OpenOnco · Treatment Plan

Treatment plan — Renal cell carcinoma

PLAN-RCC-NIVO-IPI-001-V1 · v1 · 2026-05-13

Patient

RCC-NIVO-IPI-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

Aggressive plan

★ DEFAULT

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

Primary current-line option selected by ALGO-RCC-METASTATIC-1L at step 3b; branch-driving red flag: RF-FITNESS-ECOG-FIT.

Other current-line alternatives (3 tracks)

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

Standard plan

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

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

Why this branch was chosen

Triggers from the patient profile that fired and drove the chosen branch.

Step 2 → branch 3b

RF-RCC-IMDC-INTERMEDIATE-POOR-RISK ★ winner: IMDC (International Metastatic RCC Database Consortium) intermediate or poor risk score in metastatic clear-cell RCC (Heng JCO 2009). Six adverse factors: KPS <80%, time from diagnosis to systemic therapy <1 year, hemoglobin < lower-limit-of-normal (≈12 g/dL), corrected calcium > ULN, neutrophils > ULN, platelets > ULN. 0 factors = favorable; 1-2 = intermediate; ≥3 = poor. CheckMate-214 (Motzer NEJM 2018) established superiority of nivolumab + ipilimumab over sunitinib for intermediate and poor-risk subgroups (mOS 47 vs 26 mo, ITT). KEYNOTE-426 (pembro+axi) benefits across all risk groups; nivo+ipi preferred in int/poor by long-term durable-response signal. Routes ALGO-RCC-METASTATIC-1L step 1 to IND-RCC-METASTATIC-1L-NIVO-IPI; favorable risk falls through to default IND-RCC-METASTATIC-1L-PEMBRO-AXI. SRC-NCCN-KIDNEY-2025SRC-ESMO-RCC-2024

Step 3b → branch IND-RCC-METASTATIC-1L-NIVO-IPI

RF-FITNESS-ECOG-FIT ★ winner: 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). SRC-NCCN-BCELL-2025SRC-ESMO-DLBCL-2024

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

Aggressive plan

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

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

Standard plan

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

21-day cycles × Pembro up to 2 years; axitinib 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: 2026-05-13.

NCT	Title	Phase	Status	Sponsor	UA	Signals
NCT04693377	Cryoablation Combined With Stereotactic Body Radiation Therapy for the Treatment of Painful Bone Metastases, the CROME Trial	NA	RECRUITING	M.D. Anderson Cancer Center	—	Small N (<50) Single country
NCT06222593	Study to Evaluate the Safety and Efficacy of Bicalutamide in Combination With Sunitinib in Patients With TKIs-resistant RCC	PHASE1 / PHASE2	RECRUITING	State University of New York at Buffalo	—	Small N (<50) Single country
NCT03977571	Deferred Cytoreductive Nephrectomy in Synchronous Metastatic Renal Cell Carcinoma: The NORDIC-SUN-Trial	NA	RECRUITING	Niels Fristrup	—	—
NCT05387863	Decision Aid (DA) for Renal Patients	NA	RECRUITING	NYU Langone Health	—	Small N (<50) Single country
NCT06500455	Testing Longer Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients With Cancer That Has Spread to the Brain	PHASE3	RECRUITING	NRG Oncology	—	—
NCT07175480	PET/CT-Directed Free of Therapy for Metastatic RCC Patients With IMDC Favorable or Intermediate Risk	PHASE2	RECRUITING	Jinling Hospital, China	—	Small N (<50) Surrogate endpoint only Single country
NCT06424080	Oncological and Perioperative Outcomes of Laparoscopic Versus Robotic Partial Nephrectomy for Treatment of Renal Tumors.	NA	RECRUITING	Menoufia University	—	Small N (<50) Single country
NCT06447103	An Investigational Scan (89Zr-DFO-GmAb PET/CT) Compared to Contrast-Enhanced CT for the Detection of Recurrent Clear Cell Renal Cell Cancer After Surgery Comparing Carbonic Anhydrase IX (CAIX) PET CT to Conventional PET CT for Post-Op Staging in Kidney Cancer	PHASE2	RECRUITING	Jonsson Comprehensive Cancer Center	—	Single country
NCT06745609	Prehabilitation Prior to Surgery for Kidney Tumors	NA	RECRUITING	Herlev and Gentofte Hospital	—	Single country
NCT07397611	Pre-NEOSHIFT-RCC: Neoadjuvant HIF-Inhibitor Immunotherapy in RCC	PHASE2	RECRUITING	Dana-Farber Cancer Institute	—	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
Aggressive plan Nivolumab + ipilimumab (RCC, 1L IMDC intermediate/poor) (REG-NIVO-IPI-RCC)	✓ registered	✓ covered	₴-? — verify pathway	NSZU formulary
Standard plan Pembrolizumab + axitinib (RCC, 1L all-risk) (REG-PEMBRO-AXI-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 · NCT04693377 Cryoablation Combined With Stereotactic Body Radiation Therapy for the Treatment of Painful Bone Metastases, the CROME Trial No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06222593 Study to Evaluate the Safety and Efficacy of Bicalutamide in Combination With Sunitinib in Patients With TKIs-resistant RCC No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT03977571 Deferred Cytoreductive Nephrectomy in Synchronous Metastatic Renal Cell Carcinoma: The NORDIC-SUN-Trial No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT05387863 Decision Aid (DA) for Renal Patients No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06500455 Testing Longer Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients With Cancer That Has Spread to the Brain No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT07175480 PET/CT-Directed Free of Therapy for Metastatic RCC Patients With IMDC Favorable or Intermediate Risk No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06424080 Oncological and Perioperative Outcomes of Laparoscopic Versus Robotic Partial Nephrectomy for Treatment of Renal Tumors. No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06447103 An Investigational Scan (89Zr-DFO-GmAb PET/CT) Compared to Contrast-Enhanced CT for the Detection of Recurrent Clear Cell Renal Cell Cancer After Surgery Comparing Carbonic Anhydrase IX (CAIX) PET CT to Conventional PET CT for Post-Op Staging in Kidney Cancer No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06745609 Prehabilitation Prior to Surgery for Kidney Tumors No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT07397611 Pre-NEOSHIFT-RCC: Neoadjuvant HIF-Inhibitor Immunotherapy in RCC 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-RCC-NIVO-IPI-001-V1 | version: 1 | generated: 2026-05-13T10:01:53.021959+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.