| Trial ID # | NCT05446298; PRESERVE-004 |
| Phase | II |
| Drug Class | Immunotherapy: Checkpoint Inhibitors/CTLA-4 |
| Drug Name | Gotistobart |
| Alternate Drug Names | BNT316, ONC-392 |
| Drugs in Trial | Gotistobart, Pembrolizumab |
| Eligible Participant | Platinum resistant high grade serous ovarian cancer; must have received prior bevacizumab |
| Patients Enrolled | 62; 1mg/kg cohort: 33 patients, median 4 prior therapies (2-9), 2mg/kg cohort: 29 patients, median 3 prior therapies (1-8) |
| Therapy Setting | Recurrence |
| Study Design | Open-Label, Randomized |
| Endpoints | ORR, DCR, evaluated per RECIST |
| Efficacy | 1mg/kg cohort: 2mg/kg cohort: |
| Clinically Significant Adverse Events | Gotistobart 1 mg/kg vs 2 mg/kg |
| Conclusion | Early results show encouraging safety and clinical activity in platinum resistant ovarian cancer patients receiving gotistobart + pembrolizumab |
| Reference | Barlin JN et al. A randomized, phase II, dose optimization of gotistobart, a pH-sensitive anti-CTLA-4, in combination with standard dose pembrolizumab in platinum-resistant recurrent ovarian cancer: Safety, efficacy and dose optimization (PRESERVE-004/GOG-3081). Ann Oncol (2024) 35 (2) abstract LBA32 |
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