Study of Mirvetuximab Soravtansine in Comb. With Bevacizumab, Carboplatin, PLD, Pembrolizumab, or Bevacizumab + Carboplatin in Adults With FRa + Adv. EOC, Primary Peritoneal or Fallopian Tube Cancer

Official Title

A Phase 1b Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Mirvetuximab Soravtansine (IMGN853) in Combination With Bevacizumab, Carboplatin, Pegylated Liposomal Doxorubicin, Pembrolizumab, or Bevacizumab+Carboplatin in Adults With Folate Receptor Alpha Positive Advanced Epithelial Ovarian Cancer, Primary Peritoneal Cancer or Fallopian Tube Cancer

Summary:

This is a phase 1b study to assess the safety, tolerability, and preliminary anti-tumour activity of IMGN853 when administered with chemotherapy. Patients will be assigned to one of four regimens: IMGN853 administered with bevacizumab, IMGN853 administered with carboplatin, IMGN853 administered with pegylated liposomal doxorubicin, IMGN853 administered with pembrolizumab, or IMGN853 administered with bevacizumab+carboplatin

Trial Description

Primary Outcome:

  • Number of TEAEs, SAEs, incidence of adverse events, clinically significant changes in laboratory/clinical tests and dose-limiting toxicities (DLTs) as a measure of safety and tolerability [dose escalation]
  • Objective response rate (ORR); the proportion of patients achieving a complete response, partial response or stable disease (CR, PR or SD) according to RECIST1.1 and CA125 evaluations [dose expansion only]
Secondary Outcome:
  • Duration of response (DOR); the time from initial response until progressive disease, will be estimated for all patients who achieve a confirmed objective response (PR or CR)
  • Progression-free survival (PFS); the time from date of first dose until the date of objective disease progression or death by any cause as defined by RECIST 1.1.
  • PK parameters: maximum plasma concentration (Cmax) of IMGN853, bevacizumab, carboplatin and PLD
  • PK parameters: area under the time-concentration curve (AUC) of IMGN853, bevacizumab, carboplatin and PLD
  • PK parameters: terminal half-life (t½) of IMGN853, bevacizumab, carboplatin and PLD
  • PK parameters: clearance (Cl) of IMGN853, bevacizumab, carboplatin and PLD
  • PK parameters: volume of distribution at steady state (Vss) of IMGN853, bevacizumab, carboplatin and PLD
  • PK parameters: maximum time (Tmax) of IMGN853, bevacizumab, carboplatin and PLD
  • Immunogenicity: Presence of Anti-Drug Antibody (ADA)
  • Number of patients with CA125 clinical response.
The dose escalation part of the study will assess safety and tolerability and determine the maximum tolerated dose (MTD) for each regimen. The dose expansion of the MTD will assess safety, tolerability and preliminary anti-tumour activity.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

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