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| ID | Type | Description | Link |
|---|---|---|---|
| GOG-3051 | Other Identifier | GOG Foundation | |
| ENGOT-GYN2 | Other Identifier | European Network of Gynaecological Oncological Trial Groups (ENGOT) |
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| Name | Class |
|---|---|
| GOG Foundation | NETWORK |
| European Network of Gynaecological Oncological Trial Groups (ENGOT) | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ipatasertib + Paclitaxel (PIK3CA/AKT1/PTEN-altered tumors) | Experimental | Participants in the Ipatasertib + Paclitaxel arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1. |
|
| Cobimetinib (BRAF/NRAS/KRAS/NF1-altered tumors) | Experimental | Participants in the Cobimetinib arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1. |
|
| Trastuzumab Emtansine (ERBB2-amplified/mutant tumors) | Experimental | Participants in the Trastuzumab Emtansine arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1. |
|
| Atezolizumab + Bevacizumab (Non-matched) | Experimental | Participants in the Atezolizumab + Bevacizumab arm will receive treatment until unacceptable toxicity or loss of clinical benefit as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status. |
|
| Giredestrant + Abemaciclib (ER+ tumors) | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ipatasertib | Drug | Ipatasertib will be administered by mouth once a day on Days 1-21 of each cycle. (Cycle length = 28 days) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Confirmed Objective Response Rate (ORR) | 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. | Up to approximately 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (DOR) | 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. | Up to approximately 5 years |
| Disease Contral Rate (DCR) |
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Inclusion Criteria:
General Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Helen Diller Family CCC | San Francisco | California | 94158 | United States | ||
| Washington University School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40022843 | Derived | Ray-Coquard I, Ledermann J, DeFazio A, Okamoto A, Gershenson D. Controversies in the organization and structure of management for rare tumors. Int J Gynecol Cancer. 2025 Mar;35(3):101669. doi: 10.1016/j.ijgc.2025.101669. Epub 2025 Jan 29. |
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For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
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Participants in the Giredestrant + Abemaciclib arm will receive treatment until unacceptable toxicity or disease progression as determined by the investigator according to RECIST v1.1. |
|
| Inavolisib + Palbociclib (PIK3CA-altered tumors) | Experimental | Participants in the Inavolisib + Palbociclib arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1. |
|
| Inavolisib + Palbociclib + Letrozole (ER+ and PIK3CA-altered tumors) | Experimental | Participants in the Inavolisib + Palbociclib + Letrozole arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1. |
|
| Inavolisib + Olaparib (Non-matched) | Experimental | Participants in the Inavolisib + Olaparib arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1. |
|
| Inavolisib + Giredestrant (ER+ and PIK3CA-altered tumors) | Experimental | Participants in the Inavolisib + Giredestrant arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1. |
|
| Inavolisib + Bevacizumab (PIK3CA-altered tumors) | Experimental | Participants in the Inavolisib + Bevacizumab arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1. |
|
| Atezolizumab + Bevacizumab + Cyclophosphamide (Non-matched) | Experimental | Participants in the Atezolizumab + Bevacizumab + Cyclophosphamide arm will receive treatment until unacceptable toxicity or loss of clinical benefit as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status. |
|
|
| Cobimetinib | Drug | Cobimetinib will be administered by mouth once a day on Days 1-21 of each cycle. (Cycle length=28 days) |
|
|
| Trastuzumab Emtansine | Drug | Trastuzumab Emtansine will be administered intravenously on Day 1 of each cycle. (Cycle length=21 days) |
|
|
| Atezolizumab | Drug | Atezolizumab will be administered intravenously on Day 1 of each cycle. (Cycle length=21 days) |
|
|
| Bevacizumab | Drug | Bevacizumab will be administered intravenously on Day 1 of each cycle. (Cycle length=21 days) |
|
|
| Paclitaxel | Drug | Paclitaxel will be administered intravenously on Days 1, 8, and 15 of each cycle. (Cycle length=28 days) |
|
| Giredestrant | Drug | Giredestrant will be administered by mouth once a day on Days 1-28 of each cycle (Cycle length=28 days) |
|
| Abemaciclib | Drug | Abemaciclib will be administered by mouth twice a day during each 28-day cycle |
|
| Inavolisib | Drug | Inavolisib will be administered by mouth once a day on Days 1-28 of each 28-day cycle |
|
| Palbociclib | Drug | Palbociclib will be administered by mouth once a day on Days 1-21 of each 28-day cycle |
|
| Letrozole | Drug | Letrozole will be administered by mouth once a day on Days 1-28 of each 28-day cycle |
|
| Olaparib | Drug | Olaparib will be administered by mouth twice a day on Days 1-28 of each 28-day cycle |
|
| Luteinizing Hormone-Releasing Hormone (LHRH) Agonists | Drug | LHRH agonists are required beginning at least 2 weeks prior to initiation of study treatment for premenopausal or perimenopausal women. Acceptable agents include goserelin or leuprolide; triptorelin is also acceptable. Monthly injections of LHRH agonist are preferred. |
|
| Cyclophosphamide | Drug | Cyclophosphamide will be administered by mouth once a day on Days 1-21 of each cycle. (Cycle length = 21 days) |
|
| Inavolisib | Drug | Inavolisib will be administered by mouth once a day on Days 1-21 of each 21-day cycle |
|
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. |
| Up to approximately 5 years |
| Progression Free Survival (PFS) | 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. | Up to approximately 5 years |
| 6-Month PFS Rate | 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. | Up to 6 month |
| Overall Survival (OS) | OS after start of treatment is defined as the time from start of treatment to death from any cause. | Up to approximately 5 years |
| Confirmed ORR as Determined by IRC (Independent Review Committee) | Confirmed ORR, as determined by the IRC according to RECIST v1.1. | Up to approximately 5 years |
| DOR as Determined by IRC | DOR, as determined by the IRC according to RECIST v1.1 | Up to approximately 5 years |
| DCR as Determined by IRC | DCR, as determined by the IRC according to RECIST v1.1 | Up to approximately 5 years |
| PFS as Determined by IRC | PFS, as determined by the IRC according to RECIST v1.1 | Up to approximately 5 years |
| Percentage of Participants With Adverse Events | Percentage of participants with adverse events. | Up to approximately 5 years |
| St Louis |
| Missouri |
| 63108 |
| United States |
| Levine Cancer Institute | Charlotte | North Carolina | 28204 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| Texas Oncology - Gulf Coast | The Woodlands | Texas | 77380 | United States |
| Virginia Oncology Associates | Norfolk | Virginia | 23502 | United States |
| University of Washington - Seattle Cancer Care Alliance | Seattle | Washington | 98109 | United States |
| Cabrini Hospital | Malvern | Victoria | 3144 | Australia |
| Princess Margaret Cancer Center | Toronto | Ontario | M5G 1Z5 | Canada |
| McGill University Health Centre - Glen Site | Montreal | Quebec | H4A 3J1 | Canada |
| Gynekologicko-porodnicka klinika | Prague | 120 00 | Czechia |
| CHU Besançon - Hôpital Jean Minjoz | Besançon | 25030 | France |
| Centre Francois Baclesse | Caen | 14076 | France |
| Centre Leon Berard | Lyon | 69373 | France |
| Groupe Hospitalier Diaconesses | Paris | 75020 | France |
| Centre Eugène Marquis | Rennes | 35042 | France |
| ICO - Site René Gauducheau | Saint-Herblain | 44805 | France |
| Institut Claudius Regaud | Toulouse | 31059 | France |
| Gustave Roussy | Villejuif | 94800 | France |
| Kliniken Essen-Mitte Evang. Huyssens-Stiftung, Klinik für Gynäkologie und gynäkologische Onkologie | Essen | 45136 | Germany |
| Universitätsklinikum Mannheim | Mannheim | 68167 | Germany |
| A.O. U. Consorziale Policlinico di Bari | Bari | Apulia | 70124 | Italy |
| Istituto Tumori Napoli | Naples | Campania | 80131 | Italy |
| Policlinico Universitario Agostino Gemelli | Rome | Lazio | 00168 | Italy |
| IRCCS S. Raffaele | Milan | Lombardy | 20132 | Italy |
| LLC Medscan | Moskva | Moscow Oblast | 119421 | Russia |
| 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 |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Institutio Catalan De Oncologia | Barcelona | 08908 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Hospital Clinico Universitario Virgen de la Victoria | Málaga | 29010 | Spain |
| Hôpitaux Universitaires de Genève | Geneva | 1205 | Switzerland |
| Adana Baskent University Medical Faculty; Oncology | Adana | 01220 | Turkey (Türkiye) |
| Baskent Universitesi Ankara Hastanesi; Tıbbi Onkoloji Bölümü | Ankara | 06490 | Turkey (Türkiye) |
| Koc University Medical Faculty; Department of Gynecology & Obstetrics | Istanbul | 34010 | Turkey (Türkiye) |
| Western General Hospital | Edinburgh | EH4 2XU | United Kingdom |
| University College London Hospitals NHS Foundation Trust - University College Hospital | London | NW1 2PG | United Kingdom |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| C583616 | ipatasertib |
| C574276 | cobimetinib |
| D000080044 | Ado-Trastuzumab Emtansine |
| C000594389 | atezolizumab |
| D000068258 | Bevacizumab |
| D017239 | Paclitaxel |
| C000720132 | giredestrant |
| C000590451 | abemaciclib |
| C000723546 | inavolisib |
| C500026 | palbociclib |
| D000077289 | Letrozole |
| C531550 | olaparib |
| D007987 | Gonadotropin-Releasing Hormone |
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D008453 | Maytansine |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D000068878 | Trastuzumab |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D009570 | Nitriles |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
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