Overview

IMGN853 With Carboplatin in Second-line Treatment of FRα Expressing, Platinum-sensitive Epithelial Ovarian Cancer

Status:
Not yet recruiting
Trial end date:
2026-12-31
Target enrollment:
0
Participant gender:
Female
Summary
IMGN853-0420 is a multicenter, open-label, phase 2 study of carboplatin plus mirvetuximab soravtansine followed by mirvetuximab soravtansine continuation in folate receptor-alpha positive, recurrent platinum sensitive, high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancer following 1 prior line of platinum-based chemotherapy.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
ImmunoGen, Inc.
Treatments:
Carboplatin
Maytansine
Criteria
Inclusion Criteria:

1. Patients must be ≥ 18 years of age.

2. Patients must have an Eastern Cooperative Oncology Group Performance Status of 0 or 1.

3. Patients must have a confirmed diagnosis of high-grade serous epithelial ovarian,
primary peritoneal, or fallopian tube cancer.

4. Patients must have relapsed after 1 prior line of platinum-based chemotherapy.

5. Patients must have platinum-sensitive disease defined as radiographic progression
greater than 6 months from last dose of platinum-based chemotherapy.

Note: Progression should be calculated from the date of the last administered dose of
platinum therapy to the date of the radiographic imaging showing progression.

6. Prior BRCA testing on the tumor or prior germline testing is required for eligibility.
If not done prior, tumor or germline testing will need to be done at study entry.
Somatic and germline BRCA-positive patients must have received prior treatment with a
PARPi.

7. Patients must have at least 1 lesion that meets the definition of measurable disease
by RECIST v1.1 (radiologically measured by the investigator).

8. Patients must provide an archival tumor tissue block or slides, or undergo procedure
to obtain a new biopsy using a low-risk, medically routine procedure for
immunohistochemistry (IHC) confirmation of FRα positivity; FRα-expressing tumors will
be defined and classified by the Ventana FOLR1 Assay into low, medium, and high
expressions defined as 25%-49%, 50%-74%, and ≥ 75% of tumor cells with PS2+ staining
intensity, respectively. Patients must have confirmation of FRα positivity of ≥ 25% of
tumor staining at ≥ 2+ intensity for entry into the study.

9. Patients must have stabilized or recovered (Grade 1 or baseline) from all prior
therapy-related toxicities (except alopecia) and have discontinued any maintenance
therapy at least 4 weeks before the first dose of carboplatin plus MIRV.

10. Patients must have completed any major surgery at least 4 weeks before the first dose
of carboplatin plus MIRV and have recovered or stabilized from the side effects of
prior surgery before the first dose of carboplatin plus MIRV.

11. Patients must have adequate hematologic, liver, and kidney functions defined as:

1. Absolute neutrophil count ≥ 1.5 × 109/L (1500/μL) without granulocyte
colony-stimulating factor or long-acting white blood cell growth factors in the
10 days prior to the C1D1 dose

2. Platelet count ≥ 100 × 109/L (100,000/μL) without platelet transfusion in the 10
days prior to the C1D1 dose

3. Hemoglobin ≥ 9.0 g/dL without packed red blood cell transfusion in the 14 days
prior to the C1D1 dose

4. Serum creatinine ≤ 1.5 × ULN

5. Aspartate aminotransferase and alanine aminotransferase ≤ 3.0 × ULN

6. Serum bilirubin ≤ 1.5 × ULN (patients with documented diagnosis of Gilbert
syndrome are eligible if total bilirubin < 3.0 × ULN)

7. Serum albumin ≥ 2 g/dL

12. Patients must be willing and able to sign the informed consent form (ICF) and to
adhere to the protocol requirements.

13. Females of childbearing potential (FCBP) must agree to use highly effective
contraceptive method(s) while on study medication and for at least 3 months after the
last dose of MIRV and 6 months after the last dose of carboplatin.

14. FCBP must have a negative pregnancy test within the 4 days prior to the C1D1 dose.

Exclusion Criteria:

1. Patients with endometrioid, clear cell, mucinous, or sarcomatous histology, mixed
tumors containing any of the above types, or low-grade/borderline ovarian tumor

2. More than one line of prior chemotherapy. Lines of prior anticancer therapy are
counted with the following considerations:

1. Neoadjuvant ± adjuvant therapies are considered 1 line of therapy if the
neoadjuvant and adjuvant correspond to 1 fully predefined regimen; otherwise,
they are counted as 2 prior regimens.

2. Maintenance therapy (eg, bevacizumab, PARPi) will be considered part of the
preceding line of therapy (ie, not counted independently).

3. Patients with prior wide-field radiotherapy affecting at least 20% of the bone marrow

4. Patients with > Grade 1 peripheral neuropathy per Common Terminology Criteria for
Adverse Events (CTCAE)

5. 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, or monocular vision

6. Patients with serious concurrent illness or clinically relevant active infection,
including, but not limited to the following:

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

2. HIV infection

3. Active cytomegalovirus infection

4. Any other concurrent infectious disease requiring IV antibiotics within 2 weeks
prior to the first dose of carboplatin plus MIRV Note: Testing at screening is
not required for the above infections unless clinically indicated.

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

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

1. Myocardial infarction ≤ 6 months prior to first dose

2. Unstable angina pectoris

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

4. Uncontrolled ≥ Grade 3 hypertension (per CTCAE)

5. Uncontrolled cardiac arrhythmias

9. Patients with a history of hemorrhagic or ischemic stroke within 6 months prior to
enrollment

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

11. Patients with a previous clinical diagnosis of noninfectious interstitial lung
disease, including noninfectious pneumonitis (exception: Grade 1 noninfectious
pneumonitis diagnosed on or within 6 weeks after treatment with an immunotherapeutic
agent used in the treatment of their malignancy that has resolved per investigator or
resolution of the radiologic findings)

12. Patients requiring use of folate-containing supplements (eg, folate deficiency)

13. Patients with prior hypersensitivity to monoclonal antibodies (mAb)

14. Females who are pregnant or breastfeeding

15. Patients who received prior treatment with MIRV or other FRα-targeting agents

16. Patients with untreated or symptomatic central nervous system metastases

17. Patients with a history of other malignancy within 3 years before enrollment Note:
patients with tumors with a negligible risk for metastasis or death (eg, adequately
controlled basal-cell carcinoma or squamous-cell carcinoma of the skin, or carcinoma
in situ of the cervix or breast) are eligible.

18. Prior known hypersensitivity reactions to study drugs or any of their excipients