Ovarian cancer
Patients may not have had any prior systemic therapy =< 21 days prior to registration for treatment of ovarian cancer
Histologically or cytologically confirmed advanced ovarian cancer: epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer (excluding borderline ovarian cancer) that is resistant or refractory to platinum therapy and no other standard therapy with proven clinical benefit is available.
Part 2: Ovarian or HNSCC, with confirmed p53 mutations
For the dose expansion cohort, patients with recurrent endometrial cancer, recurrent BRCA mutated ovarian cancer (except first-recurrence platinum sensitive ovarian cancer), and platinum resistant ovarian cancer are eligible
For the dose expansion cohort patients with first-recurrence platinum-sensitive ovarian cancer must be excluded
Ovarian cancer of serous histology
Patients with platinum resistant ovarian cancer must have progressed through at least one prior chemotherapy regimen for recurrent ovarian cancer
History of blocked intestines because of ovarian cancer, unless fully resolved.
Treatment with cytotoxic chemotherapy for malignancies other than ovarian cancer within the past 5 years
gBRCAm ovarian cancer (modules 3 and 5)
gBRCAm negative ovarian cancer (modules 6 and 7)
Subjects with ovarian and endometrial cancer (endometrial cancer only in the expansion cohort) with:
Subjects with comorbidities that would limit their two year survival for reasons other than ovarian cancer
EXCLUSION CRITERIA FOR REGISTRATION: subjects with comorbidities which would lead to a clinical expectation that they will not survive two years for reasons other than ovarian cancer
Any prior treatment for ovarian cancer, other than the first-line platinum regimen
Previous chemotherapy or hormonal therapy for treatment of ovarian cancer.
Participants must have primary or secondary platinum-resistant ovarian cancer.
Diagnosis of clear cell or low grade ovarian cancer
Patient has mucinous or clear cell subtypes of epithelial ovarian cancer, carcinosarcoma or undifferentiated ovarian cancer
Phase 2 expansion: Ovarian cancer
Phase 1 patients (breast or ovarian cancer)
Phase 2 patients (breast or ovarian cancer)
Ovarian Cancer
Patients must have received at least one prior salvage regimen for recurrent ovarian cancer
Prior therapy for ovarian or uterine cancer with ribociclib or an aromatase inhibitor (letrozole, anastrozole or exemestane)
Must have pancreatic, ovarian, gastric, non-small cell cancer or mesothelioma. For dose expansion, must have tumor that is positive for mesothelin
Previous treatment with > 2 anticancer regimens for ovarian cancer
Has epithelial ovarian cancer (EOC) with mucinous histology subtype
Ovarian cancer confirmed BRCA wild-type from a prior test.
Prior diagnosis of Stage IV ovarian cancer; Stage III ovarian cancer must have a 5-year disease-free interval; Stage II ovarian cancer must have a 2-year disease-free interval
Ovarian Carcinoma
Patients may have synchronous endometrial and ovarian cancer primaries
More than 3 prior lines of cytotoxic chemotherapy for ovarian cancer.
Have been diagnosed with noninvasive or invasive (stage 1, 2, or 3A) breast cancer, colon cancer, lymphoma, or ovarian cancer
History of breast cancer, endometrial cancer or ovarian cancer or taking aromatase inhibitors or selective estrogen receptor modulators
Metastatic ovarian epithelial cancer that are platinum-resistant, and has no better option available in the investigator's opinion
Part 2 includes target expressing NSCLC, ovarian or breast cancer patients
Systemic drug treatment to induce ovarian suppression if woman is premenopausal
Prior treatment with paclitaxel and carboplatin for recurrent platinum-sensitive ovarian cancer
Not more than two prior chemotherapy regimens for the treatment of platinum-resistant ovarian cancer Participants with Pancreatic Cancer:
Epithelial ovarian cancer or gynecological cancer
Less than 4 weeks since last treatment for ovarian cancer
Breast cancer in BRCA1 or BRACA2 positive ovarian cancer patients
For ovarian cancer participants only, platinum treatment with more than two platinum-based chemotherapy regiments or more than four anti-cancer regimens, overall, for the treatment of ovarian cancer.
Borderline ovarian cancer with ascites
Non-epithelial ovarian cancer or metastatic cancer to the ovaries
Borderline ovarian cancer without ascites
Presumed early stage ovarian cancer
Patients with borderline ovarian tumors, recurrent epithelial ovarian or primary peritoneal cancer or non-epithelial ovarian cancer are not eligible
PATIENTS: Platinum-sensitive recurrent ovarian cancer without a significant clinical event
Desires to undergo ovarian stimulation and oocyte retrieval prior to cancer treatment
Does not plan to undergo ovarian stimulation and oocyte retrieval prior to diagnosis
Prior genetic counseling or testing for hereditary breast/ovarian cancer
Any condition which might be worsened by estrogen, such as breast cancer, uterine cancer, ovarian cancer, endometriosis or uterine fibroids
Women with a history of leukemia, ovarian cancer or a cancer that likely involve the ovaries at the time of ovarian tissue collection
Have blood relatives diagnosed with ovarian cancer
Have 2 or more family members on the same side of the family with breast, ovarian, pancreatic, or prostate cancer
Ongoing treatment for ovarian or other cancer (e.g., chemotherapy, radiation, surgery, etc.)
Confirmed diagnosis of primary breast, cervical, endometrial, or ovarian cancer
Pilot: Ovarian cancer patients who have completed cancer treatment
ovarian cancer: 2-4 prior treatments
Diagnosis of clear cell or low grade ovarian cancer
Patients with recurrent ovarian cancer receiving chemotherapy
Diagnosis of stage III-IV epithelial ovarian cancer (EOC)
Stage I-IV gynecologic cancer (including ovarian, uterine, cervical, vulvar, or vaginal cancer)
Have one relative with ovarian cancer
Scheduled for surgery at Brigham and Women’s Hospital for known or highly suspected stage III or IV ovarian cancer (i.e. elevated cancer antigen [CA]-125 with a pelvic mass, ascites, and carcinomatosis)
Active malignancy other than ovarian cancer
No measurable disease or suspected stage I or II ovarian cancer on preoperative imaging
Patients with prior ovarian cancer or surgery involving removal of one or both ovaries
History of ovarian cancer
Ovarian cancer:
Patients must have breast or ovarian cancer
Patients must have completed primary breast or ovarian cancer therapy (i.e., surgery, chemotherapy, immunotherapy and/or radiation therapy as appropriate per standard of care for patient's specific cancer)
Women must be enrolled in the Ovarian Cancer Screening Program (OCSP); eligibility criteria for the OCSP are: 50 years of age or older, or be postmenopausal and have not had a prior salpingo-oophorectomy or have a family history of ovarian cancer in a primary relative or have a self-history of breast cancer
Patients have a documented ovarian abnormality on ultrasound
History of ovarian cancer
No prior treatment for ovarian cancer
Patients who have non-invasive or non-epithelial ovarian cancer on pathological confirmation; patients with synchronous stage I endometrial cancer will not be excluded
OVARIAN CANCER PARTICIPANTS: Participant has suspected or biopsy proven ovarian cancer and is scheduled to undergo surgical excision of the cancerous lesion(s) OR\r\n* Participant has biopsy proven ovarian cancer but is not a surgical candidate
OVARIAN CANCER PARTICIPANTS: Patients participating in other research imaging protocols will be excluded from this study
Epithelial ovarian cancer which is contained within the abdomen, but may include pleural effusion if that is the limit of non-peritoneal cavity disease. If subject has recurrent epithelial ovarian cancer, the disease must be platinum sensitive (recurrence >6 months from prior chemotherapy regimen that included a platinum agent and cytoreductive surgery)
Borderline ovarian cancer with ascites is allowable
Non-epithelial ovarian cancer or metastatic cancer from another site to the ovaries
Borderline ovarian cancer without ascites
Female patients 18 years of age and older 2. Have a primary diagnosis, or at high clinical suspicion, of primary ovarian cancer (of epithelial type), planned for primary surgical cytoreduction, interval debulking, or have recurrent ovarian cancer surgery, and:
Evaluable disease by serum markers in the case of ovarian cancer [Gynecologic Cancer Intergroup (GCIG) specific criteria]; and
Known FR alpha-negative ovarian cancer