Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Urinary Bladder Neoplasms

Pregnancy Complications

Urologic Neoplasms

Urogenital Diseases

Urinary Bladder Diseases

Urogenital Neoplasms

Male Urogenital Diseases

Female Urogenital Diseases

Female Urogenital Diseases and Pregnancy Complications

Urologic Diseases

Antineoplastic Agents

All Drugs and Chemicals

Nivolumab

Relatlimab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

1 cycle of intravenous nivolumab on day 1 and 1 cycle of intraveous nivolumab on day 29. Total administration frequency is twice.

1 cycle of intravenous nivolumab and relatlimab on day 1 and 1 cycle of intraveous nivolumab and relatlimab on day 29. Total administration frequency is twice.

Induction with immune checkpoint blockade nivolumab on day 1. Nivolumab will also be administered on day 29. Response evaluation will be after the last cycle of checkpoint inhibition.

Induction with immune checkpoint blockade nivolumab and relatlimab on day 1. Nivolumab and relatlimab will also be administered on day 29. Response evaluation will be after the last cycle of checkpoint inhibition.

Michiel Van der Heijden, PhD

Hamza Ali, MSc

Michiel van der Heijden, Dr.

This is a non-blinded phase 2 trial in Stage II-IIIa urothelial cancer randomizing pre-operative nivolumab with or without relatlimab to assess whether bladder preservation after dual immunotherapy would be a viable treatment option for patients responding to treatment

This is a phase 2 study in which ninety adult patients with cT2-4aN0 or cT1-4aN1urothelial bladder cancer will be included.

Included patients will be treated with two cycles of checkpoint inhibition with nivolumab or two cycles of nivolumab+relatlimab every 28 days.

Response of this induction therapy will be evaluated by cystoscopy, mpMRI and a CT scan.

The primary endpoint is efficacy, defined as pathological complete response (pCR) defined as pT0N0 or pTisN0 at cystectomy.

Secondary end-points consist of feasibility analysis, defined as percentage of patients completing cystectomy within 12 weeks of start of treatment. Other key secondary end points are drug safety and overall and event-free survival. Events consist of death by any cause; disease recurrence inside or outside the urinary tract and switching to other treatments.

The first evaluation after completion of both treatment cycles will be after six months. Further follow-up visits will take place at 12 and 24 months after completion of the treatment. During these visits, focused physical examination, cystoscopy and a CT chest-abdomen will be performed, combined with registration of treatment-related adverse events and a questionnaire for evaluating QoL, bladder function and long-term effects of immunotherapy on QoL.

Stage II-IIIa Urothelial Cancer Randomizing Pre-operative Nivolumab With or Without Relatlimab

A Phase 2 Trial in Stage II-IIIa Urothelial Cancer Randomizing Pre-operative Nivolumab With or Without Relatlimab

Pathological complete response defined as pT0N0 or pTisN0 in all evaluable patients

Safety in terms of immunotherapy-related adverse events according to CTCAE 5.0 criteria

Percentage of patients that completes cystectomy within 12 weeks of start of treatment. Patients who elect to not undergo surgery or have a delay due to logistical reasons not related to study treatment will be excluded from this analysis.

PD-L1 expression of tumor tissue (obtained pre-treatment) will be determined using immunohistochemistry of tissue slides. For PD-L1, tumor proportion score (TPS) will be determined. Pathological complete response will be related to PD-L1 expression

RNA sequencing and multiplex immunofluorescence will be carried out on TUR and cystectomy tumor tissue. Methods may include RNA expression profiling and multiplex immunofluorescence.

Event-free survival is a composite endpoint, defined by the time from randomization to occurrence of any of the events below:

* Disease recurrence outside the urinary tract (distant metastases, pelvic recurrence).
* Disease progression precluding surgery.
* Muscle invasive recurrence in the bladder or distal ureters in case surgery is not performed for other reasons than progression.
* Switch to other treatments pre- or post-surgery directed at systemic UC (e.g. platinum-based chemotherapy combinations, antibody-drug conjugates etc.). In case adjuvant chemotherapy or immunotherapy is administered without evidence of residual disease, patients will be censored at the start of adjuvant therapy. Locoregional therapy to the bladder, such as (chemo)radiotherapy will not be considered an event in the absence of progressive disease.

OS is defined as the time between the date of enrollment and the date of death

Bristol-Myers Squibb

The Netherlands Cancer Institute

Symptoms and General Pathology

Gland and Hormone Related Diseases

Rare Diseases

Behaviors and Mental Disorders

Carcinoma

Neoplasm Metastasis

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Genital Diseases, Female

Endocrine Gland Neoplasms

Genital Neoplasms, Female

Endocrine System Diseases

Neoplasms, Glandular and Epithelial

Genital Diseases

Adnexal Diseases

Ovarian Diseases

Gonadal Disorders

Neoplasms by Histologic Type

Ovarian Cancer

Quality of Life

Ovarian Epithelial Cancer

Pharmaceutical Solutions

Paclitaxel

Albumin-Bound Paclitaxel

Carboplatin

Cisplatin

Ocoxin-Viusid® before, during and after the Chemotherapy treatment.

Ocoxin-Viusid group (Experimental): Oral solution Ocoxin-Viusid (30 ml vials) were used at a rate of 60ml / day (1 vial every 12 hours), preferably administered after breakfast and dinner. The treatment will start a week before start Chemotheray treatment (CT) and, It will maintenance until 3 weeks after finished the last cycle of CT (3 cycles of CT of Carboplatin/Paclitaxel or Cisplatin/ Paclitaxel with neoadjuvant intent).

Ocoxin-Viusid

Our hypothesis is: the nutritional supplement Ocoxin-viusid improves the quality of life of patients, including a better tolerance to neoadjuvant chemotherapy.

General Objectives -To identify the efficacy of the nutritional supplement Ocoxin-viusid to increase the quality of life of patients with epithelial advanced or metastatic ovarian cancer. Specific Objectives - Identify the influence of the research product on the nutritional status and quality of life of patients. - Describe the toxicity of the research product. - Identify the adverse reactions to the chemotherapy scheme and quantify the interruptions to it by acute toxicity.

Quality of life. It will be measured as: - EORTC Questionnaire QLQ-C30 (Score of each item and general score). Measurement time: at the beginning and 3 weeks after the 3rd cycle of QT - EORTC Questionnaire QLQ-OV28 (Score of each item and general score). Measurement time: at the beginning and 3 weeks after the 3rd cycle of QT - Karnofsky index (Score of 0-100 points at intervals of 10). Measurement time: at the beginning, in each cycle of QT and 3 weeks after the 3rd cycle of QT

Evaluation of Ocoxin-Viusid® in Advanced or Metastatic Ovarian Epithelial Cancer

Efficacy of the Oncoxin-Viusid® Nutritional Supplement on the Quality of Life of Patients With Advanced or Metastatic Ovarian Epithelial Cancer. Clinical Trial Phase II.

It will measured by: - EORTC QLQ-C30 (Points of every item and final points)

Karnofsky index (Score of 0-100 points at intervals of 10)

EORTC QLQ-OV28 (Points of every item and final points)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Stage II-IIIa Urothelial Cancer Randomizing Pre-operative Nivolumab With or Without Relatlimab	NCT06237920	Urologic Neopla... Urogenital Neop... Neoplasms by Si... Neoplasms Female Urogenit... Female Urogenit... Urogenital Dise... Urinary Bladder... Male Urogenital... Urinary Bladder... Antineoplastics...	Nivolumab Relatlimab	18 Years -	The Netherlands Cancer Institute
Evaluation of Ocoxin-Viusid® in Advanced or Metastatic Ovarian Epithelial Cancer	NCT03562897	Carcinoma Ovarian Neoplas... Endocrine Gland... Urogenital Neop... Ovarian Disease... Adnexal Disease... Genital Disease... Female Urogenit... Female Urogenit... Endocrine Syste... Gonadal Disorde... Genital Neoplas... Neoplasms, Glan...	Ocoxin-Viusid	18 Years -	Catalysis SL
Stage II-IIIa Urothelial Cancer Randomizing Pre-operative Nivolumab With or Without Relatlimab	NCT06237920	Urologic Neopla... Urogenital Neop... Neoplasms by Si... Neoplasms Female Urogenit... Female Urogenit... Urogenital Dise... Urinary Bladder... Male Urogenital... Urinary Bladder... Antineoplastics...	Nivolumab Relatlimab	18 Years -	The Netherlands Cancer Institute
Evaluation of Ocoxin-Viusid® in Advanced or Metastatic Ovarian Epithelial Cancer	NCT03562897	Carcinoma Ovarian Neoplas... Endocrine Gland... Urogenital Neop... Ovarian Disease... Adnexal Disease... Genital Disease... Female Urogenit... Female Urogenit... Endocrine Syste... Gonadal Disorde... Genital Neoplas... Neoplasms, Glan...	Ocoxin-Viusid	18 Years -	Catalysis SL

Spots Global Cancer Trial Database for female urogenital diseases and pregnancy complications