OpenOnco · Treatment Plan

Treatment plan — Urothelial carcinoma

PLAN-VAR-UROTHELIAL-HIGHRISK-V1 · v1 · 2026-06-27

Patient

VAR-UROTHELIAL-HIGHRISK · Algorithm: ALGO-UROTHELIAL-METASTATIC-1L

DiagnosisUrothelial carcinoma

MOH / ICD-10C67

ICD-O-38120/3; C67.9, C65.9, C66.9

Clinical significance of mutations (ESCAT)

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

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

Primary current-line option

Standard plan

★ DEFAULT

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

Primary current-line option selected by ALGO-UROTHELIAL-METASTATIC-1L at step 1.

Other current-line alternatives (1 tracks)

Same treatment line; review when biomarker, access, contraindication, or patient-context assumptions change.

Aggressive plan

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

Current-line alternative presented for HCP consideration

Pre-treatment investigations

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

ID	Name	Priority	Category	Where to order	Needed for
TEST-CECT-CAP	CECT chest/abdomen/pelvis	Critical	imaging	—	all tracks

Timeline

Treatment timeline — derived from regimen + monitoring schedule

Standard plan

Induction · Enfortumab vedotin + pembrolizumab (metastatic urothelial, 1L)

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

Aggressive plan

Induction · Cisplatin + gemcitabine (urothelial neoadj + metastatic)

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

MDT brief

MDT talk tree (2 steps)

#	Owner	Topic	Action
1	clinical_pharmacist	Specialist review	Chemoimmunotherapy regimen — drug-drug interactions, dose adjustments, premedication.
2	radiologist	Specialist review	Imaging findings present — radiologist needed for staging/restaging.

Skills (recommended) — for consideration (2)

Clinical pharmacist recommended
Chemoimmunotherapy regimen — drug-drug interactions, dose adjustments, premedication.
Radiologist recommended
Imaging findings present — radiologist needed for staging/restaging.

Data quality

Usable with caveats. No critical default-track gap was found, but the MDT should review the listed caveats before final sign-off.

Biomarker coverage: 0/0 known (100%), 0 missing, 0 default-track gaps
Unevaluated RedFlags: RF-ACTIVE-AUTOIMMUNE-DISEASE-ICI-RISK, RF-ENVIRONMENTAL-ARSENIC-WATER-PREVENTION, RF-IATROGENIC-CYCLOPHOSPHAMIDE-LATE-PREVENTION, RF-IATROGENIC-PEDIATRIC-PELVIC-RT-PREVENTION, RF-LIFESTYLE-TOBACCO-CANCER-PREVENTION, RF-LYNCH-CONFIRMED-CARRIER, RF-LYNCH-FAMILY-HISTORY-SUSPICION, RF-OCC-AROMATIC-AMINES-MALIGNANCY-PREVENTION, RF-OCC-DIESEL-EXHAUST-PREVENTION, RF-OCC-FIREFIGHTER-PREVENTION, RF-OCC-PAH-PREVENTION, RF-OCC-PAINTERS-PREVENTION, RF-SCHISTOSOMA-HAEMATOBIUM-BLADDER-PREVENTION, RF-UROTHELIAL-EV-CONTRAINDICATED, RF-UROTHELIAL-FRAILTY-AGE, RF-UROTHELIAL-HIGH-RISK-BIOLOGY, RF-UROTHELIAL-INFECTION-SCREENING, RF-UROTHELIAL-ORGAN-DYSFUNCTION, RF-UROTHELIAL-TRANSFORMATION-PROGRESSION

Technical MDT skill metadata (2/16 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
Cellular therapy specialist (CAR-T)	`cellular_therapy_specialist`	v0.1.0	2026-04-25	cellular_therapy
Clinical pharmacist	`clinical_pharmacist`	v0.1.0	2026-04-25	clinical_pharmacy
Hematologist / oncohematologist	`hematologist`	v0.1.0	2026-04-25	hematology_oncology
Hematopathologist (lymphoma / leukemia / myeloma)	`hematopathologist`	v0.1.0	2026-04-25	hematopathology
Infectious disease / hepatology	`infectious_disease_hepatology`	v0.1.0	2026-04-25	infectious_diseases
Medical oncologist (solid-tumor chemotherapist)	`medical_oncologist`	v0.1.0	2026-04-25	solid_oncology
Molecular geneticist / molecular oncologist	`molecular_geneticist`	v0.1.0	2026-04-25	molecular_oncology
Palliative care	`palliative_care`	v0.1.0	2026-04-25	palliative_care
Pathologist (general)	`pathologist`	v0.1.0	2026-04-25	pathology
Primary care / family physician	`primary_care`	v0.1.0	2026-04-25	primary_care
Psycho-oncologist	`psychologist`	v0.1.0	2026-04-25	psychosocial
Radiation oncologist	`radiation_oncologist`	v0.1.0	2026-04-25	radiation_oncology
Radiologist	`radiologist`	v0.1.0	2026-04-25	diagnostic_imaging
Social worker / case manager	`social_worker_case_manager`	v0.1.0	2026-04-25	psychosocial
Surgical oncologist	`surgical_oncologist`	v0.1.0	2026-04-25	surgical_oncology
Transplant specialist (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)

Experimental options (clinical trials)

Third plan track — open-enrollment trials from ClinicalTrials.gov. Render-time metadata; engine selection is not affected by this block (CHARTER §8.3). Last synced: 2026-06-27.

NCT	Title	Phase	Status	Sponsor	UA	Signals
NCT05843448	IDO and PD-L1 Peptide Based Immune-Modulatory Therapeutic (IO102-IO103) in Combination With Pembrolizumab for BCG-Unresponsive or Intolerant, Non-Muscle Invasive Bladder Cancer	PHASE1	RECRUITING	University of California, Davis	—	Phase 1 only Small N (<50) Single country
NCT05296564	Anti-NY-ESO-1 TCR-Gene Engineered Lymphocytes Given by Infusion to Patients With NY-ESO-1 -Expressing Metastatic Cancers	PHASE1 / PHASE2	RECRUITING	Hadassah Medical Organization	—	Small N (<50) Single country
NCT05775471	Pembrolizumab and Enfortumab Vedotin With Pembrolizumab Prior to and After Radical Nephroureterectomy for High-Risk Upper Tract Urothelial Cancer	PHASE2	RECRUITING	Jonsson Comprehensive Cancer Center	—	Small N (<50) Surrogate endpoint only Single country
NCT06349642	Immune Checkpoint Inhibitor Response in Solid Tumors Using a Live Tumor Diagnostic Platform	N/A	RECRUITING	Mayo Clinic	—	Single country
NCT06210490	A Clinical Study of the Efficacy and Safety of Disitamab Vedotin in Combination With Radiotherapy for the Adjuvant Treatment of HER2 Overexpressing UTUC Patients With High Risk Factors for Recurrence After Radical Surgery	PHASE2	RECRUITING	Peking University First Hospital	—	Surrogate endpoint only Single country
NCT07241793	Phase II Study of Trastuzumab Rezetecan or in Combination With Adebrelimab in HER2-Expressing Locally Advanced or Metastatic Urothelial Carcinoma (la/mUC)	PHASE2	RECRUITING	Sun Yat-sen University	—	Surrogate endpoint only Single country
NCT05107674	A Study of NX-1607 in Adults With Advanced Malignancies	PHASE1	RECRUITING	Nurix Therapeutics, Inc.	—	Phase 1 only Surrogate endpoint only
NCT06167057	POST URS Chemotherapy Instillation	NA	RECRUITING	Carmel Medical Center	—	Single country
NCT06805630	Urine Methylation Markers in UTUC	NA	RECRUITING	Duke University	—	Single country
NCT07164950	Compression Stockings to Prevent Peripheral Neuropathy Caused by Antibody-Drug Conjugates in Urothelial Carcinoma Patients	NA	RECRUITING	Sheng Zhang	—	Single country

Verify recruitment status directly with the trial site. ctgov data can lag behind current UA-site status.

Option availability in Ukraine

Per-track UA registration · NSZU · cost · access pathway. Render-time metadata; engine selection does not depend on these fields (CHARTER §8.3).

Option	UA registration	NSZU	Cost orientation	Access pathway
Standard plan Enfortumab vedotin + pembrolizumab (metastatic urothelial, 1L) (REG-EV-PEMBRO-UROTHELIAL) 1/2 component drug(s) not registered in Ukraine +1	✗ not registered	✗ out-of-pocket	₴-? — verify pathway	not recorded
Aggressive plan Cisplatin + gemcitabine (urothelial neoadj + metastatic) (REG-CISPLATIN-GEMCITABINE-UROTHELIAL)	✓ registered	✓ covered	₴-? — verify pathway	NSZU formulary
Trial · NCT05843448 IDO and PD-L1 Peptide Based Immune-Modulatory Therapeutic (IO102-IO103) in Combination With Pembrolizumab for BCG-Unresponsive or Intolerant, Non-Muscle Invasive Bladder Cancer No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT05296564 Anti-NY-ESO-1 TCR-Gene Engineered Lymphocytes Given by Infusion to Patients With NY-ESO-1 -Expressing Metastatic Cancers No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT05775471 Pembrolizumab and Enfortumab Vedotin With Pembrolizumab Prior to and After Radical Nephroureterectomy for High-Risk Upper Tract Urothelial Cancer No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06349642 Immune Checkpoint Inhibitor Response in Solid Tumors Using a Live Tumor Diagnostic Platform No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06210490 A Clinical Study of the Efficacy and Safety of Disitamab Vedotin in Combination With Radiotherapy for the Adjuvant Treatment of HER2 Overexpressing UTUC Patients With High Risk Factors for Recurrence After Radical Surgery No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT07241793 Phase II Study of Trastuzumab Rezetecan or in Combination With Adebrelimab in HER2-Expressing Locally Advanced or Metastatic Urothelial Carcinoma (la/mUC) No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT05107674 A Study of NX-1607 in Adults With Advanced Malignancies No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06167057 POST URS Chemotherapy Instillation No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06805630 Urine Methylation Markers in UTUC No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT07164950 Compression Stockings to Prevent Peripheral Neuropathy Caused by Antibody-Drug Conjugates in Urothelial Carcinoma Patients No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor

Cost information is orientation. Verify with a specific pharmacy / foundation / trial site. Status updated: 2026-06-27.

plan_id: PLAN-VAR-UROTHELIAL-HIGHRISK-V1 | version: 1 | generated: 2026-06-27T09:41:02.449633+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.