Phase II Sequential Treatment Trial of Single Agent Nivolumab, Then Combination Ipilimumab + Nivolumab in Metastatic or Unresectable Non-Clear Cell Renal Cell Carcinoma (ANZUP1602)

PHASE2UnknownINTERVENTIONAL
Enrollment

85

Participants

Timeline

Start Date

October 19, 2017

Primary Completion Date

December 31, 2021

Study Completion Date

December 31, 2022

Conditions
Renal Cell CarcinomaPapillary Renal Cell Carcinoma Type 1Papillary Renal Cell Carcinoma Type 2Chromophobe Renal Cell CarcinomaSarcomatoid Renal Cell CarcinomaXp11 Translocation Carcinoma
Interventions
DRUG

Nivolumab

"Dosage Form: Nivolumab BMS-936558-01 Solution for Injection Potency: 100 mg (10 mg/mL) Primary Packaging: 10 mL vial Appearance: Clear to opalescent colourless to pale yellow liquid. May contain particles.~Storage Condition: 2 to 8°C. Protect from light and freezing."

DRUG

Ipilimumab

Dosage Form: Ipilimumab Solution for Injection Potency: 200 mg (5 mg/mL) Primary Packaging: 40 mL vial Appearance: Clear, colourless to pale yellow liquid. May contain particles. Storage Condition: 2 to 8°C. Protect from light and freezing.

Trial Locations (19)

2010

St Vincents Hospital, Darlinghurst

2031

Prince of Wales Hospital, Randwick

2050

Chris O'Brien Lifehouse, Camperdown

2086

Northern Cancer Institute, Frenchs Forest

2145

Westmead Hospital, Westmead

2217

St. George Hospital, Kogarah

2298

Calvary Mater Newcastle, Newcastle

2340

Tamworth Hospital - North West Cancer Centre, Tamworth

2444

Port Macquarie Base Hospital, Port Macquarie

2460

Border Medical Oncology, Albury

2560

Campbelltown Hospital, Campbelltown

3128

Box Hill Hospital - Eastern Health, Box Hill

3168

Monash Medical Centre, Clayton

3355

Ballarat Oncology & Haematology Services, Ballarat

4000

Royal Brisbane & Women's Hospital, Brisbane

4575

Sunshine Coast University Hospital, Birtinya

5000

Flinders Medical Centre, Adelaide

5037

Ashford Cancer Centre, Adelaide

6150

Fiona Stanley Hospital, Murdoch

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

Australian and New Zealand Urogenital and Prostate Cancer Trials Group

OTHER

NCT03177239 - Phase II Sequential Treatment Trial of Single Agent Nivolumab, Then Combination Ipilimumab + Nivolumab in Metastatic or Unresectable Non-Clear Cell Renal Cell Carcinoma (ANZUP1602) | Biotech Hunter | Biotech Hunter