38 results
Primary objectives Phase Ib: To estimate the MTD and/or RP2D of LGX818 in combination with cetuximab ± BYL719. Incidence of dose-limiting toxicities (DLTs). Phase II: To compare the efficacy of the dual (LGX818, cetuximab) and triple (LGX818, BYL719…
The main objective of this study is to determine whether a single neoadjuvant gift of anti-EGFR mAb, administered 48 hours prior to local treatment of colorectal liver metastases, reduces the number of CTCs. Secondary endpoints are determination of…
Primary Objectives:(1) Objective: To compare the overall survival (OS) in subjects with R/M HNSCC treated with pembrolizumab compared to standard treatment.Secondary Objectives:PD-L1 Positive Population:(1) Objective: To compare Overall Survival (OS…
Primary: Phase Ib: To estimate the MTD(s) and/or RP2D(s) of the triple combination of WNT974, LGX818 andcetuximab in patients with BRAFV600-mutant CRC harboring Wnt pathway mutations.Phase II: To estimate the preliminary anti-tumor activity of the…
Primary objective: To compare the severe (acute and late) toxicity (Grade 3-5), as assessed by CTCAE Version 4, caused by cetuximab and RT to that caused by cisplatin and RT in patients with HPV+OPSCC.Secondary objectives:- Compare overall number of…
Primary Objectives1) To compare the Progression Free Survival (PFS) per RECIST 1.1 as assessed by blinded independent central review (BICR) in first line recurrent / metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) subjects, treated…
Primary:- To evaluate the antitumor activity of the combination of encorafenib, binimetinib and cetuximab by assessing the confirmed overall response rate (cORR) by local radiologist/investigator assessment in adult subjects with previously…
Rationale:The aim of this study is to investigate the pharmacodynamics (PD), pharmacokinetics (PK), safety, tolerability, immunogenicity, and clinical efficacy of efgartigimod coformulated with recombinant human hyaluronidase PH20 (rHuPH20)…
Primary:•To determine the antitumor activity of SAR444245 in combination with other anti-cancer therapies in patients with HNSCCSecondary:•To assess the safety profile of SAR444245 when combined with other anti-cancer therapies• To assess other…
PART I: 1) to demonstrate 89Zr-cetuximab uptake in non-hepatic tumor lesions at standard dose or at cohort wise increased cetuximab doses (dose escalation). 2) to determine the association between 89Zr-cetuximab uptake in non-hepatic tumor lesions…
Main objectiveStep 1: To determine the recommended phase 2 dose (RP2D) of MEN1611 when administered orally in combination with cetuximab to patients with PIK3CA mutated colorectal cancer failing irinotecan, oxaliplatin, 5-FU and anti-EGFR containing…
Primary objectives:To compare the efficacy of Adagrasib in combination with cetuximab versus chemotherapy (FOLFIRI or mFOLFOX6) administered in the second-line treatment setting to patients with CRC with KRAS G12C mutation.Secondary objectives:• To…
Primary Objective & HypothesisIn subjects with first line (1L) stage IV MSI-H or dMMR CRC treated with first line (1L) pembrolizumab (MK-3475) versus SOC chemotherapies,Objective: To compare Progression Free Survival (PFS) per RECIST 1.1 by…
To evaluate the efficacy and safety of tucatinib in combination with trastuzumab and mFOLFOX6 in comparison to mFOLFOX6 given with or without either bevacizumab or cetuximab as first-line (1L) treatment in adults with HER2 positive (HER2+)…
To evaluate the efficacy and safety of tucatinib in combination with trastuzumab and mFOLFOX6 in comparison to mFOLFOX6 given with or without either bevacizumab or cetuximab as first-line (1L) treatment in adults with HER2 positive (HER2+)…
Comparing the efficacy of encorafenib and cetuximab plus pembrolizumab (triplet group [group A]) vs. pembrolizumab (control group [group B]).Assessing the overall safety and tolerability of group A vs. group B.Assessing the efficacy of group A vs.…
This Phase Ia/Ib study will evaluate the safety, pharmacokinetics, immunogenicity (as applicable for study biotherapeutics), preliminary activity, and biomarkers of GDC-6036 as a single agent (Arm A) and in combination with other anti-cancer…
The study will compare the effect of monalizumab and cetuximab (Arm A) relative to placebo and cetuximab (Arm B) by assessment of Overall Survival in HPV-unrelated participants. The formal statistical analysis will be performed to test the following…