OpenOnco · Treatment Plan

Treatment plan — Urothelial carcinoma

PLAN-VERIFIED-UROTHELIAL-L2-UROTHELIAL_2L_EV-V1 · v1 · 2026-07-15

Patient

VERIFIED-UROTHELIAL-L2-UROTHELIAL_2L_EV · Algorithm: ALGO-UROTHELIAL-METASTATIC-2L

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-2L-EV

Regimen

Enfortumab vedotin monotherapy (urothelial carcinoma)

Drugs + NSZU

Enfortumab vedotin (DRUG-ENFORTUMAB-VEDOTIN) 1.25 mg/kg IV over 30 min (max dose: 125 mg for patients ≥100 kg) · Days 1, 8, 15 of each 28-day cycle · IV ✗ Not registered in UA

Reason

Provisional current-line default from ALGO-UROTHELIAL-METASTATIC-2L: step 1 did not select a treatment branch. Clinical trial preferred at relapse. Discuss with MDT.

Other current-line alternatives (3 tracks)

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

Standard plan

Indication

IND-UROTHELIAL-2L-PEMBROLIZUMAB

Regimen

Pembrolizumab monotherapy

Drugs + NSZU

Pembrolizumab (DRUG-PEMBROLIZUMAB) 200 mg IV over 30 min (flat dose) · Day 1 q21d (q3w); or 400 mg q6w (alternative flat dose — equivalent exposure) · IV ⚠ NSZU — not for this indication

Reason

Current-line alternative presented for HCP consideration

Aggressive plan

Indication

IND-UROTHELIAL-2L-ERDAFITINIB

Regimen

Erdafitinib monotherapy (THOR cohort 1) — 2L+ FGFR2/3-altered metastatic urothelial carcinoma

Drugs + NSZU

Erdafitinib (DRUG-ERDAFITINIB) 8 mg PO once daily, with up-titration to 9 mg PO once daily on day 14-21 if serum phosphate <5.5 mg/dL and no significant toxicity · PO daily, continuous (28-day cycle for accounting) · PO ✗ Not registered in UA

Reason

Current-line alternative presented for HCP consideration

Standard plan

Indication

IND-UROTHELIAL-2L-PLATINUM-CHEMO

Regimen

Gemcitabine + carboplatin (urothelial carcinoma, cisplatin-ineligible)

Drugs + NSZU

Gemcitabine (DRUG-GEMCITABINE) 1000 mg/m² IV over 30 min · Days 1 and 8 q21d · IV ⚠ NSZU — not for this indication
Carboplatin (DRUG-CARBOPLATIN) AUC 5 IV over 30 min (Calvert formula: dose [mg] = AUC × [GFR + 25]) · Day 1 q21d (after gemcitabine infusion) · 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-CBC	Complete Blood Count with Differential	Critical	lab	—	all tracks
TEST-CMP	Comprehensive Metabolic Panel	Critical	lab	—	all tracks
TEST-CT-CHEST-ABDOMEN-PELVIS	CT chest + abdomen + pelvis with IV contrast	Critical	imaging	—	aggressive
TEST-LFT	Liver Function Tests (ALT, AST, bilirubin, ALP, GGT, albumin)	Critical	lab	—	all tracks
TEST-CT-CAP	CT chest/abdomen/pelvis	Standard	imaging	—	standard
TEST-NGS-COMPREHENSIVE	Comprehensive NGS tumor panel (DNA + RNA, ≥300 genes)	Desired	histology	CSD Lab: M065	desired (aggressive)

What NOT to do

Explicit prohibitive rules, each grounded in a regimen / supportive care / contraindication entity

Standard plan (IND-UROTHELIAL-2L-EV)

Не призначати EV після попереднього EV+пємбролізумаб (відсутno даno про ефективnoсть повторного призначення EV)
Не пропускати тестування FGFR2/3 перед 2L — FGFR+ пацієнти мають перевагу від ердафітиnoбу (HR 0.58)
Не призначати при неконтрольованому ЦД — гіперглікемія є значущою токсичnoстю

Standard plan (IND-UROTHELIAL-2L-PEMBROLIZUMAB)

Не призначати при попередньому ICI лікуванno (авелумаб, пembro, атезолізумаб) — повторне ICI не підтверджено
Не пропускати FGFR2/3 тестування перед 2L — FGFR+ пацієнти мають кращу відповідь на ердафітиnoб
Не застосовувати при активних аутоімунних захворюваннях (ГКС >10 мг/д)

Aggressive plan (IND-UROTHELIAL-2L-ERDAFITINIB)

НЕ призначати без підтвердження FGFR2/3 alteration (Therascreen companion diagnostic OR comprehensive NGS) — generic FGFR overexpression by IHC недостатня.
НЕ використовувати в PD-(L)1-naive setting — THOR cohort 2 negative vs pembrolizumab.
НЕ підвищувати дозу до 9 мг без перевірки фосфату на день 14-21 — up-titration лише при phosphate <5.5 мг/дл.
НЕ ігнорувати baseline + serial офтальмологічний огляд — central serous retinopathy ~25%, often reversible але потребує hold.
НЕ ігнорувати фосфат моnoторинг — гіперфосфатемія ~76%; дієта + sevelamer; затримка / зниження дози при >7 мг/дл.
НЕ комбінувати з потужними CYP3A4 OR CYP2C9 інгібіторами / індукторами — експозиція erdafitinib різко змінюється.
НЕ ігнорувати nail / skin / mucosal care — onycholysis, paronychia, stomatitis високої частоти.
НЕ підтверджувати план без funding pathway — erdafitinib не зареєстрований в UA (Janssen EAP / named-patient only).

Standard plan (IND-UROTHELIAL-2L-PLATINUM-CHEMO)

Не призначати при FGFR2/3-позитивному статусі — ердафітиnoб (THOR: PFS HR 0.58; ORR 35% vs 8.5% хімії) — кращий варіант
Не забути тестування FGFR2/3 ПЕРЕД призначенням — 15-20% UC мають FGFR2/3 альтерацію
Не призначати цисплатин при GFR <60 мл/хв або Grade ≥2 нейропатії — використовувати карбоплатин
Не призначати при CrCl <30 мл/хв — карбоплатин протипоказаний
Не переоцінювати AUC — перераховувати карбоплатин за формулою Кальверта перед КОЖНИМ циклом

Timeline

Treatment timeline — derived from regimen + monitoring schedule

Standard plan

Induction · Enfortumab vedotin monotherapy (urothelial carcinoma)

28-day cycles × Until progression or unacceptable toxicity

Aggressive plan

Induction · Erdafitinib monotherapy (THOR cohort 1) — 2L+ FGFR2/3-altered metastatic urothelial carcinoma

28-day cycles × Until progression / unacceptable toxicity

Standard plan

Induction · Gemcitabine + carboplatin (urothelial carcinoma, cisplatin-ineligible)

21-day cycles × 4-6 cycles (until progression, unacceptable toxicity, or complete response)

MDT brief

Discussion questions (2, 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
OQ-BIOMARKER-FGFR3-MUTATION
What is the status of FGFR3 mutation/fusion (BIO-FGFR3-MUTATION)? It is required by track(s): IND-UROTHELIAL-2L-ERDAFITINIB. Expected value: FGFR3 activating mutation (S249C, R248C, G370C, Y373C) OR FGFR2 / FGFR3 fusion (THOR-eligible alterations); confirm with Therascreen companion diagnostic OR NGS.
A treatment-track biomarker requirement is missing from the patient profile; the MDT should verify the test result, method, specimen, and date before relying on this option.
→ molecular_geneticist

MDT talk tree (3 steps)

#	Owner	Topic	Action
1	hematologist	Staging / disease burden	What is the current LDH? Marker of tumor burden and transformation.
2	molecular_geneticist	Biomarker status	What is the status of FGFR3 mutation/fusion (BIO-FGFR3-MUTATION)? It is required by track(s): IND-UROTHELIAL-2L-ERDAFITINIB. Expected value: FGFR3 activating mutation (S249C, R248C, G370C, Y373C) OR FGFR2 / FGFR3 fusion (THOR-eligible alterations); confirm with Therascreen companion diagnostic OR NGS.
3	clinical_pharmacist	Specialist review	Chemoimmunotherapy regimen — drug-drug interactions, dose adjustments, premedication.

Skills (recommended) — for consideration (2)

Clinical pharmacist recommended
Chemoimmunotherapy regimen — drug-drug interactions, dose adjustments, premedication.
Molecular geneticist / molecular oncologist recommended
Indication references an actionable genomic biomarker — mutation / target / actionability interpretation needed.
Owns: OQ-BIOMARKER-FGFR3-MUTATION

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: 0/1 known (0%), 1 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

Missing biomarker	Label	MDT owner	Default track	Required by	Next action
`BIO-FGFR3-MUTATION`	FGFR3 mutation/fusion	molecular_geneticist	no	IND-UROTHELIAL-2L-ERDAFITINIB	Verify result, method, specimen, and report date before sign-off. Expected/constraint: FGFR3 activating mutation (S249C, R248C, G370C, Y373C) OR FGFR2 / FGFR3 fusion (THOR-eligible alterations); confirm with Therascreen companion diagnostic OR NGS

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-EV301-POWLES-2021: Enfortumab vedotin in previously treated advanced urothelial carcinoma ()
SRC-KEYNOTE-045-BELLMUNT-2017: Pembrolizumab as second-line therapy for advanced urothelial carcinoma ()
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: 2026-07-15.

NCT	Title	Phase	Status	Sponsor	UA	Signals
NCT07302230	Home-Based Physical Activity Program With Digital App Versus Health Education Group for Improving Physical Activity Among Patients With Non-muscle Invasive Bladder Cancer, The EMPOWER Trial	NA	RECRUITING	University of Washington	—	Single country
NCT07285044	The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Treatment Satisfaction in Cancer Patients Living in the Florida Panhandle and Surrounding Areas	PHASE2	RECRUITING	Mayo Clinic	—	Small N (<50) Single country
NCT06354231	DV Combined With Toripalimab for Renal Preservation in Solitary Kidney or Renal Insufficiency or Bilateral Multiple UTUC	PHASE2	RECRUITING	Fudan University	—	Small N (<50) Surrogate endpoint only Single country
NCT05595408	Circulating and Urine Tumor DNA Dynamics Predict Minimal Residual Disease and Recurrence Risk in Locally Advanced Upper Tract Urothelial Carcinoma	N/A	RECRUITING	RenJi Hospital	—	Single country
NCT07602010	Comparison of CT and MR (VI-RADS) Imaging for Local Bladder Cancer Staging	N/A	RECRUITING	Oslo University Hospital	—	Single country
NCT06582017	Safety, PK and Efficacy of QXL138AM in Patients With Solid Tumors and Multiple Myeloma	PHASE1	RECRUITING	Nammi Therapeutics Inc	—	Phase 1 only Single country
NCT07097142	Testing Shorter Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients Receiving the Usual Chemotherapy Treatment for Bladder Cancer, ARCHER Study	PHASE3	RECRUITING	NRG Oncology	—	Single country
NCT06822010	SeqUential GeMcitabine and MITomycin Treatment for Favorable High-Risk Upper Urinary Tract Urothelial Carcinoma	PHASE2	RECRUITING	Rutgers, The State University of New Jersey	—	Small N (<50) Single country
NCT06257017	Surveillance of the Genetic Signature in Circulating Tumor DNA for Guiding Adjuvant Chemotherapy in Urothelial Carcinoma	PHASE2	RECRUITING	Yung NA	—	Small N (<50) Surrogate endpoint only Single country
NCT05929235	A Study of FX-909 in Patients With Advanced Solid Malignancies, Including Advanced Urothelial Carcinoma	PHASE1	RECRUITING	Flare Therapeutics Inc.	—	Phase 1 only 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 monotherapy (urothelial carcinoma) (REG-EV-MONO-UROTHELIAL) 1/1 component drug(s) not registered in Ukraine +1	✗ not registered	✗ out-of-pocket	₴-? — verify pathway	not recorded
Standard plan Pembrolizumab monotherapy (REG-PEMBROLIZUMAB-MONO)	✓ registered	✓ covered	₴-? — verify pathway	NSZU formulary
Aggressive plan Erdafitinib monotherapy (THOR cohort 1) — 2L+ FGFR2/3-altered metastatic urothelial carcinoma (REG-ERDAFITINIB-UROTHELIAL-2L) 1/1 component drug(s) not registered in Ukraine +1	✗ not registered	✗ out-of-pocket	₴-? — verify pathway	not recorded
Standard plan Gemcitabine + carboplatin (urothelial carcinoma, cisplatin-ineligible) (REG-GEM-CARBO-UROTHELIAL)	✓ registered	✓ covered	₴-? — verify pathway	NSZU formulary
Trial · NCT07302230 Home-Based Physical Activity Program With Digital App Versus Health Education Group for Improving Physical Activity Among Patients With Non-muscle Invasive Bladder Cancer, The EMPOWER Trial No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT07285044 The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Treatment Satisfaction in Cancer Patients Living in the Florida Panhandle and Surrounding Areas No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06354231 DV Combined With Toripalimab for Renal Preservation in Solitary Kidney or Renal Insufficiency or Bilateral Multiple UTUC No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT05595408 Circulating and Urine Tumor DNA Dynamics Predict Minimal Residual Disease and Recurrence Risk in Locally Advanced Upper Tract Urothelial Carcinoma No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT07602010 Comparison of CT and MR (VI-RADS) Imaging for Local Bladder Cancer Staging No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06582017 Safety, PK and Efficacy of QXL138AM in Patients With Solid Tumors and Multiple Myeloma No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT07097142 Testing Shorter Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients Receiving the Usual Chemotherapy Treatment for Bladder Cancer, ARCHER Study No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06822010 SeqUential GeMcitabine and MITomycin Treatment for Favorable High-Risk Upper Urinary Tract Urothelial Carcinoma No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06257017 Surveillance of the Genetic Signature in Circulating Tumor DNA for Guiding Adjuvant Chemotherapy in Urothelial Carcinoma No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT05929235 A Study of FX-909 in Patients With Advanced Solid Malignancies, Including Advanced Urothelial Carcinoma 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: 2026-07-15.

plan_id: PLAN-VERIFIED-UROTHELIAL-L2-UROTHELIAL_2L_EV-V1 | version: 1 | generated: 2026-07-15T13:33:23.075544+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.