High grade ovarian cancer, including high grade serous; clear cell; endometrioid, grade 3; and others (adenocarcinoma, nitric oxide synthase [NOS]; mixed epithelial carcinoma; undifferentiated carcinoma); NOTE: low grade serous, mucinous and carcinosarcoma histologies are excluded; ovarian cancer = ovarian, fallopian tube or primary peritoneal cancer; required data element: submission of pathology report
Cohort A Dose Expansion (Ribociclib + PDR001): Metastatic epithelial ovarian cancer, fallopian tube or peritoneal cancer; all histologies (including serous, mucinous, endometrioid, clear cell, MMMTs and mixed histologies) and tumor grades are eligible
Have a histologically confirmed diagnosis of high-grade serous or Grade 2 or Grade 3 endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer
In Part A, the patients must have an advanced malignancy including but not limited to high-grade serous cancer of the ovary, fallopian tube, or peritoneum (EOC), triple negative breast cancer (TNBC), SCLC, primary peritoneal cancer, and any tumor likely to harbor DNA damage repair deficiencies susceptible to treatment with a PARP inhibitor or likely to be responsive to a PD-1 blocker.
Women who have high-grade serous ovarian, primary peritoneal or fallopian tube cancer.
Part 2, Cohorts 1-3, all patients must have a histologically-confirmed diagnosis of high grade serous ovarian cancer (including fallopian tube cancer and/or primary peritoneal cancer)
Cohorts 1, 2, and 3: Patients with low-grade ovarian cancer (eg, low grade serous, mucinous carcinoma) are not eligible
Patients must have histologically confirmed high grade serous ovarian or primary peritoneal or fallopian tube cancer; platinum resistant disease is defined as progression within 6 months after last platinum regimen
Recurrent, persistent, or progressive epithelial ovarian, fallopian tube, or primary peritoneal cancer after treatment with bilateral oophorectomy and either cisplatin or carboplatin and either paclitaxel, albumin-bound paclitaxel, or docetaxel; histologic confirmation of the primary tumor is required; eligible histologies include serous, endometrioid, clear cell, mucinous, transitional cell, undifferentiated, or mixed carcinoma
Patients enrolling in the sporadic high grade serous epithelial or high grade endometrioid ovarian cancer group, cohort 2, must have a negative family history of hereditary breast ovarian cancer (HBOC) syndrome, or negative gBRCA1/2m test
Patients must have histologically or cytologically confirmed high grade serous or high grade endometrioid ovarian, fallopian tube, primary peritoneal cancer
Patients must have histologically or cytologically confirmed:\r\n* Recurrent endometrial cancer (all histologies, including carcinosarcoma)\r\n* Recurrent ovarian, primary peritoneal (female only), or fallopian tube cancer\r\n** all histologies except low grade serous or clear cell carcinoma unless the patient has a known\r\nsomatic or germline breast cancer (BRCA) mutation disease that is metastatic and for which standard curative\r\nmeasures do not exist or are no longer effective
Original diagnosis and/or histological confirmation of high-grade serous, high-grade endometrioid, undifferentiated/unclassifiable epithelial ovarian, fallopian tube or primary peritoneal cancer.
Patients must have histologically confirmed metastatic or recurrent endometrial cancer; eligible histologies include but are not limited to endometrioid, serous, clear cell, carcinosarcoma, adenosquamous, and mixed histologies
Participant may have serous, endometrioid, clear cell, mucinous or undifferentiated type of recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer\r\n* Histologic confirmation of the original primary tumor is required via the pathology report
Diagnosis of International Federation of Gynecology and Obstetrics (FIGO) grade 3 endometrioid cancer, serous, clear cell, or mixed high grade endometrial cancer with confirmation on research-related endometrial biopsy
A histologically confirmed diagnosis of high-grade serous epithelial ovarian cancer including primary peritoneal and fallopian tube malignancies; all other histologies, including mixed histology, are excluded
Patients with FIGO 2009 surgical Stage I or II endometrial clear cell or serous carcinoma and with positive peritoneal cytology.
Pathologically confirmed diagnosis of high-grade serous ovarian, primary peritoneal, or fallopian tube carcinoma
Histology consistent with primary peritoneal mesothelioma rather than primary peritoneal serous carcinoma
Patients for whom the diagnosis of high-grade serous or undifferentiated carcinoma of ovarian, peritoneal, or fallopian tubal origin is confirmed at surgery
Papillary serous, endometrioid, clear cell, undifferentiated and mixed histologies
ELIGIBILITY CRITERIA FOR REGISTRATION: subjects must have histologically confirmed carcinoma consistent with ovarian, fallopian tube, or primary peritoneal carcinoma (any of these three are referred to in this protocol as “ovarian cancer [OvCA]” OR a cytological diagnosis of carcinoma); the following histologic subtypes are included: serous, endometrioid, undifferentiated, clear cell, mixed, transitional, malignant Brenner tumor or adenocarcinoma not otherwise specified (NOS); subjects eligible for this study may be in one of three surgical categories: status post primary debulking surgery; undergoing neoadjuvant chemotherapy at a site not participating in correlative tissue collection sub study OR undergoing neoadjuvant chemotherapy at a site participating in correlative tissue collection sub study
Pathologically (histologically or cytologically) proven diagnosis of recurrent/persistent ovarian, or peritoneal endometrioid/clear cell carcinoma, OR recurrent/persistent low grade (grade 1 or 2) endometrioid endometrial adenocarcinoma; primary ovarian tumors must be at least 50% endometrioid/clear cell morphology, or have histologically documented recurrence with at least 50% endometrioid/clear cell morphology; appropriate tissue sections must be available for histologic evaluation for central pathology review by National Research Group (NRG) Oncology
Patients with clinical or surgical stage III or IV low-grade serous ovarian, primary peritoneal, or fallopian tube carcinomas who in the judgement of the treating physician are unlikely to achieve optimal surgical cytoreduction and have been recommended to receive neoadjuvant therapy.
The participant must have a histologic diagnosis of recurrent high grade serous ovarian cancer (ovarian, tubal, peritoneal), to be treated with chemotherapy
Histologically confirmed high grade serous or endometrioid ovarian, peritoneal or fallopian tube malignancy that is metastatic and for which curative measures do not exist; pathology must be reviewed and confirmed at Mayo Clinic Department of Pathology; the histology can be confirmed from tissue that was taken at the time of diagnosis; a biopsy at the time of recurrence prior to enrollment on study is not required
Gynecologic cancer cohort only: histologic proof of epithelial cervical, endometrial, ovarian, fallopian, or primary peritoneal cancers; allowable histologies for cervical cancer include squamous cell carcinoma, adenocarcinoma, and mixed/adenosquamous carcinoma; allowable histologies for endometrial cancer include endometrioid, serous, clear cell, mucinous, squamous, transitional cell, undifferentiated, mixed, and carcinosarcoma (this is considered a poorly differentiated epithelial tumor); allowable histologies for ovarian, fallopian, and peritoneal cancer include serous, clear cell, endometrioid, mucinous, transitional cell, undifferentiated, mixed, and carcinosarcoma
Patients with histologically proven stage III or IV ovarian, fallopian tube or primary peritoneal serous carcinoma (or patients of any stage with recurrent disease) who demonstrate lack of disease progression as determined by clinical assessment as well as cancer antigen 125 (CA-125) levels and/or radiographic assessment
Participants must have histologically or cytologically confirmed diagnosis of either:\r\n* Ovarian, fallopian tube, or primary peritoneal cancer of high grade serous histology which has recurred despite standard therapy or\r\n* Triple-negative breast cancer which has recurred despite standard therapy
Solid tumor patients in stage 2 must have a diagnosis of papillary serous, endometrioid or clear cell endometrial carcinoma or, high grade serous, clear cell, endometrioid or mucinous ovarian, fallopian or primary peritoneal carcinoma
High-grade serous adenocarcinoma
Patient must have histologically confirmed, advanced (FIGO Stage III or IV) high-grade predominantly serous or endometrioid ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have completed first line platinum based chemotherapy (neoadjuvant or adjuvant)
Histologically confirmed Stage III-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer, including malignant mixed Müllerian tumors with high grade serous component
Patients must have histologically diagnosed high-grade (Grade 2 or 3) serous epithelial ovarian, fallopian tube, or primary peritoneal cancer with recurrent disease and must have been previously treated with chemotherapy and experienced a response lasting at least 6 months to first-line platinum based therapy.
Histologically confirmed epithelial ovarian, fallopian tube, or peritoneal cancer, including malignant mixed Müllerian tumors with high grade serous component.
Confirmed High Grade Serous Ovarian Cancer, and positive nuclear immunohistochemical (IHC) staining for p53
Patients with the following tumors are included in the study:\r\n* Patients initially diagnosed with low-grade serous ovarian or peritoneal carcinoma that recur as low-grade serous carcinoma (invasive micropapillary serous carcinoma or invasive grade I serous carcinomas as defined by GOG, Federation of Obstetricians and Gynecologists [FIGO], World Health Organization [WHO] or Silverberg)\r\n* Patients initially diagnosed with serous borderline ovarian or peritoneal carcinoma that recur as low-grade serous carcinoma (invasive micropapillary serous carcinoma or invasive grade I serous carcinomas as defined by GOG, FIGO WHO or Silverberg)
Patients must have histologically or cytologically confirmed epithelial ovarian, primary peritoneal and fallopian tube carcinoma; all histologic subtypes of epithelial ovarian cancer are eligible, but only patients with high grade serous ovarian cancer will be considered for the statistical analysis; non-high grade serous cancers will be allowed in an exploratory cohort
Patients with histologically diagnosed relapsed high grade serous ovarian cancer (including primary peritoneal and/or fallopian tube cancer) or high grade endometrioid cancer. Patients are eligible to undergo BRCA testing even if they have not yet had recurrence or progression of disease >6 months (>/=183 days) after completion of their last platinum therapy.
Persistent or recurrent serous epithelial ovarian cancer or primary peritoneal carcinoma
Confirmed diagnosis of high-grade serous or endometrioid epithelial ovarian, primary peritoneal, or fallopian tube cancer.
Females aged ?18 years with previous histologically proven diagnosis of high grade serous, high grade endometroid or clear cell ovarian cancer, fallopian tube or primary peritoneal carcinoma
Participants must have histologic or cytologic confirmation of epithelial ovarian cancer, fallopian tube or peritoneal cancer; all histologies (including serous, mucinous, endometrioid, clear cell, malignant mixed mesodermal tumor [MMMTs], and mixed histologies) are eligible; all tumor grades are eligible
Patients with histologically documented diagnosis of epithelial ovarian cancer including serous papillary, endometrioid, mucinous, clear cell, poorly differentiated or mixed adenocarcinomas
Histologically confirmed surgical diagnosis of stage IIIC or stage IV epithelial ovarian, fallopian tube, or primary peritoneal cancer; patients with stage III cancer must have had peritoneal metastasis beyond pelvis more than 2 cm in greatest dimension and/or regional lymph node metastasis; NOTE: Histologic confirmation of the primary tumor is required; eligible histologies include serous, endometrioid, clear cell, mucinous, transitional cell, undifferentiated, or mixed carcinoma
Female patients with histologically diagnosed relapsed high grade serous ovarian cancer (including primary peritoneal and / or fallopian tube cancer) or high grade endometrioid cancer.
Female patients with newly diagnosed, histologically confirmed, high risk advanced (FIGO stage III - IV) BRCA mutated high grade serous or high grade endometrioid ovarian cancer, primary peritoneal cancer and / or fallopian - tube cancer who have completed first line platinum based chemotherapy (intravenous or intraperitoneal).
Histologically confirmed epithelial ovarian, peritoneal, or fallopian tube cancer, and uterine papillary serous carcinomas (UPSC), and gynecologic malignant mixed müllerian tumors (MMMTs).
Participants must have histologically or cytologically confirmed invasive epithelial ovarian, tubal or primary peritoneal cancer; all histologies (including serous, mucinous, endometrioid, clear cell, malignant mixed mesodermal tumors [MMMTs] and mixed histologies) are eligible
Female subjects with histologically diagnosed relapsed high-grade serous or high-grade endometrioid ovarian cancer;
PHASE II: Participants must have histologically or cytologically grade 2 or 3 (high-grade) papillary-serous or endometrioid epithelial ovarian cancer, primary peritoneal serous cancer, or fallopian tube cancer; participants with epithelial ovarian, primary peritoneal, or fallopian tube cancers of other high-grade histologies who carry a known deleterious breast cancer gene (BRCA) germline mutation by standard clinical testing (Myriad BRAC Analysis) will also be considered eligible
Patient must have persistent or recurrent high grade endometrioid or serous ovarian, primary peritoneal or fallopian tube carcinoma; histologic documentation of the original primary tumor is required via the pathology report
Advanced (metastatic or locally advanced) serous epithelial ovarian, serous fallopian tubal or serous primary peritoneal cancer or advanced clear cell or papillary renal cell carcinoma who have received or are intolerant to all therapy known to confer clinical benefit for their disease, as determined by the investigator.
Histologically documented, epithelial ovarian, fallopian tube, or primary peritoneal, high grade serous or clear cell carcinoma are eligible; all patients must have a confirmed pathology; stage 3 and 4 initial disease with response to primary surgery and neo/adjuvant chemotherapy, platinum refractory disease, and patients with recurrent disease are candidates
Histologically confirmed serous epithelial ovarian cancer with peritoneal metastases
Patients must have a histologically-confirmed ovarian, fallopian, or peritoneal malignancy with a component of high-grade papillary serous carcinoma; (example: a patient with ovarian carcinosarcoma with a component of high-grade papillary serous carcinoma will be eligible)
The female subject has a diagnosis of one of the following: a) low-grade serous ovarian or peritoneal carcinoma, or grade 1 serous ovarian or peritoneal carcinoma or well-differentiated serous ovarian or peritoneal carcinoma or b) serous borderline ovarian or peritoneal tumor, ovarian or peritoneal tumor of low-malignant potential, ovarian or peritoneal atypical proliferative serous tumor that recurs as low grade serous carcinoma or has invasive peritoneal implants.
Patients must have high-grade serous or endometrioid or high-grade predominantly serous or endometrioid histology, regardless of HRD or germline breast cancer susceptibility gene (gBRCA) mutation status. Patients with non mucinous epithelial ovarian cancer and gBRCA mutation are eligible.
For the dose expansion cohort, participants must have histologically or cytologically confirmed diagnosis of either: i) ovarian, fallopian tube, or primary peritoneal cancer of high grade serous histology which has recurred despite standard therapy or ii) triple-negative breast cancer which has recurred despite standard therapy
The study population will include women with stage IB1 cervical cancer (any histologic subtype) deemed eligible for surgery, and women with a clinical stage I high-grade endometrial cancer planning to undergo surgical staging; high grade is defined by the following:\r\n* Uterine serous carcinoma \r\n* Clear cell endometrial carcinoma  \r\n* Grade 3 endometrioid carcinoma \r\n* Endometrial carcinosarcoma
Patient must have epithelial ovarian, fallopian tube, or primary peritoneal cancer; this includes high-grade serous ovarian cancer, endometroid, clear cell, mixed epithelial, undifferentiated carcinoma, transitional cell carcinoma histologies\r\n* Patients with carcinosarcoma, non-epithelial, low grade tumors, or tumors with low malignant potential are excluded
Histologically confirmed or suspected stage III or IV high-grade serous ovarian cancer
Epithelial ovarian cancer, including fallopian tube cancer or primary peritoneal cancer, of high-grade serous histology, with platinum refractory or resistant disease after prior treatment with at least one platinum-based chemotherapeutic regimen. In Part B (dose expansion), subjects may have received no more than 3 lines of systemic cytotoxic chemotherapy.
Histologically confirmed high grade endometrial cancer including grade 3 endometroid, serous, clear cell, malignant mixed Mullerian tumor (MMMT) or any mixed tumor containing one of these cell types
Patients with presumed advanced-stage high grade serous ovarian, fallopian tube, or primary peritoneal carcinoma, based on the presence of carcinomatosis, and/or elevated cancer antigen (CA)125, and/or ovarian mass(es), or at the discretion of the treating physician
No prior therapy for high-grade serous ovarian, fallopian tube, or primary peritoneal carcinoma
Patients with presumed advanced-stage high grade serous ovarian, fallopian tube, or primary peritoneal carcinoma, based on the presence of carcinomatosis, and/or elevated cancer antigen 125 (CA125), and/or ovarian mass(es), or at the discretion of the treating physician
No prior therapy for high-grade serous ovarian, fallopian tube, or primary peritoneal carcinoma
Participants receiving a histologic diagnosis of epithelial ovarian cancer (EOC), peritoneal primary carcinoma, or fallopian tube cancer
Have recurrent invasive epithelial ovarian, fallopian tube, or primary peritoneal cancer that was treated only with surgery (example [e.g.], participants with Stage IA or Stage IB epithelial ovarian or fallopian tube cancers)
Received prior chemotherapy for any abdominal or pelvic tumor that include neoadjuvant chemotherapy (NACT) for ovarian, primary peritoneal or fallopian tube cancer
The study population will include women with a high preoperative suspicion of advanced primary epithelial ovarian, fallopian tube, or primary peritoneal carcinoma (stage IIIC or IV) as determined by computed tomography (CT) or magnetic resonance imaging (MRI) of abdomen and pelvis planning to undergo exploratory laparotomy and surgical cytoreduction with the operative goal of this procedure to achieve optimal cytoreduction to less than 1 cm of residual disease
Platinum resistant Grade 2 or 3 ovarian, primary peritoneal or fallopian tube cancer
Patients must have a histological or cytological evidence/confirmation of epithelial ovarian cancer, primary peritoneal carcinomatosis, or fallopian tube cancer
Histologic confirmation of ovarian, primary peritoneal or fallopian tube cancer of any subtype
Patient with primary or recurrent International Federation of Gynecology and Obstetrics (FIGO) stage III or IV ovarian, fallopian tube, peritoneal carcinoma, or uterine cancer, confined to abdominal cavity, including those who have completed neoadjuvant chemotherapy and primary surgery
Preoperative or intraoperative (frozen section) diagnosis of ovarian, peritoneal, fallopian tubal or uterine cancer
Have a diagnosis of advanced platinum resistant epithelial ovarian cancer (EOC)/fallopian tube cancer/primary peritoneal cancer (PPC) • Up to 2-3 prior lines of therapy
Histological diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal cancer, excluding the mucinous subtype.
Patient with Colorectal cancer, epithelial ovarian cell or fallopian tube carcinoma, urothelial carcinoma, Triple Negative Breast cancer, pancreatic cancer, AML/MDS or Multiple Myeloma
Patients must have clinically and radiographically suspected and previously untreated International Federation of Gynecologic and Obstetrics (FIGO) stage III or IV epithelial ovarian, primary peritoneal or fallopian tube cancer, high grade, for whom the plan of management will include neoadjuvant chemotherapy (NACT) with interval tumor reductive surgery (TRS) who have undergone biopsies for histologic confirmation
Patients who have received any targeted therapy (including but not limited to vaccines, antibodies, tyrosine kinase inhibitors) or hormonal therapy for management of their epithelial ovarian, fallopian tube or peritoneal primary cancer
Histologically confirmed stage IIc-IV epithelial ovarian, fallopian tube or peritoneal cancer
For Part 2 Only: Platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer, or Triple Negative Breast Cancer with measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in at least 1 lesion, that in the opinion of the Investigator is appropriate to treat with nab-paclitaxel.
Epithelial ovarian carcinoma (including primary peritoneal disease and/or fallopian tube carcinomas and/or endometrial adenocarcinomas) regardless of platinum sensitivity.
Part 1: Ovarian, fallopian tube, primary peritoneal, endometrial, or cervical cancer
Measurable disease by physical exam or CT scan, or evaluable disease by CA-125; (NOTE: CA-125-evaluable disease is defined as serum CA-125 >= 2 x ULN that is determined by the treating clinician to be due to recurrent ovarian, fallopian tube, or primary peritoneal cancer)
For cohorts 1-3, 5 and 6: patients must have breast and/or epithelial or endometrioid ovarian cancer, primary peritoneal cancer, and/or fallopian tube cancer histologically or cytologically confirmed at the National Cancer Institute (NCI) that is metastatic or unresectable and for which standard curative measures do not exist or are no longer effective; ER/PR/HER2 status needs to be documented either by an outside source or at NCI; patients with gBRCA1/2m with history of or active breast and ovarian cancers are considered for cohort 1; those without gBRCA1/2m will follow exclusion criteria
Eligible patients will be women with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma after chemotherapy with no evidence of disease or minimal residual disease for primary or recurrent disease; this may or may not be measurable; these patients would normally enter a period of observation after standard management
Patients with recurrent endometrial, ovarian, fallopian tube or primary peritoneal cancer must have received at least one platinum-based chemotherapy regimen
STUDY ENTRY: No prior treatment for primary advanced (stage III or IV) epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
GENERAL: Prior systemic chemotherapy for epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Ovarian Expansion Cohort: Subjects with recurrent disease or histologically or cytologically confirmed Stage III/IV diagnosis of epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal carcinoma who have previously progressed while receiving or within 6 months of completing a platinum-containing regimen.
Subjects must have histologically or cytologically confirmed advanced epithelial ovarian, fallopian tube, or primary peritoneal (>= International Federation of Gynecology and Obstetrics [FIGO] Stage IIIC)
Diagnosis of primary ovarian cancer of any histology (patients with diagnoses of fallopian tube and primary peritoneal cancer are also eligible), or primary uterine cancer of papillary serous histology
Patients with a histologic diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma, stage IIIB – IIIC with optimal (=< 1 cm) residual disease
Histologic diagnosis of recurrent epithelial ovarian, fallopian, peritoneal cancer
Platinum-refractory ovarian, fallopian tube, or primary peritoneal carcinoma
Patients must have histologically or cytologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma; histologic documentation (via the pathology report) of the original primary tumor is required
Patients must have clinically and radiographically suspected International Federation of Gynecology and Obstetrics (FIGO) stage 3 or 4 epithelial ovarian, primary peritoneal or fallopian tube cancer, high grade, for whom the plan of management will include neoadjuvant chemotherapy (NACT) with interval tumor reductive surgery (TRS); patients will be selected for NACT according to established criteria (Society of Gynecologic Oncology and the American Society of Clinical Oncology Guideline); patients must have undergone core needle biopsy for histologic confirmation prior to start of treatment
Patients who have received any prior treatment for management of their epithelial ovarian, fallopian tube or peritoneal primary cancer
Patients with newly diagnosed advanced stage (III/IV) ovarian cancer (ovarian/fallopian tube/peritoneal cancer) who have been recommended to receive neoadjuvant carboplatin/paclitaxel chemotherapy with subsequent cytoreductive surgery
Histology (reviewed at MD Anderson Cancer Center [MDACC]) showing recurrent high grade epithelial ovarian, peritoneal, or fallopian tube cancer.
Patients must have histologically or cytologically confirmed advanced metastatic or unresectable epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer that is relapsed and resistant (recurred less than 6 months after chemotherapy) or refractory (progressed on chemotherapy) to prior platinum- and taxane-based standard care systemic regimen; or patients who are not eligible for additional platinum therapy; histopathologic diagnosis must be confirmed in the laboratory of pathology (LP), National Cancer Institute (NCI)
Histologically confirmed stage III-IV high-grade epithelial non-mucinous ovarian, fallopian tube, or primary peritoneal cancers
Patients must have histologically confirmed endometrial cancer, epithelial ovarian, fallopian tube, or primary peritoneal cancer (all histologic subtypes)
Have histologically or cytologically confirmed gynecologic tumor of mullerian origin, specifically epithelial ovarian, fallopian tube, primary peritoneal, or uterine endometrial cancer
Histology showing high-grade epithelial non-mucinous ovarian, primary peritoneal, or fallopian tube cancer
No prior treatment for primary advanced (stage III or IV) epithelial ovarian, primary peritoneal, or fallopian tube carcinoma such as irradiation, chemotherapy, hormonal therapy, immunotherapy, investigational therapy, surgery, and/or other concurrent agents or therapies
Prior treatment for ovarian, fallopian tube, or primary peritoneal cancer
Patients with histologic diagnosis of epithelial ovarian carcinoma, primary peritoneal carcinoma, or fallopian tube carcinoma that has recurred > 6 months since platinum-based chemotherapy (first recurrence) and who are scheduled for secondary surgical evaluation/cytoreduction
Patients must have had one prior platinum-based chemotherapeutic regimen for management of ovarian, primary peritoneal, or fallopian tube carcinoma and at least two prior chemotherapy regimens
Patients must have recurrent or persistent EOC (epithelial ovarian, fallopian tube or primary peritoneal carcinoma); histologic documentation of the original primary tumor is required via the pathology report
Subject has primary ovarian (including low malignant potential), fallopian tube, or primary peritoneal cancer Federation of Gynecology and Obstetrics (FIGO) stage III or IV defined surgically at the completion of initial abdominal surgery
Patients must have peritoneal recurrence of epithelial adenocarcinoma or carcinosarcoma of ovarian, tubal, or peritoneal origin; histologic documentation of the original primary tumor is required via the pathology report; original tumor blocks from primary diagnosis will be reviewed by our study pathologist at Magee
Patients must have histologically or cytologically confirmed, known or highly suspected advanced (International Federation of Gynecology and Obstetrics [FIGO] stage II-IV) ovarian, primary peritoneal, or fallopian tube cancer, scheduled for primary or interval cytoreductive surgery
Recurrent epithelial ovarian, fallopian tube or primary peritoneal carcinoma; histologic confirmation of the original primary tumor is required
Patients must have received at least one-prior platinum based chemotherapy regimen, to include cisplatin, carboplatin or other organoplatinum compound, for treatment of primary or recurrent ovarian, fallopian tube or primary peritoneal cancer
Must have:\r\n* Recurrent or progressive ovarian cancer, primary peritoneal cancer or fallopian tube cancer after prior treatment with platinum and taxanes\r\n* Histologic confirmation of the original primary tumor\r\n* Prior bilateral oophorectomy
Histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma
Patients with histologically or cytologically confirmed diagnosis of advanced, epithelial ovarian cancer (except carcinosarcoma), primary peritoneal, or fallopian tube cancer who have all of the following:
Newly diagnosed advanced (FIGO stage III-IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Diagnosis of Federation of Gynecology and Obstetrics (FIGO) stage III or grade IV epithelial ovarian, fallopian tube or primary peritoneal carcinoma, has received at least 3 cycles of first line intravenous (IV)/IP cisplatin and paclitaxel chemotherapy and has stable disease or better as defined by measurable/evaluable tumor and/or CA-125 levels
Subjects with locally invasive or metastatic, epithelial ovarian, fallopian tube, or primary peritoneal cancer
Subjects with low-grade ovarian, fallopian tube, or Primary peritoneal cancer
Histologically confirmed recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer for which there is no known or established treatment available with curative intent.
Patients with biopsy-confirmed ovarian or other gynecologic cancers (fallopian tube, peritoneal, endometrial, or cervical cancer) who have recurred after or progressed on frontline and one or more second-line standard treatments are eligible for the dose-finding phase; enrollment for the expansion cohort will be limited to subjects with high grade epithelial ovarian, fallopian tube, or peritoneal carcinomas
Patients with low grade ovarian/fallopian tube/peritoneal cancers
Histology showing recurrent high grade epithelial ovarian, peritoneal, or fallopian tube cancer
Chemotherapy, hormonal, or biologic treatment for ovarian, fallopian tube, or primary peritoneal cancer in the last 21 days
Women with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma with platinum-resistant disease (defined as having relapsed within 6 months of last platinum-containing regimen because we would like to include both primary and secondary resistance); patients are allowed to have had more than 2 prior cytotoxic treatment regimens; all patients should have received standard of care agents, which confer clinical benefit
Participants must have recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal carcinoma; histologic documentation of the original primary tumor is required via the pathology report
Diagnosis of recurrent epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer that has failed or progressed after at least 1 prior salvage chemotherapy regimen directed at recurrent/metastatic disease
Patients who have undergone therapeutic debulking surgery for independent clinical indications and have tissue frozen and stored under sterile conditions as part of protocol 07-319 (Study of Primary Tumor Harvest for the Purpose of Possible Use in a Future Clinical Trial in Patients with Ovarian, Fallopian Tube, or Primary Peritoneal Cancer)
Participants must have pathology-confirmed epithelial ovarian, fallopian tube, or\n             primary peritoneal carcinoma.
Participants with histologically or cytologically confirmed diagnosis of epithelial ovarian, primary peritoneal or fallopian tube cancer will be enrolled in this study; patients must have experienced recurrence or progression within 6 months after completion of platinum based chemotherapy (by Response Evaluation Criteria in Solid Tumors [RECIST] 1.1 criteria).
Newly diagnosed stage III or IV epithelial ovarian, fallopian or primary peritoneal carcinoma with or without ascites and potentially resectable disease agreeing to debulking surgery as standard therapy
Patients who have had prior systemic therapy or radiotherapy for stage III or IV epithelial ovarian, fallopian or primary peritoneal carcinoma
Patients with a histologic diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma, or carcinosarcoma stage II, III, or IV with either optimal (=< 1 cm residual disease) or suboptimal residual disease
All patients must have a procedure for determining diagnosis of epithelial ovarian, fallopian tube, primary peritoneal, or carcinosarcoma with appropriate tissue for histologic evaluation
Patients with a current diagnosis of borderline epithelial ovarian tumor (formerly “tumors of low malignant potential”) or recurrent invasive epithelial ovarian, primary peritoneal or fallopian tube cancer treated with surgery only (such as patients with stage IA or IB low-grade epithelial ovarian or fallopian tube cancers) are not eligible\r\n* NOTE: Patients with a prior diagnosis of a borderline tumor that was surgically resected and who subsequently develop an unrelated, new invasive epithelial ovarian, peritoneal primary or fallopian tube cancer are eligible, provided that they have not received prior chemotherapy for any ovarian tumor
Histologic diagnosis of International Federation of Gynecology and Obstetrics (FIGO) Stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal carcinoma, with the appropriate tissue available for histologic evaluation.
Diagnosed with advanced epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer
Patients must have histologic diagnosis of epithelial ovarian carcinoma, peritoneal primary or fallopian tube carcinoma, which is now recurrent
Patients who have received prior chemotherapy for any abdominal or pelvic tumor (other than ovarian, fallopian tube, and primary peritoneal) are excluded
1b. Ovarian Recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal carcinoma requiring original or subsequent relapse histologic documentation. A platinum-taxane based chemotherapy regimen as frontline therapy must have been completed. Any histologic diagnosis of borderline, low malignant potential epithelial carcinoma are excluded.
Patients must have recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal carcinoma; histologic documentation of the original primary tumor is required via the pathology report
Phase 1: Individuals with epithelial ovarian cancer, fallopian tube carcinoma, or primary peritoneal carcinomas who are considered to have platinum-resistant disease (progression within 6 months from completion of platinum-based chemotherapy).
Phase 2: Individuals with epithelial ovarian cancer, fallopian tube carcinoma, or primary peritoneal carcinomas who are considered to have platinum-resistant disease (progression within 6 months from completion of a minimum of 4 platinum therapy cycles).
Histologically proven advanced-relapsed epithelial ovarian, primary peritoneal, or fallopian tube cancer
Patients with recurrent epithelial ovarian cancer, fallopian tube cancers or primary peritoneal carcinoma defined as:
Patients must have recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. Histologic documentation of the original primary tumor is required via the pathology report.
Patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancers who have received up to two prior treatment regimens
epithelial ovarian cancer (fallopian tube and primary peritoneal cancers are eligible)
Has histologically confirmed epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer
Patients must have recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal cancer with documented disease progression (disease not amendable to curative therapy); histologic confirmation of the original primary tumor is required via the pathology report; NOTE: patients with mucinous histology are NOT eligible; patients with carcinosarcoma histology are NOT eligible
Ovarian cancer defined as a histologically confirmed diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal cancer refractory to standard therapies of for which no standard therapy exists. Confirmed BRCA1 or BRCA2 mutation from a prior test. Patient progressed while receiving and/or following treatment with a PARP-inhibitor for advanced disease (recurrent or metastatic.
The patient must have a pathologically confirmed (by histology or cytology) diagnosis of epithelial ovarian, fallopian tube or primary peritoneal carcinoma, which is currently recurrent or persistent Stage 3 or Stage 4 disease. A histologic diagnosis of borderline, low malignant potential epithelial carcinoma is not permitted.
Have a histologically confirmed diagnosis of epithelial ovarian cancer, fallopian tube or peritoneal cancer; all histologies of epithelial ovarian cancer are eligible except for carcinosarcomas
Pathologic diagnosis of ovarian, fallopian tube or primary peritoneal cancer confirmed by pathology review at Memorial Sloan Kettering (MSK)
Histologically or cytologically confirmed primary disease histology of solid ovarian, fallopian tube, or primary peritoneal tumor categorization
Histologically confirmed ovarian epithelial (including fallopian tube and primary peritoneal) carcinoma.
Patients must have histologic diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma per pre-treatment biopsies by laparoscopy, or interventional radiology or CT guided core biopsy. Histologic documentation of the original primary tumor is required via the pathology report.
Patients with recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma
Must have confirmation of the histologic diagnosis of high-grade (grade 2 or 3) epithelial, non-mucinous, non-borderline, ovarian, fallopian tube, or primary peritoneal carcinoma; may be based on original pathology report or review of original slides
Confirmed diagnosis of unresectable epithelial ovarian, fallopian tube or primary peritoneal cancer.
Any histologically confirmed locally advanced recurrent endometrial adenocarcinoma (except for carcinosarcoma), recurrent high-grade serous ovarian/primary peritoneal/fallopian tube carcinoma, or deleterious BRCA mutant recurrent ovarian/primary peritoneal/fallopian tube cancer for whom no curative option is available will be eligible; any patient proven to have metastatic triple negative breast cancer, defined from standard pathologic assays as negative for estrogen receptor (ER) and progesterone receptor (PR) (< 10% tumor staining) will be eligible
Subjects with histologic diagnosis of epithelial ovarian carcinoma, primary peritoneal carcinoma, or fallopian tube carcinoma, following initial surgery; all subjects must have had appropriate surgery for ovarian, primary peritoneal, or fallopian tube carcinoma with appropriate tissue available for histologic evaluation to confirm diagnosis and stage; pathology must be verified at Memorial Sloan-Kettering Cancer Center; patients with initial cytoreduction surgery performed at outside hospitals will be eligible for this protocol
Patients are eligible if they have the following: metastatic or unresectable breast cancer, recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal cancer
Patients who have previously been diagnosed and treated for earlier stage ovarian, fallopian tube or primary peritoneal cancer.
Histologically confirmed epithelial ovarian, primary peritoneal or fallopian tube malignancy that is metastatic and for which standard curative measures do not exist
Have been diagnosed with ovarian, fallopian tube, or primary peritoneal cancer
Have been previously treated with Gemcitabine for ovarian, fallopian tube or primary peritoneal cancer
Must have a diagnosis of recurrent epithelial ovarian, primary peritoneal or fallopian tube carcinoma with refractory or platinum resistant disease and/or have received ? 2 lines of chemotherapy
Histologically-confirmed ovarian epithelial (including fallopian tube and primary peritoneal) carcinoma
Patients assumed to have a stageII?IV epithelial ovarian, fallopian tube, or primary peritoneal cancer as a pre-surgery diagnosis
Patients assumed to have a borderline malignancy of the ovary, fallopian tube, or primary peritoneal cancer
Patients who receive neoadjuvant chemotherapy for their ovarian, primary peritoneal, or fallopian tube cancer
Patients with non-epithelial ovarian tumors that do not require adjuvant chemotherapy, borderline epithelial ovarian tumor, or recurrent invasive epithelial ovarian, low grade ovarian cancer, primary peritoneal, or fallopian tube cancer treated with surgery only (such as patients with stage IA or IB); patients with a prior diagnosis of a borderline tumor that was surgically resected and who subsequently develop an unrelated new invasive epithelial ovarian, primary peritoneal, or fallopian tube cancer are eligible, provided that they have not received chemotherapy for any tumor; no stromal cancers or germ cell cancers or low malignant potential; patients found post operatively to have ineligible histology will be removed from the study
Patients who have received targeted therapy (including but not limited to vaccines, antibodies, tyrosine kinase inhibitors) or hormonal therapy for management of their primary peritoneal, ovarian, or fallopian tube cancer
Metastases to the ovaries from other organs except fallopian tube or primary peritoneal carcinoma
Have a histologically confirmed diagnosis of high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer
Subject has recurrent ovarian (including low malignant potential), fallopian tube or primary peritoneal cancer
PHASE I: Participants must have histologically or cytologically confirmed epithelial ovarian cancer, primary peritoneal serous cancer, fallopian tube cancer, or triple-negative breast cancer
PHASE I-T: Participants must have histologically or cytologically confirmed epithelial ovarian cancer, primary peritoneal serous cancer, or fallopian tube cancer
Patients with a histologic diagnosis of epithelial ovarian cancer, peritoneal primary carcinoma or fallopian tube cancer; FIGO stage III and IV defined surgically at the completion of initial abdominal surgery and with appropriate tissue available for histologic evaluation. The minimum surgery required is an abdominal surgery providing tissue for histologic evaluation and establishing and documenting the primary site and stage, as well as a maximal effort at tumor debulking.
Patients with borderline epithelial ovarian tumor (formerly \tumors of low malignant potential\) or recurrent invasive epithelial ovarian, primary peritoneal or fallopian tube cancer treated with surgery only are not eligible. Patients with a prior diagnosis of a borderline tumor that was surgically resected and who subsequently develop an unrelated, new invasive epithelial ovarian, peritoneal primary or fallopian tube cancer are eligible, provided that they have not received prior chemotherapy for any ovarian tumor.
Women with suspected epithelial ovarian, fallopian tube or primary peritoneal carcinoma scheduled to undergo surgical exploration with no prior treatment for the cancer; signs of ovarian cancer include, but are not limited to: an elevated CA125, a complex pelvic mass, ascites, and carcinomatosis; these signs are not necessary for suspicion or enrollment in this protocol
Diagnosis of recurrent epithelial ovarian, primary peritoneal or fallopian tube cancer; histologic or cytologic confirmation of the original primary tumor is required
Histologically or cytologically confirmed epithelial ovarian, fallopian tube, or peritoneal cancer
Histologically documented ovarian, primary peritoneal or fallopian tube cancer
Histological documentation of epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer
Histologically diagnosed ovarian cancer, fallopian tube cancer or primary peritoneal cancer
Part 3 (enrollment closed): advanced, metastatic or non-resectable epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer with
Histologically documented epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer that is platinum sensitive.
PSOC (i.e., epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer) with documented radiographic progression or relapse within 6 to 18 months of most recent platinum-based chemotherapy.
Subjects must have cytologically or histologically confirmed ovarian, primary peritoneal or fallopian tube cancer.. In addition, subjects must have a tumor that is at least 1 cm in a single dimension and is radiographically apparent on CT, PET-CT or MRI (i.e., RECIST version 1.1 measurable disease).
Patients must be suspected of having a diagnosis of ovarian, fallopian tube or primary peritoneal cancer with a planned cytoreductive surgery
Histologic diagnosis of epithelial ovarian, fallopian tube or primary peritoneal cancer on frozen section diagnosis
Advanced or recurrent epithelial ovarian, fallopian tube or primary peritoneal carcinoma; histologic documentation of the original primary tumor is required via the pathological report
Patients must have newly diagnosed International Federation of Gynecology and Obstetrics (FIGO) Stage IIIB to IV epithelial ovarian, fallopian tube, or peritoneal cancer and have recovered from debulking surgery.
Up to 6 patients with histological or cytological documentation of advanced ovarian, fallopian tube, or primary peritoneal carcinoma with a history of progression or recurrence following at least one prior platinum and one taxane based chemotherapy
Cytologic or histologic diagnosis of a carcinoma felt by the investigator to be compatible with epithelial cancer of the ovary, fallopian tube, or primary peritoneum
Women with stages II-IV epithelial ovarian, fallopian tube, or primary peritoneal carcinoma who have completed standard therapy for primary or recurrent disease (i.e., patients who would normally be observed); eligible patients may have asymptomatic residual measurable disease on physical examination and/or computed tomography (CT) scan, and/or may have an elevated cancer antigen 125 (CA-125); or may be in complete clinical remission after treatment for primary or recurrent disease; these patients would normally enter a period of observation after standard management
Diagnosis of stage III, IV or recurrent gynecologic malignancy (uterine, ovarian, cervical, vulvar, vaginal, fallopian tube, primary peritoneal)
Diagnosis of ovarian epithelial, fallopian tube, or primary peritoneal carcinoma\r\n* Stage II, III, or IV disease with optimal (=< 1 cm residual disease) or suboptimal residual disease\r\n* All patients must have a procedure for determining diagnosis of epithelial ovarian, fallopian tube, primary peritoneal, with appropriate tissue for histologic evaluation\r\n* The minimum surgery required is an abdominal surgery providing tissue for histologic evaluation and establishing and documenting the primary site and stage, as well as a maximal effort at tumor debulking; if additional surgery was performed, it should have been in accordance with appropriate surgery for ovarian or peritoneal carcinoma described in the Gynecologic Oncology Group (GOG) Surgical Procedures Manual
Woman diagnosed with ovarian, primary peritoneal or fallopian tube cancer
Have had ovarian cancer or fallopian tube cancer at any age
Newly diagnosed with any stage of primary ovarian cancer, primary peritoneal cancer or primary fallopian tube cancer in the past 6 months
Diagnosed with advanced epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer
Histology showing high-grade epithelial non-mucinous ovarian, primary peritoneal, or fallopian tube cancer
No more than 4 prior cycles of chemotherapy for primary advanced (stage III or IV) epithelial ovarian, primary peritoneal, or fallopian tube cancer
Patients with an initial diagnosis of ovarian, fallopian tube or primary peritoneal cancer who completed primary ovarian cancer surgery or 3 cycles of neoadjuvant chemotherapy with interval cytoreductive surgery (ICS)
Final pathologic diagnosis of stage I-IV ovarian, primary peritoneal or fallopian tube cancer with plan to receive primary adjuvant chemotherapy or completion of chemotherapy after ICS
Undergoing surgical management for a suspected diagnosis of gynecologic malignancy (endometrial, ovarian, vulvar, vaginal, primary peritoneal, fallopian tube)
Patients with any stage epithelial ovarian cancer, including cancers arising from the fallopian tube and primary peritoneal cancer, or patients with other gynecologic malignancy (any stage), who are chemotherapy-naive, and scheduled to undergo at least 6 cycles of intravenous platinum/taxane-based chemotherapy
Patients with a histological diagnosis of epithelial ovarian cancer, fallopian tube or primary peritoneal carcinoma, clinical stage II, III or IV at diagnosis
Patients with a histological diagnosis of clinical stage I epithelial ovarian cancer, fallopian tube or primary peritoneal carcinoma
Patients who are currently undergoing treatment (primary or consolidation) for stage II, III or IV ovarian, fallopian tube or primary peritoneal cancer or who completed treatment less than six weeks ago
Women with a personal history of ovarian, fallopian tube, or primary peritoneal cancer
Presence of at least one fallopian tube; prior tubal ligation is allowed
Women with a history of ovarian, fallopian tube, or primary peritoneal cancer
Adult patients who have a presumed diagnosis of advanced stage epithelial ovarian, fallopian tube, or peritoneal\r\n* Pelvic mass and/or omental caking with Ca-125:carcinoembryonic antigen (CEA) ratio 25:1
Prior treatment for ovarian, fallopian tube, or primary peritoneal cancer
BIODISTRIBUTION COHORT: History of known or suspected epithelial ovarian, fallopian tube, or primary peritoneal cancer (may have primary or metastatic cancer at the time of study enrollment)
DYNAMIC COHORT: History of known or suspected epithelial ovarian, fallopian tube, or primary peritoneal cancer (may have primary or recurrent cancer at the time of study enrollment)
Patients must be suspected of having a diagnosis of ovarian, fallopian tube or primary peritoneal cancer with a planned cytoreductive surgery
Histologic diagnosis of epithelial ovarian, fallopian tube or primary peritoneal cancer confirmed on frozen section diagnosis during debulking surgery
Prior treatment for ovarian, fallopian tube, or primary peritoneal cancer
Epithelial ovarian cancer (including primary peritoneal disease and/or fallopian tube carcinomas and/or endometrial adenocarcinomas).
Histologically confirmed Epitheilial Ovarian Cancer (EOC), Fallopian Tube Cancer (FTC) or Primary Peritoneal Cancer (PPC).
Patients must have histological or cytological confirmation of melanoma that is metastatic or unresectable and clearly progressive\r\n* NOTE: Any patient with BRAF V600 mutant melanoma (whether cutaneous, acral or mucosal primary) who meets the eligibility criteria is eligible for participation in this trial; patients with uveal melanoma are not eligible for this trial
Patients with ocular melanoma.
Ocular melanoma.
Ocular melanoma
Ocular melanoma
Uveal melanoma is excluded
Histopathologically confirmed diagnosis of metastatic or unresectable uveal melanoma or non-uveal melanoma harboring a GNAQ or GNA11 mutation; Note: For subjects with a diagnosis of uveal melanoma, documentation of mutation status for uveal melanoma will not be required prospectively given the high rate of GNAQ/11 mutations (> 90%) in this population
Melanoma (excluding uveal melanoma);
Subjects with melanoma or with a history of melanoma, invasive squamous cell carcinomas, or aphakia (due to contraindication for use of methoxsalen).
Patients with melanoma of cutaneous, mucosal or acral-lentiginous origin or of unknown primary
Melanoma
Has Ocular Melanoma
Patients with uveal melanoma will not be eligible as these tumors show low expression of GD3
Patients with ocular, mucosal and unknown primary melanoma will also be eligible
History of uveal melanoma
Metastatic melanoma eligible for {or currently o
Rapidly progressing multi-focal metastatic melanoma
Melanoma
Study subjects previously treated with one of the peptides used in this trial, melanoma protein vaccine, melanoma whole cell vaccines, or with Montanide are not eligible
Patients with primary ocular or mucosal melanoma are excluded
Patients with melanoma arising from uveal/ocular primary sites.
Prior melanoma vaccinations may be an exclusion criterion in the following circumstances:\r\n* Patients who have received, within the prior 5 years, melanoma vaccines or other vaccines containing an incomplete Freund’s adjuvant (IFA; such as montanide ISA-51).\r\n* Patients who have received any melanoma vaccine within the past 12 months.\r\n* Patients who have been vaccinated in the past with any of the melanoma peptides in the LPV7 vaccine included in this study.
Patients must have a diagnosis of metastatic melanoma which is measurable either clinically or radiologically
Patients with carcinomatosis meningitis or a history of ocular/uveal melanoma are excluded
Phase 2 Cohort: ocular melanoma
Participants must not have ocular melanoma
Patients must have completely resected (as per standard of care) melanoma of cutaneous origin in order to be eligible for this study; patients must be classified as stage IIB or IIC cutaneous melanoma using the American Joint Committee on Cancer eighth edition; patients with melanoma of mucosal or other non-cutaneous origin are not eligible; patients with melanoma of ocular origin are not eligible
Ocular melanoma
Patients whose primary diagnosis was ocular melanoma
Diagnosis of choroidal melanoma
Melanoma located on face or digits
Histologic diagnosis of metastatic uveal melanoma.
Histologically or cytologically confirmed malignant melanoma from skin, or mucosal melanoma (i.e. ocular melanoma subjects are not eligible)
Patients must have unresectable cutaneous, mucosal or ocular metastatic stage III/IV melanoma, and in the opinion of the institutional principal investigator (PI) is an acceptable candidate for adoptive cell therapy (ACT) with high dose interleukin-2 (IL-2); patients with ocular or mucosal metastatic melanoma may be included, as our prior experience indicates that TIL can be successfully propagated from these subtypes of melanoma metastases
CAPMATINIB EXCLUSION CRITERIA: Uveal melanoma
ENTRECTINIB EXCLUSION CRITERIA: Uveal melanoma
Inclusion criteria Part 1: Safety run-in\n\n          -  Histologically confirmed, unresectable or metastatic melanoma with BRAF V600 mutation\n\n          -  Aspartate transaminase (AST) < 2.5× ULN and Alanine transaminase (ALT) < 2.5× ULN\n\n          -  ECOG performance status ? 1\n\n        Part 2: Biomarker cohort\n\n          -  Histologically confirmed, unresectable or metastatic melanoma with BRAF V600 mutation\n\n          -  At least two cutaneous or subcutaneous or nodal lesions for tumor sample collection\n\n          -  ECOG performance status ? 2\n\n        Part 3: Double-blind, randomized, placebo-controlled part\n\n          -  Histologically confirmed, unresectable or metastatic melanoma with BRAF V600 mutation\n\n          -  ECOG performance status ? 2\n\n        Exclusion Criteria:\n\n        Part 1: Safety run-in\n\n          -  Subjects with uveal or mucosal melanoma\n\n          -  Any history of CNS metastases\n\n          -  Prior systemic anti-cancer treatment for unresectable or metastatic melanoma\n\n          -  Prior loco-regional treatment for unresectable or metastatic melanoma in the last 6\n             month\n\n          -  Prior neoadjuvant and/or adjuvant therapy for melanoma completed less than 6 months\n\n          -  Radiation therapy within 4 weeks prior to start of study treatment\n\n          -  Active, known, suspected or a documented history of autoimmune disease\n\n        Parts 2 & 3: Biomarker cohort & double-blind, randomized, placebo-controlled part\n\n          -  Subjects with uveal or mucosal melanoma\n\n          -  Clinically active cerebral melanoma metastasis\n\n          -  Prior systemic anti-cancer treatment for unresectable or metastatic melanoma\n\n          -  Prior loco-regional treatment for unresectable or metastatic melanoma in the last 6\n             month\n\n          -  Prior neoadjuvant and/or adjuvant therapy for melanoma completed less than 6 months\n\n          -  Radiation therapy within 4 weeks prior to start of study treatment\n\n          -  Active, known, suspected or a documented history of autoimmune disease\n\n        Other protocol-defined Inclusion/Exclusion may apply.
Histologically-confirmed primary uveal melanoma
Metastatic uveal melanoma
Histologic diagnosis of melanoma
Ocular melanoma
Metastatic uveal melanoma patients with bone-only disease
50% or less histologically or cytologically-proven ocular melanoma metastases in the parenchyma of the liver.
Patients with advanced melanoma defined as unresectable stage III or metastatic stage IV disease. Patients with acral or mucosal melanoma or patients with unknown primary melanoma are acceptable in Phase 1b but are excluded from Phase II. Patients with uveal melanoma are excluded from the study.
Patients must have metastatic melanoma, uveal melanoma or stage III in-transit or regional nodal disease (Turnstile I)
Histologic diagnosis of stage IV metastatic melanoma, with 1 melanoma lesion that can be safely irradiated in the opinion of the radiation oncologist (note: subjects with primary ocular and mucosal melanoma are permitted). Lesions may include, but are not limited to:
Melanoma of ocular primary
Patient with detectable c-kit JM mutation confirmed by DNA or RNA sequencing, which is expected to be mainly found after screening of mucosal or acral melanoma or melanoma on skin with chronic sun-induced damages (defined by a microscopically marked elastosis involving the skin surrounding their primary melanoma)
Measurable metastatic uveal melanoma
Histologic diagnosis of metastatic melanoma
Patients with uveal/ocular melanoma are excluded
Histologically confirmed melanoma of cutaneous primary; metastatic melanoma from unknown primary are allowed
Patients with melanoma of mucosal or ocular primary
Mucosal melanoma and uveal melanoma are not allowed
Has primary ocular melanoma
Histologically or cytologically confirmed uveal melanoma that is metastatic or unresectable; if histologic or cytologic confirmation of the primary is not available, confirmation of the primary diagnosis of uveal melanoma by the treating investigator can be clinically obtained, as per standard practice for uveal melanoma; pathologic confirmation of diagnosis will be performed at the participating site
Measurable metastatic ocular melanoma
No prior anti-cancer treatment for melanoma (except surgery for the melanoma lesion(s) and/or except for adjuvant radiation therapy (RT) after neurosurgical resection for central nervous system (CNS) lesions)
History of uveal melanoma
Subjects must not have primary uveal or mucosal melanoma, history or evidence of melanoma associated with immunodeficiency states or history of other malignancy within the past 3 years.
For Phase 2 expansion cohorts: Subjects with NSCLC, melanoma (checkpoint inhibitor naïve, primary refractory melanoma, relapsed melanoma), transitional cell carcinoma of the GU tract, SCCHN, ovarian cancer, MSI high CRC, RCC, DLBCL, and TNBC.
Ocular melanoma is excluded.
Patients must have completely resected melanoma of cutaneous origin or of unknown primary in order to be eligible for this study; patients must be classified as stage IIIA (N2a), IIIB, IIIC, or stage IV melanoma; patients with non-ulcerated T1b N1a disease are not eligible; patients with melanoma of mucosal or other non-cutaneous origin are eligible; patients with melanoma of ocular origin are not eligible; patients with a history of brain metastases are ineligible
For melanoma: Uveal melanoma or LDH >1.1 x ULN
Subjects with melanoma:
Subject must not have primary ocular or mucosal melanoma, or history or evidence of melanoma associated with immunodeficiency states (eg, hereditary immune deficiency, organ transplant, or leukemia).
Patients are excluded if they have known involvement of melanoma within the gastrointestinal tract
Histologic or cytologic documentation of metastatic or Stage IIIc unresectable melanoma, with BRAFV600 mutation as assessed by BRAFV600 Mutation Test. Origin of the primary tumor may be of skin, mucosal, or acral locations but not of uveal origin. Participants having an unknown primary tumor may be eligible if uveal melanoma can be ruled out
Uveal or ocular melanoma
Ocular or uveal melanoma
Subjects with ocular melanoma
Histologically or cytologically confirmed diagnosis of unresectable or metastatic malignant melanoma, including cutaneous, ocular, mucosal and unknown primary tumour.
Prior adjuvant melanoma therapy is permitted; any number of previous treatments for melanoma is permitted.
Uveal or ocular MEL
Patients must have measurable metastatic melanoma
Primary uveal or mucosal melanoma
Diagnosis of non-cutaneous melanoma or melanoma with unknown primary origin
The patient has uveal melanoma.
Mucosal melanoma and uvueal melanoma.
Patients with ocular melanoma.
Eligibility for pheresis: (Turnstile 1) Histopathologic documentation of melanoma concurrent with the diagnosis of metastatic disease. A diagnosis of uveal melanoma can be made clinically without primary tissue evaluation, based on history and records. A prior history of brachytherapy to the eye is sufficient clinical support for a diagnosis of uveal melanoma.
Patient has uveal melanoma
Patients diagnosed with advanced melanoma
Desmoplastic or neurotropic melanoma.
Subungual melanoma
Primary ocular or mucosal melanoma
Mucosal or ocular melanoma
Histologic confirmation of advanced (metastatic or unresectable) uveal melanoma; if uveal melanoma has been diagnosed clinically and/or by gene expression profiling, patients may be included following discussion with the principal investigator
Metastatic histologically or cytologically confirmed uveal melanoma with pathologic confirmation at a participating center that is judged to be progressive in the opinion of the treating physician; for the dose escalation portion of the trial only, patients with non-uveal melanoma harboring a GNAQ or GNA11 mutation will also be eligible
Histopathologic documentation of melanoma concurrent with the diagnosis of metastatic disease
Melanoma
Uveal and mucosal melanoma
Ocular melanoma
Patients with metastatic uveal melanoma
Group 4: Patients with NRAS mutated melanoma
Uveal or mucosal melanoma
Ocular melanoma
Known mucosal or ocular melanoma or the presence of unresectable in-transit metastases.
Prior systemic anti-cancer treatment and radiotherapy for melanoma; prior surgery for melanoma is allowed.
Patients must have metastatic histologically or cytologically confirmed uveal melanoma; (if histologic or cytologic confirmation of the primary is not available, confirmation of the primary diagnosis of uveal melanoma by the treating investigator can be clinically obtained, as per standard practice for uveal melanoma); pathologic confirmation of diagnosis will be performed at Columbia University, Memorial Sloan-Kettering Cancer Center (MSKCC) or Vanderbilt University Medical Center
Measurable metastatic melanoma with available autologous TIL
Uveal melanoma with biopsy proven metastatic disease
Patients who have a diagnosis for which a PD-(L)-1 inhibitor has been approved must have previously received treatment with one of these therapies. a. Melanoma Dose Expansion: Patients must have histologically confirmed metastatic melanoma (ocular melanoma not included) which has progressed on or after treatment with a PD-(L)1 inhibitor.
Has a history of ocular melanoma
Histological or cytological confirmed melanoma that is metastatic or unresectable; patients must have measurable disease (at least one measurable lesion) as defined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria; NOTE: all sites of disease must be evaluated within 4 weeks prior to registration to treatment; patients must have a history of melanoma of one of the following subtypes: \r\n* Acral (as defined as occurring on the palms, soles, or subungual sites)\r\n* Melanoma arising from the vagina and/or vulva\r\n* Melanoma arising on other mucosal surface (not vagina or vulva)
Patients must not have ocular melanoma
Prior therapy for melanoma except surgery
Histologic diagnosis of melanoma.
Ocular Melanoma
Melanoma of uveal origin
Patients must have histologically or cytologically confirmed metastatic or locally recurrent uveal melanoma; because histologic or cytologic confirmation of primary uveal melanoma is not always possible, confirmation of the clinical diagnosis of uveal melanoma by the treating investigator is allowed; clinical diagnosis of uveal melanoma is often made by an ophthalmologist, not by tissue diagnosis; if an ophthalmologist diagnosed and treated a patient for uveal melanoma in the past, it is sufficient for a clinical diagnosis
Primary Ocular Melanoma
All melanomas, except ocular/uveal melanoma, regardless of primary site of disease will be allowed; mucosal melanomas are eligible.
Patients with carcinomatosis meningitis or a history of ocular/uveal melanoma are excluded.
Clinical diagnosis of primary uveal melanoma involving the posterior uveal tract in the study eye
Planned enucleation or brachytherapy of the study eye due to uveal melanoma
Uveal melanoma in the study eye originating in the anterior uveal tract (iris)
Histologically or cytologically confirmed diagnosis of advanced or metastatic cutaneous melanoma that is determined to be BRAFV600 wild type and either NRAS wild type or NRAS mutation type. Note: Subjects with a melanoma of unknown primary origin may be allowed to enrol if all other types of melanoma (e.g., uveal, mucosal, or acral) can be reasonably ruled out.
Patients must have metastatic histologically or cytologically confirmed uveal melanoma; if histologic or cytologic confirmation of the primary is not available, confirmation of the primary diagnosis of uveal melanoma by the treating investigator can be clinically obtained, as per standard practice for uveal melanoma; pathologic confirmation of metastatic disease will be performed at Memorial Sloan Kettering (MSK) or at a participating site
Uveal Melanoma with liver metastasis
Part A2 & B (RCC, NSCLC, HCC, and uveal melanoma): Have measurable disease as defined by RECIST v1.1.
Patients must have histologically or cytologically confirmed metastatic uveal melanoma
Melanoma of ocular origin
Are at risk for melanoma due to having a first degree relative with a history of melanoma and/or at least 3 second or third degree relatives on the same side of the family with a history of melanoma and/or
AIMS 1 AND 2: Healthy individuals with pigmented lesions or a partially biopsied melanoma or cutaneous melanoma metastasis whose treatment plan includes excision
Patient must not have melanoma
Histopathologically confirmed diagnosis of metastatic or unresectable malignant melanoma arising from skin. Ocular melanoma subjects are not eligible.
Primary ocular or mucosal melanoma.
Received a current diagnosis of borderline epithelial ovarian tumor (formerly tumors of low malignant potential)
OVCA pts excluded with any of the following: non-epithelial, including malignant mixed mullerian tumors, unresolved bowel obstruction
For endometrial carcinoma patients, a diagnosis of epithelial endometrial carcinoma is required. Stromal tumors and carcinosarcoma (mixed malignant Mullerian tumor) are excluded.
Epithelial tumors of low malignant potential, stromal tumors, and germ cell tumors of the ovary
Patients with a current diagnosis of borderline epithelial ovarian tumor (formerly “tumors of low malignant potential”) or recurrent invasive epithelial ovarian cancer treated with surgery only (such as those with stage Ia or Ib low grade lesions) are not eligible; patients with a prior diagnosis of a borderline tumor that was surgically resected and who subsequently develop an unrelated, new invasive epithelial ovarian or peritoneal primary cancer are eligible, provided that they have not received prior chemotherapy for any ovarian tumor
Borderline or low-malignant potential histology
Tumors of low malignant potential (borderline carcinomas)
Patients with tumors of low malignant potential, except ovarian pseudomyxoma or with no peritoneal disease
Patients with pathology demonstrating mucinous, carcinosarcoma or low malignant potential tumor histology are excluded; in addition, non-ovarian malignancies, malignant germ cell or stromal tumors are also excluded
Epithelial tumors of low malignant potential, stromal tumors, and germ cell tumors of the ovary
Diagnosis of \tumor of low-malignant potential\.
Patients with a prior histologic diagnosis of borderline, low malignant potential (grade 0) epithelial carcinoma that was surgically resected and who subsequently developed an unrelated, new invasive epithelial ovarian or peritoneal primary cancer are eligible provided that they meet the criteria listed above
Borderline, low-malignant-potential epithelial carcinoma per histopathology is excluded.
Non epithelial tumors or ovarian tumors with low malignant potential (ie, borderline tumors) or mucinous tumors
Non epithelial tumor or ovarian tumors with low malignant potential (ie, borderline tumors).
Tumors of low malignant potential
Non-epithelial, including malignant mixed Mullerian tumors
Ovarian tumors with low malignant potential (i.e. borderline tumors)
Subjects with a current diagnosis of epithelial ovarian tumor of low malignant potential (borderline carcinomas) are not eligible
Epithelial ovarian cancer of low malignant potential (borderline tumor)
Non-epithelial ovarian carcinomas or ovarian tumors with low malignant potential (i.e., borderline tumors)
Non-epithelial ovarian carcinoma, including malignant mixed Mullerian tumors
Non epithelial tumor, including malignant mixed Müllerian tumors without high grade serous component, or ovarian tumors with low malignant potential (i.e., borderline tumors)
Non-epithelial ovarian carcinoma, including malignant mixed Mullerian tumors.
Patients with ovarian tumors of non-epithelial origin (eg, germ cell tumor) or any low grade tumors.
Subjects with a current diagnosis of epithelial ovarian tumor of low malignant potential (borderline carcinomas) are not eligible
Non-epithelial ovarian cancers, including malignant mixed Müllerian tumors.
Ovarian tumors with low malignant potential (i.e. borderline tumors).
Patients must have endometrial carcinoma including endometrioid adenocarcinoma, adenocarcinoma with squamous differentiation, mucinous adenocarcinoma, squamous cell carcinoma, mixed carcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, and serous adenocarcinoma histologies
Patients must have recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma; histologic documentation of the original primary tumor is required via the pathology report; the following histologic epithelial cell types are eligible:\r\n* Serous, endometrioid, mucinous, or clear cell adenocarcinoma\r\n* Undifferentiated, mixed epithelial or transitional cell carcinoma\r\n* Brenner’s tumor\r\n* Adenocarcinoma not otherwise specified (N.O.S)
Institutional confirmation of Mullerian epithelial adenocarcinoma on core biopsy (not cytology or fine needle aspiration) or laparoscopic biopsy; (for phase II of the study formalin-fixed paraffin-embedded [FFPE] tissue should be available for laboratory analysis); patients with the following histologic epithelial cell types are eligible: high grade serous carcinoma, high grade endometrioid carcinoma, clear cell carcinoma, or a combination of these
Patients with the following histologic epithelial cell types are eligible:\r\n* Serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, or adenocarcinoma not otherwise specified
Patients must have recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal carcinoma, diagnosed within 6 months of completing their most recent platinum-containing chemotherapy; histologic documentation of the original primary tumor is required via a pathology report; \r\n* Patients with the following histologic cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma not otherwise specified (N.O.S.)
Patients must have a diagnosis endometrial carcinoma on a tissue sample obtained at MSK (biopsy); patients with the following histologic epithelial cell types are eligible: endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.), mucinous adenocarcinoma, squamous cell carcinoma, transitional cell carcinoma
Patients must have measurable stage IVA, stage IVB (with or without measurable disease) or recurrent (with or without measurable disease) endometrial carcinoma; largest tumor diameter =< 5 cm\r\n* NOTE: histologic confirmation of the original primary tumor is required; patients with the following histologic epithelial cell types are eligible: Endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, carcinosarcoma, adenocarcinoma not otherwise specified (NOS)\r\n* NOTE: measurable disease is defined by Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1)
Histologic or cytologic diagnosis of endometrial carcinoma (including endometrioid, serous, mixed adenocarcinoma, clear-cell carcinoma, or carcinosarcoma).
Histologic epithelial cell types include serous, endometrioid, clear cell, or undifferentiated carcinomas, transitional cell carcinoma, mixed epithelial carcinoma, malignant Brenner's tumor, or adenocarcinoma not otherwise specified (NOS)
The following histologic epithelial cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner’s tumor, or adenocarcinoma not otherwise specified (NOS)
Patients must have recurrent or persistent endometrial cancer (endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, mixed epithelial carcinoma or adenocarcinoma not otherwise specified [NOS]); histologic confirmation of the primary tumor is required
Patients must have recurrent or persistent endometrial carcinoma, which is refractory to curative therapy or established treatments; histologic confirmation of the original primary tumor is required\r\n* Patients with the following histologic epithelial cell types are eligible: endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, mixed epithelial carcinoma, uterine clear cell carcinoma, and adenocarcinoma not otherwise specified (N.O.S.)
Patients with the following histologic cell types are eligible: \r\n* Serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial adenocarcinoma, transitional cell carcinoma, malignant Brenner's tumor, adenocarcinoma not otherwise specified (N.O.S.) or carcinosarcoma
Endometrioid adenocarcinoma, carcinosarcoma, undifferentiated carcinoma, mixed epithelial adenocarcinoma, adenocarcinoma not otherwise specified, mucinous adenocarcinoma, clear cell adenocarcinoma, low-grade serous adenocarcinoma, or malignant Brenner's tumor.
Patients with the following histologic epithelial cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's tumor, or adenocarcinoma not otherwise specified (N.O.S.)
Patients must have measurable stage III, measurable stage IVA, stage IVB (with or without measurable disease) or recurrent (with or without measurable disease) endometrial carcinoma\r\n* Histologic confirmation of the original primary tumor is required; patients with the following histologic epithelial cell types are eligible:\r\n** Endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.)
Histologically confirmed and documented disease to include: adenocarcinoma NOS (not otherwise specified), clear cell adenocarcinoma, endometrioid adenocarcinoma, malignant Brenner’s tumor, mixed epithelial carcinoma, mucinous adenocarcinoma, serous adenocarcinoma, transitional cell carcinoma, and undifferentiated carcinoma
Patients with the following histologic epithelial cell types are eligible: High grade serous adenocarcinoma, endometrioid adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, or adenocarcinoma not otherwise specified (N.O.S.).
Patients with the following histologic cell types are eligible: \r\n* High grade serous adenocarcinoma\r\n* Endometrioid adenocarcinoma \r\n* Undifferentiated carcinoma\r\n* Clear cell adenocarcinoma \r\n* Mixed epithelial adenocarcinoma \r\n* Adenocarcinoma not otherwise specified (N.O.S.) \r\n* Carcinosarcoma
Suspected preoperative diagnosis of invasive epithelial ovarian cancer, primary peritoneal carcinoma, fallopian tube cancer based on imaging and cancer antigen (Ca) 125; histologic epithelial cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell carcinoma, mixed epithelial carcinoma, or adenocarcinoma not otherwise specified; patients with primarily carcinoma histology but mixed features can be included; the surgically confirmed histologic features must be compatible with primary Mullerian epithelial adenocarcinoma
Subjects must have recurrent or persistent endometrial carcinoma (including: endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, dedifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified [N.O.S.], mucinous adenocarcinoma, squamous cell carcinoma, and transitional cell carcinoma) or endometrial carcinosarcoma; histologic documentation of diagnosis of carcinoma is required; microsatellite instability (MSI)-high patients will be identified based on immunohistochemistry or MSI testing of archival tumor specimens by department of pathology or via known mutations found in mismatch repair genes via the Integrated Mutation Profiling of Actionable Cancer Targets (IMPACT) assay through Memorial Sloan Kettering Cancer Center (MSKCC) Institutional Review Board (IRB)# 12-245
The histologic features of the tumor must be compatible with a primary Müllerian epithelial adenocarcinoma. Patients with the following histologic epithelial cell types are eligible: Serous adenocarcinoma, Endometrioid adenocarcinoma, Mucinous adenocarcinoma, Undifferentiated carcinoma, Clear cell adenocarcinoma, Mixed epithelial carcinoma, Transitional cell, Malignant Brenner's Tumor, Adenocarcinoma N.O.S. Patients may have co-existing fallopian tube carcinoma in-situ so long as the primary origin of invasive tumor is ovarian, peritoneal or fallopian tube.
Patients with the following histologies of endometrial cancer are not eligible for enrollment: papillary serous adenocarcinoma, clear cell carcinoma, adenosquamous carcinoma, mucinous adenocarcinoma, carcinosarcoma, sarcoma
Patients must have recurrent or persistent endometrial carcinoma; patients with the following histologic epithelial cell types are eligible: endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.), mucinous adenocarcinoma, squamous cell carcinoma, transitional cell carcinoma, and carcinosarcoma
Subjects with the following histologic epithelial cell types are eligible: Serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma N.O.S.
Patients with the following histologic cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial adenocarcinoma, transitional cell carcinoma, malignant Brenner's tumor, or adenocarcinoma not otherwise specified
Patients with the following histologic epithelial cell types are eligible:\r\n* Serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma not otherwise specified (N.O.S.) \r\n* However, the histologic features of the tumor must be compatible with a primary Müllerian epithelial adenocarcinoma; if doubt exists, it is recommended that the investigator should have the slides reviewed by an independent pathologist prior to entry \r\n* Patients may have co-existing endometrial cancer so long as the primary origin of invasive tumor is  ovarian or peritoneal for clarification of synchronous primary endometrial cancer
Patients with the following histologic epithelial cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner’s tumor or adenocarcinoma not otherwise specified (N.O.S.); however, the histologic features of the tumor must be compatible with a primary Mullerian epithelial adenocarcinoma