Ovarian Cancer Clinical Trial
A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors
Summary
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.
Eligibility Criteria
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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There are 62 Locations for this study
Tucson Arizona, 85710, United States
Irvine California, 92618, United States
San Francisco California, 94158, United States
Saint Paul Minnesota, 55102, United States
Saint Louis Missouri, 63108, United States
New York New York, 10065, United States
Charlotte North Carolina, 28204, United States
Columbus Ohio, 43212, United States
Oklahoma City Oklahoma, 73104, United States
Tigard Oregon, 97223, United States
Harrisburg Pennsylvania, 17101, United States
Pittsburgh Pennsylvania, 15213, United States
Houston Texas, 77030, United States
The Woodlands Texas, 77380, United States
Salt Lake City Utah, 84112, United States
Norfolk Virginia, 23502, United States
Seattle Washington, 98109, United States
Malvern Victoria, 3144, Australia
Leuven , 3000, Belgium
Liège , 4000, Belgium
Kingston Ontario, K7L 2, Canada
Toronto Ontario, M5G 1, Canada
Montreal Quebec, H4A 3, Canada
Brno , 625 0, Czechia
Prague , 120 0, Czechia
Besançon Cedex , 25030, France
Bordeaux , 33076, France
Caen , 14076, France
Lyon , 69373, France
Montpellier , 34298, France
Paris , 75020, France
Rennes , 35000, France
Saint Herblain , 44805, France
Toulouse , 31059, France
Villejuif , 94805, France
Dresden , 01307, Germany
Essen , 45136, Germany
Mannheim , 68167, Germany
Muenchen , 81377, Germany
Napoli Campania, 80131, Italy
Roma Lazio, 00168, Italy
Milano Lombardia, 20132, Italy
Milano Lombardia, 20141, Italy
Candiolo Piemonte, 10060, Italy
Bari Puglia, 70124, Italy
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06351, Korea, Republic of
Moskva Moskovskaja Oblast, 11942, Russian Federation
Sankt-peterburg Sankt Petersburg, 19734, Russian Federation
Chelyabinsk Sverdlovsk, 45408, Russian Federation
Badalona Barcelona, 08916, Spain
Madrid , 28041, Spain
Madrid , 28046, Spain
Malaga , 29010, Spain
Genève , 1205, Switzerland
Adana , 01220, Turkey
Ankara , 06490, Turkey
Istanbul , 34010, Turkey
Edinburgh , EH4 2, United Kingdom
London , NW1 2, United Kingdom
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