Edward Arrowsmith
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View article: Phase 1/2, open-label study of oral bacterial supplementation (EDP1503) plus pembrolizumab in participants with advanced or metastatic microsatellite-stable colorectal cancer, triple-negative breast cancer, and checkpoint inhibitor–relapsed tumors
Phase 1/2, open-label study of oral bacterial supplementation (EDP1503) plus pembrolizumab in participants with advanced or metastatic microsatellite-stable colorectal cancer, triple-negative breast cancer, and checkpoint inhibitor–relapsed tumors Open
We report a phase 1/2 study evaluating EDP1503 (capsule containing Bifidobacterium animalis lactis) ± pembrolizumab in participants with microsatellite-stable colorectal cancer (MSS CRC), triple-negative breast cancer (TNBC), or other tumo…
View article: A phase 2 study of AZD4635 in combination with durvalumab or oleclumab in patients with metastatic castration-resistant prostate cancer
A phase 2 study of AZD4635 in combination with durvalumab or oleclumab in patients with metastatic castration-resistant prostate cancer Open
View article: Clinical Value of Timely Targeted Therapy for Patients With Advanced Non–Small Cell Lung Cancer With Actionable Driver Oncogenes
Clinical Value of Timely Targeted Therapy for Patients With Advanced Non–Small Cell Lung Cancer With Actionable Driver Oncogenes Open
Background A recent real-world study observed that 24% of patients with advanced non–small cell lung cancer (aNSCLC) with actionable driver oncogenes (ADOs) initiated nontargeted therapies before biomarker test results became available. Th…
View article: 599 Single-agent safety and activities of target-preserving anti-CTLA-4 antibody gotistobart (ONC-392/BNT316) in PD-(L)1 resistant metastatic NSCLC and population PK analysis in patients with solid tumors
599 Single-agent safety and activities of target-preserving anti-CTLA-4 antibody gotistobart (ONC-392/BNT316) in PD-(L)1 resistant metastatic NSCLC and population PK analysis in patients with solid tumors Open
Background Although CTLA-4 was the first validated target in immunotherapy, available anti-CTLA-4 monoclonal antibodies (mAbs) have shown very limited therapeutic activity as a single agent. Preclinical studies showed that gotistobart (ONC…
View article: LBA87 Phase II LITESPARK-003 study of belzutifan in combination with cabozantinib for advanced clear cell renal cell carcinoma (ccRCC)
LBA87 Phase II LITESPARK-003 study of belzutifan in combination with cabozantinib for advanced clear cell renal cell carcinoma (ccRCC) Open
View article: Avelumab Plus Talazoparib in Patients With <i>BRCA1/2</i>- or <i>ATM</i>-Altered Advanced Solid Tumors
Avelumab Plus Talazoparib in Patients With <i>BRCA1/2</i>- or <i>ATM</i>-Altered Advanced Solid Tumors Open
Importance Nonclinical studies suggest that the combination of poly(ADP-ribose) polymerase and programmed cell death 1/programmed cell death–ligand 1 inhibitors has enhanced antitumor activity; however, the patient populations that may ben…
View article: 1396P Phase II study of AZD4635 in combination with durvalumab or oleclumab in patients (pts) with metastatic castrate-resistant prostate cancer (mCRPC)
1396P Phase II study of AZD4635 in combination with durvalumab or oleclumab in patients (pts) with metastatic castrate-resistant prostate cancer (mCRPC) Open
View article: Safety and efficacy of nivolumab plus ipilimumab in patients with advanced non-clear cell renal cell carcinoma: results from the phase 3b/4 CheckMate 920 trial
Safety and efficacy of nivolumab plus ipilimumab in patients with advanced non-clear cell renal cell carcinoma: results from the phase 3b/4 CheckMate 920 trial Open
Background CheckMate 920 ( NCT02982954 ) is a multicohort, phase 3b/4 clinical trial of nivolumab plus ipilimumab treatment in predominantly US community-based patients with previously untreated advanced renal cell carcinoma (RCC) and clin…
View article: Safety and efficacy of nivolumab plus ipilimumab in patients with advanced renal cell carcinoma with brain metastases: CheckMate 920
Safety and efficacy of nivolumab plus ipilimumab in patients with advanced renal cell carcinoma with brain metastases: CheckMate 920 Open
Background Nivolumab plus ipilimumab (NIVO + IPI) has demonstrated long‐term efficacy and safety in patients with previously untreated, advanced renal cell carcinoma (aRCC). Although most phase 3 clinical trials exclude patients with brain…
View article: A phase I/<scp>II</scp> study of the combination of panobinostat and carfilzomib in patients with relapsed or relapsed/refractory multiple myeloma: Final analysis of second dose‐expansion cohort
A phase I/<span>II</span> study of the combination of panobinostat and carfilzomib in patients with relapsed or relapsed/refractory multiple myeloma: Final analysis of second dose‐expansion cohort Open
The maximum tolerated dose of the panobinostat and carfilzomib combination in patients with relapsed/refractory multiple myeloma (RRMM) was not reached in our previous dose‐escalation study. We report additional dose levels in the phase I/…
View article: Phase 1 Expansion Cohort of Ramucirumab Plus Pembrolizumab in Advanced Treatment-Naive NSCLC
Phase 1 Expansion Cohort of Ramucirumab Plus Pembrolizumab in Advanced Treatment-Naive NSCLC Open
View article: Safety and Efficacy of Nivolumab in Patients With Advanced Clear Cell Renal Cell Carcinoma: Results From the Phase IIIb/IV CheckMate 374 Study
Safety and Efficacy of Nivolumab in Patients With Advanced Clear Cell Renal Cell Carcinoma: Results From the Phase IIIb/IV CheckMate 374 Study Open
This study validates the safety and efficacy of nivolumab 240 mg Q2W flat-dose monotherapy for previously treated advanced ccRCC and adds to previous safety and efficacy data using the 3 mg/kg Q2W dose.
View article: Safety and Efficacy of Nivolumab in Patients With Advanced Non–Clear Cell Renal Cell Carcinoma: Results From the Phase IIIb/IV CheckMate 374 Study
Safety and Efficacy of Nivolumab in Patients With Advanced Non–Clear Cell Renal Cell Carcinoma: Results From the Phase IIIb/IV CheckMate 374 Study Open
Safety of flat-dose nivolumab 240 mg Q2W was consistent with previous results. Clinically meaningful efficacy was observed with responses in several histologies, supporting nivolumab as a treatment option for patients with advanced nccRCC,…
View article: Ramucirumab combined with FOLFOX as front-line therapy for advanced esophageal, gastroesophageal junction, or gastric adenocarcinoma: a randomized, double-blind, multicenter Phase II trial
Ramucirumab combined with FOLFOX as front-line therapy for advanced esophageal, gastroesophageal junction, or gastric adenocarcinoma: a randomized, double-blind, multicenter Phase II trial Open
View article: MA14.07 Phase I Expansion Cohort of Ramucirumab Plus Pembrolizumab in Advanced Treatment-Naïve Non-Small Cell Lung Cancer (JVDF)
MA14.07 Phase I Expansion Cohort of Ramucirumab Plus Pembrolizumab in Advanced Treatment-Naïve Non-Small Cell Lung Cancer (JVDF) Open
View article: A Phase II Study with Lead-In Safety Cohort of 5-Fluorouracil, Oxaliplatin, and Lapatinib in Combination with Radiation Therapy as Neoadjuvant Treatment for Patients with Localized HER2-Positive Esophagogastric Adenocarcinomas
A Phase II Study with Lead-In Safety Cohort of 5-Fluorouracil, Oxaliplatin, and Lapatinib in Combination with Radiation Therapy as Neoadjuvant Treatment for Patients with Localized HER2-Positive Esophagogastric Adenocarcinomas Open
Lessons Learned Neoadjuvant 5-fluorouracil, oxaliplatin, and lapatinib in combination with radiation therapy is safe for neoadjuvant treatment for patients with localized human epidermal growth receptor 2-positive esophagogastric adenocarc…
View article: A Phase II Trial Evaluating the Safety of Rapid Infusion of Ofatumumab in Patients with Previously Treated Chronic Lymphocytic Leukemia
A Phase II Trial Evaluating the Safety of Rapid Infusion of Ofatumumab in Patients with Previously Treated Chronic Lymphocytic Leukemia Open
Lessons Learned Ofatumumab infusion reactions can be diminished by escalating the dose rate in individual patients in sequential infusions. Background Ofatumumab (OFA) is a fully humanized, anti-CD20 antibody approved for use in chronic ly…
View article: Phase <scp>II</scp> study of bendamustine, bortezomib and dexamethasone (<scp>BBD</scp>) in the first‐line treatment of patients with multiple myeloma who are not candidates for high dose chemotherapy
Phase <span>II</span> study of bendamustine, bortezomib and dexamethasone (<span>BBD</span>) in the first‐line treatment of patients with multiple myeloma who are not candidates for high dose chemotherapy Open
Summary The combination of bendamustine, bortezomib and dexamethasone ( BBD ) was evaluated as a first‐line therapy for multiple myeloma. The original treatment regimen of bendamustine 80 mg/m 2 , days 1, 4; bortezomib 1·3 mg/m 2 , days 1,…
View article: Ramucirumab combined with FOLFOX as front-line therapy for advanced esophageal, gastroesophageal junction, or gastric adenocarcinoma: a randomized, double-blind, multicenter Phase II trial
Ramucirumab combined with FOLFOX as front-line therapy for advanced esophageal, gastroesophageal junction, or gastric adenocarcinoma: a randomized, double-blind, multicenter Phase II trial Open
View article: Phase I/II study of the combination of panobinostat and carfilzomib in patients with relapsed/refractory multiple myeloma
Phase I/II study of the combination of panobinostat and carfilzomib in patients with relapsed/refractory multiple myeloma Open
The purpose of this study was to assess the safety and efficacy of the combination of panobinostat and carfilzomib in patients with relapsed/refractory multiple myeloma. Patients with multiple myeloma who had relapsed after at least one pr…