OTHER GYN CANCERS Flashcards

1
Q

Study #: CASE 8818 MICROBIOME

Investigating Platinum Chemotherapy Response and Resistance in Patients with Ovarian Cancer Receiving Chemotherapy Through the Gut Microbiome

Schema:

N/A

Prior Therapies

No

Inclusion:

• Histologically or cytologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal (EOC)

• Age >18 years.

• Must have ability to produce and provide fecal samples for analysis.

Exclusion:

•Pre-existing colostomy or ileostomy prior to chemotherapy

A
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2
Q

Study #: S1609 (DART)

Phase 1

Cohort 47: GTD Cohort 49: Small cell carcinoma of the ovary, hypercalcemic type Cohort 50: PD-L1 amplified tumor

Schema:

Ipilimumab: CTLA-4 Antibody

Nivolumab: PD-1 antibody

Prior Therapies:

Unlimited

Inclusion:

Contact Phase 1 Team: tciphase1trials@ccf.org

Exclusion:

Contact Phase 1 Team: tciphase1trials@ccf.org

A
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3
Q

Study #: NRGCC008

Non-Randomized Prospective Clinical Trial Comparing the Non-Inferiority of Salpingectomy to Salpingo-oophorectomy to Reduce the Risk of Ovarian Cancer Among BRCA1 Carriers

Schema:

Patients choose between BLS cohort and BSO cohort –> CA125 annually –>medical decision making BLS crossover to bilateral oophorectomy at 12 mon

Prior Therapies:

N/A

Measureable Disease:

N/A

A

Inclusions:

•Women ≥ 35 and ≤ 50 years of age with BRCA1 mutations

•Patients who have declined or elected to defer RRSO after proper counselling to clearly explain the standard of care for BRCA1 mutation carriers (for the BLS with delayed oophorectomy arms) or patients who are undergoing RRSO (for the RRSO arm).

•At least one intact ovary and fallopian tube.

•Positive CLIA-approved test results for pathogenic or likely pathogenic germline BRCA1 mutation in the patient herself. Documentation of the result is required.

•Premenopausal; defined as <12 months of amenorrhea

Exclusion:

•Women with a history of any prior cancer who have received chemotherapy within the past 12 months, hormonal therapy in the past 90 days, or radiotherapy to abdomen or pelvis at any prior time.

•Patients with abnormal screening tests (TVUS, CA-125) suspicious for occult or gross pelvic malignancy or neoplasm within the past 180 days.

•Women who are currently pregnant or plan to become pregnant in the future.

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4
Q

Study #: PNYR1Y21

A Phase 1a/1b Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PY314 as a Single Agent and In Combination with Pembrolizumab in Subjects with Advanced Solid Tumors

Schema:

PY314: afucosylated humanized IgG1k mAb that targts TREM2

Prior Therapies:

Resistant or refractory disease with or without prior maintenance therapy

Measureable Disease:

Epithelial ovarian cancer, fallopian tube cancer, peritoneal cancer

Inclusion/ Exclusion:

Contact Phase 1 Team: tciphase1trials@ccf.org

A
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