A phase 1b, dose finding, open label study of the safety and tolerability of carboplatin-cyclophosphamide combined with atezolizumab, an antibody that targets programmed death ligand 1 (PD-L1), in patients with advanced breast cancer, ovarian, cervical and endometrial cancer.
- Conditions
- gynaecologische neoplasmatabreast cancergynaecological cancer10006291
- Registration Number
- NL-OMON45572
- Lead Sponsor
- ederlands Kanker Instituut
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 12
1.Histological or cytological proof of advanced breast cancer (M1) or gynaecological (cervix (M1, FIGO IVA/IVB), ovarian (after recurrence on carboplatin and/or paclitaxel) or endometrial (T3-T4, FIGO IVA/IVB) cancer) cancer pre-treated with maximally one line of systemic chemotherapy in the advanced setting and any line of hormonal therapy for advanced disease and potentially benefitting from carboplatin-cyclophosphamide and atezolizumab. (prior (neo-) adjuvant chemotherapy is accepted and does not count as one line, since administered in early stage disease);
2. Maximally one line of platinum containing pre-treatment is allowed in either adjuvant or metastatic setting
3. Men and women >=18 years;
4. Able and willing to give written informed consent;
5. WHO performance status of 0 or 1;
6. Life expectancy >= 3 months, allowing adequate follow up of toxicity evaluation and antitumor activity;
7. Minimal acceptable safety laboratory values
1. Any treatment with investigational drugs within 28 days prior to receiving the first dose of investigational treatment; or 21 days for standard (neo-)adjuvant chemotherapy, hormonal and immunotherapy;
2. Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis, fatty liver, and inherited liver disease;
3. Known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies.
4. Women who have a positive pregnancy test (urine/serum) and/or who ware breast feeding;
5. Unreliable contraceptive methods
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>• To determine a safe dose combination of carboplatin-cyclophosphamide combined<br /><br>with atezolizumab fixed dose in patients with advanced breast cancer and<br /><br>gynecologic cancer (ovarian, cervical and endometrial cancer).</p><br>
- Secondary Outcome Measures
Name Time Method <p>• To evaluate the tolerability of carboplatin-cyclophosphamide in combination<br /><br>with atezolizumab;<br /><br>• To assess preliminary antitumor activity of carboplatin-cyclophosphamide<br /><br>combined with atezolizumab in advanced breast cancer, ovarian, cervical and<br /><br>endometrial cancer.</p><br>