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OpenOnco · Treatment Plan
Treatment plan — Head and neck squamous cell carcinoma
PLAN-VERIFIED-HNSCC-L2-HNSCC_RM_2L_NIVOLUMAB-V1 · v1 · 2026-07-15
Patient
VERIFIED-HNSCC-L2-HNSCC_RM_2L_NIVOLUMAB · Algorithm: ALGO-HNSCC-RM-2L
DiagnosisHead and neck squamous cell carcinoma
MOH / ICD-10C00-C14, C30-C32
ICD-O-38070/3; C00, C01, C02, C03, C04, C05, C06, C07, C08, C09, C10, C11, C12, C13, C14, C30, C31, C32

Etiological driver

Etiological driver · etiologically_driven archetype
Head and neck squamous cell carcinoma
  • Tobacco (smoked + smokeless) — dominant in HPV-negative disease
  • Alcohol (synergistic with tobacco)
  • HPV (high-risk, mostly type 16) — defines HPV+ oropharyngeal SCC, distinct biology and better prognosis
  • EBV — defines nasopharyngeal carcinoma (separate entity in many guidelines but tracked under HNSCC umbrella)
  • Betel nut chewing (South / Southeast Asia)
  • Fanconi anemia, dyskeratosis congenita (germline susceptibility)

Clinical significance of mutations (ESCAT)

Tumor-board context — the engine does not use these tiers to rank tracks
BiomarkerVariantESCATEvidenceClinical significanceDrugsSources
No clinically actionable variants matched in this profile.

Primary current-line option

Standard plan
★ DEFAULT
Indication
IND-HNSCC-RM-2L-NIVOLUMAB
Regimen
Nivolumab monotherapy
Drugs + NSZU
  • Nivolumab (DRUG-NIVOLUMAB) 240 mg IV over 30 min (flat dose q2w) OR 480 mg IV over 60 min q4w (flat dose) · q2w (240 mg) or q4w (480 mg flat dose — FDA-approved equivalent) · IV ⚠ NSZU — not for this indication
Reason
Provisional current-line default from ALGO-HNSCC-RM-2L: step 1 did not select a treatment branch. ECOG ≥3: best supportive care; palliative RT for symptomatic sites.

Other current-line alternatives (1 tracks)

Same treatment line; review when biomarker, access, contraindication, or patient-context assumptions change.
Standard plan
Indication
IND-HNSCC-RM-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

Pre-treatment investigations

Investigations before treatment start · critical / standard / desired · merged across tracks
IDNamePriorityCategoryWhere to orderNeeded for
TEST-CBCComplete Blood Count with DifferentialCriticallab—all tracks
TEST-CMPComprehensive Metabolic PanelCriticallab—all tracks
TEST-LFTLiver Function Tests (ALT, AST, bilirubin, ALP, GGT, albumin)Criticallab—all tracks
TEST-CT-CAPCT chest/abdomen/pelvisStandardimaging—all tracks

Red flags — PRO / CONTRA aggressive

PRO-AGGRESSIVE

Triggers that push toward the aggressive track
  • Active or latent infection requiring resolution / prophylaxis before initiating cisplatin-based chemoradiation, cetuximab + RT, or pembrolizumab in HNSCC: HBsAg-positive (HBV reactivation on cytotoxic chemotherapy + checkpoint inhibitors), anti-HBc-positive (occult HBV on cetuximab — anti-EGFR class), HIV-positive (ART coordination, often comorbid in HPV-related HNSCC), or active TB.
    Cetuximab — anti-EGFR mAb — has documented HBV reactivation reports (less than rituximab but non-zero); FDA label notes warning. Standard HBsAg + anti-HBc + anti-HBs serology pre-treatment; entecavir / tenofovir for HBsAg+. HIV-related…
    RF-HNSCC-INFECTION-SCREENINGSRC-NCCN-HNSCC-2025SRC-ESMO-HNSCC-2020
  • Baseline organ dysfunction precluding standard cisplatin-based chemoradiation or pembrolizumab + 5-FU + cisplatin / cetuximab in head and neck squamous cell carcinoma: CrCl <60 mL/min (cisplatin contraindicated at full dose, switch to carboplatin or cetuximab), hearing loss / ototoxicity baseline (cisplatin contraindicated), LVEF <50% (5-FU cardiac risk), bilirubin >3× ULN (taxane / 5-FU metabolism), or severe peripheral neuropathy (cisplatin + taxane contraindicated).
    Cisplatin-based CRT is the curative-intent standard (Intergroup 0099, TAX 324, EORTC 24891) but ~30% of HNSCC patients are cisplatin- ineligible at presentation due to age + organ dysfunction. CrCl <60: switch to carboplatin (RTOG 81-17…
    RF-HNSCC-ORGAN-DYSFUNCTIONSRC-NCCN-HNSCC-2025SRC-ESMO-HNSCC-2020

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-HNSCC-RM-2L-NIVOLUMAB)
  • Не призначати при попередnoй ICI-терапії (пembro, атезолізумаб) — повторний ICI не підтверджений
  • Не відміняти noвалумаб при ендокринних іrAE — гормональна замісна терапія без відміни
  • Не призначати при активному аутоімунному захворюванno під системними ГКС
Standard plan (IND-HNSCC-RM-2L-PEMBROLIZUMAB)
  • Не призначати при попередньому ICI — повторний anti-PD-1 не підтверджений
  • Не відміняти при ендокринних іrAE — тільки гормональна замісна терапія
  • Не додавати пembro до хіміотерапії в цьому сетингу — тільки монотерапія

MDT brief

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-HNSCC-FRAILTY-AGE, RF-HNSCC-HIGH-RISK-BIOLOGY, RF-HNSCC-INFECTION-SCREENING, RF-HNSCC-ORGAN-DYSFUNCTION, RF-HNSCC-TRANSFORMATION-PROGRESSION, RF-LIFESTYLE-SMOKELESS-TOBACCO-PREVENTION, RF-OCC-FORMALDEHYDE-PREVENTION, RF-OCC-WOOD-LEATHER-DUST-PREVENTION
Technical MDT skill metadata (0/16 activated in this plan)
All registered virtual specialists. ✓ — activated for this case; ○ — not activated (available for other clinical scenarios).
Specialistskill_idVersionLast reviewedSign-offsDomain
Cellular therapy specialist (CAR-T)cellular_therapy_specialistv0.1.02026-04-250cellular_therapy
Clinical pharmacistclinical_pharmacistv0.1.02026-04-250clinical_pharmacy
Hematologist / oncohematologisthematologistv0.1.02026-04-250hematology_oncology
Hematopathologist (lymphoma / leukemia / myeloma)hematopathologistv0.1.02026-04-250hematopathology
Infectious disease / hepatologyinfectious_disease_hepatologyv0.1.02026-04-250infectious_diseases
Medical oncologist (solid-tumor chemotherapist)medical_oncologistv0.1.02026-04-250solid_oncology
Molecular geneticist / molecular oncologistmolecular_geneticistv0.1.02026-04-250molecular_oncology
Palliative carepalliative_carev0.1.02026-04-250palliative_care
Pathologist (general)pathologistv0.1.02026-04-250pathology
Primary care / family physicianprimary_carev0.1.02026-04-250primary_care
Psycho-oncologistpsychologistv0.1.02026-04-250psychosocial
Radiation oncologistradiation_oncologistv0.1.02026-04-250radiation_oncology
Radiologistradiologistv0.1.02026-04-250diagnostic_imaging
Social worker / case managersocial_worker_case_managerv0.1.02026-04-250psychosocial
Surgical oncologistsurgical_oncologistv0.1.02026-04-250surgical_oncology
Transplant specialist (BMT)transplant_specialistv0.1.02026-04-250cellular_therapy

Sources cited

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.
NCTTitlePhaseStatusSponsorUASignalsEligibility (excerpt)
NCT06452602Induction Immunochemotherapy Followed by Concurrent Chemoradiotherapy in Patients With ESCC.PHASE2RECRUITINGTianjin Medical University Cancer Institute and Hospital—Surrogate endpoint only Single country
NCT05740995Neoadjuvant Anti-PD-1 Plus Chemotherapy in Locally Advanced Resectable Esophageal Squamous Cell CarcinomaN/ARECRUITINGShanghai Zhongshan Hospital—Small N (<50) Single country
NCT07033572Hybrid Endoscopic Hemithyroidectomy and Targeted Ablation for Bilateral Papillary Thyroid CarcinomaNARECRUITINGFujian Medical University—Single country
NCT05446467Pembrolizumab in Combination With Low-dose PFas Neoadjuvant Treatment for Locally Advanced HNSCCPHASE2RECRUITINGZhejiang Provincial People's Hospital—Single country
NCT07457528Efficacy and Safety of Neo-CRT Plus Serplulimab, Nimotuzumab in Patients With Locally Advanced Resectable ESCCPHASE2RECRUITINGTianjin Medical University Cancer Institute and Hospital—Small N (<50) Single country
NCT07285044The 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 AreasPHASE2RECRUITINGMayo Clinic—Small N (<50) Single country
NCT06509568Neoadjuvant ChemoRadiotherapy Followed by Immunotherapy and Surgery for Resectable Esophageal Squamous Cell Carcinoma（CRIS-2 Trial）PHASE2RECRUITINGZhejiang Cancer Hospital—Single country
NCT06323369Tislelizumab Combined With Chemotherapy Followed by Surgery Versus Up-front Surgery in Resectable Clinically Node-negative Head and Neck Squamous Cell CarcinomaPHASE2RECRUITINGSun Yat-Sen Memorial Hospital of Sun Yat-Sen University—Surrogate endpoint only Single country
NCT06580054Pembrolizumab for the Treatment of Locally Advanced and/or Recurrent Orbital or Periocular Cutaneous Squamous Cell CarcinomaPHASE2RECRUITINGUniversity of Michigan Rogel Cancer Center—Small N (<50) Surrogate endpoint only Single country
NCT04671667Testing What Happens When an Immunotherapy Drug (Pembrolizumab) is Given by Itself Compared to the Usual Treatment of Chemotherapy With Radiation After Surgery for Recurrent Head and Neck Squamous Cell CarcinomaPHASE2RECRUITINGNational Cancer Institute (NCI)—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).
OptionUA registrationNSZUCost orientationAccess pathway
Standard plan
Nivolumab monotherapy (REG-NIVOLUMAB-MONO)
✓ registered✓ covered₴-? — verify pathwayNSZU formulary
Standard plan
Pembrolizumab monotherapy (REG-PEMBROLIZUMAB-MONO)
✓ registered✓ covered₴-? — verify pathwayNSZU formulary
Trial · NCT06452602
Induction Immunochemotherapy Followed by Concurrent Chemoradiotherapy in Patients With ESCC.
No UA site listed — international referral required
— unknown— unknown
self-pay: ₴0/course
Trial sponsor
Trial · NCT05740995
Neoadjuvant Anti-PD-1 Plus Chemotherapy in Locally Advanced Resectable Esophageal Squamous Cell Carcinoma
No UA site listed — international referral required
— unknown— unknown
self-pay: ₴0/course
Trial sponsor
Trial · NCT07033572
Hybrid Endoscopic Hemithyroidectomy and Targeted Ablation for Bilateral Papillary Thyroid Carcinoma
No UA site listed — international referral required
— unknown— unknown
self-pay: ₴0/course
Trial sponsor
Trial · NCT05446467
Pembrolizumab in Combination With Low-dose PFas Neoadjuvant Treatment for Locally Advanced HNSCC
No UA site listed — international referral required
— unknown— unknown
self-pay: ₴0/course
Trial sponsor
Trial · NCT07457528
Efficacy and Safety of Neo-CRT Plus Serplulimab, Nimotuzumab in Patients With Locally Advanced Resectable ESCC
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 · NCT06509568
Neoadjuvant ChemoRadiotherapy Followed by Immunotherapy and Surgery for Resectable Esophageal Squamous Cell Carcinoma（CRIS-2 Trial）
No UA site listed — international referral required
— unknown— unknown
self-pay: ₴0/course
Trial sponsor
Trial · NCT06323369
Tislelizumab Combined With Chemotherapy Followed by Surgery Versus Up-front Surgery in Resectable Clinically Node-negative Head and Neck Squamous Cell Carcinoma
No UA site listed — international referral required
— unknown— unknown
self-pay: ₴0/course
Trial sponsor
Trial · NCT06580054
Pembrolizumab for the Treatment of Locally Advanced and/or Recurrent Orbital or Periocular Cutaneous Squamous Cell Carcinoma
No UA site listed — international referral required
— unknown— unknown
self-pay: ₴0/course
Trial sponsor
Trial · NCT04671667
Testing What Happens When an Immunotherapy Drug (Pembrolizumab) is Given by Itself Compared to the Usual Treatment of Chemotherapy With Radiation After Surgery for Recurrent Head and Neck Squamous Cell 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-HNSCC-L2-HNSCC_RM_2L_NIVOLUMAB-V1 | version: 1 | generated: 2026-07-15T13:33:22.920342+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.