Background
Treatment options for recurrent ovarian cancer are of limited clinical benefit and adversely affect patient quality of life, representing an unmet need for tolerable and effective therapies.
About the Study
This is a phase 2 clinical trial where all eligible patients had recurrent ovarian cancer and received the 3 drug combination.
The study assessed the efficacy and safety of the combination of Keytruda with Avastin and oral Cyclophosphamide in patients with recurrent platinum-sensitive, platinum-resistant or refractory epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Patients were enrolled regardless of their PD-L1 expression and BRCA status.
Patients received intravenous Keytruda plus Avastin every 3 weeks and oral Cyclophosphamide once daily during the treatment until disease progression, unacceptable toxic effects or withdrawal of consent.
Results
- 40 women were enrolled. Three women (7.5%) had complete remission, 16 (40%) had partial shrinkage of their disease and 19 (47.5%) had stable disease with no worsening in response to the treatment. This means that 95% of the patients benefited from the 3 drug combination.
- Among the 95%, durable benefit of more than 12 months was seen in 10 (25%) patients
- Median time with no progression of disease was 10 months.
Side Effects
The most common treatment-related adverse events were hypertension and lymphopenia. The most frequently reported adverse events included fatigue, diarrhea and hypertension.
Conclusions
- In this phase 2 clinical trial, the combination of Keytruda with Avastin and oral Cyclophosphamide was well tolerated and demonstrated clinical benefit in 95% of patients and durable treatment benefit was observed in 25% of the 95% patients with recurrent ovarian cancer.
- This combination may represent a future treatment strategy for recurrent ovarian cancer.
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