Bevacizumab and Anetumab Ravtansine or Paclitaxel in Treating Participants With Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Titre officiel

A Randomized Phase 2 Study of Bevacizumab and Either Weekly Anetumab Ravtansine or Weekly Paclitaxel in Platinum-Resistant or Platinum Refractory Ovarian Cancer

Sommaire:

Cet essai de phase II étudie les effets secondaires du bévacizumab et de l’anétumab ravtansine ou du paclitaxel dans le traitement de participants atteints d’un cancer des ovaires, d’un cancer des trompes de Fallope ou d’un cancer péritonéal primaire qui ne répond pas au traitement. Les anticorps monoclonaux comme le bévacizumab et l’anétumab ravtansine peuvent nuire à la capacité des cellules tumorales de se développer et de se propager. Les médicaments utilisés en chimiothérapie, comme le cisplatine, agissent de différentes manières pour stopper la croissance des cellules tumorales, soit en tuant les cellules soit en les empêchant de se diviser ou de se propager. On ignore encore si l’administration de bévacizumab et d’anétumab ravtansine ou de paclitaxel peut mieux fonctionner pour traiter les participants atteints d’un cancer des ovaires, d’un cancer des trompes de Fallope ou d’un cancer péritonéal primaire.

Description de l'essai

Primary Outcome:

  • Progression free survival (PFS)
Secondary Outcome:
  • Response rate assessed using Response Evaluation Criteria in Solid Tumours
PRIMARY OBJECTIVES:
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. SECONDARY OBJECTIVES:
I. To determine the overall response rate (ORR) according to Response Evaluation Criteria in Solid Tumours (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 tumour tissue using the Oncomine panel, and explore whether genomic mutations such as BRCA1/2 and homologous repair deficiency status are associated with clinical outcome. EXPLORATORY OBJECTIVES:
I. To assess tumour tissue-based VEGF-dependent gene expression signature as a biomarker of response. OUTLINE:

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.

Voir cet essai sur ClinicalTrials.gov

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