A Study in Platinum-Sensitive Ovarian Cancer is Now Enrolling: Learn More and See Who is Eligible
WHAT IS OVARIAN CANCER?
Ovarian cancer is cancer that first occurs in the ovaries, or in the fallopian tubes or peritoneum, which are related areas nearby.1
WHAT IS PLATINUM-SENSITIVE OVARIAN CANCER?
Ovarian cancer is called “platinum sensitive” if the cancer responded to treatment with a chemotherapy that contained the metal platinum and then came back, or progressed, after more than 6 months from the last dose of the treatment.2
TALK TO YOUR DOCTOR TO SEE IF YOU MAY BE ELIGIBLE
If you or someone you love has been diagnosed with ovarian cancer, consider discussing clinical trial participation with your doctor.
If you are a healthcare professional who has a patient who has been diagnosed with ovarian cancer, they may be eligible to participate in a clinical trial studying IMGN853 in combination with carboplatin in people with platinum-sensitive ovarian cancer.
Why participate in a clinical trial?
Clinical trials are research studies. The goal of clinical trials is to find new ways to treat a disease or a condition. Your participation in this trial may help doctors learn more about your type of cancer and how to treat it. The information learned from clinical trials may be useful to future patients and researchers.
What is IMGN853, also known as mirvetuximab soravtansine-gynx?
Mirvetuximab soravtansine-gynx is an antibody-drug conjugate (ADC) designed to target and kill certain ovarian cancer cells. ADCs are different from traditional chemotherapies and are designed to treat cancer in a targeted way.3
The antibody, or protein, part of mirvetuximab soravtansine-gynx is designed to target cancer cells that carry a surface protein called folate receptor alpha (FRα) and then delivers a cell-killing drug inside the cancer cell. The cell-killing drug can also impact other nearby cells that may be cancerous.3-6
In this study, the safety and efficacy of mirvetuximab soravtansine-gynx is being investigated in combination with a platinum-based chemotherapy called carboplatin for the treatment of people with FRα-positive, recurrent platinum-sensitive, high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancer.* The VENTANA FOLR1 assay will measure FRα expression on cancer cells.3
*IMGN853 in combination with carboplatin is investigational and is not approved by the FDA or any other health authority. The safety and efficacy of IMGN853 in combination with carboplatin has not been determined.
FOLR1=folate receptor 1.
About the clinical Trial
IMGN853-0420 is a Phase 2 study to understand the safety and efficacy of mirvetuximab soravtansine-gynx plus a platinum-based chemotherapy called carboplatin in people with FRα-positive, platinum-sensitive ovarian cancer that has returned after one line of therapy. This study will first look at how mirvetuximab soravtansine-gynx works when used with carboplatin. In patients whose disease remains stable or improves with the combination, mirvetuximab soravtansine-gynx will be continued alone.3
OTHER STUDY DETAILS
- Every patient who participates in the trial will receive mirvetuximab soravtansine-gynx and carboplatin in combination3
- Patients will receive the study regimen every 3 weeks3
- Treatment can be administered by your study doctor in either an outpatient setting or in the hospital (your doctor will let you know what is best for you)
- There are no additional costs to patients for participating in the study (beyond those associated with your usual care)
- Travel reimbursement may be available; the study costs are being paid for by ImmunoGen, Inc., the sponsor of the study
KEY INCLUSION CRITERIA
- 18 years and older3
- Platinum-sensitive, high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancer that has been treated with one prior line of platinum-based chemotherapy and disease progressed after more than 6 months of treatment3
- FRα-positive disease as assessed by the VENTANA FOLR1 IHC assay (25% of cancer cells or more stain with PS2+ intensity)3
- Patients who are BRCA positive must have received prior treatment with a PARP inhibitor3
BRCA=breast cancer gene; IHC=immunohistochemistry; PARP=poly(ADP-ribose) polymerase.
WHO MAY BE ELIGIBLE?
To discuss eligibility for the clinical trial, contact your nearest treatment center directly, or speak with your healthcare professional.
WHAT TREATMENT CENTERS ARE PARTICIPATING IN THIS TRIAL?
See a complete list of participating treatment centers and relevant contact information to learn more.
References: 1. Centers for Disease Control and Prevention. Basic information about ovarian cancer. Updated June 14, 2023. Accessed October 24, 2023. https://www.cdc.gov/cancer/ovarian/basic_info/index.htm 2. Mutch DG, Orlando M, Goss T, et al. Randomized phase III trial of gemcitabine compared with pegylated liposomal doxorubicin in patients with platinum-resistant ovarian cancer. J Clin Oncol. 2007;25(19):2811-2818. 3. U.S. National Library of Medicine. IMGN853 with carboplatin in second-line treatment of FRα expressing, platinum-sensitive epithelial ovarian cancer. Updated May 17, 2023. Accessed October 24, 2023. https://clinicaltrials.gov/study/NCT05456685 4. Erickson HK, Park PU, Widdison WC, et al. Antibody-maytansinoid conjugates are activated in targeted cancer cells by lysosomal degradation and linker-dependent intracellular processing. Cancer Res. 2006;66(8):4426-4433. 5. Kovtun YV, Audette CA, Ye Y, et al. Antibody-drug conjugates designed to eradicate tumors with homogeneous and heterogeneous expression of the target antigen. Cancer Res. 2006;66(6):3214-3221. 6. Altwerger G, Bonazzoli E, Bellone S, et al. In vitro and in vivo activity of IMGN853, an antibody–drug conjugate targeting folate receptor alpha linked to DM4, in biologically aggressive endometrial cancers. Mol Cancer Ther. 2018;17(5):1003-1011.