EUCTR2017-004556-27-ES
Active, not recruiting
Phase 1
A Phase II, Randomized, Multi-Center, Double-Blind, Comparative Global Study to Determine the Efficacy and Safety of Durvalumab in Combination With Olaparib for First-Line Treatment in Cisplatin-Ineligible Patients With Unresectable Stage IV Urothelial Cancer - BAYO
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- nresectable Stage IV Urothelial Cancer
- Sponsor
- AstraZeneca AB
- Enrollment
- 154
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Provision of signed and dated, written ICF 3\. 4
- •2\. Histologically or cytologically documented TCC/UC of the urothelium (including renal pelvis, ureters, urinary bladder, and urethra) also meeting the following: Unresectable, Stage IV disease; No prior systemic therapy for unresectable, Stage IV disease.
- •3\. Ineligible for cisplatin\-based chemotherapy defined as meeting one of the following criteria: CrCl \<60 mL/min calculated by Cockcroft\-Gault equation; Common Terminology Criteria for Adverse Events (CTCAE) Grade \=2 audiometric hearing loss (25 dB in 2 consecutive wave ranges); CTCAE Grade \=2 peripheral neuropathy; New York Heart Association Class III heart failure; ECOG 2\.
- •4\. Known tumor HRR mutation status prior to randomization.
- •5\. World Health Organization (WHO)/ECOG performance status of 0, 1, or 2\.
- •6\. Patients with at least 1 RECIST 1\.1 target lesion at baseline.
- •7\. Ability to swallow oral medications.
- •8\. Evidence of post\-menopausal status, or negative urinary or serum pregnancy test for female pre\-menopausal patients.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
Exclusion Criteria
- •1\. Active or prior documented autoimmune or inflammatory disorders.
- •2\. Other invasive malignancy within 5 years before the first dose of the IP.
- •3\. Major surgical procedure within 28 days prior to the first dose
- •4\. Brain metastases or spinal cord compression unless the patient’s condition is stable and off steroid for at least 14 days
- •5\. History of active primary immunodeficiency.
- •6\. Active infection including tuberculosis (TB)
- •7\. History of allogenic organ transplantation.
- •8\. Uncontrolled intercurrent illness
- •9\. Prior exposure to a PARP inhibitor or immune\-mediated therapy.
- •10\. Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
Proof of Concept Study to Evaluate the Efficacy and Safety of BMS-931699 (lulizumab) or BMS-986142 in Primary Sjögren's SyndromeEUCTR2016-000101-37-ITBRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIO120
Active, not recruiting
Phase 1
Proof of Concept Study to Evaluate the Efficacy and Safety of BMS-931699 (lulizumab) or BMS-986142 in Primary Sjögren's Syndromesubjects with moderate to severe Sjögren's syndromeMedDRA version: 19.1Level: LLTClassification code 10040766Term: Sjogren's diseaseSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersMedDRA version: 19.1Level: PTClassification code 10040767Term: Sjogren's syndromeSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersMedDRA version: 19.1Level: LLTClassification code 10042846Term: Syndrome Sjogren'sSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersMedDRA version: 19.1Level: LLTClassification code 10040765Term: Sjogren'sSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersMedDRA version: 19.1Level: PTClassification code 10048676Term: Sjogren-Larsson syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]EUCTR2016-000101-37-GRBristol-Myers Squibb International Corporation160
Recruiting
Not Applicable
A Phase II, Randomized, Multi-Center, Double-Blind, Placebo Controlled Study to Evaluate theEfficacy and Safety of BMS-931699 (lulizumab) or BMS-986142 in Subjects with Moderate to Severe Primary Sjogren´s Syndrome-M350 Sicca syndrome [Sjogren]Sicca syndrome [Sjogren]M350PER-035-16BRISTOL MYERS SQUIBB COMPANY,1
Active, not recruiting
Not Applicable
A Phase II, Randomized, Multi-Centre, Double-Blind, Placebo-Controlled Trial of HMPL-004 in Patients with Mild to Moderate Active Ulcerative Colitis with or without MesalamineEUCTR2007-005166-12-DEHutchison MediPharma Enterprises Limited210
Not yet recruiting
Phase 2
A Study of Tobemstomig/RO7247669 Combined With Nab-Paclitaxel Compared With Pembrolizumab Combined With Nab-Paclitaxel in Participants With Previously Untreated, PD-L1-Positive, Locally-Advanced Unresectable or Metastatic Triple-Negative Breast CancerCancerPACTR202404480503746Hoffmann La Roche160