OncoMatch/Clinical Trials/NCT05255471
MITO 35B: Olaparib Beyond Progression Compared to Platinum Chemotherapy After Secondary Cytoreductive Surgery in Recurrent Ovarian Cancer Patients.
Is NCT05255471 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Olaparib and Chemotherapy drug for ovarian cancer.
Treatment: Olaparib · Chemotherapy drug — MITO 35b is designed as randomized, open label, phase III trial that aims to assess the efficacy of olaparib maintenance beyond progression compered to standard platinum-based chemotherapy after secondary cytoreductive surgery. The target population of this study are ovarian cancer patients who experience a disease recurrence or progression to a first line maintenance therapy with PARPi; at progression patients must have received a secondary cytoreduction according to clinical practice.
Check if I qualifyExtracted eligibility criteria
Cancer type
Ovarian Cancer
Biomarker criteria
Allowed: BRCA1 mutation
Documented BRCA1/2 status. Both mutated and wild type patients are eligible.
Allowed: BRCA2 mutation
Documented BRCA1/2 status. Both mutated and wild type patients are eligible.
Allowed: BRCA1 wild-type
Documented BRCA1/2 status. Both mutated and wild type patients are eligible.
Allowed: BRCA2 wild-type
Documented BRCA1/2 status. Both mutated and wild type patients are eligible.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: platinum-based chemotherapy — first-line
Patients must have received only one previous line of a platinum containing regimen not containing bevacizumab
Must have received: PARP inhibitor — first-line maintenance
Patient must have received a first-line maintenance therapy with a PARPi for at least 6 months
Cannot have received: bevacizumab (bevacizumab)
Patients must have received only one previous line of a platinum containing regimen not containing bevacizumab
Cannot have received: allogenic bone marrow transplant
Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT)
Lab requirements
Blood counts
Haemoglobin ≥ 10.0 g/dL with no blood transfusion in the past 28 days; ANC ≥ 1.5 x 10^9/L; Platelet count ≥ 100 x 10^9/L
Kidney function
Creatinine clearance estimated of ≥51 mL/min using Cockcroft-Gault equation or 24 hour urine test
Liver function
Total serum bilirubin ≤ 1.5 x institutional ULN; AST and ALT ≤ 2.5 x ULN (or ≤ 5x ULN if liver metastases are present)
Patients must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined below
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify