Bevacizumab and Anetumab Ravtansine or Paclitaxel in Treating Participants With Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
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|ClinicalTrials.gov Identifier: NCT03587311|
Recruitment Status : Recruiting
First Posted : July 16, 2018
Last Update Posted : August 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Fallopian Tube Endometrioid Adenocarcinoma High Grade Fallopian Tube Serous Adenocarcinoma High Grade Ovarian Serous Adenocarcinoma Ovarian Endometrioid Adenocarcinoma Platinum-Resistant Ovarian Carcinoma Primary Peritoneal High Grade Serous Adenocarcinoma Refractory Fallopian Tube Carcinoma Refractory Ovarian Carcinoma Refractory Primary Peritoneal Carcinoma||Biological: Anetumab Ravtansine Biological: Bevacizumab Drug: Paclitaxel||Phase 2|
I. To assess the safety and tolerability of the combination of weekly anetumab ravtansine (anetumab) and bi-weekly bevacizumab.
II. To determine whether the progression free survival (PFS) of the combination weekly anetumab and bi-weekly bevacizumab is superior to weekly paclitaxel and bi-weekly bevacizumab.
I. To determine the overall response rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1.
II. To evaluate the pharmacokinetic (PK) profiles of weekly anetumab in serum and in peripheral blood mononuclear cells (PBMCs).
III. To evaluate anti-drug antibody (ADA) titers (only for patients receiving anetumab).
IV. To evaluate mononuclear phagocyte system (MPS) function, Fc-gamma receptors (FcgammaRs), hormone and chemokine mediators.
V. To correlate the expression of CA125 (immunohistochemistry [IHC] & serum) with mesothelin expression in archival tissue and circulating megakaryocyte potentiating factor (MPF).
VI. To investigate blood-based angiome profiling as a potential biomarker. VII. To characterize the molecular profile of archival tumor tissue using the Oncomine panel, and explore whether genomic mutations such as BRCA1/2 and homologous repair deficiency status are associated with clinical outcome.
I. To assess tumor tissue-based VEGF-dependent gene expression signature as a biomarker of response.
PHASE I: Participants receive anetumab ravtansine intravenously (IV) over 1 hour on days 1, 8, 15, and 22 and bevacizumab over 30-90 minutes IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
PHASE II: Participants are randomized to 1 of 2 groups.
GROUP I: Participants receive anetumab ravtansine and bevacizumab as in Phase I.
GROUP II: Participants receive paclitaxel on days 1, 8, 15, and 22 and bevacizumab over 30-90 minutes IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, participants are followed up at 30-37 days and then every 8 weeks thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||96 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Phase 2 Study of Bevacizumab and Either Weekly Anetumab Ravtansine or Weekly Paclitaxel in Platinum-Resistant or Platinum Refractory Ovarian Cancer|
|Actual Study Start Date :||June 29, 2018|
|Estimated Primary Completion Date :||June 30, 2020|
|Estimated Study Completion Date :||June 30, 2020|
Experimental: GROUP I (anetumab ravtansine, bevacizumab)
Participants receive anetumab ravtansine IV over 1 hour on days 1, 8, 15, and 22 and bevacizumab over 30-90 minutes IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Biological: Anetumab Ravtansine
Other Name: BAY 94-9343
Experimental: GROUP II (paclitaxel, bevacizumab)
Participants receive paclitaxel on days 1, 8, 15, and 22 and bevacizumab over 30-90 minutes IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- Progression free survival (PFS) [ Time Frame: From the time of treatment start assessed up to 1 year ]PFS will be estimated using the Kaplan-Meier method and compared between groups with log rank test. Summary statistics will be provided, such as the median, 6-month and estimates, along with 95% confidence intervals. Plots will also be constructed which show the PFS estimate and 95% confidence intervals.
- Response rate assessed using Response Evaluation Criteria in Solid Tumors [ Time Frame: Up to 1 year ]Only one, single, final analysis is planned and statistical significance will be defined at the alpha = 0.05 level. All tests will be two-sided and 95% confidence levels will be constructed for outcomes of interest.
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): NCT03587311
|United States, Missouri|
|Washington University School of Medicine||Recruiting|
|Saint Louis, Missouri, United States, 63110|
|Contact: Site Public Contact 800-600-3606 email@example.com|
|Principal Investigator: Premal H. Thaker|
|United States, Ohio|
|Ohio State University Comprehensive Cancer Center||Recruiting|
|Columbus, Ohio, United States, 43210|
|Contact: Site Public Contact 800-293-5066 Jamesline@osumc.edu|
|Principal Investigator: David M. O'Malley|
|United States, Tennessee|
|Vanderbilt University/Ingram Cancer Center||Recruiting|
|Nashville, Tennessee, United States, 37232|
|Contact: Site Public Contact 800-811-8480|
|Principal Investigator: Marta A. Crispens|
|University Health Network-Princess Margaret Hospital||Recruiting|
|Toronto, Ontario, Canada, M5G 2M9|
|Contact: Site Public Contact 416-946-4501 firstname.lastname@example.org|
|Principal Investigator: Stephanie Lheureux|
|Principal Investigator:||Stephanie Lheureux||University Health Network Princess Margaret Cancer Center LAO|