platinum resistant ovarian cancer
Conditions
Interventions
Group 1
Mocertatug rezetecan will be administered
Group 2
Paclitaxel will be administered
PLD will be administered
Topotecan will be administered
Gemcitabine will be administered
Pembrolizumab will
Sponsors
Ishibashi Hideyasu
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: -Is at least 18 years of age and the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the Informed Consent Form (ICF). -Has epithelial ovarian cancer, inclusive of primary peritoneal or fallopian-tube cancer with a histologically confirmed diagnosis of high grade serous, high grade endometrioid, or clear cell carcinoma, or carcinosarcoma that is resistant to platinum-based therapy. Platinum-resistance is defined as follows: -Participants who have only had 1 line of platinum-based therapy must have received at least 4 cycles of platinum therapy, must have had a response (CR, PR, stable disease) and then progressed from >3 months to 1 line of platinum therapy must have progressed on or - 75% of viable tumor cells with moderate (2+) and/or strong (3+) membrane staining) per a test compliant to local regulation, AND oDoes not have a documented contraindication per label or local institutional guidelines, including but not limited to chronic corneal disorders, history of corneal transplantation, or active ocular conditions requiring ongoing treatment/monitoring, such as uncontrolled glaucoma, active diabetic retinopathy with macular edema, macular degeneration, presence of papilledema, monocular vision, peripheral neuropathy, interstitial lung disease, or hypersensitivity. AND oIt is available in the enrolment country. A regimen is considered available if it is approved and reimbursed (covered by national healthcare or private insurance) in the participating country. -Bevacizumab, unless the participant has a documented contraindication per label or local institutional guidelines. Contraindications include but are not limited to vascular disorders (uncontrolled hypertension, arterial thromboembolic events), fistula, gastro-intestinal disorders (rectosigmoid involvement, bowel obstruction), delayed wound healing, bleeding diathesis (haemoptysis, epistaxis, pulmonary haemorrhage, acquired coagulopathy), nephrotic syndrome or significant proteinuria, or osteonecrosis of the jaw, or hypersensitivity -PARPi, in participants with known or suspected deleterious germline or somatic BRCA mutations and who achieved a complete or partial response to platinum-based chemotherapy must have been t
Exclusion criteria
Exclusion criteria: -Has primary platinum-refractory Ovarian Cancer (OC), defined as disease that did not respond to or has progressed within -14 days prior to date of C1D1 are not excluded from participation. -Has any evidence of current ILD or pneumonitis, or a prior history of ILD or non-infectious pneumonitis. -Has ongoing adverse reaction(s) from prior therapy that has (have) not recovered to - Grade 3, immune-mediated severe neurologic events of any grade (e.g., myasthenic syndrome/myasthenia gravis, encephalitis, Guillain-Barre Syndrome, or transverse myelitis), exfoliative dermatitis of any grade (Stevens-Johnson Syndrome [SJS], Toxic Epidermal Necrolysis [TEN], or drug reaction with eosinophilia and systemic symptoms [DRESS] syndrome), or myocarditis of any grade -For participants selected to receive bevacizumab as part of the pembrolizumab + paclitaxel +/-bevacizumab intended physician's choice regimen only: Has a history of vascular disorders (uncontrolled hypertension, arterial thromboembolic events), fistula, gastro-intestinal disorders (rectosigmoid involvement, bowel obstruction), delayed wound healing, bleeding diathesis (hemoptysis, epistaxis, pulmonary hemorrhage, acquired coagulopathy), nephrotic syndrome or significant proteinuria, or osteonecrosis of the jaw, or hypersensitivity. -Has had any major surgery within 28 days prior to date of C1D1 or received focal radiotherapy within 21 days prior to date of C1D1. -Has received treatment with an investigational agent within 30 days prior to date of C1D1. -Has received treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) Overall Survival (OS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS) by investigator assessment Objective Response Rate (ORR) by BICR assessment Duration of Response (DOR) by BICR Objective Response Rate (ORR) by investigator assessment Duration of Response (DOR) by investigator assessment PFS2 Number of participants with Treatment-Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESIs), and Treatment-Emergent Serious Adverse Events (TESAEs) Number of participants with TEAEs/AESIs/TESAEs leading to dose modifications or study intervention discontinuation Number of participants with changes in vital signs, laboratory tests (hematology and clinical chemistry), and electrocardiograms (ECGs) Serum concentration of Mo-Rez (conjugated antibody and free payload) Number of participants with anti-drug antibodies (ADA) and neutralizing antibodies (NAb) against Mo-Rez Titers of ADA against Mo-Rez Change from baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) score Change from baseline in EORTC QLQ-Ovarian Cancer Module (OV28) score Time to deterioration (TTD) of EORTC QLQ-OV28 Time to deterioration (TTD) of EORTC QLQ-C30 Maximum post-baseline Patient-reported outcome Common Terminology Criteria for Adverse Events (PRO-CTCAE) score CA-125 response rate as per Gynecologic Cancer InterGroup (GCIG) criteria | — |
Countries
Australia, Austria, Belgium, Brazil, Canada, Costa Rica, Czechia, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Norway, Spain, Sweden, Turkiye, United Kingdom, United States
Contacts
Public ContactHideyasu Ishibashi
GlaxoSmithKline K.K.
Outcome results
None listed