FORWARD 1: A Randomized, Open Label Phase 3 Study to Evaluate the Safety and Efficacy of Mirvetuximab Soravtansine (IMGN853) Versus Investigator’s Choice of Chemotherapy in Women with Folate Receptor a-positive Advanced Epithelial Ovarian Cancer, Primary Peritoneal Cancer or Fallopian Tube Cancer


To compare the progression free survival (PFS) of patients randomized to IMGN853 versus selected standard of care chemotherapy (IC


Female patients ≥ 18 years of age

Patients must have one of the following pathologically documented, definitively diagnosed tumor types:

Advanced EOC

Primary peritoneal cancer

Fallopian tube cancer

Patients must have platinum-resistant ovarian cancer, defined as progression within 6 months from completion of a minimum of four cycles of platinum-containing therapy

Patients must have at least one lesion that meets the definition of measurable disease

Patients must have received at least one but no more than three prior systemic lines of anti-cancer therapy and for whom single agent chemotherapy is appropriate as the next line of treatment

Can not:

Patients can not have primary platinum-refractory disease as defined by those who progressed during or within four weeks of completion of first platinum-based chemotherapy Pat

Patients  can not have  > Grade 1 peripheral neuropathy

Patients  can not have  active or chronic corneal disorders such as Sjogren’s syndrome, Fuchs corneal dystrophy (requiring treatment), history of corneal transplantation, active herpetic keratitis, active ocular conditions requiring on-going treatment/monitoring such as uncontrolled glaucoma, wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, macular degeneration, presence of papilledema, and /or monocular vision

Patients  can not have history of multiple sclerosis or other demyelinating disease and/or Eaton-Lambert syndrome (para-neoplastic syndrome)

Patients  can not have history of hemorrhagic or ischemic stroke within the last 6 months

No history of cirrhotic liver disease

No previous clinical diagnosis of non-infectious interstitial lung disease, including noninfectious pneumonitis

Can not require use of folate –containing supplements (e.g. folate deficiency)

No history of other clinically active malignancy within 3 years of enrollment, except for tumors with a negligible risk for metastasis or death, such as adequately controlled basal-cell carcinoma or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix or breast


Group Drug Dose Dosing Schedule

Arm 1 IMGN853 6 mg/kg AIBW Day 1, of a 3-week cycle

Arm 2

Paclitaxel 80 mg/m2 Days 1, 8, 15 and 22 of a 4-week cycle

PLD 40 mg/m2 Day 1 of a 4-week cycle

Topotecan (4 week cycle) 4 mg/m2 Days 1, 8 and 15 of a 4-week cycle

Topotecan (3 week cycle) 1.25 mg/m2 Days 1 through 5 of a 3-week cycle

Patients will continue to receive study treatment until they develop disease progression, experience unacceptable toxicity or withdraw consent, whichever comes first, or until the Sponsor terminates the study

Interested in more information? Contact Us:

Destin Black, M.D., Principal Investigator
Gynecologic Oncology Associates
(318) 212-8727

IRB Number:
Trial Type: Drug
Sponsor: Immunogen