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

NCT ID: NCT02606305

Last Updated: 2024-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 264 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-02
• Study Completion Date: 2021-03-12

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. All mirvetuximab soravtansine doses were calculated according to adjusted ideal body weight.

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.

Conditions

Epithelial Ovarian Cancer; Primary Peritoneal Cancer; Fallopian Tube Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Regimen A (Mirvetuximab soravtansine + Bevacizumab)

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

Group Type: EXPERIMENTAL

Mirvetuximab soravtansine

Intervention Type: DRUG

Bevacizumab

Intervention Type: DRUG

Regimen B (Mirvetuximab soravtansine + Carboplatin)

Mirvetuximab soravtansine + Carboplatin administered on Day 1 of each 21-day cycle in Dose Escalation phase.

Group Type: EXPERIMENTAL

Mirvetuximab soravtansine

Intervention Type: DRUG

Carboplatin

Intervention Type: DRUG

Regimen C (Mirvetuximab soravtansine + Pegylated liposomal doxorubicin)

Mirvetuximab soravtansine + Pegylated liposomal doxorubicin administered on Day 1 of each 28-day cycle in Dose Escalation Phase.

Group Type: EXPERIMENTAL

Mirvetuximab soravtansine

Intervention Type: DRUG

Pegylated Liposomal Doxorubicin

Intervention Type: DRUG

Regimen D (Mirvetuximab soravtansine + Pembrolizumab)

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

Group Type: EXPERIMENTAL

Mirvetuximab soravtansine

Intervention Type: DRUG

Pembrolizumab

Intervention Type: DRUG

Regimen E (Mirvetuximab soravtansine + Bevacizumab + Carboplatin)

Mirvetuximab soravtansine + Bevacizumab + Carboplatin administered on Day 1 of each 21-day cycle in Dose Expansion phase.

Group Type: EXPERIMENTAL

Mirvetuximab soravtansine

Intervention Type: DRUG

Bevacizumab

Intervention Type: DRUG

Carboplatin

Intervention Type: DRUG

Interventions

Mirvetuximab soravtansine

Intervention Type: DRUG

Bevacizumab

Intervention Type: DRUG

Carboplatin

Intervention Type: DRUG

Pegylated Liposomal Doxorubicin

Intervention Type: DRUG

Pembrolizumab

Intervention Type: DRUG

Other Intervention Names

IMGN853

Eligibility Criteria

Inclusion Criteria

• Diagnosed with advanced epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer
• Folate receptor α (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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

ImmunoGen, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of California at Los Angeles

Los Angeles, California, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

City of Hope

Reno, Nevada, United States

The Ohio State University

Hilliard, Ohio, United States

Peggy and Charles Stephenson Oklahoma Cancer Center

Oklahoma City, Oklahoma, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Universitaire Ziekenhuizen (UZ) Leuven - Gasthuisberg - Leuvens Kankerinstituut

Leuven, , Belgium

Centre Hospitalier de l'universite de Montreal (CHUM)

Montreal, , Canada

McGill University Health Center

Montreal, , Canada

Hospital Vall D'Hebron

Barcelona, , Spain

MD Anderson

Madrid, , Spain

Countries

United States; Belgium; Canada; Spain

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

KEYNOTE PN409

Identifier Type: OTHER

Identifier Source: secondary_id

IMGN853-0402

Identifier Type: -

Identifier Source: org_study_id