Epithelial Ovarian CancerPhase 3NCT05622890

A Single-arm Clinical Trial of IMGN853 in Chinese Adult Patients With Platinum-resistant, Epithelial Ovarian Cancer

A Phase 3 study testing Mirvetuximab Soravtansine in people with Epithelial Ovarian Cancer and Peritoneal Cancer, run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. at 28 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

This Phase III single-arm study is to evaluate the efficacy and safety of IMGN853 in Chinese adult patients with platinum-resistant high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancers (hereafter referred to as PROC) with high FRα expression. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Epithelial Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer
What is being tested?: Mirvetuximab Soravtansine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 35 participants
Where: 28 sitesChina
Study dates: 18 Aug 2022to 31 Dec 2023
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Female patients ≥ 18 years of age
Patients must have a histopathologically confirmed diagnosis of high-grade serous EOC.
Patients must have platinum-resistant disease:
Patients must have had a response (CR or PR) after previous 1 line of platinum-based therapy for at least 4 cycles of treatment, and then progressed between > 3 months and ≤ 6 months after the date for last dose of platinum.
Patients who relapsed after > 6 months since the last platinum-based treatment with at least 4 cycles of one line platinum-based therapy: 1) continued to receive at least 4 cycles of 2 or 3 lines of platinum-based treatment and must have had PD within 6 months from the last dose of platinum; or 2) had PD during treatment with 2 or 3 lines of platinum-containing chemotherapy.
Note: PD should be calculated from the date of the last dose of platinum-containing therapy to the date of PD indicated by radiographic imaging.

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Note: Patients who are platinum-refractory during 1 line treatment are excluded (see exclusion criterion 3).
Patients must have radiological PD on or after the most recent anti-cancer therapy.
Patients must be willing to provide the archival tumor tissue slides or undergo low-risk routine medical procedures to collect new biopsy samples for immunohistochemistry (IHC) confirmation of FRα positivity.
Per VENTANA FOLR1 (FOLR-2.1) Assay criteria, patient's tumor must be positive for FRα expression by a central laboratory.
Patients must have at least one lesion that meets the definition of measurable disease by RECIST v1.1 (radiologically assessed by the investigator).
Patients must have received at least 1 but no more than 3 lines of prior systemic anti-cancer therapy, including at least 1 line of therapy containing bevacizumab, and for whom monotherapy is appropriate for the next line of treatment:
Neoadjuvant ± adjuvant is considered as 1 line of therapy;
Maintenance therapy (eg, bevacizumab, PARP inhibitors) will be considered as part of the prior line of therapy (ie, not counted independently);
Therapy changed due to toxicity in the absence of PD will be considered as part of the same line (ie, not counted independently);
Hormonal therapy (except as maintenance therapy) will be considered as a separate line of therapy.
Patients must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
Patients must have completed prior therapy within the following specified times:
Systemic anti-tumor therapy (the last prior systemic anti-tumor therapy should be at least 5 half-lives or 4 weeks from the initiation of the investigational drug, whichever is shorter);
Focal radiotherapy: previous focal radiotherapy should be at least 2 weeks from the initiation of investigational drug.
All toxicities (except alopecia) associated with prior therapy must be stable or resolved (Grade 1 or normal).
Any major surgery that a patient has undergone must have been completed at least 4 weeks prior to the first dose of IMGN853 and the postoperative complications of prior surgical treatment have resolved or are stable.
Patients must have adequate hematologic, hepatic, and renal functions as defined by the following parameters (without G-CSF [a 20-day drug washout period for long-acting growth factors], human albumin injection and other corrective treatment drugs are not allowed within 14 days before obtaining laboratory test values):
Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L (1,500 μL);
Platelet count ≥ 100 × 10^9/L (100,000/μL) without platelet transfusion in the prior 10 days;
Hemoglobin ≥ 9.0 g/dL without packed red blood cell (PRBC) transfusion in the prior 21 days;
Serum creatinine ≤ 1.5 × upper limit of normal (ULN);
Both aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 × ULN;
Serum bilirubin ≤ 1.5 × ULN (patients with Gilbert syndrome may be enrolled if total bilirubin is < 3.0 × ULN);
Serum albumin ≥ 2 g/dL.
Patients or their legally authorized representatives must be willing and able to sign the ICF and comply with the requirements of the protocol.
Women of child bearing potential (WCBP), defined as a sexually mature woman who have not undergone surgical sterilization or who have not been naturally postmenopausal for at least 12 consecutive months (ie, who have had menses any time in the preceding 12 consecutive months) must agree to use effective contraceptive methods; examples included oral, parenteral, or implantable hormonal contraceptive, intrauterine device, barrier contraceptive with spermicide, partner's latex condom or vasectomy) while on study treatment and for at least 12 weeks after the last dose of investigational drug.
WCBP must have a negative pregnancy test within 4 days prior to the first dose of IMGN853.
The expected survival of the subject is at least 12 weeks as assessed by the investigator.

Who cannot join

Male patients.
Patients with endometrioid carcinoma, clear cell carcinoma, mucinous carcinoma, or sarcoma tissue, mixed tumor containing any of the above histologies, or low grade/borderline ovarian tumor.
Patients with primary platinum-refractory disease, defined as disease that did not respond to (CR or PR) or has progressed within 3 months of the last dose of first-line platinum-containing chemotherapy.
Patients who have received prior wide-field radiotherapy (RT) with at least 20% of the bone marrow affected.
Patients with > Grade 1 peripheral neuropathy per Common Terminology Criteria for Adverse Events (CTCAE).
Patients with active or chronic corneal disorders, history of corneal transplant, or active ocular conditions requiring ongoing treatment/monitoring such as uncontrolled glaucoma, wet age-related macular degeneration requiring treatment with intravitreal injections, active diabetic retinopathy with macular edema, macular degeneration, presence of papilloedema, and /or monocular vision.

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Patients with serious concurrent illness or clinically relevant active infection, including, but not limited to the following:
Known acute or chronic active hepatitis B (HBsAg positive and HBV DNA viral load ≥ 2500 copies/mL or > 500 IU/mL, if necessary, patients may receive nucleoside prophylactic anti-hepatitis B virus therapy) or acute or chronic active hepatitis C (HCV antibody positive and HCV RNA positive);
Human immunodeficiency virus (HIV) infection;
Active cytomegalovirus infection;
Any other concurrent infectious disease requiring systematic treatment within 2 weeks prior to the first dose of IMGN853.
Patients with a history of multiple sclerosis (MS) or other demyelinating diseases and/or Lambert-Eaton syndrome (paraneoplastic syndrome).
Patients with clinically significant cardiac disorders, including but not limited to any of the following:
Myocardial infarction ≤ 6 months prior to the first dose;
Unstable angina pectoris;
Uncontrolled congestive cardiac failure (New York Heart Association classification > II);
Uncontrolled ≥ Grade 3 hypertension (per CTCAE criteria);
Uncontrolled cardiac arrhythmias.
Patients with a history of hemorrhagic or ischemic stroke within 6 months prior to signing the ICF.
Patients with a history of hepatic cirrhosis (Child-Pugh B or C).
Patients with a previous clinical diagnosis of or currently ongoing non-infectious interstitial lung disease (ILD), including noninfectious pneumonitis, lung disorders such as pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-related pulmonitis, severely impaired lung function, etc.
Patients requiring folic acid-containing supplements (e.g., folate deficiency).
Known hypersensitivity to previous monoclonal antibody therapy or maytansinoids, or to the investigational drug and/or any excipients.
Pregnant or lactating women.
Patients with prior IMGN853 or other FRα-targeted drug therapies.
Known active central nervous system (CNS) and/or leptomeningeal metastases. Patients with untreated but asymptomatic brain metastases, or patients who have radiographically documented progression-free status for at least 4 weeks after treatment and do not require hormonal or antiepileptic therapy for at least 2 weeks may be considered for enrollment.
Patients with a history of other malignancies within 3 years prior to enrollment.
Note: patients with tumors with a negligible risk of metastasis or death (e.g., adequately controlled basal-cell carcinoma or squamous-cell carcinoma of the skin, or carcinoma in situ of the cervix or breast) are eligible for inclusion.
Patients with pleural effusion, pericardial effusion, or ascites that cannot be controlled by drainage or other means, except the small amount of effusion that without clinical symptoms or do not require clinical intervention.
Patients who are detained by a court or administrative decision, receiving psychiatric care against their will, adults who are under the protection of law (under tutorship/curatorship), people who are unable to give their consent, and people who are subject to a legal guardianship.
Participated in other clinical studies and received their investigational drugs within 4 weeks prior to the first dose.
Subject has other serious systemic diseases or other reasons that are not suitable for participation in this clinical study as evaluated by the investigator.

Trial locations and contacts

28 sites in 1 country.

Xu Sun, Master contact

+8613645153601

sunxu@eastchinapharm.com

City, postcode or hospital

Sites recruiting now only

28 sites in 1 country

China28 sites, 28 recruiting

Beijing Obstetrics and Gynecology Hospital, Capital Medical University
Beijing, Beijing Municipality, 100010
Xu Sun, Master, +8613645153601, sunxu@eastchinapharm.com
Not yet recruiting
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233000
Bo Yang, Master, +8618155258266, yangbo2016@163.com
Xiaoli Li, Master, +8615215520809, 158169847@qq.com
Recruiting
Jilin Cancer Hospital
Changchun, Jilin, 130000
Ying Cheng, Doctor, +8613943012851, jl.cheng@163.com
Hongxia Cui, Doctor, +86 13504436090, 2503074283@qq.com
Recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410000
Jing Wang, Doctor, +8613875902083, wangjing@hnca.org.cn
Li Li, Doctor, +8615874293489, lili@hnca.org.cn
Recruiting
West China Second Hospital of Sichuan University
Chengdu, Sichuan, 610000
Xu Sun, Master, +8613645153601, sunxu@eastchinapharm.com
Recruiting
The Second Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116000
Kui Jiang, Master, +8617709873696, JK0411@163.COM
Hongruo Liu, Master, +86 17709873397, liuhongruo@sina.com
Recruiting
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, 350000
Xu Sun, Master, +8613645153601, sunxu@eastchinapharm.com
Recruiting
Sun Yat-Sen University Cancer Hospital
Guangzhou, Guangdong, 510000
Xu Sun, Master, +8613645153601, sunxu@eastchinapharm.com
Recruiting
People's Hospital of Zhejiang Province
Hangzhou, Zhejiang, 310000
Zhiquan Qin, Master, +8613857123637, qzq66@126.com
Yun Chen, Doctor, +8613858087167, hlqm1986@163.com
Recruiting
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Xuejun Chen, Doctor, +8613757119632, 2303011@zju.ed.cn
Jiong Ma, Doctor, +8613675875605, majiong1231@126.com
Recruiting
Zhejiang Tumor Hospital
Hangzhou, Zhejiang, 310000
Aijun Yu, Master, +8613857155327, yaj1993@126.com
Jie Xing, Master, +8613758219923, xingjie@zjcc.org.cn
Recruiting
Anhui Provincial Hospital
Hefei, Anhui, 230000
Weidong Zhao, Doctor, +8613955105591, Victorzhao@163.com
Zhengzheng Chen, Doctor, +8613865915342, 546038221@99.com
Recruiting
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230000
Bing Wei, Doctor, +8613605696088, weibing1965@163.com
Runhua He, Doctor, +8613676767676, ayzfyhrh@126.com
Recruiting
The Second Affiliated Hospital of Zhengzhou University
Henan, Zhengzhou, 450000
Xu Sun, Master, +8613645153601, sunxu@eastchinapharm.com
Recruiting
Shandong Cancer Hospital
Jinan, Shandong, 250000
Qingshui Li, Doctor, +8613854158117, liqingshui64@163.com
Jingwei peng, Doctor, +8615688455900, tudou4212@163.com
Recruiting
Yunnan Cancer Hospital
Kunming, Yunnan, 650000
Xu Sun, Master, +8613645153601, sunxu@eastchinapharm.com
Recruiting
Gansu Provincial Hospital
Lanzhou, Gansu, 730000
Xu Sun, Master, +8613645153601, sunxu@eastchinapharm.com
Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330008
Xu Sun, Master, +8613645153601, sunxu@eastchinapharm.com
Recruiting
Affiliated Cancer Hospital of Guangxi Medical University
Nanning, Guangxi, 530015
Li Li, Master, +8613788889999, liligxmu2022@163.com
Recruiting
Shanghai Tumor Hospital
Shanghai, Shanghai Municipality, 200000
Xiaohua Wu, master, +86136 0177 2486, docwuxh@hotmail.com
Yong Wu, master, +86 15618369676, edison-1016@163.com
Recruiting
SIMC
Shanghai, Shanghai Municipality, 200000
Xu Sun, Master, +8613645153601, sunxu@eastchinapharm.com
Recruiting
Liaoning Cancer Hospital
Shengyang, Liaoning, 110084
Xu Sun, Master, +8613645153601, sunxu@eastchinapharm.com
Recruiting
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Yue Hu, Master, +8613957790915, wzhuyue@163.com
Qiong Zhang, Master, +8613587605820, joan_zhang@sina.com
Recruiting
Hubei Cancer Hospital
Wuhan, Hubei, 430000
Xu Sun, Master, +8613645153601, sunxu@eastchinapharm.com
Recruiting
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technolog
Wuhan, Hubei, 430000
Xu Sun, Master, +8613645153601, sunxu@eastchinapharm.com
Recruiting
Zhongnan Hospital Affiliated to Wuhan University
Wuhan, Hubei, 430000
Hongbing Cai, Doctor, +8613397168990, Chb2105@163.com
Hua Wang, Doctor, +86 15871037481, 940983900@qq.com
Recruiting
People's Hospital of Shanxi province
Xi’an, Shanxi, 710000
Lihong Chen, Master, +8615309217015, lihongchen29@163.com
Echo Li, Doctor, +8615229334396, echo85535063@163.com
Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450000
Xu Sun, Master, +8613645153601, sunxu@eastchinapharm.com
Recruiting

Other trials in China

About this study

Official title: A Single-arm, Phase III Clinical Trial of IMGN853 in Chinese Adult Patients With Platinum-resistant, Advanced High-grade Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer With High Expression of Folate Receptor-α

Read the detailed description

This is a single-arm, phase III clinical trial of IMGN853 in Chinese adult patients with platinum-resistant, advanced high-grade epithelial ovarian, primary peritoneal or fallopian tube cancer with high expression of folate receptor-α.

The objective of this study is to determine the efficacy of IMGN853 in platinum-resistant ovarian cancer (PROC) patients with high folate receptor alpha (FRα) expression.

A total of 35 patients will be enrolled. All patients must have measurable disease (per Response Evaluation Criteria in Solid Tumors version 1.1, RECIST v1.1) at baseline and be eligible for receiving IMGN853.

All patients will be treated with the IMGN853 monotherapy with a dose at adjusted ideal body weight (AIBW) of 6 mg/kg on Day 1 of every 3-week cycle (Q3W).

Conditions: Epithelial Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer
Being tested: Mirvetuximab Soravtansine
Keywords: Platinum resistant, Folate-receptor alpha expression, Phase 3, Antibody-drug conjugate, mirvetuximab soravtansine, IMGN853, Epithelial Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer, MIRV, FRα
Medical subject headings: Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mirvetuximab SoravtansineDrug
Also called IMGN853, MIRV
Mirvetuximab Soravtansine is an antibody drug conjugate designed to target folate receptor α (FRα). It consists of the humanized anti-FRα mAb M9346A attached via a cleavable disulfide linker to the cytotoxic maytansinoid, DM4.

Study groups in NCT05622890
Study group	Role	What they receive
treatment	Experimental	All patients will receive single-agent mirvetuximab soravtansine (MIRV) at 6 mg/kg adjusted ideal body weight (AIBW) administered on Day 1 of every 3-week cycle (Q3W). Receives: Drug: Mirvetuximab Soravtansine

What is being measured

The primary outcome is the main question the study is designed to answer.

Objective Response Rate (ORR)
Objective response rate (ORR), which includes best response of complete response (CR) or partial response (PR) as assessed by the BIRC.
Measured: Up to 2 years

Secondary outcomes (10)

Duration of response (DOR)
The time interval from initial response (CR or PR) assessed by the investigator and the BIRC to progressive disease (PD) assessed by the BIRC
Measured: Up to 2 years
ORR assessed by the investigator
The best response of CR or PR assessed by the investigator.
Measured: Up to 2 years
DOR assessed by the investigator
The time interval from initial response (CR or PR) assessed by the investigator to PD assessed by the investigator
Measured: Up to 2 years
Treatment-emergent adverse events (TEAEs) and Laboratory results,physical examinations, or vital signs
Adverse Events (AE's) will be evaluated according to the NCI CTCAE v5.0. AE's will be coded using the latest Medical Dictionary for Regulatory Activities (MedDRA) version and summarized per system organ class (SOC) and preferred term (PT).
Measured: Up to 2 years
Determination of CA-125 response with GCIG criteria
GCIG CA-125 response rate will be calculated using the CA-125 Response-Evaluable population and its exact 95% CI will be estimated using the Clopper-Pearson method.
Measured: Up to 2 years
PFS assessed by the BIRC
The time interval from the first dose of IMGN853 to radiographic PD or death assessed by the BIRC, whichever occurs first.
Measured: Up to 2 years
PFS assessed by the investigator
The time interval from the first dose of IMGN853 to radiographic PD or death assessed by the investigator, whichever occurs first.
Measured: Up to 2 years
Overall survival (OS)
The time interval from the first dose of IMGN853 to death
Measured: Up to 2 years
Summary statistics of intact ADC, total Ab (TAb), DM4 and S-methyl DM4 concentration data over time
To assess the PK properties of IMGN853 and its key metabolites
Measured: Up to 2 years
Incidence of seroconversion of ADA caused by IMGN853 and its relationship to safety and efficacy
Subjects will be evaluated for anti-drug antibody (ADA) levels. Confirmatory experiments will be conducted for positive samples. ADA titers and neutralizing antibodies (Nabs) will be further determined as appropriate after the confirmation of positivity.
Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Aug 202231 Dec 2023

First posted21 Nov 2022
Study start18 Aug 2022
Primary completion30 Apr 2023 (estimated)
Study completion31 Dec 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Epithelial Ovarian CancerStudies of the same condition, open and under way.
More trials run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 35 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05622890
Sponsor's protocol ID: IMGN853-301
Other IDs: CTR20220190
Status last verified: Oct 2022
First submitted: 14 Nov 2022
Last updated: 21 Nov 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

Xu Sun, Master

+8613645153601

sunxu@eastchinapharm.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
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Torvutatug Samrotecan Plus Bevacizumab as First-line Maintenance in Non-Homologous Recombination Deficiency (Non-HRD) Positive Advanced Epithelial Ovarian Cancer
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All Epithelial Ovarian Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-arm, Phase III Clinical Trial of IMGN853 in Chinese Adult Patients With Platinum-resistant, Advanced High-grade Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer With High Expression of Folate Receptor-α
ClinicalTrials.gov ID: NCT05622890
Acronym / sponsor ID: IMGN853-301
Conditions: Epithelial Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer
Keywords: Platinum resistant, Folate-receptor alpha expression, Phase 3, Antibody-drug conjugate, mirvetuximab soravtansine, IMGN853, Epithelial Ovarian Cancer, Peritoneal Cancer
Phase: Phase 3
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 35 participants (estimated)
Lead sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 18 Aug 2022 (actual)
Primary completion: 30 Apr 2023 (estimated)
Study completion: 31 Dec 2023 (estimated)
First posted: 21 Nov 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The objective of this study is to determine the efficacy of IMGN853 in platinum-resistant ovarian cancer (PROC) patients with high folate receptor alpha (FRα) expression.

All patients will be treated with the IMGN853 monotherapy with a dose at adjusted ideal body weight (AIBW) of 6 mg/kg on Day 1 of every 3-week cycle (Q3W).

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
treatment	Experimental	Drug: Mirvetuximab SoravtansineAll patients will receive single-agent mirvetuximab soravtansine (MIRV) at 6 mg/kg adjusted ideal body weight (AIBW) administered on Day 1 of every 3-week cycle (Q3W).

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (34 listed)

Female patients ≥ 18 years of age
Patients must have a histopathologically confirmed diagnosis of high-grade serous EOC.
Patients must have platinum-resistant disease:
Note: PD should be calculated from the date of the last dose of platinum-containing therapy to the date of PD indicated by radiographic imaging.
Note: Patients who are platinum-refractory during 1 line treatment are excluded (see exclusion criterion 3).

Key exclusion criteria (32 listed)

Male patients.
Patients with endometrioid carcinoma, clear cell carcinoma, mucinous carcinoma, or sarcoma tissue, mixed tumor containing any of the above histologies, or low grade/borderline ovarian tumor.
Patients with primary platinum-refractory disease, defined as disease that did not respond to (CR or PR) or has progressed within 3 months of the last dose of first-line platinum-containing chemotherapy.
Patients who have received prior wide-field radiotherapy (RT) with at least 20% of the bone marrow affected.
Patients with > Grade 1 peripheral neuropathy per Common Terminology Criteria for Adverse Events (CTCAE).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Mirvetuximab SoravtansineAlso: IMGN853, MIRVMirvetuximab Soravtansine is an antibody drug conjugate designed to target folate receptor α (FRα). It consists of the humanized anti-FRα mAb M9346A attached via a cleavable disulfide linker to the cytotoxic maytansinoid, DM4.	Drug	treatment

Primary outcome

Objective Response Rate (ORR)
Time frame: Up to 2 years
Objective response rate (ORR), which includes best response of complete response (CR) or partial response (PR) as assessed by the BIRC.

10 secondary outcomes

Duration of response (DOR)
Time frame: Up to 2 years
ORR assessed by the investigator
Time frame: Up to 2 years
DOR assessed by the investigator
Time frame: Up to 2 years
Treatment-emergent adverse events (TEAEs) and Laboratory results,physical examinations, or vital signs
Time frame: Up to 2 years
Determination of CA-125 response with GCIG criteria
Time frame: Up to 2 years
PFS assessed by the BIRC
Time frame: Up to 2 years
PFS assessed by the investigator
Time frame: Up to 2 years
Overall survival (OS)
Time frame: Up to 2 years
Summary statistics of intact ADC, total Ab (TAb), DM4 and S-methyl DM4 concentration data over time
Time frame: Up to 2 years
Incidence of seroconversion of ADA caused by IMGN853 and its relationship to safety and efficacy
Time frame: Up to 2 years

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2022.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Xu Sun, Master contact

+8613645153601

sunxu@eastchinapharm.com

28 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Mirvetuximab Soravtansine in people with Epithelial Ovarian Cancer and Peritoneal Cancer, run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. at 28 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 34 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Xu Sun, Master (+8613645153601, sunxu@eastchinapharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05622890.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2022.