A Study of Mirvetuximab Soravtansine vs. Investigator's Choice of Chemotherapy in Women With Folate Receptor (FR) Alpha Positive Advanced Epithelial Ovarian Cancer (EOC), Primary Peritoneal or Fallopian Tube Cancer (FORWARD I)

ImmunoGen

Status and phase: Completed; Phase 3

Conditions: Epithelial Ovarian Cancer; Primary Peritoneal Carcinoma; Fallopian Tube Cancer; Ovarian Cancer

Treatments: Drug: Pegylated liposomal doxorubicin; Drug: Topotecan; Drug: Paclitaxel; Drug: Mirvetuximab soravtansine

Study type: Interventional

Funder types: NETWORK; Industry

Identifiers

NCT02631876

IMGN853-0403

Details and patient eligibility

About

This is a Phase 3, open label, randomized study designed to compare the safety and efficacy of mirvetuximab soravtansine to that of selected single-agent chemotherapy (Investigator's choice) in women with platinum-resistant FR-alpha positive advanced EOC, primary peritoneal cancer and/or fallopian tube cancer.

Full description

Participants will be randomized to either mirvetuximab soravtansine or investigator's choice chemotherapy.

Enrollment: 366 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants must be diagnosed with advanced epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer
• Participants must have folate receptor alpha positive tumor expression as defined in the protocol
• Participants must have platinum-resistant ovarian cancer, defined as progression within 6 months from completion of a minimum of four cycles of platinum-containing therapy.
• Participants must have received at least one but no more than three prior systemic treatment regimens and for whom single-agent chemotherapy is appropriate as the next line of treatment
• Participants must have at least one lesion that meets the definition of measurable disease by RECIST 1.1

Exclusion criteria

• Diagnosis of clear cell, low grade ovarian cancer or mixed tumors
• Participants with primary platinum-refractory disease
• Serious concurrent illness or clinically relevant active infection as defined in the protocol
• Prior treatment with mirvetuximab soravtansine
• Women who are pregnant or breast feeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

366 participants in 2 patient groups

Mirvetuximab Soravtansine

Experimental group

Description:

Participants will receive mirvetuximab soravtansine at 6 milligrams/kilogram (mg/kg) adjusted ideal body weight (AIBW) administered intravenously (IV) on Day 1 of a 3 week cycle. Participants will continue to receive study drug until they experience progressive disease (PD) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (as assessed by the blinded independent review committee \[BIRC\]), experience unacceptable toxicity, or withdraw consent, whichever comes first, or until the sponsor terminate the study. (Maximum exposure: 86.9 weeks)

Treatment:

Drug: Mirvetuximab soravtansine

Investigator's Choice (IC) Chemotherapy

Experimental group

Description:

Participants will receive a dose of IC chemotherapeutic agent calculated using body surface area (BSA). Paclitaxel will be administered at 80 milligrams/square meter (mg/m\^2) as a 1-hour IV infusion on Days 1, 8, 15, and 22 of a 4-week cycle; or topotecan will be administered at 4 mg/m\^2 over 30 minutes on Days 1, 8, and 15 of a 4-week cycle. Alternatively, topotecan could be administered at 1.25 mg/m\^2 over 30 minutes on Days 1 to 5 of a 3-week cycle; or pegylated liposomal doxorubicin will be administered at 40 mg/m\^2 as a 1 mg/minute IV infusion on Day 1 of a 4-week cycle. After Cycle 1, if tolerated, pegylated liposomal doxorubicin could be administered as a 1-hour infusion. Participants will continue to receive study drug until they experience PD per RECIST version 1.1 (as assessed by BIRC), experience unacceptable toxicity, or withdraw consent, whichever comes first, or until the sponsor terminate the study. (Maximum exposure: 62.9 weeks)

Treatment:

Drug: Topotecan

Drug: Paclitaxel

Drug: Pegylated liposomal doxorubicin