Summary
The projects involve conducting multiple Phase 2 clinical trials to evaluate novel drug combinations for various rare genitourinary cancers, including bladder, urethra, penile, and renal cell carcinomas.
Rare genitourinary tumors projects
US · IL
NIH
grant
open
#nih-1ZIABC011928-07
What they want
1. ICONIC-A: A phase 2 study of Ipilimumab, Cabozantinib, and Nivolumab in 12 cohorts of rare genitourinary (GU) tumors, including bladder squamous cell carcinoma, bladder small cell carcinoma, bladder adenocarcinoma, bladder plasmacytoid, bladder sarcomatoid, urethra (all histologies), penile cancer, sarcomatoid RCC, collecting duct RCC, renal medullary carcinoma, bone-only non-prostate GU tumor, and miscellaneous rare GU tumors. This study includes extensive translational correlatives such as analysis of immune subsets of circulating PBMCs, ctDNA, whole-exome sequencing, and RNA sequencing.
2. Laser: A phase 2 study of Lurbinectedin +/- Avelumab in patients with small cell (and all neuroendocrine tumors) of the bladder and upper tract.
3. SMART: A phase 2 study of Sacituzumab Govitecan +/- Atezolizumab in patients with adenocarcinoma of the bladder/urachal, small cell (and all neuroendocrine tumors) of the bladder, squamous cell carcinoma of the bladder, renal medullary carcinoma, and penile squamous cell carcinoma.
Deliverables
- Clinical trial data and results for ICONIC-A, Laser, and SMART studies
- Analysis of immune subsets of circulating PBMCs
- Analysis of ctDNA
- Whole-exome sequencing data and analysis to define tumor mutational burden and its relationship to drug response
- RNA sequencing data and analysis to define expression-based subtypes, the immune context of tumors, and relationship to drug response
Technical requirements
- Ability to conduct Phase 2 clinical trials
- Expertise in analyzing immune subsets of circulating PBMCs
- Expertise in ctDNA analysis
- Capability for whole-exome sequencing
- Capability for RNA sequencing
