Tivozanib plus Nivolumab:Tivozanib will be administered once daily for 3 weeks followed by 1 week off. Nivolumab will be administered every 2 weeks starting on Day 1.

Carcinoma, Renal Cell

Tivozanib (AV-951): Phase 1b study and Phase 2a study: Subjects will receive 1 dose of tivozanib daily for 21 days followed by a 7 day rest period (1 cycle = 4 weeks).

Tivozanib

Nivolumab: Phase 1b study and Phase 2a study: All subjects will receive IV nivolumab 240 mg every 2 weeks administered over 1 hour.

Nivolumab

Bordeaux Hospital University Center (CHU)

Center Léon Bérard

Centre Paul Strauss

Institut Gustave Roussy

Phase 1/2 Study of Tivozanib in Combination With Nivolumab in Subjects With RCC

A Phase 1b/2, Open-Label, Multi-Center Study of Tivozanib in Combination With Nivolumab in Subjects With Metastatic Renal Cell Carcinoma

A traditional escalation rule, also known as "3 + 3" rule, will be used for this study. Subjects are treated in groups of 3 with each receiving the same dose. If none of the 3 subjects experience a DLT within Cycle 1, the next group of 3 subjects receives the next higher dose, otherwise, the group will expand to 6 subjects treated at the same dose level. If ≤ 1 of the 6 subjects treated at that dose level experience a DLT within Cycle 1, the trial will continue to the next higher dose level. If ≥ 2 of the 6 experience a DLT at the dose level within Cycle 1, then escalation stops at that level and the prior dose level will be considered the MTD. If MTD is not identified and both dose levels are tolerated, 1.5 mg will be considered the recommended Phase II dose (RP2D) for the expansion.

Upon determination of MTD, up to 20 additional subjects with measurable disease will be enrolled in the MTD Expansion Cohort for an expanded assessment of safety and activity.

AVEO Pharmaceuticals, Inc.

Bristol-Myers Squibb

Metastatic Renal Cancer

Prednisone + Everolimus: Everolimus is formulated as tablets of 5-10 mg strength, blister-packed under aluminium foil in units of 10 tablets. Prednisone will be dispensed to patients at the dose of 5 mg twice daily (BID). Everolimus at dose of 10 mg (one 10 mg tablet or two 5 mg tablets). Both drugs will be self-administered orally, continuously from Day 1 (Visit 2) until progression of disease, unacceptable toxicity, death or discontinuation for any other reason.
A treatment cycle consists of 28 days.

Prednisone + Everolimus

U.O Oncologia Medica, IRST IRCCS

Oncologia Medica, PO Faenza, AUSL della Romagna

Oncologia Medica, PO RAVENNA, AUSL della Romagna

Oncologia Medica, PO Rimini-Cattolica, AUSL della Romagna

PRednisone Plus EVerolimus in Patients With Metastatic Renal Cell Cancer After Failure of VEGFR -TKI

Phase II Study of Oral PRednisone 5 mg Bid Plus EVerolimus in Patients With Metastatic Renal Cell Cancer After Failure of Vascular Endothelial Growth Factor Receptor-tyrosine Kinase Inhibitors

to evaluate the incidence of grade ≥ 2 stomatitis and non-infectious pneumonitis in RCC patients treated with prednisone 5 mg bid and everolimus 10 mg/day.

the sum of partial responses plus complete responses

time from the date of starting of the treatment to the date of the first observation of documented disease progression or death due to any cause. Patients without tumor progression at the time of analysis will be censored at their last date of tumor evaluation.

time from the date of starting of the treatment to the date of the death due to any cause. Patients living at the time of analysis will be censored at their last date of tumor evaluation.

Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Patients in this arm start first with sodium chloride 0.9% mouth rinses and go crossover to supersaturated calcium-phosphate mouth rinses.

Patients in this arm start first with supersaturated calcium-phosphate mouth rinses and go crossover to sodium chloride 0.9% mouth rinses.

Oral Complaints

Renal Cell Carcinoma

Hepatocellular Carcinoma

Gastrointestinal Stromal Tumors

4 times daily, 2 minutes rinse with 30 ml solution during active rinse period (14 days)

supersaturated calcium-phosphate

sodium chloride 0.9 %

The Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital

Leiden University Medical Centre (LUMC)

Caphosol in Oral Mucositis Due to Targeted Therapy

Phase III Randomized Double-blind Cross-over Trial of Caphosol® Versus NaCl 0.9% in the Relief of Oral Mucositis in Renal Cell Carcinoma, Hepatocellular Carcinoma, and Gastrointestinal Stromal Tumor Patients Receiving Targeted Therapy

stomatitis/tyrosine

Phase 1/2 Study of Tivozanib in Combination With Nivolumab in Subjects With RCC

PRednisone Plus EVerolimus in Patients With Metastatic Renal Cell Cancer After Failure of VEGFR -TKI

Caphosol in Oral Mucositis Due to Targeted Therapy

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