Sacituzumab Govitecan in Combination with Cisplatin for the Treatment of Patients with Recurrent Platinum-sensitive Ovarian or Endometrial Cancer

Inclusion Criteria

• Pathologic (histology or cytology) confirmed diagnosis of epithelial ovarian cancer (ovarian, fallopian tube or primary peritoneal cancer) or endometrial cancer
• Radiographic evidence of recurrent epithelial ovarian cancer (ovarian, fallopian tube, or primary peritoneal cancer) or endometrial cancer that is “platinum-sensitive,” defined as progression of disease beyond 6 months from the last dose of platinum-based chemotherapy
• Female, age ≥ 18 years
• World Health Organization (WHO) performance status 0-1 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks
• Patient has measurable disease (at least one lesion that can be accurately assessed repeatedly by CT) as evidenced on pre-treatment baseline CT of chest/abdomen/pelvis or PET/CT, or evaluable disease
• Hemoglobin ≥ 8.5 g/dL (without transfusion or growth factor support within 2 weeks of study drug initiation)
• Absolute neutrophil count ≥ 1500/mm^3 (without transfusion or growth factor support within 2 weeks of study drug initiation)
• Platelets ≥ 100,000/μL (without transfusion or growth factor support within 2 weeks of study drug initiation)
• Total bilirubin ≤ 1.5 upper limit of normal (ULN)
• Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ≤ 2.5 x ULN or ≤ 5 x ULN if known liver metastases
• Serum albumin > 3 g/dL
• Creatinine clearance ≥ 50 mL/min per the Cockcroft-Gault equation
• Women of child-bearing potential must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 6 months after the last dose of study drug sacituzumab govitecan and cisplatin. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately * A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: ** Has not undergone a hysterectomy or bilateral oophorectomy; or ** Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
• Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria

• Treatment with any of the following: * Any investigational agents or study drugs from a previous clinical study within 28 days or 5 half-lives (whichever is longer) of the first dose of study treatment * Any other chemotherapy, immunotherapy or anticancer agents within 14 days of the first dose of study treatment
• Major surgery (excluding placement of vascular access) within 4 weeks of the first dose of study treatment
• Radiotherapy with a wide field of radiation within 4 weeks or radiotherapy with a limited field of radiation for palliation within 2 weeks of the first dose of study treatment
• With the exception of alopecia and endocrine-related adverse events (AEs) (including hypothyroidism, diabetes mellitus, or adrenal insufficiency) adequately treated with appropriate therapy (for example, but not limited to, hormone replacement therapy), any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of starting study treatment
• As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses, or uncontrolled infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required
• Known or severe (Grade 3 or higher) hypersensitivity to sacituzumab govitecan (SG) and/or cisplatin, their metabolites, or formulation excipients
• Peripheral neuropathy grade 2 or greater
• Refractory nausea and vomiting, chronic gastrointestinal diseases
• Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants
• Women of childbearing potential unwilling to use effective contraception during study until conclusion of 6-months last post-treatment
• Known history of unstable angina, myocardial infarction (MI), or congestive heart failure (CHF) present within 6 months of randomization or clinically significant cardiac arrhythmia (other than stable atrial fibrillation) requiring anti-arrhythmia therapy
• Known history of clinically significant active chronic obstructive pulmonary disease (COPD), or other moderate-to-severe chronic respiratory illness present within 6 months of enrollment
• Prior history of clinically significant bleeding, intestinal obstruction, or gastrointestinal (GI) perforation within 6 months of enrollment
• Other concurrent medical or psychiatric conditions that, in the investigator’s opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations
• Prior therapy with sacituzumab govitecan, irinotecan, Trop-2-directed antibody drug conjugate, or any topoisomerase I-containing antibody-drug conjugates at any time for early stage disease
• Have active chronic inflammatory bowel disease (ulcerative colitis, Crohn’s disease) or GI perforation within 6 months of enrollment
• Requirement for ongoing therapy with any prohibited medications
• Have an active second malignancy. Participants with a history of malignancy that have been completely treated, with no evidence of active cancer for 3 years prior to randomization, or participants with surgically cured tumors with low risk of recurrence (eg, nonmelanoma skin cancer, histologically confirmed complete excision of carcinoma in situ, or similar) are allowed to enroll
• Use of any live vaccine against infectious diseases within 30 days of the first dose of study drugs
• Have an active serious infection requiring systemic antimicrobial therapy