Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Adenocarcinoma

Carcinoma, Renal Cell

Kidney Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

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

Pharmaceutical Solutions

Anti-Infective Agents

Central Nervous System Depressants

Docetaxel

Ethanol

Tubulin Modulators

Antimitotic Agents

Intratumoral injection of NanoDoce (2.0 to 6.0 mg/mL) at a volume not to exceed 5.0 mL. NanoDoce will be administered on up to two occasions with at least 4 weeks between doses.

NanoDoce is manufactured using a Precipitation with Compressed Antisolvent (PCA) technique that employs supercritical carbon dioxide and acetone to generate docetaxel nanoparticles within a well-characterized particle-size distribution. Prior to administration, the NanoDoce powder in vial is suspended with a sterile solution of Polysorbate 80 (0.0075% - 0.0375% (w/w))/Ethanol (0.06% - 0.3% (w/w)) in 0.9% Sodium Chloride for injection.

NanoDoce (sterile nanoparticulate docetaxel) Powder for Suspension

Rose Marie Cavanna-Mast, RT, CCRA

This study evaluates the use of NanoDoce injected directly into tumors in the kidney of people with renal cell carcinoma.

NanoDoce is very small (submicron) particles of the chemotherapy drug, docetaxel, which is administered intravenously in a number of types of cancer. These submicron particles are injected directly into solid tumors to target cancer at the site of disease with less systemic exposure than intravenously administered chemotherapy. In this study, the submicron particle docetaxel will be injected directly into tumors in the kidney of people with renal cell carcinoma that is localized to (has not spread beyond) the kidney. All subjects in this study will receive NanoDoce and will be evaluated to see if NanoDoce is safe.

Trial of NanoDoce Intratumoral Injection in Renal Cell Carcinoma

Phase 1 Trial Evaluating the Safety and Tolerability of NanoDoce® Intratumoral Injection in Subjects With Localized Renal Cell Carcinoma

Treatment emergent adverse events (including changes in laboratory assessments, physical examination findings, and vital signs)

Pharmacokinetic samples will be obtained on the days of NanoDoce injection and other clinic visits

US Biotest, Inc.

NanOlogy, LLC

Nivolumab

Ipilimumab

Participants diagnosed with advanced renal cell carcinoma (RCC) and whose physician has decided to initiate a treatment with Nivolumab for the first time for the treatment of RCC

Participants diagnosed with advanced RCC and whose physician has decided to start a new systemic therapy with nivolumab + ipilimumab for the first time for the treatment of RCC

Bristol-Myers Squibb

This is a French, nationwide, prospective, observational, multi-center study in participants diagnosed with advanced renal cell carcinoma, who start a new systemic therapy with nivolumab with or without ipilimumab for the first time and within the market authorization approval.

Non-Interventional Study (NIS) of Nivolumab With or Without Ipilimumab in Participants With Advanced Kidney Cancer

A National, Prospective, Non-Interventional Study (NIS) of Nivolumab (BMS-936558) With or Without Ipilimumab (BMS-734016) in Patients With Advanced Renal Cell Carcinoma in Real Life Setting

The FKSI-19 will be graded by the patient on a scale from 0 to 4 (range "not at all to very much")

The EQ-5D descriptive system consists of 5 dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression, each with 3 levels (eg, no problems, moderate problems, extreme problems)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Trial of NanoDoce Intratumoral Injection in Renal Cell Carcinoma	NCT04260360	Renal Cell Carc... Kidney Cancer Adenocarcinoma ... Adenocarcinoma,... Renal Cell Canc...	NanoDoce (steri...	18 Years -	NanOlogy, LLC
Non-Interventional Study (NIS) of Nivolumab With or Without Ipilimumab in Participants With Advanced Kidney Cancer	NCT03455452	Renal Cell Carc... Renal Cell Canc... Adenocarcinoma ... Adenocarcinoma,... Kidney Cancer Cancer of the K...		18 Years -	Bristol-Myers Squibb

Spots Global Cancer Trial Database for adenocarcinoma of kidney