MIRASOL: A randomized, open label, phase 3 study of Mirvetuximab Soravtansine vs. Investigator’s choice of chemotherapy in Platinum-Resistant Advance High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers with high folate receptor-alpha expression. (GOG 3045)

Purpose

To compare the progression-free survival of patients randomized to Mirvetuximab Soravtansine vs. investigator’s choice of chemotherapy.

Criteria

1.       Must have confirmed diagnosis of high-grade serous EOC, primary peritoneal cancer, or fallopian tube cancer.

2.       Must have Platinum-resistance

·         Patients who have had only 1 line of platinum-based therapy must have received at least 4 cycles of platinum, must have had a response and then progressed between >3 months and ≤6 months after the last date of platinum.

·         Patients who have received 2 or 3 lines of platinum therapy must have progressed on or within 6 months after the last date of the last dose of platinum.

3.       Must have progressed radiographically.

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

5.       Must have adequate hematologic, liver, and kidney functions.

6.       Women of childbearing potential must agree to use highly effective contraceptive methods.

You Cannot

1.       Have endometroid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, or low-grade or borderline ovarian tumor.

2.       Have primary platinum-refractory disease, defined as a disease that did not respond or has progressed within 3 months of the last dose of first line platinum-containing chemotherapy.

3.       Have active or chronic corneal disorders.

4.       Have serious concurrent illness or clinically relevant active infection including but not limited to

·         Active hepatitis B or C infection

·         HIV infection

·         Active cytomegalovirus

·         Any other concurrent infectious disease requiring IV antibiotics within two weeks of starting study drug.

5.       Have history of multiple sclerosis

6.       Have clinically significant cardiac disease

7.       Have history of stroke within 6 months of study start

8.       Have history of cirrhotic liver disease

9.       Have required use of folate-containing supplements

10.   Be pregnant or lactating

11.   Have history of other malignancy

Details

1.       Patient will receive 3-week cycle chemotherapy treatment.

2.       Imaging will be done every 6 weeks for the first 36 weeks, then every 12 weeks.

3.       Blood samples will be collected with standard of care labs.  

Interested in more information on clinical research? Contact WK Health System Clinical Research Department 318-212-8130 or ckay@wkhs.com

Interested in more information? Contact Us:

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

IRB: Western
IRB Number:
Trial Type: NA
Sponsor: Immunogen