A phase II study of the anti-PDL1 antibody atezolizumab, bevacizumab and acetylsalicylic acid to investigate safety and efficacy of this combination in recurrent platinum-resistant ovarian, fallopian tube or primary peritoneal adenocarcinoma

Phase 2

Completed

Conditions: Ovarian cancer and fallopian tube cancer
10038594

Registration Number: NL-OMON50342

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 38

Inclusion Criteria

- Recurrent, histologically proven, platinum-resistant, epithelial ovarian,
fallopian tube and primary peritoneal cancer in advanced or metastatic stage.
Histological diagnosis by image guided biopsy, laparoscopy or laparotomy.
Tumors diagnosed on cytology only and borderline tumors are excluded.
- At least one lesion accessible to biopsy without putting patient at risk
- WHO PS: 0-2 for patients having received no more than two previous lines of
therapy. WHO PS: 0-1 for patients having received >2 previous lines of therapy
- Prior chemotherapy or bevacizumab:
* No prior treatment with hyperthermic intraperitoneal chemotherapy
(HIPEC) is allowed
* Any number of platinum-based chemotherapy lines are allowed but a
maximum of 2 previous non-platinum containing lines
* Prior treatment with bevacizumab or other targeted agent against VEGF or
VEGF receptor is allowed, but at least 18 weeks must have elapsed since their
last administration
* Eligible patients with * 2 previous treatment lines must have been
previously exposed to bevacizumab or other targeted agents against VEGF or VEGF
receptor
- Patients may have had prior therapy providing the following conditions are
met:
* Radiation therapy: recovery period of 14 days prior to the first study
treatment; exception: single fraction radiotherapy with the indication of pain
control
* Systemic anti-tumoral treatment: wash-out period of 21 days prior to the
first study treatment
- Recovery from any toxic effects of prior therapy to * Grade 1 per the
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI
CTCAE v4.0) except fatigue or alopecia
- Absence of any psychological, familial, sociological or geographical
condition potentially hampering compliance with the study protocol
- Signed Informed Consent Form

Exclusion Criteria

- Age < 18 years
- Life expectancy of < 12 weeks
- No adequate hematologic and end-organ function
- Use of acetylsalicylic acid, NSAIDs or other COX-2 inhibitors that cannot be
stopped at baseline and for the whole duration of the study. Occasional use is
allowed.
- History of bowel obstruction related to abdominal fistula, tracheoesophageal
fistula, gastrointestinal perforation or intra-abdominal abscess.
- Clinical symptoms of recent bowel obstruction or paralytic ileus, but
excluding postoperative obstruction (within 4 weeks after abdominal surgery),
or evidence of recto-sigmoid involvement by pelvic examination or bowel
involvement on CT scan
- Treatment with a live, attenuated vaccine within 4 weeks prior to initiation
of study treatment, or anticipation of need for such a vaccine during
atezolizumab treatment or within 5 months after the final dose of atezolizumab.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective of the study is to assess the efficacy and safety of 3<br /><br>different treatment arms (bevacizumab alone, atezolizumab-bevacizumab<br /><br>combination with acetylsalicylic acid and atezolizumab-bevacizumab combination<br /><br>with placebo) in advanced recurrent platinum-resistant ovarian, fallopian tube,<br /><br>or primarily peritoneal cancer patients in order to select the optimal<br /><br>treatments for further development in phase III<br /><br><br /><br>The outcome parameter is the rate of Progression-Free Survival at 6 months<br /><br>(PFS-6) according to RECIST v1.1 as assessed by the local investigator.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secundary study parameters: overall survival, progression free survival, second<br /><br>progression free survival, clinical response, disease control and duration of<br /><br>response as measured by RECIST v1.1 and irRECIST.</p><br>