OpenOnco · Treatment Plan

Treatment plan — Cutaneous melanoma

PLAN-SHOWCASE-MELANOMA-BRAF-001-V1 · v1 · 2026-05-12

Patient

SHOWCASE-MELANOMA-BRAF-001 · Algorithm: ALGO-MELANOMA-METASTATIC-1L

DiagnosisCutaneous melanoma

MOH / ICD-10C43

ICD-O-38720/3; C44.9

StageIV

Histologycutaneous melanoma

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-BRAF-V600E	V600E	IA	Molecular evidence option SRC-CIVIC: Level A (Supports, Sensitivity/Response) SRC-CIVIC: Level B (Supports, Poor Outcome) Resistance or avoidance signal SRC-CIVIC: Level B ⚠ Resistance SRC-CIVIC: Level C ⚠ Resistance SRC-CIVIC: Level D ⚠ Resistance Trial or research option SRC-CIVIC: Level C (Supports, Sensitivity/Response) SRC-CIVIC: Level D (Supports, Sensitivity/Response)	BRAF V600E (and V600K) in cutaneous melanoma is the prototypical driver: combination BRAF + MEK inhibition (dabrafenib + trametinib; encorafenib + binimetinib; vemurafenib + cobimetinib) yields high ORR (~65-70%) and improves OS vs single-agent BRAFi (COMBI-d/v, coBRIM, COLUMBUS). Adjuvant dabrafenib + trametinib improves RFS in resected stage III (COMBI-AD). Triplet with anti-PD-1 (atezolizumab + vemurafenib + cobimetinib; IMspire150) extends PFS over doublet.	dabrafenib + trametinib encorafenib + binimetinib vemurafenib + cobimetinib atezolizumab + vemurafenib + cobimetinib (triplet)	SRC-NCCN-MELANOMA-2025 SRC-ESMO-MELANOMA-2024

⚠️ Not included in plan

Biomarker	Status
NRAS	Excluded (negative)
KIT	Excluded (negative)
PD-L1	Not in KB — ask clinician to verify

Primary current-line option

Standard plan

★ DEFAULT

Indication

IND-MELANOMA-METASTATIC-1L-NIVO-IPI

Regimen

Nivolumab + ipilimumab (melanoma, 1L metastatic)

Drugs + NSZU

Nivolumab (DRUG-NIVOLUMAB) 1 mg/kg IV induction → 480 mg flat IV q4w maintenance · Induction with ipi cycles 1-4 · IV ✓ NSZU covered
Ipilimumab (DRUG-IPILIMUMAB) 3 mg/kg IV (higher than RCC) · Days 1 of cycles 1-4 · IV ✓ NSZU covered

Reason

Primary current-line option selected by ALGO-MELANOMA-METASTATIC-1L at step 4.

Other current-line alternatives (3 tracks)

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

Standard plan

Indication

IND-MELANOMA-ADJUVANT-PEMBRO-STAGE-III

Regimen

Pembrolizumab adjuvant (resected stage III/IV melanoma; KEYNOTE-054)

Drugs + NSZU

Pembrolizumab (DRUG-PEMBROLIZUMAB) 200 mg IV q3w (or 400 mg IV q6w) · Day 1 every 3 weeks (or q6w), for up to 18 cycles (~12 months total) starting within 12 weeks of definitive surgery · IV ✓ NSZU covered

Reason

Current-line alternative presented for HCP consideration

Aggressive plan

Indication

IND-MELANOMA-BRAF-METASTATIC-1L-DABRA-TRAME

Regimen

Dabrafenib + trametinib (BRAF V600E+ NSCLC)

Drugs + NSZU

Dabrafenib (DRUG-DABRAFENIB) 150 mg PO BID · Continuous · PO ✓ NSZU covered
Trametinib (DRUG-TRAMETINIB) 2 mg PO once daily · Continuous · PO ✓ NSZU covered

Reason

Current-line alternative presented for HCP consideration

Standard plan

Indication

IND-MELANOMA-METASTATIC-1L-PEMBRO-MONO

Regimen

Pembrolizumab monotherapy (advanced/metastatic melanoma, 1L; KEYNOTE-006)

Drugs + NSZU

Pembrolizumab (DRUG-PEMBROLIZUMAB) 200 mg IV q3w (or 400 mg IV q6w) · Day 1 every 3 weeks (or q6w), for up to 35 cycles (~2 years) or until progression / unacceptable toxicity · IV ✓ NSZU covered

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
TEST-LDH	Lactate Dehydrogenase	Critical	lab	—	standard
TEST-BRAIN-MRI-CONTRAST	Brain MRI with contrast	Standard	—	—	all tracks

Red flags — PRO / CONTRA aggressive

PRO-AGGRESSIVE

Triggers that push toward the aggressive track

LDH >2x ULN OR severe hepatic dysfunction — predictor of inferior ICI outcomes.RF-MELANOMA-ORGAN-DYSFUNCTION
Symptomatic CNS metastases — ICI doublet (nivo+ipi) intracranially active; BRAFi+MEKi for visceral crisis.RF-MELANOMA-TRANSFORMATION-PROGRESSION

CONTRA-AGGRESSIVE

Hard contraindications to escalation

What NOT to do

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

Standard plan (IND-MELANOMA-ADJUVANT-PEMBRO-STAGE-III)

Do not start adjuvant IO without negative baseline brain MRI with contrast — occult cerebral metastases are a frequent finding.
Do not skip baseline TSH / cortisol / glucose — endocrine irAE are the most frequent, and pre-existing endocrinopathies change management.
Do not start later than 12 weeks from surgery — KEYNOTE-054 window is shorter; benefit poorly characterized after that.
Do not continue with gr ≥3 irAE without reassessing benefit/risk — adjuvant is curative intent, threshold for permanent discontinuation lower than metastatic.
Do not combine with immunosuppression or live vaccines.
Do not skip pre-treatment counseling — irAE may be permanent (endocrinopathies) and impact quality of life more than relapse in some scenarios.

Standard plan (IND-MELANOMA-METASTATIC-1L-PEMBRO-MONO)

Do not start pembrolizumab without baseline TSH / cortisol / glucose — endocrine irAE are the most frequent.
Do not ignore active autoimmune disease — relative contraindication, assess risk/benefit with rheumatologist.
Do not skip baseline brain MRI with contrast — cerebral metastases are often asymptomatic in melanoma.
Do not continue with gr ≥3 irAE without high-dose steroids (1-2 mg/kg prednisolone-equivalent) — delay in management can be fatal.
Do not combine with immunosuppressants / live vaccines during treatment.
Do not prescribe with ECOG ≥3 — limited data, palliative approach more appropriate.

Timeline

Treatment timeline — derived from regimen + monitoring schedule

Standard plan

Induction · Nivolumab + ipilimumab (melanoma, 1L metastatic)

21-day cycles × 4 induction; nivo maintenance until progression OR 2 years

Standard plan

Induction · Pembrolizumab adjuvant (resected stage III/IV melanoma; KEYNOTE-054)

21-day cycles × 18 cycles (~12 months) per KEYNOTE-054 protocol

Aggressive plan

Induction · Dabrafenib + trametinib (BRAF V600E+ NSCLC)

28-day cycles × Continuous until progression

Standard plan

Induction · Pembrolizumab monotherapy (advanced/metastatic melanoma, 1L; KEYNOTE-006)

21-day cycles × Up to 35 cycles (~2 years) or 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

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

Biomarker coverage: 1/1 known (100%), 0 missing, 0 default-track gaps
Unevaluated RedFlags: RF-ACTIVE-AUTOIMMUNE-DISEASE-ICI-RISK, RF-MELANOMA-BRAF-V600-ACTIONABLE, RF-MELANOMA-HIGH-RISK-BIOLOGY, RF-MELANOMA-INFECTION-SCREENING, RF-MELANOMA-IO-RESISTANT, RF-MELANOMA-KIT-MUT-ACTIONABLE, RF-MELANOMA-NF1-MUT-CANDIDATE, RF-MELANOMA-ORGAN-DYSFUNCTION, RF-MELANOMA-STAGE-III-RESECTED, RF-MELANOMA-TRANSFORMATION-PROGRESSION, RF-UVEAL-MELANOMA-BAP1-MUT-CANDIDATE

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-CHECKMATE-067-LARKIN-2019: Five-Year Survival with Combined Nivolumab and Ipilimumab in Advanced Melanoma (2019)
SRC-CHECKMATE-238-WEBER-2017: Adjuvant Nivolumab versus Ipilimumab in Resected Stage III or IV Melanoma (2017)
SRC-COMBI-D-LONG-2014: Combined BRAF and MEK Inhibition versus BRAF Inhibition Alone in Melanoma (2014)
SRC-ESMO-MELANOMA-2024: ESMO Cutaneous Melanoma (2024)
SRC-KEYNOTE-006-ROBERT-2015: Pembrolizumab versus Ipilimumab in Advanced Melanoma (2015)
SRC-KEYNOTE-054-EGGERMONT-2018: Adjuvant Pembrolizumab versus Placebo in Resected Stage III Melanoma (2018)
SRC-NCCN-MELANOMA-2025: NCCN Cutaneous Melanoma (2025.v2)

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: 2026-05-12.

NCT	Title	Phase	Status	Sponsor	UA	Signals
NCT07130032	Efficacy And Safety Of Anti-PD-1/PD-L1 Antibodies In Combination With Bevacizumab And Metronomic Cyclophosphamide In Patients With Non-Small Cell Lung Cancer And Cutaneous Melanoma Previously Treated With Immune Checkpoint Blockade	PHASE2	RECRUITING	EuroCityClinic LLC	—	Single country
NCT06660420	Phase 1 Dose Escalation and Expansion Study of PRAME T Cell Receptor (TCR) Engineered NK Cells in Participants With Recurrent and/or Refractory Melanoma (PRAMETIME-Mel)	PHASE1	RECRUITING	M.D. Anderson Cancer Center	—	Phase 1 only Small N (<50) Single country
NCT04068155	Alpha Radiation Emitters Device for the Treatment of of Malignant Cutaneous Tumors	NA	RECRUITING	Alpha Tau Medical LTD.	—	Surrogate endpoint only Single country
NCT04855435	Safety and Preliminary Efficacy of MBS8(1V270) in Cancer Patients With Advanced Solid Tumours	PHASE1	RECRUITING	MonTa Biosciences ApS	—	Phase 1 only
NCT04729543	MAGE-C2 TCR T Cell Trial to Treat Melanoma and Head and Neck Cancer	PHASE1 / PHASE2	RECRUITING	Erasmus Medical Center	—	Small N (<50) Single country
NCT06545682	Phase Ib Study of AlpeliSib With PEmbroLizumab in Patients With mEtastatic Breast caNcer or melanomA (SELENA)	PHASE1	RECRUITING	M.D. Anderson Cancer Center	—	Phase 1 only Single country
NCT05086692	A Beta-only IL-2 ImmunoTherapY Study	PHASE1 / PHASE2	RECRUITING	Medicenna Therapeutics, Inc.	—	—
NCT04895709	A Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants With Advanced Solid Tumors	PHASE1 / PHASE2	RECRUITING	Bristol-Myers Squibb	—	—
NCT06444815	A Study of VET3-TGI in Patients With Solid Tumors	PHASE1	RECRUITING	KaliVir Immunotherapeutics	—	Phase 1 only Single country
NCT06880198	Study to Evaluate Impact® as Support to Anti PD1 or Anti PD1 Based Regimen Treatment in Patients With Inoperable Locally Advanced or Metastatic Melanoma	NA	RECRUITING	Fondazione Melanoma Onlus	—	Small N (<50) 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 Nivolumab + ipilimumab (melanoma, 1L metastatic) (REG-NIVO-IPI-MELANOMA)	✓ registered	✓ covered	₴-? — verify pathway	NSZU formulary
Standard plan Pembrolizumab adjuvant (resected stage III/IV melanoma; KEYNOTE-054) (REG-PEMBRO-ADJUVANT-MELANOMA)	✓ registered	✓ covered	₴-? — verify pathway	NSZU formulary
Aggressive plan Dabrafenib + trametinib (BRAF V600E+ NSCLC) (REG-DABRAFENIB-TRAMETINIB-NSCLC)	✓ registered	✓ covered	₴-? — verify pathway	NSZU formulary
Standard plan Pembrolizumab monotherapy (advanced/metastatic melanoma, 1L; KEYNOTE-006) (REG-PEMBRO-MONO-MELANOMA)	✓ registered	✓ covered	₴-? — verify pathway	NSZU formulary
Trial · NCT07130032 Efficacy And Safety Of Anti-PD-1/PD-L1 Antibodies In Combination With Bevacizumab And Metronomic Cyclophosphamide In Patients With Non-Small Cell Lung Cancer And Cutaneous Melanoma Previously Treated With Immune Checkpoint Blockade No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06660420 Phase 1 Dose Escalation and Expansion Study of PRAME T Cell Receptor (TCR) Engineered NK Cells in Participants With Recurrent and/or Refractory Melanoma (PRAMETIME-Mel) No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT04068155 Alpha Radiation Emitters Device for the Treatment of of Malignant Cutaneous Tumors No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT04855435 Safety and Preliminary Efficacy of MBS8(1V270) in Cancer Patients With Advanced Solid Tumours No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT04729543 MAGE-C2 TCR T Cell Trial to Treat Melanoma and Head and Neck Cancer No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06545682 Phase Ib Study of AlpeliSib With PEmbroLizumab in Patients With mEtastatic Breast caNcer or melanomA (SELENA) No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT05086692 A Beta-only IL-2 ImmunoTherapY Study No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT04895709 A Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants With Advanced Solid Tumors No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06444815 A Study of VET3-TGI in Patients With Solid Tumors No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06880198 Study to Evaluate Impact® as Support to Anti PD1 or Anti PD1 Based Regimen Treatment in Patients With Inoperable Locally Advanced or Metastatic Melanoma 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: 2026-05-12.

plan_id: PLAN-SHOWCASE-MELANOMA-BRAF-001-V1 | version: 1 | generated: 2026-05-12T18:41:25.903768+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.