Cancer Research in HKUMed
7. Genitourinary



  • 7.1. Clinical Trial
    • 7.1.1. Kidney
    • 7.1.2. Bladder
    • 7.1.3. Prostate

7.0 Genitourinary

7.1 Clinical Trial

7.1.1 Kidney

Locally Advanced or Metastatic, Unresectable

Specific Selection Criteria: MET+ve

First-line treatment: Phase 3

Immunotherapy (Anti-PD-L1 Antibody), Targeted Therapy (c-Met Receptor Inhibitor)/ (VEGFR Inhibitor)

Study Title

Main Inclusion/Exclusion

Investigational Product

Principal Investigator

Department

Email

Contact number

SAMETA (Protocol ID: D5086C00001):

A Phase III, Open Label, Randomised, 3-Arm, Multi-Centre Study of Savolitinib Plus Durvalumab Versus Sunitinib and Durvalumab Monotherapy in MET-Driven, Unresectable and Locally Advanced or Metastatic Papillary Renal Cell Carcinoma.

Key Inclusion Criteria:

  1. Histologically confirmed unresectable and locally advanced or metastatic PRCC.

     

  2. PRCC must be centrally confirmed as MET-driven.

     

  3. No prior systemic anti-cancer treatment in the metastatic setting; no prior exposure to MET inhibitors, durvalumab or sunitinib in any setting.

 

Durvalumab (Anti-PD-L1 Monoclonal Antibody) + savolitinib (c-Met Receptor Inhibitor)

 

Vs.

 

Durvalumab

 

Vs.

 

Sunitinib (VEGFR Inhibitor)

Dr. Bryan Li

Department of Medicine (Medical Oncology)

medicaloncology@hku.hk

2255 5582

7.1.2 Kidney

Locally Advanced or Metastatic, Unresectable

First-line treatment: Phase 3

Targeted Therapy (MET, VEGFR2 inhibitor)

Study Title

Main Inclusion/Exclusion

Investigational Product

Principal Investigator

Department

Email

Contact number

XL092-304

A Randomized Open-Label Phase 3 Study of XL092 + Nivolumab vs Sunitinib in Subjects with Advanced or Metastatic Non-Clear Cell Renal Cell Carcinoma

Key Inclusion Criteria:

  1. Histologically confirmed nccRCC that is unresectable, advanced or metastatic. Histologic subtypes including papillary, unclassified, and translocation-associated are allowed. Among the eligible histologic subtypes, sarcomatoid features are allowed.

 

Key Exclusion Criteria:

1. Chromophobe, renal medullary carcinoma, and pure collecting duct histologic subtypes of nccRCC.

 

2. Prior systemic anticancer therapy for unresectable locally advanced or metastatic nccRCC including investigational agents.

XL092 + Nivolumab

 

Vs.

 

Sunitinib

Dr. Bryan Li

Centre of Cancer Medicine

cancermed@hku.hk

3910 3339

7.1 Clinical Trial

7.1.2 Bladder

Early Stage

Prior Neoadjuvant Therapy: ypT2-4a or ypN+ and M0

Not received Neoadjuvant Therapy: pT2-4a or pN+ and M0

Specific Selection Criteria: PD-L1 (≥1%), ctDNA+ve after cystectomy

Adjuvant treatment: Phase 3

Immunotherapy: Anti-PD-L1 Monoclonal Antibody

Study Title

Main Inclusion/Exclusion

Investigational Product

Principal Investigator

Department

Email

Contact number

IMvigor011 (Protocol ID: BO42843):

A Phase III, Double-Blind, Multicenter, Randomized Study of Atezolizumab (Anti-PDL1 Antibody) Versus Placebo as Adjuvant Therapy in Patients With High-Risk Muscle-Invasive Bladder Cancer Who Are ctDNA Positive Following Cystectomy.

Key Inclusion Criteria:

  1. Histologically confirmed MIUC (also termed TCC) of the bladder.

     

  2. Surgical resection of MIUC of the bladder.

     

  3. Patients who have received prior platinum-based NAC.

     

  4. Patients who have not received prior platinum-based NAC, have refused, or are ineligible ("unfit") for cisplatin-based adjuvant chemotherapy.

     

  5. Tumor PD-L1 expression.

Atezolizumab (Anti-PD-L1 Monoclonal Antibody)

 

Vs.

 

Placebo

 

Dr. Bryan Li

Department of Medicine (Medical Oncology)

medicaloncology@hku.hk

2255 5582

7.1 Clinical Trial

7.1.3.1 Prostate

Metastatic

Specific Selection Criteria: Hormone-Sensitive, PTEN deficiency

First-line treatment: Phase 3

Targeted therapy (Akt inhibitor), Androgen inhibitor

Study Title

Main Inclusion/Exclusion

Investigational Product

Principal Investigator

Department

Email

Contact number

CAPItello-281 (Protocol ID: D361BC00001):

A Phase III Double-Blind, Randomized, Placebo-Controlled Study Assessing the Efficacy and Safety of Capivasertib + Abiraterone Versus Placebo + Abiraterone as Treatment for Patients with De Novo Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) Characterized by PTEN deficiency.

Key Inclusion Criteria:

  1. Histologically diagnosed prostate adenocarcinoma.

     

  2. Distant metastatic disease.

     

  3. No prior pharmacotherapy, radiation therapy or surgery.

     

  4. PTEN deficiency status"

Capivasertib (Akt inhibitor)

+ Abiraterone (Androgen biosynthesis inhibitors)

 

Vs.

 

Placebo + Abiraterone

Dr. Steven Wai Kwan Siu

Department of Clinical Oncology

oncology@hku.hk

Cliff CHONG

2255 5102

7.1.3.2 Prostate

Hormone-Sensitive, Metastatic

Specific Selection Criteria: PSMA+ve

First-line treatment: Phase 3

Radioconjugate

PSMAddition (Protocol ID: CAAA617C12301):

An Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With Standard of Care, Versus Standard of Care Alone, in Adult Male Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC).

Key Inclusion Criteria:

  1. Metastatic Hormone-Sensitive Prostate Cancer (mHSPC).

     

  2. Metastatic prostate cancer with histologically or cytologically confirmed adenocarcinoma.

     

  3. Evidence of PSMA-positive disease.

     

  4. Treatment naïve.

177 Lu-PSMA-617 (Radioconjugate)

+ SOC

 

Vs.

 

SOC

Dr. Steven Wai Kwan Siu

Department of Clinical Oncology

oncology@hku.hk

Cliff CHONG

2255 5102