| Eligibility Criteria |
Inclusion Criteria
- Has histologically confirmed diagnosis of epithelial high-grade ovarian, fallopian tube or primary peritoneal carcinoma (including but not limiting to serous, endometrioid, clear cell, carcinosarcoma, mucinous).
- Is newly diagnosed FIGO Stage III or IV.
- Has HER2 expression per 2016 ASCO-CAP gastric cancer IHC scoring (3+/2+/1+) guidelines1 by prospective central testing.
- Has adequate tumor tissue sample available for assessment of HER2 by central laboratory.
- Has a local HRD or breast cancer gene (BRCA) test result available. Participants with BRCA wildtype will have a local HRD test results, as applicable.
- Has received standard of care bevacizumab in combination with front line platinum based chemotherapy as per approved indication and clinical guidelines and is eligible to continue single agent bevacizumab maintenance per standard of care and investigator discretion.
- Has non-PD after completion of at least 6 cycles and maximum of 8 cycles of front-line carboplatin-paclitaxel
- Trial intervention to start within 3 to 12 weeks of the last dose of front-line chemotherapy. Participants who started bevacizumab maintenance monotherapy before randomization are not eligible.
- Participants not deemed candidates for surgery or who have completed planned cytoreductive surgery (either PDS or IDS) are eligible.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Has urine dipstick for proteinuria <2+. If urine dipstick is ≥2+, 24-hour urine mustdemonstrate <1 g of protein in 24 hours.
- Has normal blood pressure or adequately treated and controlled hypertension (systolic BP ≤140 mmHg and/or diastolic BP ≤90 mmHg).
- Adequate bone marrow function
Platelet count ≥100 × 109/L
Hemoglobin ≥9.0 g/dL
ANC ≥1.5 × 109/L
Adequate renal function
Creatinine ≥30 mL/min, as calculated using the Cockcroft-Gault equation*
Adequate hepatic function
ALT and/or AST ≤3.0 × ULN if no liver metastasis or ≤5.0 × ULN with liver metastasis at Baseline
Total bilirubin ≤1.5 × ULN if no liver metastases or ≤3.0 × ULN if liver metastases at Baseline or documented Gilbert’s syndrome
Serum Albumin ≥2.5 g/dL
Adequate blood clotting function
PT/INR and either aPTT or PTT ≤ 1.5 × ULN
Exclusion Criteria
- Participant to receive PARP inhibitor as maintenance per standard of care and investigator discretion.
- Has a history of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening.
- Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
- Has multiple primary malignancies within 3 years, except adequately resected nonmelanoma skin cancer or curatively treated in-situ disease.
- Has active or uncontrolled hepatitis B virus infection.
- Has active or uncontrolled hepatitis C virus infection.
- Has active or uncontrolled HIV infection.
- Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to Grade ≤ 1 or baseline.
Note: Participants may be enrolled with chronic, stable Grade 2 toxicities (defined as no worsening to > Grade 2 for at least 3 months prior to randomization and managed with standard of care treatment) that the investigator deems related to previous anticancer therapy, including:
- Chemotherapy-induced neuropathy
Fatigue
Residual toxicities from prior IO treatment: Grade 1 or Grade 2 endocrinopathies
which may include:
a) Hypothyroidism/hyperthyroidism
b) Type I diabetes
c) Hyperglycemia
d) Adrenal insufficiency
e) Adrenalitis
f) Skin hypopigmentation (vitiligo)
Please contact Legacy Oncology Research for additional study inclusion/exclusion information.
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