A5073605756- Lung Cancer Treatments and Mutations
- Cancer Immunotherapy and Biomarkers
- Colorectal Cancer Treatments and Studies
- Lung Cancer Diagnosis and Treatment
- Cancer Genomics and Diagnostics
- Lung Cancer Research Studies
- Colorectal and Anal Carcinomas
- Pancreatic and Hepatic Oncology Research
- Advanced Breast Cancer Therapies
- Peptidase Inhibition and Analysis
- Head and Neck Cancer Studies
- Cancer Diagnosis and Treatment
- CAR-T cell therapy research
- Gastric Cancer Management and Outcomes
- Melanoma and MAPK Pathways
- PI3K/AKT/mTOR signaling in cancer
- Esophageal Cancer Research and Treatment
- Neuroendocrine Tumor Research Advances
- Lymphoma Diagnosis and Treatment
- Bladder and Urothelial Cancer Treatments
- PARP inhibition in cancer therapy
- Cardiovascular Health and Risk Factors
- Nonmelanoma Skin Cancer Studies
- Colorectal Cancer Screening and Detection
- Testicular diseases and treatments
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
2021-2025
Indiana University – Purdue University Indianapolis
2016-2025
Indiana University Health
2015-2025
Indiana University
2024-2025
Indiana University School of Medicine
2014-2024
Indiana Cancer Consortium
2021-2024
University School
2018-2021
University of Indianapolis
2021
Background Five‐year overall survival (OS) for patients with unresectable stage III non–small cell lung cancer (NSCLC) is poor. Until recently, a standard of care was concurrent chemoradiation alone. Patients metastatic NSCLC treated anti–programmed death 1 antibodies have demonstrated improved OS. This trial evaluated pembrolizumab as consolidation therapy after in disease. Methods received cisplatin and etoposide, pemetrexed, or carboplatin paclitaxel 59.4 to 66.6 Gy radiation....
The NCCN Guidelines for Head and Neck Cancers address tumors arising in the oral cavity (including mucosal lip), pharynx, larynx, paranasal sinuses, as well occult primary cancer, salivary gland melanoma (MM). specific site of disease, stage, pathologic findings guide treatment (eg, appropriate surgical procedure, radiation targets, dose fractionation radiation, indications systemic therapy). Panel meets at least annually to review comments from reviewers within their institutions, examine...
8500 Background: Concurrent chemoradiation (CRT) has been the standard Rx for pts with unresectable stage III NSCLC. A recent phase trial (PACIFIC) of consolidation durvalumab [PDL-1 inhibitor] demonstrated improved median PFS vs. placebo (16.8 5.6 mo, HR 0.52, p < 0.001). 12-mo (55.9% 35.3%) and 18-mo (44.2% 27%) were also improved. Toxicity was manageable a grade 3-4 pneumonitis rate 3.4%, 4 patients experienced 5 pneumonitis. We report results 2 pembrolizumab [PD-1 following concurrent...
Background Probody ® therapeutics are antibody prodrugs that activated in the tumor microenvironment by tumor-associated proteases, thereby restricting activity to and minimizing ‘off-tumor’ toxicity. We report dose-escalation single-agent expansion phase data from first-in-human study of CX-072 (pacmilimab), a checkpoint inhibitor directed against programmed death-ligand 1 (PD-L1). Methods In this multicenter, open-label ( NCT03013491 ), adults with advanced solid tumors (naive...
8509 Background: The PACIFIC trial demonstrated that a year of consolidation PD-(L)1 inhibition following concurrent chemoradiation (CRT) for unresectable stage III NSCLC improves overall survival (OS). optimal duration IO therapy in this setting is undefined. Studies metastatic demonstrate combination PD-(L)1/CTLA-4 OS over chemotherapy alone. This evaluated the use Nivolumab (N) plus Ipilimumab (IPI) or N alone up to 6 months after CRT. Methods: randomized phase II, multicenter 105 pts...
594 Background: The epidermal growth factor receptor (EGFR) and ErbB2/HER2 signaling is overactive in many solid tumors. Afatinib, an irreversible inhibitor of ErbB signaling, downregulates thymidine synthase synergizes with capecitabine preclinical models. This phase I trial evaluated the safety, maximum tolerated dose (MTD) preliminary efficacy afatinib plus patients (pts) refractory tumors pancreatic ductal adenocarcinoma (PDA) biliary tract cancers (BTC). Methods: study had a 3+3 design...
Living guidelines are developed for selected topic areas with rapidly evolving evidence that drives frequent change in recommended clinical practice. updated on a regular schedule by standing expert panel systematically reviews the health literature continuous basis, as described ASCO Guidelines Methodology Manual . follow Conflict of Interest Policy Implementation Clinical Practice and updates not intended to substitute independent professional judgment treating clinician do account...
4018 Background: Kirsten rat sarcoma viral oncogene homolog (KRAS) p.G12C mutation is associated with poor prognosis in colorectal cancer (CRC). AMG 510 a first-in-class small molecule that specifically and irreversibly inhibits KRAS G12C by locking it the inactive guanosine diphosphate-bound state. In previous interim analysis of phase 1, first-in-human trial 510, we observed favorable safety profile preliminary antitumor activity patients (pts) advanced solid tumors harboring p.G12C. Here,...
Abstract Background Immunotherapy using a checkpoint inhibitor (CPI) alone or in combination with chemotherapy is the standard of care for treatment‐naive patients advanced non–small cell lung cancer (NSCLC) without driver mutations which targeted therapies have been approved. It unknown whether continuing CPI treatment beyond disease progression results improved outcomes. Methods Patients who experienced progressive (PD) after clinical benefit from plus were enrolled. received pembrolizumab...
PD-L1 IHC 22C3 pharmDx is an FDA-approved companion test to select patients for anti-PD-L1 immunotherapy. In head and neck squamous cell carcinoma expression determined using a Combined Positive Score (CPS), which evaluates in tumor cells tumor-associated leukocytes. We hypothesized that nodal metastasis, the CPS should be higher given their inherent proportion of A significant difference between sites would mean tissue chosen testing impact patient eligibility therapy. Currently, guidelines...
9010 Background: Consolidation PD-1/PD-L1 inhibition after chemoradiation (CRT) for unresectable stage III NSCLC improves overall survival. In IV NSCLC, the combination of nivolumab/ipilimumab improved survival compared to chemotherapy in patients with PD-L1 > 1% and performed favorably < 1%. The safety consolidation CRT has not been previously assessed. Methods: this randomized, multi-center, phase II study, a total 105 planned pts IIIA/IIIB will receive chemoradiation, then randomize...
e13770 Background: Lung cancer is the leading cause of related deaths. The median age those diagnosed with lung continues to increase as overall population ages. Consolidation immunotherapy after chemoradiation has become standard treatment for patients unresectable stage III NSCLC. However, little been reported regarding safety and efficacy this strategy in an elderly patient population. Methods: Data was analyzed from a randomized phase II clinical trial non-small cell (NSCLC) who were...
TPS2669 Background: Kirsten rat sarcoma viral oncogene homolog ( KRAS) p.G12C mutation is an oncogenic driver in several solid tumors. Sotorasib a specific, irreversible, small molecule inhibitor of KRAS G12C that has demonstrated durable clinical benefit NSCLC, with mild and manageable toxicities. The combination sotorasib other anticancer therapies may enhance antitumor efficacy. This master protocol designed to evaluate safety, tolerability, pharmacokinetics (PK), efficacy multiple...
8534 Background: The current standard of care for patients with inoperable stage III non-small cell lung cancer (NSCLC) includes chemoradiation (CRT) followed by up to 1 year checkpoint inhibitor (CPI) therapy. However, many are not able complete treatment and the optimal duration consolidation therapy remains unknown. Identifying minimal residual disease (MRD) via detection circulating tumor DNA (ctDNA) may help inform treatment. Here we report results a preplanned correlative study...
8523 Background: The standard of care for unresectable stage III NSCLC is concurrent chemorad. Following treatment, the risk radiation pneumonitis greatest at 1-3 mo. Pneumonitis increases with consolidation chemotherapy. A previous trial by our group (Hanna et al, JCO 2008) docetaxel showed 80.8% completed 3 planned cycles chemo a grade 3-5 rate 9.6% and 1 death. PD-1 inhibitors are also associated an increased in metastatic setting. We conducted phase II pembro initiated 1-2 mo after...
8535 Background: Consolidation PD-1 inhibition after chemoradiation (chemoRT) for unresectable stage IIIA/IIIB NSCLC improves overall survival. The efficacy and safety of combining a CTLA-4 inhibitor with in this setting are unknown but may further improve patient population. Methods: In randomized, multi-center, phase II study, 105 pts will receive chemoRT, then randomize 1:1 to either nivolumab 480mg IV q4 wks (nivo) or 3mg/kg q2 + ipilimumab 1mg/kg q6 (nivo/ipi), up 24 wks. interim...
e15088 Background: LY3214996 (L) is a potent inhibitor of ERK1/2 kinases that can potentially obviate resistance mechanisms in cancers harbor BRAF, RAS, NF1, MAP2K1/2, and other MAPK alterations. Abemaciclib (A) CDK 4/6 inhibitor. Studies have shown concomitant inhibition the pathway exemplified by ERK inhibitors may augment antitumor activity CDK4/6 inhibitors. In this biomarker-informed phase 2 study, we assess clinical efficacy L combination with A. Methods: The study enrolled patients...