This label update follows the FDA’s Oncologic Drugs Advisory Committee (ODAC) meetings held earlier this year as part of an industry-wide evaluation of indications based on accelerated approvals that have not met their post-marketing requirements. ...
Patients must consent to collection of liquid biopsy (blood) samples for ctDNA analysis by a CLIA central laboratory and for correlative analysis by a research central laboratory. Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient ...
KEYNOTE-A39 is an open-label, multicenter, randomized, active-controlled Phase 3 trial (ClinicalTrials.gov, NCT04223856) evaluating KEYTRUDA plus enfortumab vedotin compared to platinum-based chemotherapy (gemcitabine ...
PSA was assessed by a central laboratory at screening and every 3 wk after allocation. Follow-up time began at allocation. PD-L1 positivity was defined as a combined positive score (CPS) ≥1, where CPS is defined as the number of PD-L1–staining cells (tumor cells, lymphocytes, ...
盲法(masking) None (Open Label) 试验开始日期 2018-11-09 主要试验完成日期 2024-11-10 试验完成日期 2024-11-10 试验分组 分组/群组 干预/治疗 Experimental :Early-Stage NK/T-cell Lymphoma/ENKTL (Stage III/IV) Drug : Pembrolizumab 200mg IVPB every 3 weeks Experimental :Early...
Atezolizumab plus bevacizumab and chemotherapy in non-small-cell lung cancer (IMpower150): Key subgroup analyses of patients with EGFR mutations or baseline liver metastases in a randomised, open-label phase 3 trial. Lancet Respir. Med. 2019, 7, 387–401. [Google Scholar] [CrossRef] Felip, ...
This open-label phase 2 clinical trial evaluates the clinical activity and safety of combination niraparib and pembrolizumab treatment in women with
Eligible patients had HLA-A∗02:01, HLA-A∗02:05, and/or HLA-A∗02:06 (assessed by high-resolution sequence-based blood typing) conducted at a central laboratory. Marrow myeloma cell expression of NY-ESO-1 and LAGE-1a were assessed by real-time polymerase chain reaction (a positive...
17. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study. 18. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 150 ...
Burtness B, Harrington KJ, Greil R et al (2019) Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-048): a randomised, open-label, phase 3 study. Lancet 394(10212):1915–1928. https:/...