Phase II Study With Safety Lead-In of Lenvatinib, Pembrolizumab, and Weekly Paclitaxel for Recurrent Endometrial, Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer

Trial ID # NCT04781088
Phase II
Drug Class Immunotherapy: Checkpoint Inhibitors/PD-1
Drug Name Pembrolizumab
Alternate Drug Names Keytruda, Lambrolizumab, SCH 900475, MK3475, MK-3475
Drugs in Trial Lenvatinib, Paclitaxel, Pembrolizumab
Eligible Participant

Platinum resistant or refractory ovarian cancer

Patients Enrolled

24 ovarian, median 2 prior therapies (1-3)

Therapy Setting

Recurrence

Study Design

Open-Label, Non-randomized

Endpoints

ORR, DoR, PFS, evaluated per RECIST

Efficacy

ORR: 47% (2CR, 9PR, n=24)
DoR: 4.2 months
PFS: 4.6 months

Clinically Significant Adverse Events

Serious AE:
Grade 3-4 AE: hypertension (28%), neutropenia (25%), anemia (19%), rash (19%), leukopenia (16%), lymphopenia (16%), fatigue (16%), diarrhea (13%)

Conclusion

Encouraging activity is seen in ovarian cancer; the regimen is tolerable with manageable side effects; however, a high number of patients discontinued treatment for toxicity per protocol or patient preference

Reference

Backer FJ et al. A phase II study of weekly paclitaxel, lenvatinib and pembrolizumab among patients with recurrent endometrial, ovarian, fallopian tube, or primary peritoneal cancer. SGO (2024)
https://www.clearityfoundation.org/wp-content/uploads/2024/05/Backes-et-al.-SGO-2024-len-pac-pem.pdf

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