OpenOnco · Treatment Plan

Treatment plan — DIS-UROTHELIAL

PLAN-BMA-MLH1_GERMLINE_UROTHELIAL-V1 · v1 · 2026-05-04

Patient

BMA-MLH1_GERMLINE_UROTHELIAL · Algorithm: ALGO-UROTHELIAL-METASTATIC-1L

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	Not in KB — ask clinician to verify

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': 2, 'outcome': False, 'branch': {'result': 'IND-UROTHELIAL-METASTATIC-1L-PLATINUM-CHEMO-AVELUMAB', 'notes': 'Cisplatin-ineligible + EV-pembro ineligible: gemcitabine+carboplatin (4-6 cycles) → avelumab maintenance. IND-UROTHELIAL-METASTATIC-1L-PLATINUM-CHEMO- AVELUMAB covers both cisplatin and carboplatin backbone — regimen selection guided by CrCl and patient fitness within the indication.\n'}, '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	Where to order	Needed for
TEST-CECT-CAP	CECT chest/abdomen/pelvis	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)

Clinical pharmacist recommended
Chemoimmunotherapy regimen — 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
What is the current LDH? Marker of tumor burden and transformation.
LDH is part of the prognostic indices of indolent lymphomas.
→ 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
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: 2026-05-04.

NCT	Title	Phase	Status	Sponsor	UA
NCT06983210	Clinical Trial of AM80 in Combination With Gemcitabine, Cisplatin, and Nivolumab in Patients With Urothelial Carcinoma	PHASE2	RECRUITING	Nagoya University	—
NCT07186842	A Clinical Trial to Test if the Investigational Drug BNT329 is Safe and Potentially Beneficial for People With Advanced Solid Tumors Known to Express the Tumor Marker CA19-9	PHASE1 / PHASE2	RECRUITING	BioNTech SE	—
NCT06724159	Observational Study of the Effectiveness of Funded Drugs for Genitourinary Tumors.	N/A	RECRUITING	Spanish Oncology Genito-Urinary Group	—
NCT04575935	Minimally Invasive Surgery After Neoadjuvant Chemotherapy for the Treatment of Stage IIIC-IV Ovarian, Primary Peritoneal, or Fallopian Tube Cancer, LANCE Trial	PHASE3	RECRUITING	M.D. Anderson Cancer Center	—
NCT06169436	Translational Cancer Observational Protocol	N/A	RECRUITING	IRCCS San Raffaele	—
NCT07217171	A Study Evaluating the Safety, Efficacy, and Pharmacokinetics (PK) of EVOLVE104 in Participants With Advanced Urothelial and Squamous Cell Carcinomas	PHASE1	RECRUITING	EvolveImmune United, Inc	—
NCT06632262	A Phase 2 Clinical Study of ABSK061 and ABSK043	PHASE2	RECRUITING	Abbisko Therapeutics Co, Ltd	—
NCT06537154	NEO-BLAST: Neoadjuvant Therapy for Bladder Cancer Followed by Active Surveillance vs Treatment	PHASE2 / PHASE3	RECRUITING	Peter Black	—
NCT05965856	A Study of SI-B003 and BL-B01D1+SI-B003 in Patients With Locally Advanced or Metastatic Urothelial Carcinoma and Other Solid Tumors	PHASE2	RECRUITING	Sichuan Baili Pharmaceutical Co., Ltd.	—
NCT04969835	A Study Evaluating the Safety, Pharmacokinetics and Early Efficacy of AVA6000 in Solid Tumours	PHASE1	RECRUITING	Avacta Life Sciences Ltd	—

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
Aggressive plan Cisplatin + gemcitabine (urothelial neoadj + metastatic) (REG-CISPLATIN-GEMCITABINE-UROTHELIAL)	✓ registered	✓ covered	₴-? — verify pathway	NSZU formulary
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
Trial · NCT06983210 Clinical Trial of AM80 in Combination With Gemcitabine, Cisplatin, and Nivolumab in Patients With Urothelial Carcinoma No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT07186842 A Clinical Trial to Test if the Investigational Drug BNT329 is Safe and Potentially Beneficial for People With Advanced Solid Tumors Known to Express the Tumor Marker CA19-9 No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06724159 Observational Study of the Effectiveness of Funded Drugs for Genitourinary Tumors. No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT04575935 Minimally Invasive Surgery After Neoadjuvant Chemotherapy for the Treatment of Stage IIIC-IV Ovarian, Primary Peritoneal, or Fallopian Tube Cancer, LANCE Trial No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06169436 Translational Cancer Observational Protocol No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT07217171 A Study Evaluating the Safety, Efficacy, and Pharmacokinetics (PK) of EVOLVE104 in Participants With Advanced Urothelial and Squamous Cell Carcinomas No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06632262 A Phase 2 Clinical Study of ABSK061 and ABSK043 No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06537154 NEO-BLAST: Neoadjuvant Therapy for Bladder Cancer Followed by Active Surveillance vs Treatment No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT05965856 A Study of SI-B003 and BL-B01D1+SI-B003 in Patients With Locally Advanced or Metastatic Urothelial Carcinoma and Other Solid Tumors No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT04969835 A Study Evaluating the Safety, Pharmacokinetics and Early Efficacy of AVA6000 in Solid Tumours 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: 2026-05-04.

plan_id: PLAN-BMA-MLH1_GERMLINE_UROTHELIAL-V1 | version: 1 | generated: 2026-05-04T14:13:16.637459+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.