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Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

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Female Urogenital Diseases and Pregnancy Complications

All Drugs and Chemicals

Antineoplastic Agents

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Antibodies, Monoclonal

Lenvatinib

Angiogenesis Inhibitors

Durvalumab

Immunoglobulins

Endothelial Growth Factors

Mitogens

Antineoplastic Agents, Immunological

Immunologic Factors

Protein Kinase Inhibitors

Enzyme Inhibitors

Combination therapy of Lenvatinib 80-120mg daily orally and durvalumab 1500mg by IV infusion every 4 weeks

Lenvatinib (Lenvima, Eisai China) is a novel angiogenesis inhibitor which targets vascular endothelial growth factor 1-3, fibroblast growth factor receptor 1-4, platelet-derived growth factor receptor β, RET and KIT

Lenvatinib Oral Product

Huan Tong

Xiaoping Wan, MD.,Ph.D

This study will evaluate the safety and efficacy of durvalumab in combination with lenvatinib in participants with advanced and recurrent endometrial carcinoma.The primary hypothesis of this study are that patients with advanced and recurrent endometrial carcinoma could benefit from durvalumab plus lenvatinib with respect to: 1)Progression Free Survival (PFS) ; 2) Objective Response Rate (ORR); and Overall survival (OS). The investigators design a clinical study to explore whether the combination above as a treatment in patients with advanced and recurrent endometrial carcinoma could prolong PFS and to analyze potential immune biomarker of therapeutic response.

The combination of Lenvatinib and Programmed death-ligand 1 (PD-L1) blocking has great potential in the treatment of advanced and recurrent endometrial cancer. This trial is designed as a prospective, open label study for 20 patients with advanced (recurrent, refractory or metastatic) endometrial cancer, including carcinosarcoma of the uterus. The aim is to investigate the efficacy of the combination therapy of Lenvatinib 80-120mg daily orally and durvalumab 1500mg by IV infusion every 4 weeks in terms of progression free survival.

Durvalumab and Lenvatinib in Participants With Advanced and Recurrent Endometrial Carcinoma

Safety and Efficacy Study of Durvalumab in Combination With Lenvatinib in Participants With Advanced and Recurrent Endometrial Carcinoma--DULECT Trial

Defined as time from randomisation to first progression by investigator assessment using modified RECIST 1.1 or death (by any cause in the absence of progression)

Objective response rate is defined as the proportion of patients with measurable disease at baseline who have confirmed complete response (CR) or partial response (PR) as determined by the Investigator at local site

Defined as the time from randomisation to death due to any cause

An AE is defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy can be determined.

Shanghai First Maternity and Infant Hospital

Digestive System Diseases

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Hematinics

Pembrolizumab

Liver Extracts

Immune Checkpoint Inhibitors

Participants receive intravenous (IV) pembrolizumab at 200 mg on Day 1 of each 21-day cycle. Number of cycles: until \>42 days before liver transplantation or unacceptable toxicity develops. Patients receive Lenvatinib 8-12mg(basing on weight), once a day, oral at least 38 days of each 6 weeks cycle until \>7 days before liver transplantation.

Participants are advised to stay as healthy as possible and wait regularly

Pembrolizumab (Keytruda, MSD China) is a recombinant anti-human PD-1 monoclonal antibody.

Pembrolizumab Injection [Keytruda]

Hao Feng, MD., Ph.D.

Hao Feng, MD, PhD

Qiang Xia, MD., Ph.D.

Objectives of Study：This study will evaluate the safety and efficacy of pembrolizumab in combination with lenvatinib as neoadjuvant therapy in participants with hepatocellular carcinoma (HCC) exceeding Milan criteria before liver transplant.

The primary hypothesis of this study are that neoadjuvant pembrolizumab plus lenvatinib is superior to regularly waiting in the list with respect to: 1) recurrence-free survival (RFS) as assessed by blinded independent central review (BICR); and 2) Objective Response Rate (ORR).The investigators design a clinical study to explore whether the combination above as a neoadjuvant treatment in patients with advanced HCC before liver transplant could reduce postoperative recurrence and to analyze potential immune biomarker of therapeutic response.

Participates would be randomly assigned (1:1) to experimental or Comparator/Control by computer-generated allocation based on the envelope method and the hierarchical block randomization method(hierarchy: BCLC stage and AFP level). The envelopes are sealed opaque, and sequentially numbered.Randomization is performed by the trial coordinator.The random number table and the block assignment number table will be kept confidential by the full-time secretary of this project.Center-stratified block-permuted randomization is used in this trial. Then permuted block randomization is used for each stratum with a block size of 4.

Pembrolizumab and LENvatinib in Participants With Hepatocellular Carcinoma (HCC) Before Liver Transplant

Safety and Efficacy Study of Pembrolizumab in Combination With LENvatinib in Participants With Hepatocellular Carcinoma (HCC) Before Liver Transplant as Neoadjuvant TherapY--PLENTY Randomized Clinical Trial

RFS is defined as the time from randomization to first documentation of disease recurrence (local, regional, or distant) as assessed by BICR or by pathology consistent with HCC if required per the site's standard of care, or death due to any cause (both cancer and non-cancer causes of death)

Proportion of patients whose tumor volume control (reduced or enlarged) reaches a predetermined value and can maintain a minimum time limit.

Proportion of patients whose tumor volume has reached a predetermined value and can maintain a minimum time limit, including complete response and partial response patients.

RenJi Hospital

Death

Amino Acids

Chlorotrianisene

Tyrosine Kinase Inhibitors

Sorafenib

Tyrosine

ICIs (PD1 or PDL-1)+TKIs (Lenvatinib or Sorafenib)

local treatment include: TACE, HAIC, RF Ablation, Microwave Ablation, Radiotherapy, etc.

Systemic therapy plus Local treatment:

ICIs (PD1 or PDL-1)+TKIs (Lenvatinib or Sorafenib) plus local treatment (TACE, HAIC, RF Ablation, Microwave Ablation, Radiotherapy, etc)

Programmed cell death protein-1 (PD-1) or Programmed cell death ligand 1 (PDL-1

PD-1 inhibitor

Local treatment include: TACE, HAIC, RF Ablation, Microwave Ablation, Radiotherapy, etc.

Local treatment

Changhai Li, Doctor

Xiaoping Chen

Xiaoping Chen, Doctor

China is a high-risk area of Hepatocellular Carcinoma (HCC). Although Chinese population accounts for 18.4% of the global population, the number of new HCC patients accounting for about half of the global, which seriously threatens the lives and health of the people. The investigators establish multi-center, retrospective research methods, collecting the data of HCC treatment with system treatment (ICIs and TKIs) plus or without local treatment in the last 3 years, comprehensive assessment of their efficacy and safety, explore whether the efficacy of system treatment combination local treatment showed better effect compared with system or local monotherapy. Our study will find a new way to improve the prognosis of HCC patients.

This was a multi-center, retrospective study involving 2000 patients with HCC receiving ICIs (Programmed cell death protein-1 (PD-1) or Programmed cell death ligand 1 (PDL-1)) and TKIs (Lenvatinib or Sorafenib), ICIs and TKIs plus local treatment (TAC, Hepatic artery infusion chemotherapy (HAIC), radiofrequency (RF) ablation, microwave ablation, radiotherapy, etc.), and local monotherapy between Jan, 2019 and Dec, 2021 in China. Efficacy was evaluated with objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), time to tumor progression (TTP), and 1year and 2 years overall survival (OS). Treatment-related adverse events (TRAEs) were recorded and graded. Efficacy and safety of three groups were compared. Stratified analysis was performed according to patients baseline characteristics and medication regimen for combination therapy.

Real-world Study of Efficacy and Safety of ICIs and TKIs Therapy for HCC

Efficacy and Safety of Immune Checkpoint Inhibitors (ICIs) and Tyrosine Kinase Inhibitors (TKIs) Therapy for Hepatocellular Carcinoma (HCC)：a Multicenter, Retrospective Study on the Real-world in China

We haven't decided whether it needs to cooperate with other PI.

Rate of participants with treatment-related adverse events as assessed by CTCAE v5.0

Tongji Hospital

Professor

Skin and Connective Tissue Diseases

Infections

Rare Diseases

Carcinoma, Neuroendocrine

Skin Neoplasms

Carcinoma, Merkel Cell

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Communicable Diseases

Polyomavirus Infections

Virus Diseases

DNA Virus Infections

Tumor Virus Infections

Skin Diseases

Merkel Cell Carcinoma

Neuroendocrine Tumor

Neuroepithelioma

Participants with Merkel cell carcinoma amenable to complete resection will receive two cycles (6 weeks) of therapy with the combination of lenvatinib plus pembrolizumab and then proceed to planned resection within 2-4 weeks following completion of cycle 2. Following surgical recovery and completion of adjuvant radiation therapy (if indicated), treatment will resume with pembrolizumab monotherapy with intent to complete 17 cycles total of pembrolizumab.

20mg of Lenvatinib will be taken orally once daily

200mg of Pembrolizumab will be administered through IV infusion every 3 weeks.

Andrew Brohl, MD

Justin Martin

Nikhil Khushalani, MD

Zeynep Eroglu, MD

Ahmad Tarhini, MD

Vernon Sondak, MD

Youngchul Kim, PhD

Ken Tsai, PhD

This is a single arm trial of participants with Merkel cell carcinoma receiving a combination of lenvatinib plus pembrolizumab.

Neoadjuvant Lenvatinib Plus Pembrolizumab in Merkel Cell Carcinoma

Neoadjuvant Lenvatinib Plus Pembrolizumab in Resectable Merkel Cell Carcinoma

Pathological Complete Response will be determined by pathologist examination of tissue after neoadjuvant treatment and resection

Progressive disease will be defined by the detection of any recurrent disease following complete surgical resection or by progression of disease that is not amenable to complete surgical resection prior to planned surgery.

Feasibility of treatment will be defined by the percentage of patients able to complete both neoadjuvant cycles of trial therapy and be able to complete surgical resection as planned.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Durvalumab and Lenvatinib in Participants With Advanced and Recurrent Endometrial Carcinoma	NCT04444193	Endometrial Can...	Durvalumab Lenvatinib Oral...	18 Years - 80 Years	Shanghai First Maternity and Infant Hospital
Pembrolizumab and LENvatinib in Participants With Hepatocellular Carcinoma (HCC) Before Liver Transplant	NCT04425226	Liver Transplan... Hepatocellular ...	Pembrolizumab I... Lenvatinib Oral...	18 Years - 80 Years	RenJi Hospital
Real-world Study of Efficacy and Safety of ICIs and TKIs Therapy for HCC	NCT05420922	Hepatocellular ... Programmed Cell... Effects of Immu...	Lenvatinib Oral... PD-1 inhibitor Local treatment	18 Years -	Tongji Hospital
Neoadjuvant Lenvatinib Plus Pembrolizumab in Merkel Cell Carcinoma	NCT04869137	Merkel Cell Car... Neuroendocrine ... Trabecular Carc...	Lenvatinib Oral... Pembrolizumab	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Real-world Study of Efficacy and Safety of ICIs and TKIs Therapy for HCC	NCT05420922	Hepatocellular ... Programmed Cell... Effects of Immu...	Lenvatinib Oral... PD-1 inhibitor Local treatment	18 Years -	Tongji Hospital
Real-world Study of Efficacy and Safety of ICIs and TKIs Therapy for HCC	NCT05420922	Hepatocellular ... Programmed Cell... Effects of Immu...	Lenvatinib Oral... PD-1 inhibitor Local treatment	18 Years -	Tongji Hospital

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