116 results
The primary objective of this study is to evaluate the patient preference for either ICI-B or ICI-P. Secondary objectives are: to assess patient satisfaction with ICI-B and ICI-P, to establish the safety of ICI-B and ICI-P to establish the…
Phase I Dose Escalation1.To determine the RP2D in terms of safety and tolerability for:•IV admin of HB-201 in patients with HPV 16+ confirmed HNSCC•IT admin of HB-201 in patients with HPV 16+ confirmed cancers•IV admin of HB-202 in patients with HPV…
1) To compare pembrolizumab plus olaparib to abiraterone acetate or enzalutamide with respect to overall survival (OS)2) To compare pembrolizumab plus olaparib to abiraterone acetate or enzalutamide with respect to radiographic progression-free…
Primary Objective• To assess the effect of ALX148 + pembrolizumab + 5FU + platinum on 12-month overall survival (OS) rate and objective response rate (ORR)in patients with metastatic or unresectable, recurrent HNSCC who have not yet been treated…
Primary Part 1:-To evaluate ORR in participants treated with MK-4280A plus EV (Arm A), MK-7684A plus EV (Arm B), and pembrolizumab plus EV(Arm C) per RECIST 1.1 by BICR.- To evaluate the safety and tolerability in participants treated with MK-4280A…
From protocol amendment 3 27JUn2022, Clinical Study Protocol Synopsis, page 1Primary Objective• To demonstrate superiority of fianlimab 1600 mg + cemiplimab and/or fianlimab 400 mg+ cemiplimab compared to pembrolizumab, as measured by progression-…
The primary objectives of this trial are to study clinical efficacy and immune activation of neoadjuvant PD-1 blockade in VSCC.
Primary/dualco-primary. To prospectively investigate whether adjuvant treatment with pembrolizumab after completion of radical surgery (lobectomy/pneumonectomy) with or without standard adjuvant chemotherapy for stage IB (T >= 4 cm) -II-IIIA…
The proposed Study J2G-MC-JZJC (hereafter referred to as JZJC) will evaluate selpercatinib in comparison to platinum-based (carboplatin or cisplatin) and pemetrexed therapy with or without pembrolizumab in patients with locally advanced or…
Dose escalation: To establish the MTD and RP2D of tisotumab vedotin in combination in subjects with cervical cancer Dose expansion: Evaluate the antitumor activity of tisotumab vedotin monotherapy and incombination in subjects with cervical cancer
Primary:To determine the safety, tolerability, MTD (maximum tolerated dose) or the MAD (maximum administered dose) of GSK3359609 in combination with pembrolizumab or chemotherapy with(out) pembrolizumab. Secondary:To determine the recommended dose…
To identify potential biomarkers for early identification of clinical benefit during pembrolizumab treatment in patients with advanced urothelial cancer. To identify potential mechanisms of primary and acquired resistance to pembrolizumab.To assess…
Primary objectives (Dose-escalation Phase):• To evaluate the safety and tolerability, describe the dose-limiting toxicities (DLTs), to determine the maximum tolerated dose (MTD), optimal biological dose (OBD), or highest protocol-defined dose (HPDD…
Primary Objective:To evaluate the efficacy of adagrasib monotherapy and in combination with pembrolizumab administered in the first-line treatment setting to patients having NSCLC with KRAS G12C mutation.Secondary Objectives:• To characterize the…
The evaluation of R-IrAE's after ICI therapy, specifically incidence, treament of R-IrAE's, response to said treatment, baseline and follow-up serology (general and symptom specific) to be combined with quality of life assessment and…
Primary objective:• Evaluate the anti-tumor activity of GEN1046 as monotherapy and in combination with pembrolizumab in subjects with relapsed/refractory metastatic NSCLCSecondary objectives:• Evaluate time to onset and durability of the anti tumor…
Dual Primary Objectives:• To compare progression-free survival (PFS) as assessed by Blinded Independent Central Review (BICR) using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) of niraparib plus pembrolizumab versus placebo…
Primary: To evaluate the safety and toxicity of TIL therapy in patients with metastatic NSCLC preceded by chemotherapy with or without immunotherapy.Secondary: Clinical response according to RECIST 1.1 criteria and immune response criteria (irRC).…
This study is designed to assess the efficacy and safety of pembrolizumab monotherapy compared with SoC platinum doublet chemotherapy for first-line treatment of participants with dMMR advanced or recurrent EC. The primary objectives are to compare…
Primary ObjectiveTo determine the incidence and grading of infusion related/hypersensitivity reactions reported per drug using the definition of Common Terminology Criteria for Adverse Events (CTCAE) criteria for: infusion related reaction during…