Atezolizumab in this study is expected to have a positive benefit-risk profile for the
treatment of patients with platinum-sensitive relapse of ovarian cancer. Of interest,
atezolizumab is being investigated also in combination with platinum-based doublet
chemotherapy in second line (2L)/ third line (3L) platinum-sensitive recurrent ovarian cancer
patients in ATALANTE (NCT02891824), which also includes bevacizumab in the combination. The
study is proceeding as expected after >100 patients enrolled and under independent Data
Monitoring Committee (IDMC) supervision.
Platinum-containing therapy is considered the treatment of choice for patients with
platinum-sensitive relapse. However the duration of response and the prolongation of the
progression free interval with chemotherapy are usually brief, among other because these
chemotherapy regimens cannot be continued until progression as they are associated with
neurological, renal and hematological toxicity and cannot generally be tolerated for more
than about 6 to 9 cycles.
Niraparib received FDA approval in March 2017 as maintenance treatment of adult patients with
recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete
or partial response to platinum-based chemotherapy. Recently, the European Medicines Agency
(EMA) has also approved niraparib as maintenance monotherapy. Despite the progress brought
about by niraparib, there is a need for a more effective treatment to extend the progression
free interval in this patient population. The combination with immune checkpoint inhibitors
such as anti-death protein 1 (anti-PD1) or anti-death protein ligand 1 (anti-PD-L1) has a
compelling rationale to this aim, especially under the light of the emerging clinical data of
The use of atezolizumab concurrent to platinum-containing chemotherapy followed by niraparib
as maintenance therapy after completion of chemotherapy, as per normal clinical practice, may
provide further benefit to patients in terms of prolonging the progression free interval and
increasing the interval between lines of chemotherapy, hence delaying further hospitalization
and the cumulative toxicities associated with chemotherapy. Additionally, preliminary studies
with atezolizumab suggest an acceptable tolerability profile for long term clinical use in
recurrent ovarian cancer patients and other indications.
Recurrent Ovarian Carcinoma,
Recurrent Ovarian Cancer
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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