The SNARE trial (NCT05593497) is a Veterans Affairs (VA) multicenter, single arm phase II study for neoadjuvant iADT with capivasertib with integral biomarker design. Key eligibility includes high-risk PCa defined as ≥1 criterion: resectable cT3; Grade Group ≥4; Memorial Sloan Kettering ...
Several limitations deserve mention. This was a single-arm study testing the efficacy of apalutamide monotherapy, and treatment with the drug alone was unable to yield any pCR, thus failing to reject the null hypothesis. Additionally, our assumption of 25% for pCR with apalutamide alone was o...
This single-arm phase 2 trial (ChiCTR2100046715) examined previously untreated patients with advanced esophageal squamous cell carcinoma (ESCC) who received four cycles of paclitaxel with carboplatin every 3 weeks. Toripalimab was infused intravenously every 3 weeks for 12 months, or until disease pro...
An academic prospective single-arm phase II clinical trial for evaluation of advanced functional neuroimaging and molecular markers during bevacizumab/irinotecan therapy for recurrent malignant gliomaPelvisRadiotherapyToxicityEnteritisGlutaminePurpose Our primary endpoint is to determine the ...
DETECT IV. - a multicenter, single arm, phase II study evaluating the efficacy of Everolimus in combination with endocrine therapy in patients with HER2-negative, hormone-receptor positive metastatic breast cancer and exclusively HER2-negative circulating tumor cells (CTCs). Oncol. ...
a Phase Ii Study of Nivolumab: A Multicenter, Open-label, Single Arm Study in Malignant Pleural Mesothelioma (merit): ma 19.01Y. GotoM. OkadaT. KijimaK. AoeT. KatoN. FujimotoK. NakagawaY. TakedaT. HidaK. Kanai
Topotecan is currently the only US Federal Drug Administration (FDA)-approved drug for second-line treatment of relapsed small-cell lung cancer (SCLC). We investigated the efficacy and safety of a novel topotecan-bevacizumab combination in treating relapsed SCLC. Each 21-day treatment cycle consisted...
The present study was an open-label, single-arm, 2-stage trial. The primary efficacy endpoint was the proportion of subjects achieving an objective response (defined as either a complete [CR] or partial [PR] response). The secondary endpoints included the duration of the response (de...
Cohort 3 was a larger dose-expansion arm of the 600 mg/m2 dose. All cohorts were recruited sequentially. All patients were scheduled to receive i.v. infusions of zolbetuximab every 2 weeks for up to five infusions. Patients who completed five infusions of zolbetuximab at the highest...
Here, we report the results of a single-arm, multi-institutional phase Ib/II trial evaluating a quadruplet regimen of pembrolizumab, trastuzumab, capecitabine, and cisplatin as a first-line therapy for HER2-positive advanced gastric cancer (AGC) with post hoc genomic studies (PANTHERA trial). Re...