NL-OMON52369
Recruiting
Not Applicable
A Phase 1b trial in Stage II-III urothelial cancer to explore pre-operative immunotherapy - TURANDOT - Pre-operative immunotherapy in stage II-III urothelial cancer
Antoni van Leeuwenhoek Ziekenhuis0 sites15 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Urothelial carcinoma and urothelial cancer
- Sponsor
- Antoni van Leeuwenhoek Ziekenhuis
- Enrollment
- 15
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Resectable muscle\-invasive UC (upper urinary tract allowed), defined as:
- •\- cT2\-4aN0M0 OR
- •\- cT1\-4aN1\-3M0
- •2\. World Health Organization (WHO) performance Status 0 or 1\.
- •3\. Urothelial cancer is the dominant histology (\>70%).
- •4\. PD\-L1 status must be determined using the 22C3 pharmDx test. Combined
- •positivity score (CPS) must be \>10 under amendment V3\.
- •5\. Screening laboratory values must meet the following criteria: WBC \>\=
- •2\.0x109/L, Neutrophils \>\=1\.0x109/L, Platelets \>\=100 x109/L, Hemoglobin \>\=5\.5
- •mmol/L, GFR\>30 ml/min, AST \<\= 1\.5 x ULN, ALT \<\=1\.5 x ULN, Bilirubin \<\=1\.5 X ULN
Exclusion Criteria
- •1\. Subjects with active autoimmune disease in the past 2 years. Patients with
- •diabetes mellitus, properly controlled hypothyroidism or hyperthyroidism,
- •vitiligo, psoriasis or other mild skin disease can still be included.
- •2\. Documented history of severe autoimmune disease (e.g. inflammatory bowel
- •disease, myasthenia gravis).
- •3\. Prior CTLA\-4 or PD\-1/PD\-L1\-targeting immunotherapy.
- •4\. Known history of Human Immunodeficiency Virus infection, or tuberculosis, or
- •other active infection requiring therapy at the time of inclusion.
- •5\. Positive tests for Hepatitis B or Hepatitis C
- •6\. Underlying medical conditions that, in the investigator's opinion, will make
Outcomes
Primary Outcomes
Not specified
Similar Trials
Recruiting
Phase 1
A phase 2 trial in stage II-IIIa urothelial cancer randomizing pre-operative nivolumab with or without relatlimab - TURANDORELAAdult patients with resectable muscle-invasive urothelial cancer of the bladder, defined as stage II and IIIa UC, who have not yet undergone systemic therapy for UBC.Therapeutic area: Diseases [C] - Neoplasms [C04]CTIS2023-507460-39-00Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting90
Recruiting
Phase 2
Stage II-IIIa Urothelial Cancer Randomizing Pre-operative Nivolumab With or Without RelatlimabUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesMale Urogenital DiseasesUrinary Bladder NeoplasmAntineoplastics ToxicityNCT06237920The Netherlands Cancer Institute90
Completed
Phase 1
Pre-operative Immunotherapy in Stage II-III Urothelial CancerUrothelial CarcinomaNCT04871594The Netherlands Cancer Institute15
Completed
Not Applicable
Anti-tumor efficacy of TAGRISSO (Osimertinib) in NSCLC Patients in Whom T790 Mutations Are Detected by Liquid Biopsy Using BALF, Plasma or Pleural EffusioNeoplasmsKCT0003232Asan Medical Center63
Active, not recruiting
Phase 1
Study on patients with recurrence of prostate cancer with PET/MRRadically treated patient for prostate cancer presenting a biochemical recurrence of disease (PSA: > o = 0.2 ng/mL)MedDRA version: 21.1Level: LLTClassification code 10026389Term: Malignant neoplasm of prostateSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2018-001036-21-ITOSPEDALE SAN RAFFAELE60