Ovarian Clear Cell Carcinoma

To learn if the combination of dostarlimab and LB-100 can help to control ovarian clear cell carcinoma

The purpose of this open-label, first-in-human (FIH) trial is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of DZR123 (Tulmimetostat, CPI-0209), both as monotherapy and in combination with enzalutamide, in patients with advanced solid tumors and lymphomas.

The goal of this phase 3 clinical trial is to evaluate whether QL1706 plus bevacizumab can effectively treat adult female patients (18 to \<75 years old) with newly diagnosed FIGO stage IC-IV ovarian clear cell carcinoma. The main questions it aims to answer are: 1. Does QL1706 plus bevacizumab, compared with standard platinum-based chemotherapy with or without bevacizumab, prolong patients' progression-free survival (PFS)? 2. What is the safety profile of QL1706 followed by QL1706 plus bevacizumab, such as what medical problems (adverse events) do participants experience? Researchers will compare QL1706 followed by QL1706 plus bevacizumab (experimental arm) with standard platinum-based chemotherapy consisting of paclitaxel plus carboplatin with or without bevacizumab (control arm) to see whether QL1706-based immunotherapy is more effective in the first-line treatment of advanced ovarian clear cell carcinoma. Participants will: 1. Be randomly assigned to receive either QL1706 alone during Cycle 1 followed by QL1706 plus bevacizumab from Cycle 2, or paclitaxel plus carboplatin with or without bevacizumab according to prespecified high-risk criteria. 2. Visit the research center regularly for drug infusions, medical examinations (such as vital signs, physical exams, laboratory tests), and tumor imaging assessments. 3. Complete quality of life questionnaires as required.

The OnPrime study is a multi-center, randomized open-label phase 3 study evaluating the safety and efficacy of Olvi-Vec followed by platinum-doublet chemotherapy and bevacizumab compared to the Active Comparator Arm with Physician's Choice of chemotherapy and bevacizumab in women diagnosed with platinum-resistant/refractory ovarian cancer (includes fallopian tube cancer and primary peritoneal cancer). This Phase III trial builds on the efficacy and safety data reported in the previous Phase II VIRO-15 trial with promising objective response rate and progression-free survival observed in heavily pre-treated patients with platinum-resistant/refractory ovarian cancer. The phase II results also showed that the intra-peritoneal route of delivery was efficient in generating tumor cell killing and immune activation, and led to clinical reversal of platinum-resistance or refractoriness in this difficult-to-treat patient population.

\*\*Primary Objective:\*\* The primary objective of this study is to evaluate the efficacy and safety of liposomal irinotecan in combination with sintilimab and anlotinib in patients with recurrent or persistent ovarian clear cell carcinoma (OCCC). \*\*Treatment Regimen:\*\* Participants will receive the following treatment: * \*\*Liposomal irinotecan:\*\* Initial dose of 50 mg/m²; if well tolerated, the dose will be increased to 70 mg/m² in subsequent cycles. Administered via intravenous infusion on Day 1 of each 3-week cycle. * \*\*Sintilimab:\*\* 200 mg administered by intravenous infusion (over 30-60 minutes) on Day 1 of each cycle. * \*\*Anlotinib:\*\* 8 mg orally once daily, starting on Day 1 of each cycle, taken for 2 consecutive weeks followed by a 1-week rest period. \*\*Follow-up Schedule:\*\* Patients will be followed every 3 months during treatment and within the first year after completion of therapy, every 6 months from Year 2 to Year 5, and annually thereafter. Follow-up assessments will include physical examination, laboratory testing, and imaging studies.

The goal of this observational study is to learn about the treatment effectiveness of physician's choice of chemotherapy and the immune checkpoint inhibitor (ICI)-based therapy in patients with relapsed/refractory ovarian clear cell carcinoma (OCCC), and compare the treatment response with the phase II, single-arm clinical trial INOVA to investigate the efficacy of combinational therapy of sintilimab plus bevacizumab. The main questions it aims to answer are: * What is the efficacy of physician's choice of chemotherapy in relapsed/refractory OCCC patients in the real world? * Is ICI-based therapy more effective than physician's choice of chemotherapy in real-world for relapsed/refractory OCCC patients? * Dose the combinational regimens of sintilimab plus bevacizumab in Sintilimab Plus Bevacizumab in Recurrent/Persistent Ovarian Clear Cell Carcinoma (INOVA) trial more effective than physician's choice of chemotherapy? Participants will be respectively retrieved and extracted de-identified, longitudinal electronic health records (EHR)-derived data.