OpenOnco · Treatment Plan

Treatment plan — Basal cell carcinoma

PLAN-SHOWCASE-BCC-LABCC-001-V1 · v1 · 2026-05-13

Patient

SHOWCASE-BCC-LABCC-001 · Algorithm: ALGO-BCC-1L

DiagnosisBasal cell carcinoma

MOH / ICD-10C44

ICD-O-38090/3; C44

Stagelocally advanced

Histologybasal cell carcinoma, infiltrative/morpheaform subtype

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
BIO-PTCH1	PTCH1 loss-of-function (somatic — sporadic BCC; germline — Gorlin/Basal Cell Nevus Syndrome); activates HH pathway via SMO disinhibition	IA	Standard care SRC-NCCN-SKIN-2025: Level Category 1 (Supports, Sensitivity/Response)	PTCH1 loss is the primary molecular driver of BCC (~90% of sporadic cases and all Gorlin syndrome-associated BCCs). Loss of PTCH1 function disinhibits SMO, constitutively activating Hedgehog (HH) signaling. Therapeutic implication is identical to SMO-mutant BCC: SMO antagonists (vismodegib, sonidegib) block SMO activity downstream of PTCH1 and restore HH pathway suppression. FDA approvals for vismodegib (2012) and sonidegib (2015) for laBCC/mBCC apply regardless of whether the underlying driver is PTCH1 loss or SMO mutation — clinical eligibility is based solely on disease extent (locally advanced or metastatic) and surgical/radiation suitability, not on molecular testing. Gorlin syndrome (germline PTCH1): same therapeutic approach but radiation therapy is relatively contraindicated (radiation-induced BCC within field). Cemiplimab FDA-approved post-HHI (2021). See BMA-SMO-BCC for full efficacy data (ERIVANCE, BOLT trials) — the PTCH1 and SMO BMA entries share identical therapeutic recommendations; the distinction is clinically relevant for resistance mechanism (secondary SMO mutation in PTCH1-driven BCC after HHI = acquired SMO mutation) and for Gorlin syndrome genetic counseling.	vismodegib 150 mg PO QD (see BMA-SMO-BCC for full regimen details) sonidegib 200 mg PO QD with food cemiplimab 350 mg IV q3w (post-HHI) Gorlin syndrome: multidisciplinary surveillance (dermatology, ophthalmology, neurology, genetics); vismodegib for high-burden BCC with toxicity break strategy	SRC-NCCN-SKIN-2025

⚠️ Not included in plan

Biomarker	Status
SMO	Not in KB — ask clinician to verify
BIO-SMO	BIO definition in KB; no ESCAT BMA entry — verify with clinician

Primary current-line option

Standard plan

★ DEFAULT

Indication

IND-BCC-1L-VISMODEGIB

Regimen

Vismodegib monotherapy (locally advanced / metastatic BCC)

Drugs + NSZU

Vismodegib (DRUG-VISMODEGIB) 150 mg PO once daily, with or without food · Continuous until progression or unacceptable toxicity · PO ✗ Not registered in UA

Reason

Primary current-line option selected by ALGO-BCC-1L at step 2.

Other current-line alternatives (1 tracks)

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

Aggressive plan

Indication

IND-BCC-1L-SONIDEGIB

Regimen

Sonidegib monotherapy (locally advanced BCC)

Drugs + NSZU

Sonidegib (DRUG-SONIDEGIB) 200 mg PO once daily on an empty stomach (≥1 h before or ≥2 h after food) · Continuous until progression or unacceptable toxicity · PO ✗ Not registered in UA

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-EXCISIONAL-SKIN-BIOPSY	Excisional skin biopsy	Critical	histology	—	all tracks
TEST-PREGNANCY	Beta-HCG	Critical	lab	—	all tracks

What NOT to do

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

Standard plan (IND-BCC-1L-VISMODEGIB)

Do NOT prescribe during pregnancy — severe embryo-fetal toxicity (teratogenicity, Black Box Warning)
Do NOT use for BCC amenable to surgery or radiation — systemic therapy only for laBCC/mBCC
Do NOT skip pregnancy prevention — two contraceptive methods required throughout + 24 months post-dose in females
Do NOT combine with strong P-gp inhibitors without monitoring

Aggressive plan (IND-BCC-1L-SONIDEGIB)

Do NOT prescribe for metastatic BCC — FDA approval is laBCC only
Do NOT prescribe during pregnancy — Black Box Warning teratogenicity
Do NOT ignore CK — monitor if muscle symptoms (rhabdomyolysis risk)
Do NOT prescribe without contraception — 20 months post-dose contraception required for females

Timeline

Treatment timeline — derived from regimen + monitoring schedule

Standard plan

Induction · Vismodegib monotherapy (locally advanced / metastatic BCC)

28-day cycles × Continuous until progression

Aggressive plan

Induction · Sonidegib monotherapy (locally advanced BCC)

28-day cycles × Continuous until progression

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 (3 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.
3	molecular_geneticist	Specialist review	Indication references an actionable genomic biomarker — mutation / target / actionability interpretation needed.

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.

Data quality

Complete for MDT review. Required MDT data checks are complete for the current case profile.

Biomarker coverage: 2/2 known (100%), 0 missing, 0 default-track gaps

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-NCCN-SKIN-2025: NCCN Clinical Practice Guidelines in Oncology: Basal Cell Skin Cancer (Version 2.2025) ()

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: 2026-05-13.

NCT	Title	Phase	Status	Sponsor	UA	Signals
NCT05020912	Alteration of the Immune Microenvironment in Basal Cell Carcinoma Following Photodynamic Therapy	PHASE2	RECRUITING	Case Comprehensive Cancer Center	—	Small N (<50) Single country
NCT05797415	Sentinel Lymph Node Biopsy in Ocular Surface and Adnexal Cancers	N/A	RECRUITING	Fondazione Policlinico Universitario Agostino Gemelli IRCCS	—	Small N (<50) Single country
NCT06981325	Evaluation of Efficacy and Safety of Cemiplimab as First Line Treatment for Advanced Basal Cell Carcinoma (BCC) Patients	PHASE2	RECRUITING	Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest	—	Small N (<50) Surrogate endpoint only Single country
NCT05929664	Cemiplimab Plus Fianlimab for the Treatment of Locally Advanced Head and Neck Basal Cell Carcinoma Before Surgery	PHASE2	RECRUITING	Thomas Jefferson University	—	Surrogate endpoint only Single country
NCT00898638	Tissue Sample Collection From Patients With Head and Neck Cancer and From Healthy Participants	N/A	RECRUITING	Vanderbilt University Medical Center	—	Single country
NCT05859074	A Study of MQ710 With and Without Pembrolizumab in People With Solid Tumor Cancer	PHASE1	RECRUITING	Memorial Sloan Kettering Cancer Center	—	Phase 1 only Single country
NCT06608511	Liquid Biomarker Study in Melanoma and Non-Melanoma Skin Cancers	N/A	RECRUITING	University of Wisconsin, Madison	—	Small N (<50) Single country
NCT07251413	Cemiplimab Plus Imiquimod and Laser Therapy As Neoadjuvant Treatment In Cutaneous Basal Cell Carcinoma	PHASE1 / PHASE2	RECRUITING	Instituto Oncológico Dr Rosell	—	Small N (<50) Single country
NCT06309836	Retrospective and Prospective Observational Study in Patients With Advanced Basal Cell Carcinoma	N/A	RECRUITING	Societa Italiana di Dermatologia Medica, Chirurgica, Estetica e di Malattie Sessualmente Trasmesse	—	Single country
NCT05741073	Outcome Research of a European Registry Platform on Real-world Treatment Data of Patients with Advanced NMSC	N/A	RECRUITING	EuMelaReg gGmbH	—	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 Vismodegib monotherapy (locally advanced / metastatic BCC) (REG-VISMODEGIB-BCC) 1/1 component drug(s) not registered in Ukraine +1	✗ not registered	✗ out-of-pocket	₴-? — verify pathway	not recorded
Aggressive plan Sonidegib monotherapy (locally advanced BCC) (REG-SONIDEGIB-BCC) 1/1 component drug(s) not registered in Ukraine +1	✗ not registered	✗ out-of-pocket	₴-? — verify pathway	not recorded
Trial · NCT05020912 Alteration of the Immune Microenvironment in Basal Cell Carcinoma Following Photodynamic Therapy No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT05797415 Sentinel Lymph Node Biopsy in Ocular Surface and Adnexal Cancers No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06981325 Evaluation of Efficacy and Safety of Cemiplimab as First Line Treatment for Advanced Basal Cell Carcinoma (BCC) Patients No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT05929664 Cemiplimab Plus Fianlimab for the Treatment of Locally Advanced Head and Neck Basal Cell Carcinoma Before Surgery No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT00898638 Tissue Sample Collection From Patients With Head and Neck Cancer and From Healthy Participants No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT05859074 A Study of MQ710 With and Without Pembrolizumab in People With Solid Tumor Cancer No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06608511 Liquid Biomarker Study in Melanoma and Non-Melanoma Skin Cancers No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT07251413 Cemiplimab Plus Imiquimod and Laser Therapy As Neoadjuvant Treatment In Cutaneous Basal Cell Carcinoma No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06309836 Retrospective and Prospective Observational Study in Patients With Advanced Basal Cell Carcinoma No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT05741073 Outcome Research of a European Registry Platform on Real-world Treatment Data of Patients with Advanced NMSC 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: 2026-05-13.

plan_id: PLAN-SHOWCASE-BCC-LABCC-001-V1 | version: 1 | generated: 2026-05-13T10:01:50.961637+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.