OpenOnco · Treatment Plan

Treatment plan — Urothelial carcinoma

PLAN-BMA-MLH1_GERMLINE_UROTHELIAL-V1 · v1 · 2026-08-18

Patient

BMA-MLH1_GERMLINE_UROTHELIAL · 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

✅ Covered biomarkers (matched in KB)

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

⚠️ Not included in plan

Biomarker	Status
BIO-DMMR-IHC	BIO definition in KB; no ESCAT BMA entry — verify with clinician

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

Discussion questions (1, 0 blocking)

OQ-LDH-CURRENT
What is the current LDH? Marker of tumor burden and transformation.
LDH is part of the prognostic indices of indolent lymphomas.
→ hematologist

MDT talk tree (2 steps)

#	Owner	Topic	Action
1	hematologist	Staging / disease burden	What is the current LDH? Marker of tumor burden and transformation.
2	clinical_pharmacist	Specialist review	Chemoimmunotherapy regimen — drug-drug interactions, dose adjustments, premedication.

Skills (recommended) — for consideration (1)

Clinical pharmacist recommended
Chemoimmunotherapy regimen — drug-drug interactions, dose adjustments, premedication.

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-CASCADE-LYNCH-FDR-POSITIVE, 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 (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
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: 2026-08-18.

NCT	Title	Phase	Status	Sponsor	UA	Signals
NCT04574960	Neoadjuvant Upper Tract Invasive Cancer Trial (NAUTICAL)	PHASE3	RECRUITING	University Health Network, Toronto	—	Small N (<50) Surrogate endpoint only Single country
NCT04510129	A Multicenter Cancer Biospecimen Collection Study	N/A	RECRUITING	Cofactor Genomics, Inc.	—	Single country
NCT06356155	Study of Neoadjuvant Enfortumab Vedotin and Pembrolizumab in Upper Tract Urothelial Cancer	PHASE2	RECRUITING	University of Michigan Rogel Cancer Center	—	Small N (<50) Single country
NCT04724018	Sacituzumab Govitecan Plus EV in Metastatic UC	PHASE1 / PHASE2	RECRUITING	Dana-Farber Cancer Institute	—	Single country
NCT06405425	A Study of BL-B01D1 + PD-1 in Patients With Locally Advanced or Metastatic Urothelial Carcinoma	PHASE2	RECRUITING	Sichuan Baili Pharmaceutical Co., Ltd.	—	Surrogate endpoint only Single country
NCT05176483	Study of Zanzalintinib in Combination With Immuno-Oncology or Other Agents in Participants With Solid Tumors	PHASE1	RECRUITING	Exelixis	—	Phase 1 only
NCT06682728	Adjuvant Sacituzumab Govitecan and Nivolumab in Muscle-Invasive Urothelial Carcinoma at High-Risk Recurrence	PHASE2	RECRUITING	University of California, Irvine	—	Small N (<50) Single country
NCT06948552	Photodynamic Diagnosis of Upper Tract Urothelial Carcinoma Using Fluorescence Endoscopy and Oral 5-ALA	PHASE2	RECRUITING	Henry Ford Health System	—	Small N (<50) Single country
NCT05269381	Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab for Treatment of Advanced Solid Tumors	PHASE1 / PHASE2	RECRUITING	Mayo Clinic	—	Surrogate endpoint only Single country
NCT07614594	Non-invasive Urinary Genomics-Based Risk Assessment for Early Urothelial Carcinoma Diagnosis	N/A	RECRUITING	Henan Provincial People's Hospital	—	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 · NCT04574960 Neoadjuvant Upper Tract Invasive Cancer Trial (NAUTICAL) No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT04510129 A Multicenter Cancer Biospecimen Collection Study No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06356155 Study of Neoadjuvant Enfortumab Vedotin and Pembrolizumab in Upper Tract Urothelial Cancer No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT04724018 Sacituzumab Govitecan Plus EV in Metastatic UC No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06405425 A Study of BL-B01D1 + PD-1 in Patients With Locally Advanced or Metastatic Urothelial Carcinoma No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT05176483 Study of Zanzalintinib in Combination With Immuno-Oncology or Other Agents in Participants With Solid Tumors No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06682728 Adjuvant Sacituzumab Govitecan and Nivolumab in Muscle-Invasive Urothelial Carcinoma at High-Risk Recurrence No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06948552 Photodynamic Diagnosis of Upper Tract Urothelial Carcinoma Using Fluorescence Endoscopy and Oral 5-ALA No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT05269381 Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab for Treatment of Advanced Solid Tumors No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT07614594 Non-invasive Urinary Genomics-Based Risk Assessment for Early Urothelial Carcinoma Diagnosis 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: 2026-08-18.

plan_id: PLAN-BMA-MLH1_GERMLINE_UROTHELIAL-V1 | version: 1 | generated: 2026-08-18T07:59:49.332280+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.