| Biomarker | Variant | ESCAT | Evidence | Clinical significance | Drugs | Sources |
|---|---|---|---|---|---|---|
| BIO-HRD-STATUS | HRD-positive — BRCA1/2 mutation OR genomic instability score (GIS) above validated threshold (Myriad MyChoice ≥42 or equivalent FoundationOne CDx HRD signature); ~50% of high-grade serous ovarian carcinoma | IA |
Evidence cited from clinical guidelines; per-source evidence levels not yet structured. See Phase-2-of-CIViC-pivot for re-cite roadmap. | HRD-positive high-grade serous ovarian carcinoma (~50% — encompassing BRCA1/2-mutated and BRCA-WT/HRD+): PARP inhibitor maintenance after platinum response is FDA-approved 1L. Olaparib monotherapy maintenance for BRCA1/2-mutated newly-diagnosed advanced ovarian after CR/PR to platinum (SOLO-1 Moore NEJM 2018 — mPFS not reached vs 13.8 mo, HR 0.30) per SRC-NCCN-OVARIAN-2025, SRC-ESMO-OVARIAN-2024. Olaparib + bevacizumab maintenance for HRD-positive (BRCA-mut OR HRD-genomic) post-1L platinum + bevacizumab (PAOLA-1 Ray-Coquard NEJM 2019 — HRD subgroup mPFS 37 vs 17 mo, HR 0.33). Niraparib monotherapy maintenance is approved for all-comers (PRIMA Gonzalez-Martin NEJM 2019), with the strongest benefit in HRD-positive subgroup. | olaparib monotherapy maintenance (1L BRCA1/2-mut per SRC-NCCN-OVARIAN-2025, SRC-ESMO-OVARIAN-2024) olaparib + bevacizumab maintenance (1L HRD-positive non-BRCA per SRC-NCCN-OVARIAN-2025) niraparib monotherapy maintenance (1L per SRC-NCCN-OVARIAN-2025, all-comers benefit, HRD-positive strongest) rucaparib monotherapy (2L maintenance / treatment per SRC-NCCN-OVARIAN-2025) |
|
| Biomarker | Status |
|---|---|
| BIO-BRCA1-BRCA2-GERMLINE | BIO definition in KB; no ESCAT BMA entry — verify with clinician |
IND-OVARIAN-ADVANCED-1L-CARBO-PACLI-HRD-OLAP| ID | Name | Priority | Category | Where to order | Needed for |
|---|---|---|---|---|---|
| TEST-CBC | Complete Blood Count with Differential | Critical | lab | — | all tracks |
| # | Owner | Topic | Action |
|---|---|---|---|
| 1 | infectious_disease_hepatology | Infection / hepatic safety BLOCKING | Has HBV serology (HBsAg, anti-HBc total) been done? Status must be known before starting anti-CD20 therapy. |
| 2 | hematologist | Staging / disease burden | What is the current LDH? Marker of tumor burden and transformation. |
| 3 | clinical_pharmacist | Specialist review | Chemoimmunotherapy regimen — drug-drug interactions, dose adjustments, premedication. |
| 4 | molecular_geneticist | Specialist review | Indication references an actionable genomic biomarker — mutation / target / actionability interpretation needed. |
| Specialist | skill_id | Version | Last reviewed | Sign-offs | Domain |
|---|---|---|---|---|---|
| Cellular therapy specialist (CAR-T) | cellular_therapy_specialist | v0.1.0 | 2026-04-25 | 0 | cellular_therapy |
| Clinical pharmacist | clinical_pharmacist | v0.1.0 | 2026-04-25 | 0 | clinical_pharmacy |
| Hematologist / oncohematologist | hematologist | v0.1.0 | 2026-04-25 | 0 | hematology_oncology |
| Hematopathologist (lymphoma / leukemia / myeloma) | hematopathologist | v0.1.0 | 2026-04-25 | 0 | hematopathology |
| Infectious disease / hepatology | infectious_disease_hepatology | v0.1.0 | 2026-04-25 | 0 | infectious_diseases |
| Medical oncologist (solid-tumor chemotherapist) | medical_oncologist | v0.1.0 | 2026-04-25 | 0 | solid_oncology |
| Molecular geneticist / molecular oncologist | molecular_geneticist | v0.1.0 | 2026-04-25 | 0 | molecular_oncology |
| Palliative care | palliative_care | v0.1.0 | 2026-04-25 | 0 | palliative_care |
| Pathologist (general) | pathologist | v0.1.0 | 2026-04-25 | 0 | pathology |
| Primary care / family physician | primary_care | v0.1.0 | 2026-04-25 | 0 | primary_care |
| Psycho-oncologist | psychologist | v0.1.0 | 2026-04-25 | 0 | psychosocial |
| Radiation oncologist | radiation_oncologist | v0.1.0 | 2026-04-25 | 0 | radiation_oncology |
| Radiologist | radiologist | v0.1.0 | 2026-04-25 | 0 | diagnostic_imaging |
| Social worker / case manager | social_worker_case_manager | v0.1.0 | 2026-04-25 | 0 | psychosocial |
| Surgical oncologist | surgical_oncologist | v0.1.0 | 2026-04-25 | 0 | surgical_oncology |
| Transplant specialist (BMT) | transplant_specialist | v0.1.0 | 2026-04-25 | 0 | cellular_therapy |
| NCT | Title | Phase | Status | Sponsor | UA | Signals | Eligibility (excerpt) |
|---|---|---|---|---|---|---|---|
| NCT06677190 | Belzutifan in Recurrent Clear Cell Carcinoma of Gynecologic Origin | PHASE2 | RECRUITING | Dana-Farber Cancer Institute | — | Small N (<50) Surrogate endpoint only Single country | |
| NCT07402915 | Drug-drug Interaction Study With AZD5335 and Itraconazole in Participants With Ovarian, Primary Peritoneal, or Fallopian Tube Cancer | PHASE1 | RECRUITING | AstraZeneca | — | Phase 1 only Small N (<50) | |
| NCT06065462 | Safety and Efficacy of Targeting PP2A in Ovarian Clear Cell Carcinoma Using Dostarlimab and LB-100 | PHASE1 / PHASE2 | RECRUITING | M.D. Anderson Cancer Center | — | Small N (<50) Single country | |
| NCT05799274 | Safety of RAD301 in Healthy Human Volunteers and Patients With Pancreatic Cancer or Other Solid Tumors | PHASE1 | RECRUITING | Radiopharm Theranostics, Ltd | — | Phase 1 only Small N (<50) Single country | |
| NCT07495397 | Single-arm, Prospective Clinical Trial of Efficacy and Safety of Daphnetin Capsules Combined With TC Regimen for Targeted Maintenance Therapy After Initial Treatment of Stage III-IV Epithelial Ovarian Cancer (RO/R1) | NA | RECRUITING | The First Hospital of Jilin University | — | Surrogate endpoint only Single country | |
| NCT04890613 | Study of CX-5461 in Patients With Solid Tumours and BRCA1/2, PALB2 or Homologous Recombination Deficiency (HRD) Mutation | PHASE1 | RECRUITING | Senhwa Biosciences, Inc. | — | Phase 1 only | |
| NCT06855706 | An Automated Personalized Physical Activity Intervention to Improve Immune Function and Clinical Outcomes in Stage II-IV Ovarian, Primary Peritoneal or Fallopian Tube Cancer and Newly Diagnosed Endometrial Cancer, Life on the Go 3 Study | NA | RECRUITING | Roswell Park Cancer Institute | — | Single country | |
| NCT06180356 | Niraparib Rechallenge After Surgery in Ovarian Cancer Patients With Oligometastatic Progression | PHASE2 | RECRUITING | MedSIR | — | Small N (<50) Surrogate endpoint only Single country | |
| NCT07470853 | A Study of MUC16-Directed Antibody Drug Conjugate HWK-016 in Participants With Advanced Solid Tumors. | PHASE1 | RECRUITING | Whitehawk Therapeutics, Inc. | — | Phase 1 only Single country | |
| NCT05659381 | Heated Intraperitoneal Chemotherapy Followed by Niraparib for Ovarian, Primary Peritoneal and Fallopian Tube Cancer | PHASE3 | RECRUITING | GOG Foundation | — | Surrogate endpoint only Single country |
Verify recruitment status directly with the trial site. ctgov data can lag behind current UA-site status.
| Option | UA registration | NSZU | Cost orientation | Access pathway |
|---|---|---|---|---|
| Aggressive plan Carboplatin + Paclitaxel (ovarian 3-weekly) (REG-CARBO-PACLI-OVARIAN) | ✓ registered | ✓ covered | ₴-? — verify pathway | NSZU formulary |
| Aggressive plan Olaparib maintenance (HRD+ ovarian post-platinum response) (REG-OLAPARIB-MAINT-OVARIAN) | ✓ registered | ✓ covered | ₴-? — verify pathway | NSZU formulary |
| Trial · NCT06677190 Belzutifan in Recurrent Clear Cell Carcinoma of Gynecologic Origin No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT07402915 Drug-drug Interaction Study With AZD5335 and Itraconazole in Participants With Ovarian, Primary Peritoneal, or Fallopian Tube Cancer No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT06065462 Safety and Efficacy of Targeting PP2A in Ovarian Clear Cell Carcinoma Using Dostarlimab and LB-100 No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT05799274 Safety of RAD301 in Healthy Human Volunteers and Patients With Pancreatic Cancer or Other Solid Tumors No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT07495397 Single-arm, Prospective Clinical Trial of Efficacy and Safety of Daphnetin Capsules Combined With TC Regimen for Targeted Maintenance Therapy After Initial Treatment of Stage III-IV Epithelial Ovarian Cancer (RO/R1) No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT04890613 Study of CX-5461 in Patients With Solid Tumours and BRCA1/2, PALB2 or Homologous Recombination Deficiency (HRD) Mutation No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT06855706 An Automated Personalized Physical Activity Intervention to Improve Immune Function and Clinical Outcomes in Stage II-IV Ovarian, Primary Peritoneal or Fallopian Tube Cancer and Newly Diagnosed Endometrial Cancer, Life on the Go 3 Study No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT06180356 Niraparib Rechallenge After Surgery in Ovarian Cancer Patients With Oligometastatic Progression No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT07470853 A Study of MUC16-Directed Antibody Drug Conjugate HWK-016 in Participants With Advanced Solid Tumors. No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT05659381 Heated Intraperitoneal Chemotherapy Followed by Niraparib for Ovarian, Primary Peritoneal and Fallopian Tube Cancer 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: 2026-06-11.