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

Purpose

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

Criteria

Female patients ≥ 18 years of age with a confirmed diagnosis of high-grade serous EOC, primary peritoneal cancer, or fallopian tube cancer

Must have platinum-resistant disease (defined as progression within 6 months from completion of a minimum of four cycles of platinum-containing therapy)

Patients must have progressed on or after their most recent line of therapy Note: Progression must be determined radiographically and/or by CA-125 GCIG progression 

Patient’s tumor must be positive for FRα expression as defined by the Ventana FOLR1 (FOLR-2.1) CDx assay

Patients must have received at least 1 but no more than 3 prior systemic lines of anticancer therapy, and for whom single-agent therapy is appropriate as the next line of treatment:

Adjuvant ± neoadjuvant considered one line of therapy

Maintenance therapy (eg, bevacizumab, PARP inhibitors) will be considered as part of the preceding line of therapy (ie, not counted independently)

Therapy changed due to toxicity in the absence of progression will be considered as part of the same line (ie, not counted independently)

Hormonal therapy will be counted as a separate line of therapy unless it was given as maintenance.

Major surgery must be completed at least 4 weeks prior to first dose and have recovered or stabilized from the side effects of prior surgery

You Cannot

Patients with primary platinum-refractory disease, defined as disease that did not respond to or has progressed within 3 months of the last dose of first line platinum-containing chemotherapy

Patients with prior wide-field radiotherapy (RT) affecting at least 20% of the bone marrow

Patients with active or chronic corneal disorders, history of corneal transplantation, or active ocular conditions requiring ongoing 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 with serious concurrent illness or clinically relevant active infection, including, but not limited to the following:

a. Active hepatitis B or C infection (whether or not on active antiviral therapy)

b. HIV infection

c. Cytomegalovirus infection

d. Any other concurrent infectious disease requiring IV antibiotics within 2 weeks before starting study drug

Patients with history of multiple sclerosis or other demyelinating disease and/or Lambert- Eaton syndrome (paraneoplastic syndrome)

Patients with clinically significant cardiac disease including, but not limited to, any one of the following:

a. Myocardial infarction ≤ 6 months prior to first dose

b. Unstable angina pectoris

c. Uncontrolled congestive heart failure (New York Heart Association > class II)

d. Uncontrolled ≥ Grade 3 hypertension (per CTCAE)

e. Uncontrolled cardiac arrhythmias Patients assigned to PLD stratum only:

Patients with a history of cirrhotic liver disease (Child-Pugh Class B or C)

Patients with a previous clinical diagnosis of non-infectious interstitial lung disease (ILD), including noninfectious pneumonitis

Patients with required use of folate-containing supplements (eg, folate deficiency)

Patients with untreated or symptomatic central nervous system (CNS) metastases

Patients with a history of other malignancy within 3 years prior to randomization

Details

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 on clinical research? Contact WK Physician Network Clinical Research at 318-212-8613

Interested in more information? Contact Us:

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

IRB: CGIRB
IRB Number:
Trial Type: Drug
Sponsor: Immunogen