27 results
The objective of the current study is to investigate the possible effects on driving ability of a new anti-depressant (10 mg Lu AA21004) after 1 day of dosing and after 15 days of dosing. These effects will be compared to those of mirtazapine (30 mg…
The primary objective of the exploratory study is to characterize the types and dynamics of changes in the tumor microenvironment that occur following programmed-death-1 (PD-1) receptor blockade with REGN2810 and to assess their relationship to the…
Primary ObjectivesIn the Dose Escalation Phase:• To assess the safety and pharmacokinetics (PK) in order to determine a maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of REGN4018 as monotherapy and in combination with cemiplimabIn…
Primary Objective:- Number of participants with dose limiting toxicity - Number of participants with treatment-related adverse events - Number of participants with treatment-emergent adverse events- Number of participants with changes in vital signs…
Primary study aim:To determine the efficacy, in terms of the meadian progression-free survival, in patients with recurrent or metastatic endometrial cancer (including carcinosarcoma of the endometrium) receiving treatment with durvalumab and…
This study will evaluate the efficacy and safety of consolidation maintenance treatment consisting of atezolizumab and tiragolumab compared with durvalumab in patients with locally advanced, unresectable Stage III NSCLC who have received at least…
(1) Main objective:Safety Run-In (SRI):To assess the safety and tolerability of durvalumab + tremelimumab + EV in participants with MIBC who are ineligible for cisplatin or who refuse cisplatinMain Study: To compare the efficacy of durvalumab +…
The research hypothesis for this study is that concurrent durvalumab plus SoC chemotherapy will be more effective than placebo plus SoC chemotherapy for the treatment of MRD+ patients who have undergone complete resection of stage II-III NSCLC when…
Primary:• 3 year recurrence free survival (RFS), in patients with MMRd HREC Secondary:• RFS (median and at 5 years)• OS (median, 3yr, 5yr)• Vaginal RFS, pelvic RFS, distant metastasis free-survival (median, 3-year, 5-year)• Disease-specific…
- To assess the safety and tolerability and to determine the RP2D of T-DXd plus durvalumab in combination with cisplatin, carboplatin or pemetrexed
This study is evaluating the preliminary efficacy of UV1-olaparib-durvalumab combination against both olaparib as monotherapy and olaparib-durvalumab combination in maintenance after platinum combination therapy for BRCAwt patients with relapsed…
The overall objectives of this study are to evaluate the efficacy and safety of multiple therapies in patients with locally advanced, unresectable, Stage III NSCLC who are selected according to biomarker status as identified by tissue-based testing.…
The standard first-line therapy for mUC patients is platinum-based chemotherapy, most commonly cisplatin. For patients that progress during or after platinum-based chemotherapy, anti-PD(L)1 therapy can be used, showing durable responses in a subset…
To evaluate PFS in participants treated with cCRT plus M7824 followed by M7824 or cCRT plus placebo followed by Durvalumab
In this study, we want to learn more about the effect and safety of Ceralasertib plus Durvalumab on the inhibition of tumour growth, and also to better understand NSCLC and associated health problems.We compare the effect and safety of Ceralasertib…
This Phase III study, the administration of durvalumab + chemotherapy prior to surgery, followed by administration of durvalumab after surgery, will be investigated in patients with resectable Stages II and III NSCLC. The efficacy of durvalumab will…
Primary Efficacy Objective:Primary objective: To evaluate if the addition of ISA101b to cemiplimab results in improved overall response rate (ORR) compared to cemiplimab alone, according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1…
The study objectives and endpoints described below will be evaluated for the following treatment regimens:• Arm A: Nivolumab + CCRT followed by nivolumab + ipilimumab maintenance• Arm B: Nivolumab + CCRT followed by nivolumab maintenance• Arm C:…
The objective of this trial is to evaluate progression-free survival in synchronous oligometastatic NSCLC patients treated with induction immunotherapy, chemotherapy and SBRT to all metastases followed by definitive surgery or radiotherapy to the…
To determine the real-world pharmacokinetics of ICIs.