ApricityRx companion digital therapeutic for evidence-based mitigation and phenotype-linked molecular characterization of irAEs in patients receiving immune checkpoint therapy (ICT).

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. TPS2089-TPS2089
Author(s):  
Matthew T Campbell ◽  
Tian Zhang ◽  
Lynda Chin ◽  
Allison Betof Warner ◽  
Matthen Mathew
Keyword(s):  
Molecular Characterization ◽  
Real World ◽  
Immune Checkpoint ◽  
Single Agent ◽  
Predictive Biomarkers ◽  
Feasibility Trial ◽  
Evidence Based ◽  
Clinical Team ◽  
Open Label ◽  
Patient Reported

TPS2089 Background: Presentation of immune-related adverse events (irAEs) is heterogeneous and unpredictable in patients receiving immune checkpoint therapy (ICT). ICT has been approved for cancer patients as single agent, combination of dual ICT, ICT plus chemotherapy, and ICT plus targeted therapy. Given the ever increasing complexity in recognizing and managing irAEs, coupled with the lack of skilled resources and clinical experience in real world practice, there is increasing demand for digital solutions that can detect early toxicity and support evidence-based interventions in real world practice. To this end, we have developed ApricityRx, a companion digital therapeutic for end-to-end irAE management. In addition to (i) teaching patients about immune-related toxicities and (ii) empowering them to monitor key symptoms and vital signs, ApricityRx continuously analyzes the combined patient-reported data and longitudinal EMR data to (iii) detect symptom-triggers and lab test-triggers of irAEs, and (iv) activate the clinical team to triage, evaluate and treat in a timely fashion, while (v) providing access to synthesized longitudinal patient information and expert guidance on evidence-based management and care. In a feasibility trial conducted in a community setting, we demonstrated two-thirds of the study participants completed on average 5 eCheck-ins per calendar week (overall average 4 times per week), with 5% of the check-ins resulting in notifications alerting the clinical team to evaluate for the early signs of an irAE. Methods: To accelerate translational research in irAEs and to develop predictive biomarkers for risk stratification, we are launching a single-arm, open-label study that utilizes ApricityRx in patients receiving ICT alone or in combination. The objectives of the study will include (i) defining the operative characteristics of ApricityRx as an irAE mitigation strategy; (ii) identifying patients and time points for phenotype-triggered biospecimen collection and molecular characterization. The study aims to enroll initially up to 100 participants per site, with a total target of 1,000.

scholarly journals 550 ARTACUS: An open-label, multicenter, phase 1b/2 study of RP1 in solid organ transplant recipients with advanced cutaneous malignancies

2021 ◽  
Vol 9 (Suppl 3) ◽  
pp. A580-A580
Author(s):  
Jason Luke ◽  
Michael Migden ◽  
Wanxing Chai-Ho ◽  
Diana Bolotin ◽  
Trisha Wise-Draper ◽  
...  
Keyword(s):  
Immune Checkpoint ◽  
Allograft Rejection ◽  
Checkpoint Inhibitors ◽  
Single Agent ◽  
Locally Advanced ◽  
Organ Transplant ◽  
Solid Organ ◽  
Transplant Recipients ◽  
Open Label ◽  
Multicenter Phase

BackgroundSolid organ transplantation (SOT) has emerged as an important lifesaving procedure for patients with a wide range of end-organ diseases characterized by dysfunction or specific organ function failure. SOT rejection is a major complication requiring patients (pts) to undergo lifelong immunosuppression to prevent allograft rejection.1Skin cancers (SCs) including cutaneous squamous cell carcinoma (CSCC) are common post transplant malignancies.2 SC in SOT pts is generally managed with surgical resection, radiation therapy and chemotherapy or targeted therapy. Use of immune checkpoint inhibitors in SOT recipients has improved outcomes but are associated with the high risk of allograft rejection.3–5 Thus, there is a high unmet need for a safe and effective treatment that also protects pts from allograft rejection. RP1 is an oncolytic virus (HSV-1) that expresses a fusogenic glycoprotein (GALV-GP R-) and granulocyte macrophage colony stimulating factor (GM-CSF). In preclinical studies, RP1 induced immunogenic tumor cell death and provided potent systemic anti-tumor activity6 and clinical data in combination with nivolumab has demonstrated a high rate of deep and durable response in patients with advanced SCs.7 The objective of this study is to assess the safety and efficacy of single agent RP1 in kidney and liver transplant recipients with SCs, with focus on CSCC. After determining the safety and tolerability in the initial cohort with kidney and liver transplants the study may also enroll heart and lung transplant recipients.MethodsThis study will enroll up to 65 evaluable allograft transplantation pts with locally advanced or metastatic SCs. Key inclusion criteria are pts with confirmed recurrent, locally advanced or metastatic CSCC and up to 10 pts with non-CSCC SC, stable allograft function and ECOG performance status of ≤1. Pts with prior systemic anti-cancer treatment are allowed. Key exclusion criteria are prior treatment with an oncolytic therapy, active herpetic infections or prior complications of HSV-1 infection and a history of organ graft rejection within 12 months. Pts will receive an initial dose of 1 x 10^6 plaque-forming units (PFU) of RP1. Two weeks later they will receive 1 x 10^7 PFU of RP1 and continue every two weeks until pre-specified study endpoints are met. RP1 will be administered by intra-tumoral injection including through imaging guidance as clinically appropriate. The primary objective of the trial is to assess efficacy determined by ORR and safety of single agent RP1. Additional secondary endpoints include DOR, CR, DCR, PFS and OS.Trial RegistrationNCT04349436ReferencesFrohn C, Fricke L, Puchta JC, Kirchner H. The effect of HLA-C matching on acute renal transplant rejection. Nephrol Dial Transplant 2001;16(2):355–60.Madeleine MM, Patel NS, Plasmeijer EI, Engels EA, Bouwes Bavinck JN, Toland AE, Green AC; the Keratinocyte Carcinoma Consortium (KeraCon) Immunosuppression Working Group. Epidemiology of keratinocyte carcinomas after organ transplantation. Br J Dermatol 2017;177(5):1208–1216.Spain L, Higgins R, Gopalakrishnan K, Turajlic S, Gore M, Larkin J. Acute renal allograft rejection after immune checkpoint inhibitor therapy for metastatic melanoma. Ann Oncol 2016;27(6):1135–1137.Herz S, Höfer T, Papapanagiotou M, Leyh JC, Meyenburg S, Schadendorf D, Ugurel S, Roesch A, Livingstone E, Schilling B, Franklin C. Checkpoint inhibitors in chronic kidney failure and an organ transplant recipient. Eur J Cancer 2016;67:66-72.Kittai AS, Oldham H, Cetnar J, Taylor M. Immune checkpoint inhibitors in organ transplant ptss. J Immunother 2017;40(7):277–281.Thomas S, Kuncheria L, Roulstone V, Kyula JN, Mansfield D, Bommareddy PK, Smith H, Kaufman HL, Harrington KJ, Coffin RS. Development of a new fusion-enhanced oncolytic immunotherapy platform based on herpes simplex virus type 1. J Immunother Cancer 2019 10;7(1):214.Middleton M, Aroldi F, Sacco J, Milhem M, Curti B, Vanderwalde A, Baum S, Samson A, Pavlick A, Chesney J, Niu J, Rhodes T, Bowles T, Conry R, Olsson-Brown A, Earl-Laux D, Kaufman H, Bommareddy P, Deterding A, Samakoglu S, Coffin R, Harrington K. 422 An open-label, multicenter, phase 1/2 clinical trial of RP1, an enhanced potency oncolytic HSV, combined with nivolumab: updated results from the skin cancer cohorts. J Immunother Cancer 2020;8(3): doi: 10.1136/jitc-2020-SITC2020.0422Ethics ApprovalThe study was approved by institutional review board or the local ethics committee at each participating site. Informed consent was obtained from patients before participating in the trial.

scholarly journals Role of Immune Checkpoint Inhibitors in Gastrointestinal Malignancies

2020 ◽  
Vol 9 (8) ◽  
pp. 2533
Author(s):  
Anita Mazloom ◽  
Nima Ghalehsari ◽  
Victor Gazivoda ◽  
Neil Nimkar ◽  
Sonal Paul ◽  
...  
Keyword(s):  
Immune Checkpoint ◽  
Immune Checkpoint Inhibitors ◽  
Checkpoint Inhibitors ◽  
Single Agent ◽  
Unmet Need ◽  
Predictive Biomarkers ◽  
Small Subset ◽  
Gastrointestinal Malignancies ◽  
Line Of Therapy

Immune checkpoint inhibitors (ICIs) have revolutionized the treatment of several solid and hematological malignancies. ICIs are not only able to produce long and durable responses, but also very well tolerated by patients. There are several approved indications of use of ICIs in treatment of metastatic gastrointestinal malignancies including gastric, esophageal, colorectal and hepatocellular carcinoma. In addition, ICIs can be used in microsatellite instability-high (MSI-H) and high tumor mutational burden (TMB) tumors in chemotherapy-resistant setting. Despite having good efficacy and superior safety profile, ICIs are clinically active in small subset of patients, therefore, there is a huge unmet need to enhance their efficacy and discover new predictive biomarkers. There are several ongoing clinical trials that are exploring the role of ICIs in various gastrointestinal cancers either as single agent or in combination with chemotherapy, radiation therapy, targeted agents or other immunotherapeutic agents. In this review, we discuss the published and ongoing trials for ICIs in gastrointestinal malignancies, including esophageal, gastric cancer, pancreatic, hepatocellular, biliary tract, colorectal and anal cancers. Specifically, we focus on the use of ICIs in each line of therapy and discuss the future directions of these agents in each type of gastrointestinal cancer.

scholarly journals Immunotherapy in Advanced Biliary Tract Cancers

Cancers ◽  
2021 ◽  
Vol 13 (7) ◽  
pp. 1569
Author(s):  
Alice Boilève ◽  
Marc Hilmi ◽  
Cristina Smolenschi ◽  
Michel Ducreux ◽  
Antoine Hollebecque ◽  
...  
Keyword(s):  
Biliary Tract ◽  
Immune Checkpoint ◽  
Single Agent ◽  
Predictive Biomarkers ◽  
Immune Checkpoint Blockade ◽  
Clinical Activity ◽  
Liver Malignancies ◽  
Biliary Tract Cancers ◽  
Advanced Stages ◽  
Molecular Therapies

Biliary tract cancers are rare tumors with a poor prognosis. Two-thirds of these primary liver malignancies are diagnosed at advanced stages where therapeutic options are limited. Whereas several molecular targeted therapies emerge in biliary tract cancers, immunotherapy is still investigational, the only approved immunotherapy to date being the immune checkpoint inhibitor pembrolizumab for the small fraction of patients with microsatellite-instable tumors. In microsatellite-stable, pre-treated biliary tract cancers, single-agent immune checkpoint blockade has a limited albeit often long-lasting clinical activity in a still ill-defined subgroup of patients. The identification of predictive biomarkers will allow a better selection of patients that may benefit from immunotherapy. Combinations of immunotherapies with each other, with chemotherapy or targeted molecular therapies are being investigated in early lines of therapy, including first-line.

scholarly journals 6 Immune correlates of clinical benefit in patients with HPV-associated malignancies treated with bintrafusp alfa

2021 ◽  
Vol 9 (Suppl 3) ◽  
pp. A6-A6
Author(s):  
Yo-Ting Tsai ◽  
Renee Donahue ◽  
Nicole Toney ◽  
Julius Strauss ◽  
James Gulley ◽  
...  
Keyword(s):  
T Cells ◽  
Cd8 T Cells ◽  
Immune Checkpoint ◽  
Clinical Benefit ◽  
Predictive Biomarkers ◽  
Cooperative Research ◽  
Open Label ◽  
Hpv 16 ◽  
Link Type ◽  
Immune Correlates

BackgroundThe safety and efficacy of bintrafusp alfa, a first-in-class bifunctional fusion protein targeting TGFβ and PD-L1 pathways, have been demonstrated in patients with HPV-related cancers in an open-label, multicenter phase 1 trial (NCT02517398), and an open-label, single-center phase 2 trial (NCT03427411). The current study aimed to identify immune related biomarkers prior to and following 1 cycle of bintrafusp alfa that associate with clinical benefit.MethodsImmune parameters were compared in patients (n=65) deriving clinical benefit from bintrafusp alfa (defined as BOR of stable disease (SD) or better, which included SD, mixed, partial, and complete responses) versus patients with a BOR of progressive disease (PD). Peripheral blood was obtained from patients before and after 1 cycle of therapy, and evaluated for complete blood counts, plasma cytokines/soluble factors, 158 immune subsets, and T cells specific for HPV-16 E6 and E7.ResultsPrior to therapy, patients who developed a BOR of SD or better had lower counts of neutrophils, monocytes, and platelets, lower levels of TGF-β1 and sCD73, and higher levels of sCD27:sCD40L than patients with a BOR of PD. Lower baseline frequencies of MDSCs, monocytes, naïve CD4+ and CD8+ T cells, and CD8+ T cells that express CD73, an immune checkpoint associated with adenosine metabolism, were detected in patients with a BOR of SD or better than those with PD. Following 1 cycle of treatment, lymphocyte counts were reduced, while neutrophil counts and the NLR were increased, in patients with PD compared to those with a BOR of SD or better. IL-8, a cytokine involved in tumor progression and associated with reduced clinical benefit to immune checkpoint inhibitors, was increased in patients with PD compared to those with a BOR of SD or better, while conventional dendritic cells and CD8+ T cells expressing the proliferative marker ki67 were increased in patients with a BOR of SD or better compared to those with PD. Greater increases in the frequency and magnitude of HPV-16 specific CD8+ T-cells were also detected in individuals with a BOR of SD or better compared to PD.ConclusionsImmune profiling identified specific measures prior to therapy, as well as changes induced early after therapy (preceding restaging), that may serve as predictive biomarkers to identify patients with HPV-related cancers most likely to benefit from bintrafusp alfa. These findings also provide the rationale to combine bintrafusp alfa with other therapies including HPV-targeted therapeutic vaccines and agents that block IL-8 signaling.AcknowledgementsThis research was supported by the Intramural Research Program of the Center for Cancer Research, NCI, National Institutes of Health, and through a Cooperative Research and Development Agreement with EMD Serono Research & Development Institute and GSK.Ethics ApprovalThe study protocol was approved by ethics committees at all participating institutions, and each patient provided written informed consent before study enrollment.

Woodcast versus standard casting material for the immobilization of nonoperatively treated distal radial fractures

2020 ◽  
Vol 102-B (1) ◽  
pp. 48-54 ◽  
Author(s):  
Stephen Gwilym ◽  
Lucy Sansom ◽  
Ines Rombach ◽  
Susan J. Dutton ◽  
Juul Achten ◽  
...  
Keyword(s):  
Adult Population ◽  
Patient Comfort ◽  
Feasibility Trial ◽  
Cast Immobilization ◽  
Open Label ◽  
Distal Radial Fractures ◽  
Patient Acceptability ◽  
Serious Adverse Events ◽  
Recruitment And Retention ◽  
Patient Reported

Aims Distal radial fractures are the most common fracture sustained by the adult population. Most can be treated using cast immobilization without the need for surgery. The aim of this study was to assess the feasibility of a definitive trial comparing the commonly used fibreglass cast immobilization with an alternative product called Woodcast. Woodcast is a biodegradable casting material with theoretical benefits in terms of patient comfort as well as benefits to the environment. Methods This was a multicentre, two-arm, open-label, parallel-group randomized controlled feasibility trial. Patients with a fracture of the distal radius aged 16 years and over were recruited from four centres in the UK and randomized (1:1) to receive a Woodcast or fibreglass cast. Data were collected on participant recruitment and retention, clinical efficacy, safety, and patient acceptability. Results Over an eight-month period, 883 patients were screened, 271 were found to be eligible, and 120 were randomized. Patient-reported outcome measures were available for 116 (97%) of participants at five weeks and 99 (83%) at three months. Clinical outcomes and patient acceptability were similar between the two interventions and no serious adverse events were reported in either intervention arm. Conclusion Both interventions were deemed efficacious and safe in the cohort studied. This study showed that a definitive study comparing Woodcast and fibreglass was feasible in terms of patient recruitment and retention. Cite this article: Bone Joint J 2020;102-B(1):48–54

Phase 2, open-label study of venetoclax in combination with carfilzomib and dexamethasone in patients with relapsed/refractory multiple myeloma.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. TPS8056-TPS8056
Author(s):  
Orlando Bueno ◽  
Tu Xu ◽  
Jaclyn Cordero ◽  
Lura Morris ◽  
Jeremy Ross ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Proteasome Inhibitor ◽  
Unmet Need ◽  
Predictive Biomarkers ◽  
The United States ◽  
Phase 2 ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Patient Reported

TPS8056 Background: A significant unmet need for multiple myeloma (MM) therapy remains as many patients eventually relapse after or become refractory to current treatment options. Investigation of novel agents and combinations in relapsed/refractory (R/R) patients are therefore critical to advance therapy and improve patient outcomes. Venetoclax is a potent, selective, orally bioavailable inhibitor of BCL-2. Combination of venetoclax with dexamethasone and bortezomib, a proteasome inhibitor that can inhibit MCL-1 indirectly via stabilizing the MCL-1-neutralizing protein NOXA, showed high rates of clinical response in a Phase 1 study. The mechanism of MCL-1 inhibition is thought to be a class effect of proteasome inhibitors. Given the clinical data supporting the combination of venetoclax with a proteasome inhibitor, this study will evaluate whether venetoclax combined with carfilzomib and dexamethasone can provide a well-tolerated and efficacious treatment option for R/R MM patients. Methods: This Phase 2, open-label study will assess the combination of venetoclax, carfilzomib, and dexamethasone in patients with R/R MM (NCT02899052). Primary objectives are to assess the safety and tolerability of this combination. Secondary objectives include evaluation of the pharmacokinetics of venetoclax and carfilzomib, preliminary efficacy of the combination (including overall response rate, very good partial response or better rate, progression-free survival, time to progression, and duration of response), and minimal residual disease (MRD) in bone marrow by next generation sequencing. Exploratory objectives will assess pharmacodynamic and predictive biomarkers, MRD by PET, pharmacogenetics, and patient-reported outcomes. Safety and pharmacokinetic profiles of the combination will be evaluated in initial dose escalation cohorts to determine appropriate doses of venetoclax and carfilzomib to be used with dexamethasone; a dose expansion phase will evaluate the safety and efficacy profiles of the combination based on selected doses. Study recruitment began in January 2017, with target enrollment of ~40 patients from 10–15 sites in the United States. Clinical trial information: NCT02899052.

The impact of blinding on patient-reported outcomes (PROs) in randomized controlled trials of immune checkpoint inhibitors versus traditional chemotherapies.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e23160-e23160
Author(s):  
James Dickerson ◽  
Evan Thomas Hall ◽  
Surbhi Singhal ◽  
Brooke Peterson Gabster ◽  
Lidia Schapira
Keyword(s):  
Immune Checkpoint ◽  
Immune Checkpoint Inhibitors ◽  
Checkpoint Inhibitors ◽  
Controlled Trial ◽  
Case Series ◽  
Symptom Burden ◽  
Open Label ◽  
Patient Reported ◽  
The Impact ◽  
Blinded Trial

e23160 Background: Immune checkpoint inhibitors (ICIs) have been met with a wave of excitement due to their novel mechanism. We hypothesized that this may impact how patients (via PROs) report treatment tolerability in comparison to traditional therapies. We sought to examine if there was a notable difference in PROs in blinded vs unblinded trials of ICIs. Methods: We systematically searched PubMed, CINAHL, Embase, Web of Science, and Scopus in August 2018 for publications with quantitative PRO data comparing ICIs to cytotoxic chemotherapy. Case series, narrative reviews, and publications lacking original data were excluded. Eligible publications were reviewed to assess if patients were blinded to the agent received, and a comparison for common PRO metrics was performed. Results: Of the 1,450 unique references identified, eight met inclusion criteria: 1 double blinded placebo-controlled trial and 7 trials where patients were aware of the assigned arm. The blinded trial had quantitative PRO data in the form of the European Organisation for Research and Treatment of Cancer (EORTC) global health status (GHS) score and patient reported symptom burden at week 12. Most (6 of 7; 86%) unblinded trials reported the GHS at either week 12 or 15, and patient symptom burden at these time points as well (5 of 7; 71%). For the EORTC GHS, the blinded trial showed no inter-arm difference at week 12. 4 of 6 (67%) open label trials noted statistically significant differences in GHS favoring the ICI arm. For symptom burden at week 12 or 15, there was no difference found in the blinded study. In unblinded trials, there were domains where patients receiving ICIs reported a statistically significant lower symptom burden than those receiving chemotherapy: fatigue (4 of 5 trials favoring ICIs; 80%), dyspnea (2 of 5; 40%), insomnia (1 of 4; 25%), appetite loss (1 of 4; 25%), and diarrhea (1 of 5; 20%). There were no differences in pain (n = 5), nausea/vomit (n = 5), and constipation (n = 5). Conclusions: We found a trend towards more favorable reporting on common symptoms in unblinded studies of patients receiving ICIs. Our analysis is limited by the lack of available comparisons in the published literature.

A digital therapeutic for proactive monitoring of patients on immune checkpoint inhibitor therapy for early detection of immune-related adverse events.

2020 ◽  
Vol 38 (5_suppl) ◽  
pp. 101-101
Author(s):  
Shyamali Mallick Singhal ◽  
Shane Dormady ◽  
Jiali Li ◽  
Shiva Singhal ◽  
Lynda Chin
Keyword(s):  
Early Detection ◽  
Adverse Events ◽  
Clinical Care ◽  
Patient Reported Outcome ◽  
Feasibility Trial ◽  
Cancer Center ◽  
Evidence Based ◽  
Close Monitoring ◽  
Patient Reported ◽  
Proactive Monitoring

101 Background: Immune-related adverse events (irAEs) occur frequently in patients receiving immuno-oncology therapy. irAEs are heterogeneous and unpredictable. Experience at academic cancer centers has shown that (1) education of patients and families must be continuous; (2) experience of the care team can improve outcomes; and (3) close monitoring of patients in between visits translate into early detection and timely intervention. Most oncologists in lower volume community practices have not gained the experience nor have the resource for continuous education frequent proactive monitoring. Methods: In addition to self-monitoring by patients on chemotherapy to improve outcome (Basch ref), we hypothesized that adoption of evidence-based management is critical as well. Thus, we have developed ApricityRx, a digital therapeutic (DTx) for end-to-end irAE management, which not only engages patients in frequent self-nonitoring but also activates the oncology team for timely intervention. In brief, ApricityRx (i) enables intelligent monitoring by educating and guiding patients to track specific expert-prioritized symptoms in between clinic visits; (ii) facilitates early recognition by prompting triage at the right time and (iii) recommends evidence-based management based on consensus guidelines. Results: In a community cancer center, 16 patients have been enrolled (44% consent rate) in an IRB approved feasibility trial to evaluate the usability of ApricityRx as a tool for frequent monitoring and timely triage. Over 435 unique longitudinal records containing over 34K data points, including patient-reported outcome (PRO) and clinical care data (EMR), were generated. Interim analyses have shown that primary and secondary endpoints were met. Detailed results will be presented. Conclusions: ApricityRx has shown usability in a low-volume community-based oncology practice to facilitate proactive monitoring and tinely triage by the oncology team. Further, ApricityRx has enabled not only generation of high-resolution patient-reported outcome (PRO) data, but also aggregation of PRO and real-world EHRs data for downstream analyses.

scholarly journals Immune Checkpoint Inhibitors in Esophageal Cancers: Are We Finally Finding the Right Path in the Mist?

2020 ◽  
Vol 21 (5) ◽  
pp. 1658
Author(s):  
Caterina Vivaldi ◽  
Silvia Catanese ◽  
Valentina Massa ◽  
Irene Pecora ◽  
Francesca Salani ◽  
...  
Keyword(s):  
Esophageal Cancer ◽  
Immune Checkpoint ◽  
Immune Checkpoint Inhibitors ◽  
Checkpoint Inhibitors ◽  
Treatment Options ◽  
Single Agent ◽  
Predictive Biomarkers ◽  
Combination Strategies ◽  
Cancer Review ◽  
The Right

Esophageal cancer remains a challenging disease due to limited treatment options and poor prognosis. In recent years, immune checkpoint inhibitors (ICI) have been proven to be safe and effective in the treatment of highly lethal malignancies, such as non-small cell lung cancer and melanoma. Recent clinical trials also showed promising activity in immune checkpoint inhibitors in pretreated advanced esophageal carcinoma and a potentially significant impact on the outcome of selected patients, independently of histology. Combination studies evaluating immunotherapy and chemotherapy and, in localized disease, radiotherapy are in progress and will hopefully confirm their promises in the near future. However, reliable predictive biomarkers are still lacking. Indeed, at present, the role of programmed cell death ligand 1 expression and other factors (such as microsatellite instability and tumor mutational burden) as predictive biomarkers of benefit to immune checkpoint inhibitors is still controversial. Our aim was to explore the rationale of ICIs in esophageal cancer, review the results already available in multiple settings, and investigate future perspectives with single-agent and combination strategies.

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