Brief Title
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/2 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
Brief Summary
This is a phase 1b/2 study to assess the safety, tolerability, and preliminary anti-tumor
activity of IMGN853 when administered with chemotherapy. Patients will be assigned to one of
five 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
Detailed Description
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-tumor activity.
Study Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
Incidence of TEAEs, SAEs, adverse events, clinically significant changes in laboratory/clinical tests and dose-limiting toxicities (DLTs) as a measure of safety and tolerability [dose escalation]
Secondary Outcome
Duration of response (DOR); the time from first objective response until progressive disease, will be calculated for all patients who achieve a confirmed objective response (PR or CR)
Condition
Epithelial Ovarian Cancer
Intervention
IMGN853
Study Arms / Comparison Groups
Regimen A
Description: Dose escalation and dose expansion with IMGN853 and bevacizumab
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
264
Start Date
December 2015
Completion Date
July 2021
Primary Completion Date
January 2021
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with advanced epithelial ovarian cancer, primary peritoneal cancer, or
fallopian tube cancer
- Folate receptor alpha positive tumor expression as defined in the protocol
- Willing to undergo tumor biopsy
- Measurable disease
Exclusion Criteria:
- Primary platinum-refractory EOC
- Diagnosis of clear cell, low grade ovarian cancer or mixed tumors
- Serious concurrent illness or clinically relevant active infection, including known
diagnosis of HIV and hepatitis B or C, as defined in the protocol
- Active autoimmune disease requiring systemic therapy in past 2 years (IMGN853 and
pembrolizumab only)
- Women who are pregnant or breastfeeding
- Male patients
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Patrick Zweidler-McKay, MD, PhD, ,
Location Countries
Belgium
Location Countries
Belgium
Administrative Informations
NCT ID
NCT02606305
Organization ID
IMGN853-0402
Secondary IDs
KEYNOTE PN409
Responsible Party
Sponsor
Study Sponsor
ImmunoGen, Inc.
Study Sponsor
Patrick Zweidler-McKay, MD, PhD, Study Director, ImmunoGen, Inc.
Verification Date
September 2019