Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Paclitaxel

Albumin-Bound Paclitaxel

Cisplatin

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Adjuvant pembrolizumab 200 mg every 3 weeks for up to 24 months. (treated with neoadjuvant concurrent chemoradiotherapy followed by curative resection)

Neoadjuvant concurrent chemoradiotherapy followed by curative resection

Curative resection

RT 44 Gy/22 Fractions for 5 weeks With Chemotherapy (Cisplatin 25mg/m2 once weekly, Paclitaxel 50mg/m2 once weekly)

Neoadjuvant concurrent chemoradiotherapy

Myung-Ju Ahn, Professor

This is a single arm, single center phase II study of adjuvant pembrolizumab in N2 positive non-small cell lung cancer (NSCLC) patients treated with neoadjuvant concurrent chemoradiotherapy followed by curative resection. Patients will receive pembrolizumab 200 mg every 3 weeks for up to 24 months.

The primary objective of this study is to assess the efficacy of adjuvant pembrolizumab treatment in terms of disease-free survival (DFS; per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 as assessed by the investigator).

The baseline assessment is part of the screening procedures and should be performed within 0 to 14 days before the start of study drug. The imaging modalities used for RECIST 1.1 assessment will be CT of chest or PET-CT if indicated. Follow-up chest CT for all patients will be assessed every 12 weeks for the first year, every 16 weeks for the second year, every 6 months for the third year, and every year thereafter. In subjects who discontinued study therapy without documented recurrence, every effort should be made to continue monitoring their disease status.

If an unscheduled assessment is performed, and the patient has not progressed, every attempt should be made to perform the subsequent assessments at their scheduled visits. RECIST 1.1 scans will be analyzed by the investigator on site; a central review will not be conducted.

Following completion or discontinuation of study drug, patients will enter a follow-up period.

Once a patient has had objective relapse recorded and has discontinued study drug, the patient will be followed for survival status every 3 months until death, withdrawal of consent or the end of the study.

Patients will also be requested to provide tumor samples from diagnostic (obtained before neoadjuvant CCRT) and surgical specimens for exploratory biomarker study. Sample provision is not optional, subject to a specific consent.

N2 positive stage IIIA non-small cell lung cancer treated with neoadjuvant concurrent chemoradiotherapy followed by curative resection

Adjuvant Pembrolizumab in N2 Positive Non-small Cell Lung Cancer Patients

Phase II, Single-arm Study of Adjuvant Pembrolizumab in N2 Positive Non-small Cell Lung Cancer Treated With Neoadjuvant Concurrent Chemoradiotherapy Followed by Curative Resection

Disease free survival to evaluate the efficacy of adjuvant pembrolizumab in N2 positive non-small cell lung cancer patients treated with neoadjuvant concurrent chemoradiotherapy followed by curative resection.

Pembrolizumab prolongs OS per RECIST 1.1.

Samsung Medical Center

Professor

Heart and Blood Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Thrombosis

Carcinoma, Renal Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Embolism

Embolism and Thrombosis

Vascular Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Lenvatinib

Immunomodulating Agents

Protein Kinase Inhibitors

Enzyme Inhibitors

Patients receive neoadjuvant lenvatinib (20 mg PO daily) for 12 weeks and pembrolizumab (200 mg IV every 3 weeks for four doses) prior to surgical resection of locally advanced RCC with IVC tumor thrombus. Following surgery, patients will receive adjuvant pembrolizumab (200 mg IV every 3 weeks for up to thirteen doses).

20 mg PO daily for 12 weeks prior to surgery

Neoadjuvant Lenvatinib

200 mg IV every 3 weeks for 4 doses prior to surgery

Neoadjuvant Pembrolizumab

Resection of locally advanced RCC with IVC tumor thrombus

Radical nephrectomy, IVC thrombectomy, retroperitoneal lymph node dissection

200 mg IV every 3 weeks for up to 13 doses after surgery

Adjuvant Pembrolizumab

Donna Mitchell

Doreen Simonsen

Vitaly Margulis

Vitaly Margulis, MD

This study will be evaluating safety and efficacy of the combination of lenvatinib and pembolizumab neoaadjuvant therapy prior to surgical resection of locally advanced renal cell carcinoma with IVC tumor thrombus.

Neoadjuvant Lenvatinib and Pembrolizumab for IVC Tumor Thrombus

Safety and Efficacy of Neoadjuvant Lenvatinib and Pembrolizumab in Patients With Renal Cell Carcinoma and IVC Tumor Thrombus

Identify metabolic signatures in plasma that are noninvasive predictors of therapy response and identify metabolic alterations following neoadjuvant therapy in patients who do and do not respond.

Evaluation of changes in size of primary tumor and size and level of IVC tumor thrombus on imaging due to neoadjuvant therapy prior to surgery.

Evaluation of local or metastatic progression on imaging prior to surgery following neoadjuvant therapy.

Assessment of 90 day post-operative safety and morbidity of neoadjuvant therapy by evaluating the incidence of 90 day post-operative grade 3-5 adverse events.

Estimated blood loss in mL during surgery

Operative time in minutes of surgery, length of stay, and intra-operative and post-operative complications

Length of stay of hospital stay for surgery in days, and intra-operative and post-operative complications

Complications that occur in the post-operative period

Evaluation of post-operative survival outcomes including recurrence-free survival and overall survival.

University of Texas Southwestern Medical Center

Professor of Medicine

Symptoms and General Pathology

Digestive System Diseases

Carcinoma, Squamous Cell

Recurrence

Esophageal Squamous Cell Carcinoma

Neoplasms, Squamous Cell

Disease Attributes

Esophageal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Adjuvant cisplatin-chemoradiotherapy followed by pembrolizumab

Cisplatin (30 mg/m2, QW, 2 cycles) and radiotherapy (18-26 Gy/10-13 fractions) as adjuvant chemoradiotherapy, followed by pembrolizumab (200mg, Q3W, 18 cycles)

Chih-Hung Hsu, MD, PhD

In this study, participants with histologically diagnosed locally advanced esophageal squamous cell carcinoma who have received preoperative cisplatin-based chemoradiotherapy followed by surgery harbouring high risk of tumor recurrence will receive adjuvant cisplatin-based chemoradiotherapy followed by pembrolizumab. The primary study hypothesis is that adjuvant pembrolizumab will improve the 1-year recurrence-free survival rate compared to historical control.

It is a single-arm phase II trial. The target population is patients with histologically diagnosed locally advanced ESCC patients (clinically staged at least T3 and/or any N and M0 by endoscopic ultrasonography \[EUS\] and fludeoxyglucose-positron emission tomography \[FDG-PET\]) who have received preoperative cisplatin-based chemoradiotherapy (CRT) followed by surgery, and exhibit high risk (closed or involved resection margin or extranodal invasion of involved lymph nodes or ypN2-3) of tumor recurrence. Eligible patients will receive adjuvant cisplatin-based CRT followed by pembrolizumab for 18 cycles.The study will enroll 46 patients in Taiwan. The estimated enrollment period is 2 years.

Adjuvant Pembrolizumab for Patients With Locally Advanced Esophageal Squamous Cell Carcinoma at High Risk of Recurrence

A Single-arm Phase II Study of Chemoradiotherapy Plus Pembrolizumab as Adjuvant Therapy for Locally Advanced Esophageal Squamous Cell Carcinoma Patients at High Risk of Recurrence Following Preoperative Chemoradiotherapy Plus Surgery

To explore the tumor tissue-based biomarkers associated with tumor recurrence.

To explore the blood-based biomarkers associated with tumor recurrence.

Recurrence-free survival is the time from enrollment to disease recurrence or the last follow-up (censored). Recurrence will be detected by regular image study (computed scan and esophagoscopy) every 3 months during the 1st to 3rd years then every 6 months during 4th and 5th years after esophagectomy. Response Evaluation Criteria in Solid Tumors 1.1 will be used for assessment.

OS is the time from enrollment to death of any cause or the last follow-up (censored).

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Adjuvant Pembrolizumab in N2 Positive Non-small Cell Lung Cancer Patients	NCT03053856	Stage IIIA Non-...	Pembrolizumab Curative resect... Neoadjuvant con... Cisplatin Paclitaxel	18 Years -	Samsung Medical Center
Neoadjuvant Lenvatinib and Pembrolizumab for IVC Tumor Thrombus	NCT05319015	Renal Cell Carc...	Neoadjuvant Len... Neoadjuvant Pem... Radical nephrec... Adjuvant Pembro...	18 Years -	University of Texas Southwestern Medical Center
Adjuvant Pembrolizumab for Patients With Locally Advanced Esophageal Squamous Cell Carcinoma at High Risk of Recurrence	NCT03322267	Esophageal Squa...	Pembrolizumab	20 Years -	National Taiwan University Hospital

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