Table 3.
Study | Patient Selection | Number of Patients | Treatment | Most Common Adverse Events Reported any Grade | DCR | ORR |
---|---|---|---|---|---|---|
MEDIOLA, NCT02734004 | Recurrent platinum-sensitive OC, FTC, PPC with germline BRCA mutations in second-line or later therapy | 32 | Durvalumab (anti PD-1) + olaparib Durvalumab + olaparib + bevacizumab |
Hypothyroidism (15%); cutaneous rash (12%) | 81% at 12 weeks | 63% at 12 weeks |
TOPACIO/Keynote-162, NCT02657889 | Recurrent OC, FTC, PPC with germline BRCA mutations | 60 | Pembrolizumb (anti PD-1) + niraparib | Fatigue (53%), nausea (42%), anemia (36%), constipation (36%) | 45% | 25% |
NCT02484404 | Recurrent OC, FTC, PPC received least two prior platinum-containing regimens, platinum resistant or refractory | 26 | Durvalumab + olaparib (N = 12) or cediranib (n = 14) | Olaparib arm: fatigue (75%), nausea (58%), Abdominal pain (42%) (any grade); Cediranib arm: hypertension (86%), diarrhea (72%) (any grade) |
Not reported | 17% (Olaparib arm); 55% (Cediranib arm) |
NCT02873962 | Recurrent OC, FTC, PPC. All histotypes. Platinum-resistant or platinum-sensitive disease. |
38 | Nivolumab (anti PD-1) + bevacizumab | Fatigue (47%), headache (29 %), myalgia (29%), serum amylase level increase (29%) (any grade). | Not reported | 40.0% in platinum-sensitive (patients) 16.7% in platinum-resistant (patients) |
ICIs: immune checkpoint inhibitors, PARPi: inhibitors of poly (ADP-ribose) polymerase, VEGF: vascular endothelial growth factor, OC: ovarian cancer, FTC: fallopian tube cancer, PPC: primary peritoneal cancer, DCR: disease control rate, ORR: objective response rate.