Pembrolizumab in Combination With Bevacizumab and Pegylated Liposomal Doxorubicin in Patients With Ovarian Cancer (PEMBOV)
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|ClinicalTrials.gov Identifier: NCT03596281|
Recruitment Status : Not yet recruiting
First Posted : July 23, 2018
Last Update Posted : July 23, 2018
French multicenter, open-label, phase 1b, evaluating via the mTPI design the paired treatment of pembrolizumab and PLD (cohort A), pembrolizumab and bevacizumab (cohort B) and finally the combination treatment of the three drugs PLD plus bevacizumab and pembrolizumab (cohort C). Thanks to an expansion cohort C+ the ORR will be evaluated in a total of 19 patients at the RP2 D using an exact binomial one-step Fleming-type design.
Cohort A and B will be opened for inclusions at the same time. Once safety of the dual combinations confirmed in cohorts A and B,cohort C will be opened for inclusions.
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer||Drug: Pembrolizumab Drug: Bevacizumab Drug: pegylated liposomal doxorubicin (PLD)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||Cohort A and B will be opened for inclusions at the same time. Once safety of the dual combinations confirmed in cohorts A and B, cohort C will be opened for inclusions.|
|Masking:||None (Open Label)|
|Official Title:||An Open-label Phase 1 of Pembrolizumab in Combination With Bevacizumab and Pegylated Liposomal Doxorubicin in Patients With Platinum Resistant Epithelial Ovarian Cancer|
|Estimated Study Start Date :||August 2018|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2024|
|Experimental: Cohort A||
200mg Q3W IV
Drug: pegylated liposomal doxorubicin (PLD)
15 or 20 or 30 mg/m² Q3W IV
|Experimental: Cohort B||
200mg Q3W IV
400 or 300 mg Q3W IV
- Dose Limiting Toxicity (DLT) [ Time Frame: Up to 3 weeks ]For all the cohorts, the dose limiting toxicity (DLT) period to determine the Maximum dose tolerated (MTD) will be 3 weeks.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03596281
|Contact: Judith MICHELS, MD, PhD||0142114376 ext +firstname.lastname@example.org|
|Contact: Xavier PAOLETTI, MD||0142116564 ext +email@example.com|
|Villejuif, Val De Marne, France, 94805|