clinical trial in patient with locally advance or metastatic cancer of the urinary tract

Phase 3

Active, not recruiting

• Conditions: Health Condition 1: null- locally advanced or metastatic urothelial cancerHealth Condition 2: C679- Malignant neoplasm of bladder, unspecifiedHealth Condition 3: C659- Malignant neoplasm of unspecifiedrenal pelvisHealth Condition 4: C669- Malignant neoplasm of unspecifiedureter

• Registration Number: CTRI/2017/01/007696
• Lead Sponsor: Pfizer Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 6

Inclusion Criteria

Inclusion Criteria:

1.Histologically confirmed, unresectable locally advanced or metastatic transitional cell carcinoma of the urothelium

2. Stage IV disease at the start of first-line chemotherapy

3. Measurable disease (per RECIST v1.1) prior to the start of first-line chemotherapy

4. Prior first-line chemotherapy must have consisted of at least 4 cycles and no more than 6 cycles of gemcitabine + cisplatin and/or gemcitabine + carboplatin

5. No evidence of progressive disease following completion of first-line chemotherapy (i.e., ongoing CR, PR, or SD per RECIST v1.1 guidelines )

Exclusion Criteria

Exclusion Criteria:

1. Prior adjuvant or neoadjuvan therapy within 12 months of randomization

2. Prior immunotherapy with IL-2, IFN-α, or an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or CTLA 4 antibody (including ipilimumab), or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways

3. Persisting toxicity related to prior therapy (Grade >1 NCI CTCAE v4.0); however, sensory neuropathy (Grade 2 or less) is allowed

4.Diagnosis of any other malignancy within 5 years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the breast or of the cervix, low grade prostate cancer on surveillance without any plans for treatment intervention

5. patients with known symptomatic central nervous system metastases requiring steroids.

Study & Design

• Study Type: Interventional
• Study Design: Not specified