (DOR)

Time frame · Up to approximately 5 years

DOR is defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1.

Disease Contral Rate (DCR)

Time frame · Up to approximately 5 years

DCR is defined as the proportion of participants with a confirmed CR or PR, or stable disease maintained for at least 16 weeks, as determined by the investigator according to RECIST v1.1.

Progression Free Survival (PFS)

Time frame · Up to approximately 5 years

PFS after start of treatment is defined as the time from start of treatment to the first occurrence of disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1.

6-Month PFS Rate

Time frame · Up to 6 month

6-month PFS rate is defined as the proportion of participants who remained alive and progression-free at 6 months after start of treatment, as determined by the investigator according to RECIST v1.1.

Overall Survival (OS)

Time frame · Up to approximately 5 years

OS after start of treatment is defined as the time from start of treatment to death from any cause.

Confirmed ORR as Determined by IRC (Independent Review Committee)

Time frame · Up to approximately 5 years

Confirmed ORR, as determined by the IRC according to RECIST v1.1.

DOR as Determined by IRC

Time frame · Up to approximately 5 years

DOR, as determined by the IRC according to RECIST v1.1

DCR as Determined by IRC

Time frame · Up to approximately 5 years

DCR, as determined by the IRC according to RECIST v1.1

PFS as Determined by IRC

Time frame · Up to approximately 5 years

PFS, as determined by the IRC according to RECIST v1.1

Percentage of Participants With Adverse Events

Time frame · Up to approximately 5 years

Percentage of participants with adverse events.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
FEMALE
Healthy volunteers
No

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

Study locations

41 registered sites.

Australia · Canada · Czechia · France · Germany · Italy · Russia · South Korea · Spain · Switzerland · Turkey (Türkiye) · United Kingdom · United States. Showing up to 24 locations stored in the fast local snapshot.

UCSF Helen Diller Family CCC

San Francisco, California, United States

Washington University School of Medicine

St Louis, Missouri, United States

Levine Cancer Institute

Charlotte, North Carolina, United States

Ohio State University

Columbus, Ohio, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Texas Oncology - Gulf Coast

The Woodlands, Texas, United States

Virginia Oncology Associates

Norfolk, Virginia, United States

University of Washington - Seattle Cancer Care Alliance

Seattle, Washington, United States

Cabrini Hospital

Malvern, Victoria, Australia

Princess Margaret Cancer Center

Toronto, Ontario, Canada

McGill University Health Centre - Glen Site

Montreal, Quebec, Canada

Gynekologicko-porodnicka klinika

Prague, Czechia

CHU Besançon - Hôpital Jean Minjoz

Besançon, France

Centre Francois Baclesse

Caen, France

Centre Leon Berard

Lyon, France

Groupe Hospitalier Diaconesses

Paris, France

Centre Eugène Marquis

Rennes, France

ICO - Site René Gauducheau

Saint-Herblain, France

Institut Claudius Regaud

Toulouse, France

Gustave Roussy

Villejuif, France

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

Essen, Germany

Universitätsklinikum Mannheim

Mannheim, Germany

A.O. U. Consorziale Policlinico di Bari

Bari, Apulia, Italy

Istituto Tumori Napoli

Naples, Campania, Italy

Related trials

More studies on Goserelin.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.