Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

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

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Central Nervous System Depressants

Capecitabine

Nivolumab

Ipilimumab

Ethanol

Ethiodized Oil

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Patients initiate ICI therapy with Nivolumab 3 mg/kg + ipilimumab 1/mg/kg IV every 3 weeks x 4 cycles, followed by nivolumab 480mg flat dose IV every four weeks for a total of 6 months of therapy unless stopped for confirmed progression or intolerable toxicities.

Patients will receive 2 cycles of systemic therapy followed by embolization of their primary tumor or metastatic lesion(s) and continue systemic therapy subsequently.

Nivolumab 3 mg/kg IV every four weeks, first in combination with capecitabine then alone

ipilimumab 1/mg/kg IV every 3 weeks x 4 cycles, in combination with Nivolumab

Lipiodol:ethanol embolization of their primary or target tumor

bland embolization

Michale Soulen, MD

This single center phase 1 trial will study the combination of nivolumab+ipilimumab with embolization in participants with renal cell carcinoma. The study will evaluate the safety of embolotherapy in patients with metastatic RCC receiving nivolumab+ipilimumab. The hypothesis is that the number of serious adverse events will be no greater than the number of serious adverse events for both therapies combined.

Previously untreated subjects with stage 4 RCC and unresected primary tumor or metastasis amenable to embolization will undergo two cycles of combination immune checkpoint inhibition (ICI) therapy, embolization of the target tumor, then resume ICI therapy. Study ends with safety and efficacy assessment at 6 months. Correlative blood and tissue specimens will be obtained.

Nivolumab + Ipilimumab With Immunostimulatory Embolization for Stage 4 Renal Cell Carcinoma With Unresected Primary

UPCC06820 Phase 1 Trial of Nivolumab + Ipilimumab With Immunostimulatory Embolization for Stage 4 Renal Cell Carcinoma With Unresected Primary

SAE rate following embolization in patients

Characterization of tumor-infiltrating leukocytes in primary and metastatic lesions before and after embolotherapy

Percentage of PD-L1 stain positivity in the primary tumor biopsy of participants

Abramson Cancer Center at Penn Medicine

To evaluate the efficacy of preoperative cabozantinib treatment as measured by the radiological response rate prior to NC in patients with advanced or metastatic renal cell cancer candidates for NC.

This study tries to clarify whether Cabozantinib could be a safe and effective preoperative treatment in patients with advanced RCC who were candidates for removing a part or all of their kidney.

Cabozantinib

Guillermo de Velasco, MD PhD

Phase II, multicenter, national, uncontrolled, multicenter, uncontrolled, phase II clinical trial for the evaluation of cabozantinib treatment prior to cytoreductive nephrectomy in patients with advanced or metastatic renal cell cancer candidates for primary tumor cytoreductive nephrectomy (NC).

Metastatic Renal cell carcinoma (RCC) is a type of kidney cancer that arises in the small tubes of the kidneys and has spread to other parts of the body (advanced cancer/metastases). Patients typically have surgery to remove a part or all of their kidney (called partial or radical nephrectomy). Other treatments include chemotherapy, targeted therapy, immunotherapy and hormone therapy and may be used before or after surgery or radiotherapy.

There is no standard drug therapy given before surgery, but such preoperative therapy is used widely in the treatment of other cancer types. This approach has several potential advantages, including shrinking the tumor to help improve surgical outcomes and to help find an appropriate drug therapy.

Cabozantinib is the generic for the trade chemotherapy drug CABOMETYX™ (cabozantinib). It is known as a cancer growth inhibitor and also an angiogenesis inhibitor. Tyrosine kinases are proteins that control how cells grow and divide. By blocking the activity of these proteins in cancer cells, the medicine reduces the growth and spread of cancer.

This study tries to clarify whether Cabozantinib could be a safe and effective preoperative treatment in patients with advanced RCC who were candidates for removing a part or all of their kidney.

Cabozantinib Treatment Prior to Cytoreductive Nephrectomy in Patients With Advanced or Metastatic Renal Cells Cancer

Phase II Study for the Evaluation of Neoadjuvant Treatment With Cabozantinib Pior to Cytoreductive Nephrectomy in Patients With Advanced or Metastatic Renal Cells Cancer

Objective response to preoperative treatment with cabozantinib, defined as the percentage of patients that reach complete or partial radiological response after a 12-week cycle of treatment with cabozantinib, defined according to the RECIST 1.1 criteria (Response Evaluation Criteria In Solid Tumors: complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD))

Fundacion Oncosur

Lenvatinib

Axitinib

Immunomodulating Agents

Participants with Stage IV Renal Cell Carcinoma will be recruited in the genitourinary medical oncology clinic at Moffitt Cancer Center. Upon consenting, participants will be provided with an mHealth interactive smart phone application.

The mHealth interactive application consists of educational intervention geared towards eligible patients who are receiving Nivolumab/ Pembro with Axitinib/Cabozantinib/Lenvatinib. These patients commonly experience immune-related side effects, higher rate of fatigue, high blood pressure, and palmar-plantar erythrodysesthesia. The educational intervention will consist of multiple modules covering relevant information on treatment and adverse events and provided over a six-week period through an mHealth platform. This educational intervention includes a patient-friendly algorithm for early detection and management of the most common adverse events in patients with advanced renal cell carcinoma receiving combination immunotherapy.

mHealth Smart Phone Application

The eHEALS digital literacy test is an 8-item measure of eHealth literacy developed to measure the participants combined knowledge, comfort and perceived skills at finding, evaluating and applying electronic health information to health problems. The test is measured with a 5-point Likert scale with response options ranging from "strongly disagree" to "strongly agree." Total scores of the eHEALS are summed to range from 8 to 40, with higher scores representing higher self-perceived eHealth literacy.

eHEALS digital literacy test

Participants will take a weekly true/false quiz to assess knowledge of their diagnosis, expected outcome and treatment associated adverse effects at baseline and longitudinally. Each quiz will be administered at the beginning of the week before the weekly educational content is available, then the same quiz will be administered after the educational content is reviewed by the patient. Each quiz will be scored based on the number of correct answers.

Weekly Quiz

The European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C-30) comprises 30 single questions, 24 of which are aggregated into nine multi-item scales, that is, five functioning scales (physical, role, cognitive, emotional and social), three symptom scales (fatigue, pain and nausea/vomiting) and one global health status scale. The remaining six single-item (dyspnea, appetite loss, sleep disturbance, constipation, diarrhea and the financial impact) scales assess symptoms. No item occurs in more than one scale.

Scoring of the QLQ-C30 is performed according to QLQ-C30 Scoring manual. All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning (i.e. a better state of the patient), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the patient).

European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire

The Patient Post Intervention Survey is a 7 question survey to help determine the effectiveness of the mHealth app. 3 questions are open fields for patient feedback, and 4 questions ask how often the app was used, how often the educational module was used and if the patient found it useful.

Patient Post Intervention Survey

Jad Chahoud, MD, MPH

The purpose of the study is to test and understand acceptability and preliminary effectiveness of a mobile educational app specifically customized to patients with advanced Renal Cell Carcinoma (RCC) receiving therapy with combination immunotherapy.

Feasibility of a Smart-Phone App for Patients With Advanced Renal Cell Carcinoma Undergoing Combination Immunotherapy

The Feasibility of an Educational and Monitoring Smart-Phone Application for Patients With Advanced Renal Cell Carcinoma Undergoing Combination Immunotherapy

Patient's acceptability of the smart phone application for education will be captured in the patient post education survey.

Efficacy of the smart phone application on patient quality of life will be assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C-30) scores.

Efficacy of the smart phone application on patient knowledge of their diagnosis and treatment will be assessed by weekly true/false quizzes.

Pfizer

H. Lee Moffitt Cancer Center and Research Institute

Respiratory Tract (Lung and Bronchial) Diseases

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Breast Neoplasms

Triple Negative Breast Neoplasms

Necrosis

Melanoma

Skin Diseases

Breast Diseases

filtration of 2X PV through the ImmunicomAIAC

filtration of 2X PV through the Immunicom AIAC, and nivolumab 240 mg given every 14 days for 4 times. Nivolumab will be initiated in C2.

filtration through the ImmunicomAIAC followed by Nivolumab Administrated IV starting C2.

ImmunicomAIAC

Ronnie Shapira, MD

Meital Bar

Ronnie Shapira, Dr.

Ronnie Shapira, Dr

Sequential immune apheresis plasma volume escalation cohort study of reduction of soluble Tumor Necrosis Factors Receptors 1/2 (sTNFR1/2), with or without Nivolumab, in patients with inoperable or metastatic solid Tumors. This study evaluates Immunicom fs LW-02 device used with Spectra Optia apheresis system, aiming to answer two different study questions:

* Safety, tolerability and effectiveness of the device.
* Safety, tolerability and effectiveness of the device, employed as monotherapy, or combined with Nivolumab.

This is a pilot, single-center, open-label, sequential immune apheresis plasma volume escalation cohort study of reduction of soluble Tumor Necrosis Factors Receptors 1/2 (sTNFR1/2), with or without Nivolumab, in patients with inoperable or metastatic solid Tumors. This study evaluates Immunicom fs LW-02 device used with Spectra Optia apheresis system, aiming to answer two different study questions:

* Safety, tolerability and effectiveness of the device.
* Safety, tolerability and effectiveness of the device, employed as monotherapy, or combined with Nivolumab.

Sequentional Immuno Apheresis Plasma Volume Escalation Cohort Study of Reduction of Soluble Tumor Necrosis Factor Receptors 1 and 2 (sTNFR1/2) With or Without Nivolumab in Patients With Inoperable or Metastatic Solid Tumors

A Pilot Study, Single-Center, Open-Label, Sequentional Immuno Apheresis Plasma Volume Escalation Cohort Study of Reduction of Soluble Tumor Necrosis Factor Receptors 1 and 2 (sTNFR1/2) With or Without Nivolumab in Patients With Inoperable or Metastatic Solid Tumors

number of patients with adverse events that emerged due to IA

number of patients with adverse events that emerged due to IA therapy in combination with nivolumab.

Changes in sTNFR-1/2 pre and post AIAC column between start and end of every treatment session, and between start and end of every cycle Total capture of sTNF-R1/2 on each column post treatment will be measured using an elution procedure

The biochemical efficacy will be evaluated throughout the study by measuring the changes of sTNFR-1/2 and TNFα in the plasma in several pre-defined time points - before, during and post every AIAC treatment

Response Rate (RR) as determined by RECIST v1.1

changes in plasma cytokines levels: sTNFR-I (pg/ml), sTNFR-II (pg/ml), TNF (pg/ml), pre and post treatment.

changes in peripheral blood mononuclear cells (PBMC) phenotypes pre and post treatment

Duration of response (DoR) as determined by RECIST v1.1

Clinical benefit rate (CBR) defined as CR plus PR plus stable disease (SD) ≥6 months

Progression-Free Survival (PFS) as determined by RECIST v1.1

Eastern Cooperative Oncology Group (ECOG) status (score 0-4)

Overall quality of life scale: 1 (very poor), 7 (excellent). higher score mean better outcome

patient's health state: 1- 'The best health you can imagine' , 5- 'The worst health you can imagine'. higher score mean worse outcome

measure anxiety and depression in a general medical population of patients. 0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Nivolumab + Ipilimumab With Immunostimulatory Embolization for Stage 4 Renal Cell Carcinoma With Unresected Primary	NCT04429321	Renal Cell Carc... Renal Cell Carc...	Nivolumab Ipilimumab bland embolizat...	18 Years -	Abramson Cancer Center at Penn Medicine
Cabozantinib Treatment Prior to Cytoreductive Nephrectomy in Patients With Advanced or Metastatic Renal Cells Cancer	NCT06377722	Renal Cell Carc... Renal Cell Carc... Renal Cell Carc...	Cabozantinib	18 Years -	Fundacion Oncosur
Feasibility of a Smart-Phone App for Patients With Advanced Renal Cell Carcinoma Undergoing Combination Immunotherapy	NCT05579847	Renal Cell Carc...	mHealth Smart P... eHEALS digital ... Weekly Quiz European Organi... Patient Post In...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Sequentional Immuno Apheresis Plasma Volume Escalation Cohort Study of Reduction of Soluble Tumor Necrosis Factor Receptors 1 and 2 (sTNFR1/2) With or Without Nivolumab in Patients With Inoperable or Metastatic Solid Tumors	NCT04142931	Stage IV Non-sm... Stage IV Melano... Triple Negative... Renal Cell Carc...	ImmunicomAIAC	18 Years -	Sheba Medical Center
Cabozantinib Treatment Prior to Cytoreductive Nephrectomy in Patients With Advanced or Metastatic Renal Cells Cancer	NCT06377722	Renal Cell Carc... Renal Cell Carc... Renal Cell Carc...	Cabozantinib	18 Years -	Fundacion Oncosur
Cabozantinib Treatment Prior to Cytoreductive Nephrectomy in Patients With Advanced or Metastatic Renal Cells Cancer	NCT06377722	Renal Cell Carc... Renal Cell Carc... Renal Cell Carc...	Cabozantinib	18 Years -	Fundacion Oncosur

Spots Global Cancer Trial Database for renal cell carcinoma stage iv