Treatment plan — DIS-UROTHELIAL

OpenOnco · Treatment Plan

PLAN-AUTO-UROTHELIAL-001-V1 · v1 · 2026-04-27

Patient

AUTO-UROTHELIAL-001 · Algorithm: ALGO-UROTHELIAL-METASTATIC-1L

Clinical significance of mutations (ESCAT / OncoKB)

Tumor-board context — the engine does not use these tiers to rank tracks

Biomarker	Variant	ESCAT	OncoKB	Clinical significance	Drugs	Sources
No clinically actionable variants matched in this profile.

Treatment options (2 tracks)

Aggressive plan

★ DEFAULT

Indication

IND-UROTHELIAL-METASTATIC-1L-PLATINUM-CHEMO-AVELUMAB

Regimen

Cisplatin + gemcitabine (urothelial neoadj + metastatic)

Drugs + NSZU

Cisplatin (DRUG-CISPLATIN) 70 mg/m² IV · Day 1 of 21-day cycle · IV ⚠ NSZU — not for this indication
Gemcitabine (DRUG-GEMCITABINE) 1000 mg/m² IV · Days 1, 8 of 21-day cycle · IV ⚠ NSZU — not for this indication

Reason

Engine default per algorithm ALGO-UROTHELIAL-METASTATIC-1L: {'step': 1, 'outcome': False, 'branch': {'result': 'IND-UROTHELIAL-METASTATIC-1L-PLATINUM-CHEMO-AVELUMAB'}, 'fired_red_flags': [], 'winner_red_flag': None}

Standard plan

Indication

IND-UROTHELIAL-METASTATIC-1L-EV-PEMBRO

Regimen

Enfortumab vedotin + pembrolizumab (metastatic urothelial, 1L)

Drugs + NSZU

Enfortumab vedotin (DRUG-ENFORTUMAB-VEDOTIN) 1.25 mg/kg IV · Days 1, 8 of 21-day cycle · IV ✗ Not registered in UA
Pembrolizumab (DRUG-PEMBROLIZUMAB) 200 mg IV q3w · Up to 2 years · IV ⚠ NSZU — not for this indication

Reason

Alternative track presented for HCP consideration

Pre-treatment investigations

Investigations before treatment start · critical / standard / desired · merged across tracks

ID	Name	Priority	Category	Needed for
TEST-CECT-CAP	КТ органів грудної клітки/черевної порожнини/таза з внутрішньовенним контрастуванням	Critical	imaging	all tracks

Timeline

Treatment timeline — derived from regimen + monitoring schedule

Aggressive plan

Induction · Cisplatin + gemcitabine (uroth

21-day cycles × 4 cycles neoadj; 6 cycles metastatic

Standard plan

Induction · Enfortumab vedotin + pembroliz

21-day cycles × EV until progression; pembro up to 2 years

MDT brief

Skills (recommended) — for consideration (1)

Клінічний фармацевт recommended
Хіміоімунотерапевтичний схема — drug-drug interactions, dose adjustments, premedication.
skill: clinical_pharmacistv0.1.0reviewed 2026-04-25STUBsign-offs: 0lead: TBD

Open questions (1, 0 blocking)

OQ-LDH-CURRENT
Який актуальний LDH? Маркер пухлинного навантаження і трансформації.
LDH входить у прогностичні індекси індолентних лімфом.
→ hematologist

Data quality

Unevaluated RedFlags: RF-UROTHELIAL-FRAILTY-AGE, RF-UROTHELIAL-HIGH-RISK-BIOLOGY, RF-UROTHELIAL-INFECTION-SCREENING, RF-UROTHELIAL-ORGAN-DYSFUNCTION, RF-UROTHELIAL-TRANSFORMATION-PROGRESSION

Skill catalog (1/16 activated in this plan)

All registered virtual specialists. ✓ — activated for this case; ○ — not activated (available for other clinical scenarios).

Specialist	skill_id	Version	Last reviewed	Domain
Specialist з клітинної терапії (CAR-T)	`cellular_therapy_specialist`	v0.1.0	2026-04-25	cellular_therapy
Клінічний фармацевт	`clinical_pharmacist`	v0.1.0	2026-04-25	clinical_pharmacy
Гематолог / онкогематолог	`hematologist`	v0.1.0	2026-04-25	hematology_oncology
Гематопатолог (специфічно для лімфом / лейкозів / мієломи)	`hematopathologist`	v0.1.0	2026-04-25	hematopathology
Інфекціоніст / гепатолог	`infectious_disease_hepatology`	v0.1.0	2026-04-25	infectious_diseases
Медичний онколог (хіміотерапевт солідних пухлин)	`medical_oncologist`	v0.1.0	2026-04-25	solid_oncology
Молекулярний генетик / молекулярний онколог	`molecular_geneticist`	v0.1.0	2026-04-25	molecular_oncology
Паліативна допомога	`palliative_care`	v0.1.0	2026-04-25	palliative_care
Патолог (загальний)	`pathologist`	v0.1.0	2026-04-25	pathology
Сімейний лікар / терапевт	`primary_care`	v0.1.0	2026-04-25	primary_care
Психолог / онкопсихолог	`psychologist`	v0.1.0	2026-04-25	psychosocial
Радіотерапевт (променева терапія)	`radiation_oncologist`	v0.1.0	2026-04-25	radiation_oncology
Лікар-радіолог	`radiologist`	v0.1.0	2026-04-25	diagnostic_imaging
Соціальний працівник / кейс-менеджер	`social_worker_case_manager`	v0.1.0	2026-04-25	psychosocial
Хірург-онколог	`surgical_oncologist`	v0.1.0	2026-04-25	surgical_oncology
Specialist з трансплантації (BMT)	`transplant_specialist`	v0.1.0	2026-04-25	cellular_therapy

Sources cited

SRC-EAU-BLADDER-2024: EAU Muscle-Invasive Bladder (2024)
SRC-NCCN-BLADDER-2025: NCCN Bladder Cancer (2025.v3)

Експериментальні опції (клінічні дослідження)

Третій трек плану — open-enrollment trials з ClinicalTrials.gov. Останнє оновлення: 2026-04-27. Render-time metadata; engine selection не змінюється цим блоком (CHARTER §8.3).

NCT	Name	Phase	Статус	Спонсор	UA
NCT05302284	A Study of RC48-ADC Combined With Toripalimab For First-line Treatment of Urothelial Carcinoma	PHASE3	RECRUITING	RemeGen Co., Ltd.	—
NCT06218433	Urothelial Cancer Screening in Individuals With Lynch Syndrome Using a Urine Tumor DNA Panel (LS-URO Study)	NA	RECRUITING	Tampere University Hospital	—
NCT06263153	Futibatinib in Combination With Durvalumab Prior to Cystectomy for the Treatment of Muscle-Invasive Bladder Cancer Patients Who Are Ineligible for Cisplatin-based Therapy	PHASE2	RECRUITING	Yuanquan Yang	—
NCT06451497	This is a Phase 1 Trial of ZM008, an Anti-LLT1 Antibody, Used as Single Agent Followed by Combination Treatment With Toripalimab in Patients With Advanced Solid Tumors	PHASE1	RECRUITING	Zumutor Biologics Inc.	—
NCT04574960	Neoadjuvant Upper Tract Invasive Cancer Trial (NAUTICAL)	PHASE3	RECRUITING	University Health Network, Toronto	—
NCT05176483	Study of Zanzalintinib in Combination With Immuno-Oncology Agents in Participants With Solid Tumors	PHASE1	RECRUITING	Exelixis	—
NCT06196736	A Study to Evaluate 9MW2821 Versus Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer	PHASE3	RECRUITING	Mabwell (Shanghai) Bioscience Co., Ltd.	—
NCT06270706	A Phase 1 Study of PLN-101095 in Adults With Advanced or Metastatic Solid Tumors	PHASE1	RECRUITING	Pliant Therapeutics, Inc.	—
NCT05520099	Observational Basket Trial to Collect Tissue to Develop and Train a Live Tumor Diagnostic Platform	N/A	RECRUITING	Elephas	—
NCT06257264	A Study to Examine the Safety of Different Doses of BG-68501 Given to Participants With Advanced-Stage Tumors	PHASE1	RECRUITING	BeiGene	—

Перевіряти статус набору безпосередньо у дослідницькому центрі. Дані ctgov можуть відставати від поточного статусу UA-сайтів.

Доступність опцій в Україні

Per-track UA registration · НСЗУ · cost · access pathway. Render-time metadata; engine selection не залежить від цих полів (CHARTER §8.3).

Опція	Реєстрація UA	НСЗУ	Cost orientation	Access pathway
Aggressive plan Cisplatin + gemcitabine (urothelial neoadj + metastatic) (REG-CISPLATIN-GEMCITABINE-UROTHELIAL)	✓ зареєстровано	✓ покривається	₴-? — verify pathway	НСЗУ formulary
Standard plan Enfortumab vedotin + pembrolizumab (metastatic urothelial, 1L) (REG-EV-PEMBRO-UROTHELIAL) 1/2 component drug(s) not registered in Ukraine +1	✗ не зареєстровано	✗ out-of-pocket	₴-? — verify pathway	not recorded
Trial · NCT05302284 A Study of RC48-ADC Combined With Toripalimab For First-line Treatment of Urothelial Carcinoma No UA site listed — international referral required	— невідомо	— невідомо	self-pay: ₴0/course	Trial sponsor
Trial · NCT06218433 Urothelial Cancer Screening in Individuals With Lynch Syndrome Using a Urine Tumor DNA Panel (LS-URO Study) No UA site listed — international referral required	— невідомо	— невідомо	self-pay: ₴0/course	Trial sponsor
Trial · NCT06263153 Futibatinib in Combination With Durvalumab Prior to Cystectomy for the Treatment of Muscle-Invasive Bladder Cancer Patients Who Are Ineligible for Cisplatin-based Therapy No UA site listed — international referral required	— невідомо	— невідомо	self-pay: ₴0/course	Trial sponsor
Trial · NCT06451497 This is a Phase 1 Trial of ZM008, an Anti-LLT1 Antibody, Used as Single Agent Followed by Combination Treatment With Toripalimab in Patients With Advanced Solid Tumors No UA site listed — international referral required	— невідомо	— невідомо	self-pay: ₴0/course	Trial sponsor
Trial · NCT04574960 Neoadjuvant Upper Tract Invasive Cancer Trial (NAUTICAL) No UA site listed — international referral required	— невідомо	— невідомо	self-pay: ₴0/course	Trial sponsor
Trial · NCT05176483 Study of Zanzalintinib in Combination With Immuno-Oncology Agents in Participants With Solid Tumors No UA site listed — international referral required	— невідомо	— невідомо	self-pay: ₴0/course	Trial sponsor
Trial · NCT06196736 A Study to Evaluate 9MW2821 Versus Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer No UA site listed — international referral required	— невідомо	— невідомо	self-pay: ₴0/course	Trial sponsor
Trial · NCT06270706 A Phase 1 Study of PLN-101095 in Adults With Advanced or Metastatic Solid Tumors No UA site listed — international referral required	— невідомо	— невідомо	self-pay: ₴0/course	Trial sponsor
Trial · NCT05520099 Observational Basket Trial to Collect Tissue to Develop and Train a Live Tumor Diagnostic Platform No UA site listed — international referral required	— невідомо	— невідомо	self-pay: ₴0/course	Trial sponsor
Trial · NCT06257264 A Study to Examine the Safety of Different Doses of BG-68501 Given to Participants With Advanced-Stage Tumors No UA site listed — international referral required	— невідомо	— невідомо	self-pay: ₴0/course	Trial sponsor

Інформація про ціни — orientation. Перевіряти у конкретній аптеці / foundation / трайл-сайті. Status updated: 2026-04-27.

plan_id: PLAN-AUTO-UROTHELIAL-001-V1 | version: 1 | generated: 2026-04-27T10:14:01.655465+00:00

Per FDA non-device CDS positioning (CHARTER §15): Outpatient oncology treatment planning to support tumor-board discussion. Not a medical device; not for autonomous clinical decision-making.

Per FDA non-device CDS positioning (CHARTER §15): Both treatment options below are presented for review. The engine's selection of a 'recommended' default does not constitute a clinical decision. Final treatment selection requires HCP judgment incorporating information not available to the system.

This document is an informational resource supporting tumor-board discussion (per CHARTER §11). It is not a system that makes clinical decisions. Every recommendation must be verified by the treating physician.