Phase 2 Randomized Open-label Multicenter Study of Combination of ONC-392 and Pembrolizumab for the Treatment of Patients With Platinum Resistant Ovarian Cancer (PROC)

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: ORR: 25% (1CR, 7PR, n=32) DCR: 46.9% (1CR, 7PR, 7SD, n=32) 2mg/kg cohort: ORR: 27.6% (2CR, 6PR, n=29) DCR: 41.4% (2Cr, 6PR, 4SD, n=29)
Clinically Significant Adverse Events	Gotistobart 1 mg/kg vs 2 mg/kg Serious AE: overall (54.5. vs 72.4%) Grade 3-4 AE: overall (41.4 vs 45.5%)
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 https://www.clearityfoundation.org/wp-content/uploads/2024/11/Gotistobart-and-Pembro-ESMO-2024-abstract.pdf