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

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

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