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Key Genitourinary Cancers Clinical Trials to Watch
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Key Genitourinary Cancers Abstracts | ASCO 2025
The 2025 ASCO Annual Meeting could reshape genitourinary (GU) Cancers (prostate, bladder, and kidney cancers). As new data emerges, a shift in clinical landscape is expected. The key abstracts within GU Cancers from DelveInsight listed below hold promise for significant advancements, aiming to positively impact the patient’s lives.
In clear cell renal cell carcinoma (ccRCC), two major abstracts are expected to be presented at ASCO 2025, i.e., Abstract 4515 (STELLAR-002 Study), and Abstract 4506 (ARC-20 Study). STELLAR-002 study explores triplet therapy as a potential breakthrough for metastatic ccRCC. COSMIC-313 study showed that cabozantinib in combination with OPDIVO and YERVOY improved progression-free survival (PFS) but had high rates of grade 3/4 treatment-related adverse events (AEs). The objective of STELLAR-002 study is to investigate whether zanzalintinib (a novel VEGF TKI with a shorter half-life) combined with OPDIVO and OPDUALAG could be a promising first-line triplet therapy for metastatic ccRCC.
Furthermore, ARC-20 Study examines the combination of casdatifan (a novel HIF-2⍺ inhibitor) with cabozantinib in previously treated metastatic ccRCC patients. Since new combinations are needed in RCC treatment, this regimen is advancing into a phase III trial. Preliminary data will be crucial as the study progresses, as this combination could potentially change clinical practice for patients with previously treated metastatic RCC.
In Prostate Cancer, PARP inhibitor data (Niraparib and abiraterone acetate plus prednisone) is set to be disclosed in patients with metastatic hormone-sensitive prostate cancer (mHSPC). Following multiple successful Phase III trials of PARP inhibitors combined with androgen receptor pathway inhibitors, assessing their effectiveness in earlier-stage disease of Prostate Cancer is important. The Phase III AMPLITUDE study (NCT04497844) could significantly influence mHSPC clinical practice, and the upcoming ASCO 2025 presentation could reveal whether it demonstrates an overall survival benefit. In addition to this, Candel Therapeutics is set to highlight positive Phase III results for CAN-2409 (ProstAtak) in newly diagnosed localized prostate cancer at ASCO 2025.
Find below the list of most anticipated trial' data being presented during the ASCO 2025 meeting
Genitourinary Cancer Key Abstracts
|
Company |
Drug |
Trial ID/ Acronym |
Phase |
Patient Segment |
Abstract ID |
Session Type |
Abstract Title |
|
|
Niraparib + Abiraterone Acetate + Prednisone |
NCT04497844 (AMPLITUDE) |
III |
mCSPC |
LBA5006 |
Oral |
Phase III AMPLITUDE trial: Niraparib (NIRA) and abiraterone acetate plus prednisone (AAP) for metastatic castration-sensitive prostate cancer (mCSPC) patients (pts) with alterations in homologous recombination repair (HRR) genes. |
|
|
Padeliporfin vascular targeted photodynamic therapy (VTP) |
NCT04620239 (ENLIGHTED) |
III |
Low-grade upper tract urothelial cancer |
LBA4513 |
Rapid Oral |
ENLIGHTED phase III study: Interim results of efficacy and safety of padeliporfin vascular targeted photodynamic therapy (VTP) in the treatment of low-grade upper tract urothelial cancer (LG UTUC) |
|
TRODELVY + KEYTRUDA |
NCT05535218 (SURE-02) |
II |
Muscle-invasive bladder cancer (MIBC) |
4518 |
Rapid Oral |
First results of SURE-02: A phase II study of neoadjuvant sacituzumab govitecan (SG) plus pembrolizumab (Pembro), followed by response-adapted bladder sparing and adjuvant pembro, in patients with muscle-invasive bladder cancer (MIBC) | |
|
|
ProstAtak (CAN-2409) |
NCT01436968 |
III |
Newly diagnosed localized prostate cancer |
5000 |
Oral |
Phase III, randomized, placebo-controlled clinical trial of CAN-2409+prodrug in combination with standard of care external beam radiation (EBRT) for newly diagnosed localized prostate cancer |
|
|
Talazoparib with enzalutamide |
NCT03395197 (TALAPRO-2) |
III |
mCRPC |
5019 |
Rapid Oral |
Exploratory analyses of homologous recombination repair alterations (HRRm) by gene subgroup and potential associations with efficacy in the HRR-deficient population from TALAPRO-2 |
|
|
Nivolumab Combined With Ipilimumab |
NCT03036098 (CheckMate 901) |
III |
Previously untreated unresectable or metastatic urothelial carcinoma (mUC) |
4500 |
Oral |
Nivolumab plus ipilimumab (NIVO+IPI) vs gemcitabine-carboplatin (gem-carbo) chemotherapy for previously untreated unresectable or metastatic urothelial carcinoma (mUC): Final results for cisplatin-ineligible patients from the CheckMate 901 trial. |
|
|
Zanzalintinib + nivolumab ± relatlimab |
NCT05176483 (STELLAR-002) |
Ib |
Previously untreated ccRCC |
4515 |
Rapid Oral |
Zanzalintinib (zanza) + nivolumab (nivo) ± relatlimab (rela) in patients (pts) with previously untreated clear cell renal cell carcinoma (ccRCC): Results from an expansion cohort of the phase 1b STELLAR-002 study |
|
|
Sasanlimab (PF 6801591) |
NCT04165317 |
III |
BCG-naive, high-risk non–muscle-invasive bladder cancer (NMIBC) |
4517 |
Rapid Oral |
Sasanlimab in combination with bacillus Calmette-Guérin (BCG) in BCG-naive, high-risk non–muscle-invasive bladder cancer (NMIBC): Event-free survival (EFS) subgroup analyses based on disease stage from the CREST study |
|
|
Casdatifan plus cabozantinib |
NCT05536141 |
I |
Clear Cell Renal Cell Carcinoma and Other Solid Tumors |
4506 |
Oral |
Combination Casdatifan plus cabozantinib expansion cohort of phase I ARC-20 study in previously treated patients with clear cell renal cell carcinoma |
|
|
Abemaciclib |
NCT03837821 |
I |
Cisplatin-ineligible muscle-invasive bladder cancer (MIBC) |
4520 |
Rapid Oral |
CLONEVO: Preoperative abemaciclib for cisplatin-ineligible muscle-invasive bladder cancer (MIBC) with molecular response assessment |
Executive Summary
The 2025 ASCO Annual Meeting could reshape genitourinary (GU) Cancers (prostate, bladder, and kidney cancers).