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 Combination With Bevacizumab, Carboplatin, Pegylated Liposomal Doxorubicin, Pembrolizumab, or Bevacizumab + Carboplatin in Participants With Folate Receptor Alpha (FRα) Positive Advanced Epithelial Ovarian Cancer, 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 study comprises a Dose Escalation phase followed by a Dose Expansion phase. Dose
      Escalation part of the study will assess the safety and tolerability and determine the
      maximum tolerated dose (MTD) as the recommended Phase 2 (RP2D) dose for each regimen.
      Participants will be assigned to one of the 4 regimens in Dose Escalation phase: Regimen A:
      mirvetuximab soravtansine administered with bevacizumab; Regimen B: mirvetuximab soravtansine
      administered with carboplatin; Regimen C: mirvetuximab soravtansine administered with
      pegylated liposomal doxorubicin; or Regimen D: mirvetuximab soravtansine administered with
      pembrolizumab. Dose Expansion of the study will further assess safety, tolerability and
      preliminary anti-tumor activity of mirvetuximab soravtansine. A Dose Expansion phase is
      planned for Regimen A and Regimen D and will open pending Sponsor decision; participants
      enrolled in the Dose Expansion phase will receive study treatment at the MTD or RP2D
      determined during Dose Escalation. For Regimen A, participants in the Dose Expansion phase
      may be enrolled according to prior exposure to bevacizumab into 3 Dose Expansion Cohorts as
      follows: 1) Dose Expansion Cohort 1: bevacizumab naïve; 2) Dose Expansion Cohort 2:
      bevacizumab pretreated; and 3) Dose Expansion Cohort 3: one to three prior treatments, one of
      which could have been bevacizumab. A triplet Regimen (Regimen E: mirvetuximab soravtansine +
      bevacizumab + carboplatin) will be opened to evaluate the safety and tolerability and to
      assess any early signs of activity in participants dosed with the combination regimen.

Detailed Description

      Participants will continue to receive mirvetuximab soravtansine and/or the combination agent
      until progressive disease (PD), unacceptable toxicity, or withdrawal of consent, whichever
      comes first, or until the Sponsor terminates the study.

Study Phase

Phase 1/Phase 2

Study Type

Interventional

Primary Outcome

Dose Escalation (Regimens A Through D): Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

Secondary Outcome

 Dose Expansion (Regimens A and D) and Triplet (Regimen E): Number of Participants With TEAEs

Condition

Epithelial Ovarian Cancer

Intervention

Mirvetuximab soravtansine

Study Arms / Comparison Groups

 Regimen A (Mirvetuximab soravtansine + Bevacizumab)

Description:  Mirvetuximab soravtansine + Bevacizumab administered on Day 1 of each 21-day cycle in Dose Escalation and Dose Expansion phase.

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

March 8, 2021

Primary Completion Date

March 8, 2021

Eligibility Criteria

        Inclusion Criteria:

          -  Diagnosed with advanced epithelial ovarian cancer, primary peritoneal cancer, or
             fallopian tube cancer

          -  FRα positive tumor expression as defined in the protocol

          -  Willing to provide an archival tumor tissue block or slides or undergo tumor biopsy.
             New tumor biopsy (Cycle 2 Day 8) is required for Regimen D.

          -  Measurable disease

        Exclusion Criteria:

          -  Primary platinum-refractory disease

          -  Diagnosis of clear cell, low grade ovarian cancer or mixed tumors

          -  Serious concurrent illness or clinically relevant active infection, including but not
             limited to known diagnosis of human immunodeficiency virus (HIV) and hepatitis B or C,
             as defined in the protocol

          -  Active autoimmune disease requiring systemic therapy in past 2 years (for Regimen D
             only)

          -  Women who are pregnant or breastfeeding

          -  Male participants

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

March 2021