This multicenter, biomarker-driven, patient-centric study aimed to evaluate the efficacy of secondary cytoreduction followed by platinum-based chemotherapy in combination with anti-PD1/CTLA-4 bispecifics therapy in patients with platinum-sensitive relapsed ovarian cancer (PSROC).
The immune phenotype of patients with relapsed ovarian cancer may correlate with their response to immunotherapy. This multicenter, biomarker-driven, patient-centric study aimed to evaluate the efficacy of secondary cytoreduction followed by platinum-based chemotherapy in combination with anti-PD1/CTLA-4 bispecifics therapy in patients with platinum-sensitive relapsed ovarian cancer (PSROC). PD-L1 expression and CD8+ tumor-infiltrating T cell count (CD8+ TILs count) were evaluated as biomarkers using archived or fresh tumor tissue samples in patients with BRCA1/2 wild type. This study would be proceeded in two phases. The phase 1b single-arm study aimed to evaluate the efficacy of Iparomlimab/tuvonralimab in the treatment of BRCA wild type, PD-L1-positive, CD8+ TILs-positive, patients with PSROC. The patent-centric phase II study with three arms aimed to evaluate the efficacy of secondary cytoreduction followed by platinum-based chemotherapy in combination with Iparomlimab/tuvonralimab in these patients. In arm 1 and 2, patients received secondary cytoreduction followed by platinum-based chemotherapy in combination with Iparomlimab/tuvonralimab. In arm 3, patients received physician's therapy of choice.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
33
secondary cytoreductive surgery followed by 6 cycles of post-operative chemotherapy
Iparomlimab/tuvonralimab will be administered at a dose of 5 mg per kilogram IV every 21 days. Treatment will continue until disease progression confirmed by RECIST criteria v1.1, intolerable toxicity or withdrawal of consent.
Zhongshan Hospital Fudan University
Shanghai, China
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
Progression-free survival in CF arm
The time from entry into the study to the diagnosis of the first progression or recurrence or death in CF arm, whichever occurs first
Time frame: Up to 3 years
3-years Overall Survival Rate in CF arm
The proportion of patients without death at 3 years after entry into the study in CF arm
Time frame: Up to 3 years
Overall survival in CF arm
The time from entry into the study to the date of death from any cause or last follow-up in CF arm
Time frame: Up to 3 years
TFST in CF arm
Time from entry into the study until the starting date of the first subsequent anticancer therapy or death, whichever occurred first, whichever occurred first, in CF arm
Time frame: Up to 3 years
TSST in CF arm
Time from entry into the study until the starting date of the second subsequent anticancer therapy or death, whichever occurred first, in CF arm
Time frame: Up to 3 years
Post-operative complications in CF and CU arms
The surgical complications will be evaluated at 30-day after secondary cytoreductive surgery in CF and CU arms
Time frame: Up to 1 months
Quality of life assessments in CF arm using EORTC QLQ-C30
Changes in EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30) scores in CF arm (baseline; 6 months, 12 months, 24 months and 36 months after entry into the study; score range 0-126; higher score = worse outcome)
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Time frame: Up to 3 years
Quality of life assessments in CF arm using FACT-O
Changes in FACT-O (Functional Assessment of Cancer Therapy-Ovarian cancer) scores in CF arm (baseline; 6 months, 12 months, 24 months and 36 months after entry into the study; score range 0-156; higher score = worse outcome)
Time frame: Up to 3 years