OpenOnco · Treatment Plan

Treatment plan — Renal cell carcinoma

PLAN-RCC-AXI-PEMBRO-001-V1 · v1 · 2026-05-12

Patient

RCC-AXI-PEMBRO-001 · Algorithm: ALGO-RCC-METASTATIC-1L

DiagnosisRenal cell carcinoma

MOH / ICD-10C64

ICD-O-38312/3; C64.9

StageIV

Histologyclear_cell_rcc

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-RCC-METASTATIC-1L-PEMBRO-AXI

Regimen

Pembrolizumab + axitinib (RCC, 1L all-risk)

Drugs + NSZU

Pembrolizumab (DRUG-PEMBROLIZUMAB) 200 mg IV q3w · Up to 2 years · IV ⚠ NSZU — not for this indication
Axitinib (DRUG-AXITINIB) 5 mg PO BID continuous · Continuous · PO ⚠ NSZU — not for this indication

Reason

Primary current-line option selected by ALGO-RCC-METASTATIC-1L at step 3a.

Other current-line alternatives (3 tracks)

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

Aggressive plan

Indication

IND-RCC-METASTATIC-1L-NIVO-IPI

Regimen

Nivolumab + ipilimumab (RCC, 1L IMDC intermediate/poor)

Drugs + NSZU

Nivolumab (DRUG-NIVOLUMAB) 3 mg/kg IV induction → 480 mg flat IV q4w maintenance · Induction q3w x 4 + ipi · IV ✓ NSZU covered
Ipilimumab (DRUG-IPILIMUMAB) 1 mg/kg IV · Days 1 of cycles 1-4 only · IV ⚠ NSZU — not for this indication

Reason

Current-line alternative presented for HCP consideration

Aggressive plan

Indication

IND-RCC-METASTATIC-1L-LENV-PEMBRO

Regimen

Lenvatinib + pembrolizumab (RCC, 1L)

Drugs + NSZU

Lenvatinib (DRUG-LENVATINIB) 20 mg PO daily · Continuous daily dosing · PO ⚠ NSZU — not for this indication
Pembrolizumab (DRUG-PEMBROLIZUMAB) 200 mg IV q3w (or 400 mg q6w) · Until progression or 2 years maximum · IV ⚠ NSZU — not for this indication

Reason

Current-line alternative presented for HCP consideration

Standard plan

Indication

IND-RCC-METASTATIC-1L-NIVO-CABO

Regimen

Nivolumab + cabozantinib (RCC, 1L)

Drugs + NSZU

Nivolumab (DRUG-NIVOLUMAB) 240 mg IV q2w (or 480 mg IV q4w) · Until progression or max 2 years · IV ✓ NSZU covered
Cabozantinib (DRUG-CABOZANTINIB) 40 mg PO daily · Continuous daily dosing (note: 40 mg in combination — lower than 60 mg monotherapy) · 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-CECT-CAP	CECT chest/abdomen/pelvis	Critical	imaging	—	all tracks
TEST-BRAIN-MRI-CONTRAST	Brain MRI with contrast	Standard	—	—	aggressive

Red flags — PRO / CONTRA aggressive

PRO-AGGRESSIVE

Triggers that push toward the aggressive track

Fit performance status (ECOG 0-1): patient is fully active or restricted in physically strenuous activity but ambulatory and able to carry out light work. Eligible for full-dose chemotherapy and intensive regimens (CHOEP, BEACOPP-escalated, HD-MTX, ASCT consolidation, CAR-T). RF-FITNESS-ECOG-FIT
Solitary kidney OR baseline CrCl <50 mL/min — limits cisplatin alternatives + impacts surveillance imaging.RF-RCC-ORGAN-DYSFUNCTION
CNS metastases — ICI doublet retains intracranial activity; cabozantinib + nivolumab also CNS-active.RF-RCC-TRANSFORMATION-PROGRESSION

CONTRA-AGGRESSIVE

Hard contraindications to escalation

What NOT to do

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

Aggressive plan (IND-RCC-METASTATIC-1L-LENV-PEMBRO)

Do NOT use in ECOG ≥ 2 — lenvatinib toxicity (hypertension, proteinuria, stomatitis) is poorly tolerated
Do NOT use with uncontrolled hypertension — manage BP to <140/90 before starting
Do NOT add sunitinib or other TKI — triplet not studied and expected additive toxicity
Do NOT extend pembrolizumab beyond 2 years (35 cycles)
Do NOT apply CLEAR dose (lenvatinib 20mg) without monitoring — dose reductions are common and expected

Standard plan (IND-RCC-METASTATIC-1L-NIVO-CABO)

Do NOT use cabozantinib 60mg in combination — use 40mg per CheckMate-9ER protocol
Do NOT use in active autoimmune disease
Do NOT extend nivolumab beyond 2 years (NCCN guidance)
Do NOT add anti-VEGF agents (bevacizumab/sunitinib) — triplet not studied

Timeline

Treatment timeline — derived from regimen + monitoring schedule

Standard plan

Induction · Pembrolizumab + axitinib (RCC, 1L all-risk)

21-day cycles × Pembro up to 2 years; axitinib until progression

Aggressive plan

Induction · Nivolumab + ipilimumab (RCC, 1L IMDC intermediate/poor)

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

Aggressive plan

Induction · Lenvatinib + pembrolizumab (RCC, 1L)

21-day cycles × Until progression or max 35 cycles (~2 years) for pembrolizumab; lenvatinib continues until progression

Standard plan

Induction · Nivolumab + cabozantinib (RCC, 1L)

28-day cycles × Until progression or max ~24 cycles nivolumab; cabozantinib continues 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 (2 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.

Skills (recommended) — for consideration (1)

Clinical pharmacist recommended
Chemoimmunotherapy regimen — drug-drug interactions, dose adjustments, premedication.

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-RCC-FRAILTY-AGE, RF-RCC-HIGH-RISK-BIOLOGY, RF-RCC-IMDC-INTERMEDIATE-POOR-RISK, RF-RCC-INFECTION-SCREENING, RF-RCC-ORGAN-DYSFUNCTION, RF-RCC-TRANSFORMATION-PROGRESSION

Technical MDT skill metadata (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-CHECKMATE-9ER-CHOUEIRI-2021: Nivolumab plus Cabozantinib versus Sunitinib for Advanced Renal-Cell Carcinoma (2021)
SRC-CLEAR-MOTZER-2021: Lenvatinib plus Pembrolizumab or Everolimus for Advanced Renal Cell Carcinoma (2021)
SRC-ESMO-RCC-2024: ESMO Renal Cell Carcinoma (2024)
SRC-NCCN-KIDNEY-2025: NCCN Kidney 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: 2026-05-12.

NCT	Title	Phase	Status	Sponsor	UA	Signals
NCT03291028	Analysis of Primary and Metastatic Tumors in Patients With Renal Cell Carcinoma and Urothelial Carcinoma	N/A	RECRUITING	Fox Chase Cancer Center	—	Small N (<50) Single country
NCT06479811	[212Pb]VMT-Alpha-NET in Metastatic or Inoperable Somatostatin-Receptor Positive Gastrointestinal Neuroendocrine Tumors, Pheochromocytoma/Paragangliomas, Small Cell Lung, Renal Cell, and Head and Neck Cancers	PHASE1	RECRUITING	National Cancer Institute (NCI)	—	Phase 1 only Single country
NCT06699602	A Study of Cemiplimab and Fianlimab in People With Clear Cell Renal Cell Carcinoma	PHASE2	RECRUITING	Memorial Sloan Kettering Cancer Center	—	Small N (<50) Single country
NCT07485114	Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors	N/A	RECRUITING	Daniel Keizman	—	Surrogate endpoint only Single country
NCT05024214	Phase Ib/II Trial of Envafolimab Plus Lenvatinib for Subjects With Solid Tumors	PHASE1 / PHASE2	RECRUITING	3D Medicines (Sichuan) Co., Ltd.	—	Surrogate endpoint only Single country
NCT05917106	Renal Cancer Monitoring Based on ctDNA Methylomics: A Prospective Cohort Study (MEMORY Study)	N/A	RECRUITING	Jinling Hospital, China	—	Single country
NCT05363657	International REgistry of COnservative or Radical Treatment of Localized Kidney Tumors	N/A	RECRUITING	Azienda Ospedaliero-Universitaria Careggi	—	—
NCT06124976	Multicenter Clinical Trial of ST-02 for Ablation of Upper Tract Urothelial Carcinoma	PHASE2 / PHASE3	RECRUITING	University of British Columbia	—	Single country
NCT07190638	Comparison of Outcomes and Surgical Time Between Cortical and Medullary Suture vs. Medullary-Only Suture: Cortex Clinical Trial	NA	RECRUITING	Brazilian Institute of Robotic Surgery	—	Single country
NCT07062549	Study of 111In-XYIMSR-01 SPECT/CT in Patients With Metastatic Clear Cell Renal Cell	PHASE1	RECRUITING	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	—	Phase 1 only 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 Pembrolizumab + axitinib (RCC, 1L all-risk) (REG-PEMBRO-AXI-RCC)	✓ registered	✓ covered	₴-? — verify pathway	NSZU formulary
Aggressive plan Nivolumab + ipilimumab (RCC, 1L IMDC intermediate/poor) (REG-NIVO-IPI-RCC)	✓ registered	✓ covered	₴-? — verify pathway	NSZU formulary
Aggressive plan Lenvatinib + pembrolizumab (RCC, 1L) (REG-LENV-PEMBRO-RCC)	✓ registered	✓ covered	₴-? — verify pathway	NSZU formulary
Standard plan Nivolumab + cabozantinib (RCC, 1L) (REG-NIVO-CABO-RCC) 1/2 component drug(s) not registered in Ukraine +1	✗ not registered	✗ out-of-pocket	₴-? — verify pathway	not recorded
Trial · NCT03291028 Analysis of Primary and Metastatic Tumors in Patients With Renal Cell Carcinoma and Urothelial Carcinoma No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06479811 [212Pb]VMT-Alpha-NET in Metastatic or Inoperable Somatostatin-Receptor Positive Gastrointestinal Neuroendocrine Tumors, Pheochromocytoma/Paragangliomas, Small Cell Lung, Renal Cell, and Head and Neck Cancers No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06699602 A Study of Cemiplimab and Fianlimab in People With Clear Cell Renal Cell Carcinoma No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT07485114 Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT05024214 Phase Ib/II Trial of Envafolimab Plus Lenvatinib for Subjects With Solid Tumors No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT05917106 Renal Cancer Monitoring Based on ctDNA Methylomics: A Prospective Cohort Study (MEMORY Study) No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT05363657 International REgistry of COnservative or Radical Treatment of Localized Kidney Tumors No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06124976 Multicenter Clinical Trial of ST-02 for Ablation of Upper Tract Urothelial Carcinoma No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT07190638 Comparison of Outcomes and Surgical Time Between Cortical and Medullary Suture vs. Medullary-Only Suture: Cortex Clinical Trial No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT07062549 Study of 111In-XYIMSR-01 SPECT/CT in Patients With Metastatic Clear Cell Renal Cell 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-RCC-AXI-PEMBRO-001-V1 | version: 1 | generated: 2026-05-12T18:41:26.885291+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.