A phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of GS-5745 combined with mFOLFOX6 as first-line treatment in patients with advanced gastric or gastroesophageal junction adenocarcinoma.

2016 ◽  
Vol 34 (15_suppl) ◽  
pp. TPS4132-TPS4132 ◽  
Author(s):  
Johanna C. Bendell ◽  
Alexander Starodub ◽  
Zev A. Wainberg ◽  
Meihua Wu ◽  
Douglas Werner ◽  
...  
Keyword(s):  
Gastroesophageal Junction ◽  
Controlled Study ◽  
Line Treatment ◽  
Efficacy And Safety ◽  
First Line ◽  
Phase 3 ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Gastroesophageal Junction Adenocarcinoma ◽  
First Line Treatment

scholarly journals KEYNOTE-826: A phase 3, randomized, double-blind, placebo-controlled study of pembrolizumab plus chemotherapy for first-line treatment of persistent, recurrent, or metastatic cervical cancer.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. TPS5595-TPS5595 ◽  
Author(s):  
Ronnie Shapira-Frommer ◽  
Jerome Alexandre ◽  
Bradley Monk ◽  
Tanja N. Fehm ◽  
Nicoletta Colombo ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
T Cell ◽  
Objective Response ◽  
Controlled Study ◽  
Line Treatment ◽  
First Line ◽  
Phase 3 ◽  
Double Blind ◽  
Double Blind Placebo ◽  
First Line Treatment

TPS5595 Background: Cervical cancer arises in the setting of persistent infection with high-risk human papillomavirus subtypes. Many patients with early-stage and locally advanced carcinoma can be salvaged with radical surgery and chemoradiation, respectively. However, women with recurrent/metastatic disease represent a poor prognostic group with high unmet clinical needs. Incorporation of anti-angiogenesis therapy has emerged as a therapeutic option, but the survival benefit of 3.7 months over chemotherapy (CT) alone is modest (Tewari et al. NEJM 2014). Because viral tumor antigen-specific T cells reside predominantly in programmed cell death 1–expressing T-cell compartments, checkpoint inhibition may unleash a diverse antitumor T-cell response. Based on the 14.3% objective response in KEYNOTE-158, the US FDA granted accelerated approval to pembrolizumab (pembro) in June 2018 for second-line therapy and beyond. Methods: KEYNOTE-826 is a phase 3, randomized, double-blind, placebo-controlled, multinational trial of CT with pembro or with placebo for first-line treatment of recurrent, persistent, or metastatic cervical cancer. Patients not previously treated with CT for recurrence who are not amenable to curative treatment will be randomized 1:1 to CT + pembro 200 mg or placebo every 3 weeks. The CT regimen (paclitaxel 175 mg/m2 + cisplatin 50 mg/m2 or carboplatin AUC 5, with or without bevacizumab 15 mg/kg) will be selected by the investigator before randomization. Stratification factors include metastasis status at diagnosis, bevacizumab use (yes/no), and tumor PD-L1 status (combined positive score <1, 1 to <10, or ≥10). Treatment will continue until disease progression, unacceptable toxicity, or voluntary patient withdrawal for up to 35 cycles (~2 years). Primary endpoints are progression-free survival (PFS) per RECIST v1.1 assessed by blinded independent central review and overall survival. Secondary endpoints are objective response, duration of response, 12-month PFS, patient-reported quality of life, and safety. Enrollment is ongoing. Clinical trial information: NCT03635567.

Efficacy and safety of IBI305 compared with bevacizumab in advanced non-squamous NSCLC patients as first-line treatment in a randomized, double-blind, phase III study.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 9095-9095
Author(s):  
Li Zhang ◽  
Bin Wu ◽  
Linian Huang ◽  
Meiqi Shi ◽  
Yunpeng Liu ◽  
...  
Keyword(s):  
Comparative Study ◽  
Maintenance Treatment ◽  
Line Treatment ◽  
Efficacy And Safety ◽  
First Line ◽  
Phase 3 ◽  
Double Blind ◽  
Nsclc Patients ◽  
Equivalence Margin ◽  
First Line Treatment

9095 Background: IBI305 is a recombinant humanized anti-VEGF monoclonal antibody, a biosimilar candidate to bevacizumab in analytical and functional comparisons. Pharmacokinetic similarity has been demonstrated in healthy males. Here we present primary efficacy and safety results from a phase 3 comparative study in non-small cell lung cancer (NSCLC). Methods: In this double-blind, active-controlled study, subjects with advanced non-squamous NSCLC on first-line treatment with carboplatin and paclitaxel were randomized (1:1) to IBI305 or bevacizumab (15 mg/kg IV Q3W). After six cycles, patients were on maintenance treatment with IBI305 or bevacizumab (7.5 mg/kg IV Q3W) till progression. Clinical equivalence of the primary endpoint, confirmed objective response rate (ORR) was evaluated by comparing the 2-sided 90% confidence interval (CI) of the risk ratio (RR) between study arms with the prespecified margin (0.75, 1.33). Results: A total of 450 subjects were randomized (IBI305: n = 224; bevacizumab: n = 226). Baseline characteristics were well balanced between treatment arms. ORR evaluated by Independent Radiological Review Committee (IRRC) in full analysis set (FAS) was 44.3% (98/221) for IBI305 and 46.4% (102/220) for bevacizumab; the RR for ORR was 0.95 (90% CI: 0.803, 1.135). Sensitive analysis result on RRs of ORR in Intention to Treat (ITT) population (IBI305: n = 224; bevacizumab: n = 226) and other analysis set were consistent and all within the prespecified equivalence margin. The medium PFS were 8.4 months for IBI305 and 8.3 months for bevacizumab and duration of response (DOR) was also similar in both arms. Treatment-emergent adverse events (TEAEs) were well balanced between treatment arms and consistent with the known adverse event profile of bevacizumab. Patients developing binding antibodies were 0.5% in the IBI305 arm vs 0% in the bevacizumab arm; no subject tested positive for neutralizing antibodies. Conclusions: This is the first released phase 3 clinical study with maintenance treatment for bevacizumab biosimilar in NSCLC patients till now. The comparative study met its predefined primary endpoint that the RR for confirmed ORR was within the prespecified equivalence margin. There was no significant difference between the two arms in safety profile and immunogenicity. Clinical trial information: NCT02954172.

scholarly journals KEYNOTE-859: a Phase III study of pembrolizumab plus chemotherapy in gastric/gastroesophageal junction adenocarcinoma

2021 ◽  
Author(s):  
Josep Tabernero ◽  
Yung-Jue Bang ◽  
Eric Van Cutsem ◽  
Charles S Fuchs ◽  
Yelena Yuriy Janjigian ◽  
...  
Keyword(s):  
Metastatic Cancer ◽  
Gastroesophageal Junction ◽  
Growth Factor Receptor ◽  
Phase Iii ◽  
Line Treatment ◽  
First Line ◽  
Double Blind ◽  
Clinical Trial Registration ◽  
Gastroesophageal Junction Adenocarcinoma ◽  
First Line Treatment

Current guidelines recommend two-drug cytotoxic chemotherapy with a fluoropyrimidine (fluorouracil or capecitabine) and a platinum-based agent (oxaliplatin or cisplatin) as first-line treatment for advanced gastric cancer. Pembrolizumab monotherapy has demonstrated durable antitumor activity in patients with advanced programmed death ligand 1-positive (combined positive score ≥1) gastric/gastroesophageal junction adenocarcinoma. Accumulating evidence indicates that combining pembrolizumab with standard-of-care chemotherapy for the treatment of advanced or metastatic cancer improves clinical outcomes. We describe the rationale for and the design of the randomized, double-blind, placebo-controlled, Phase III KEYNOTE-859 study, which is investigating pembrolizumab in combination with chemotherapy as first-line treatment for patients with human epidermal growth factor receptor 2-negative advanced unresectable or metastatic gastric/gastroesophageal junction adenocarcinoma. The planned sample size is 1542 patients, and the primary end point is overall survival. Clinical trial registration: NCT03675737 (ClinicalTrials.gov)

Camrelizumab combined with SOX regimen in the first-line treatment of unresectable advanced or recurrent gastric cancer: A single-arm, prospective, open clinical study.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e16017-e16017
Author(s):  
Zhengxiang Han
Keyword(s):  
Gastric Cancer ◽  
Clinical Study ◽  
Advanced Gastric Cancer ◽  
Gastroesophageal Junction ◽  
Line Treatment ◽  
Efficacy And Safety ◽  
First Line ◽  
Gastroesophageal Junction Adenocarcinoma ◽  
Recurrent Gastric Cancer ◽  
First Line Treatment

e16017 Camrelizumab combined with SOX regimen in the first-line treatment of unresectable advanced or recurrent gastric cancer£ºA single-arm, prospective, open clinical study. Background: Gastric cancer is one of the most common malignant tumors of the digestive system. In China, 80% of patients with gastric cancer are already in advanced or locally advanced stage at the time of detection. Even after receiving radical gastrectomy, more than half of patients will have local recurrence or distant metastasis, and the 5-year survival rate of patients with gastric cancer with metastasis is less than 10%.In recent years, more and more evidence supports the application of immune checkpoint inhibitors in advanced gastric cancer.In 2020, PD-1 was approved for advanced gastric cancer receiving second-line or above treatment in China, which is an affirming of the efficacy of PD-1 in the clinical treatment of gastric cancer. Immunotherapy combined with conventional chemotherapy, this study aims to explore the efficacy and safety of PD1 combined with chemotherapy in the treatment of first-line gastric cancer. Methods: This was a single center, prospective clinical study conducted at the Affiliated Hospital of Xuzhou Medical University, Jiangsu Province.Patients with newly treated unresectable advanced or recurrent gastric or gastroesophageal junction adenocarcinoma were enrolled.All enrolled subjects were treated with camrelizumab combined with SOX regimen every 3 weeks.The primary endpoint was progression-free survival (PFS).Secondary endpoints were overall survival (OS), objective response rate (ORR), disease control rate (DCR), and safety.This study was registered at Chictr.org.cn with the number Chictr2000029691. Results: The study plans to enroll 30 patients, and 16 patients have been included in the study from March 2020 to December 2020. Among them, 7 patients can be evaluated, 14 males, 2 females, ECOG score 0 or 1. Of the 7 patients who can be evaluated for efficacy, 1 achieved PR and 5 achieved SD, ORR was 14.29%, and DCR was 85.71 %. This is the early stage of data analysis, PFS has not yet reached, and the side effects are mild, mainly with grade 1 adverse reactions. The most common AEs are neutropenia (3/7) and decreased appetite (2/7). There were no treatment-related deaths. Conclusions: This study provides preliminary evidence for the first-line treatment of unresectable advanced or recurrent gastric or gastroesophageal junction adenocarcinoma with camrelizumab combined with chemotherapy. The current number of enrolled cases is small, but the preliminary effect of immunotherapy combined with chemotherapy in first-line patients with advanced gastric cancer can still be seen. This trial will further explore the clinical efficacy and safety of immunotherapy in the first-line gastric cancer. Clinical trial information: ChiCTR2000029691.

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