ClinicalTrials.gg
RecruitingNCT06890338Updated Oct 20, 2026

A Study to Assess Anti-Tumor Activity of Intravenously (IV) Infused Carboplatin With Mirvetuximab Soravtansine in Participants With Newly Diagnosed Folate Receptor Alpha (FRα)Expressing Advanced-Stage Serous Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer.

A Phase 2 interventional study of Carboplatin and Mirvetuximab Soravtansine in Epithelial Ovarian Cancer, Fallopian Tube Cancer and Primary Peritoneal Cancer, sponsored by AbbVie. Recruiting at 73 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.

Sponsored by AbbVie · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Nov 2025; still recruiting 11 months later.
Updated Oct 20, 2026Site recruiting status changed5 sites added+1 moreGo to Updates ↓

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Phase
Phase 2
Study type
Interventional
Enrollment
140
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 75 studies testing carboplatin in Carcinoma, Ovarian Epithelial — 3 open to participants now, 4 under way, 1 of them phase 3. Carboplatin · Carcinoma, Ovarian Epithelial.

Planned enrollment
13th of 60
140 · median 40
Started
2025
the only one that year
Phase 2
34 of 75
2 open now
Registered
74th of 75
by date
Lead sponsor
1 of 75
AbbVie

Among the 75 studies testing carboplatin in Carcinoma, Ovarian Epithelial, this one is the 13th largest by planned enrollment of the 60 interventional ones that give a count, is the only one that started in 2025, is one of 34 in phase 2, and was the 74th registered.

Carcinoma, Ovarian Epithelial

798 studies on the registry are indexed under Carcinoma, Ovarian Epithelial; 102 are open to participants now.

Browse Carcinoma, Ovarian Epithelial studies →

Open to participants now

3 of the 75 studies testing carboplatin in Carcinoma, Ovarian Epithelial are open now, in 2 countries. Recruiting first, the newest first:

By country, each count listing its studies:

All 3 open studies →

About carboplatin

Carboplatin: first FDA approval 1989 (PARAPLATIN). What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 75 Carcinoma, Ovarian Epithelial studies recruiting now, 50 (67%) set no upper age limit and 12 (16%) stop at 75 or younger; 2 take children under 18; 4 take healthy volunteers.

This study: 18 Years and older · female · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 75 studies testing carboplatin in Carcinoma, Ovarian Epithelial, or all of them as a file.
02

Study summary

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess the safety and efficacy of neoadjuvant carboplatin and mirvetuximab soravtansine in participants with folate receptor alpha (FRα) -expressing advanced-stage serous epithelial ovarian, fallopian tube or primary peritoneal cancer (EOC).

Mirvetuximab Soravtansine (MIRV) is an investigational antibody drug conjugate designed to selectively kill cancer cells. The antibody (protein) part of MIRV targets tumors by delivering a cell-killing drug to cancer cells carrying a protein called folate receptor alpha (FRα). This is a single arm study in adult participants with advanced-stage Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) III-IV FRα-expressing serous EOC. Around 140 participants will be enrolled in the study at approximately 80 sites in the United States.

Participants will receive intravenous infusion of MIRV in combination with carboplatin on day 1 of each cycle, every 21 days for up to 6 - 9 Cycles. The total study duration will be approximately 3 years .

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.

03

Conditions studied

  • Epithelial Ovarian Cancer
  • Fallopian Tube Cancer
  • Primary Peritoneal Cancer
  • Neoadjuvant

Keywords

  • Epithelial Ovarian Cancer
  • Fallopian Tube Cancer
  • Primary Peritoneal Cancer
  • Neoadjuvant
  • Interval Debulking Surgery
  • Mirvetuximab Soravtansine
  • MIRV
  • IMGN853
  • ELAHERE(R)
  • Carboplatin
  • Bevacizumab
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • (ECOG) performance status of 0, 1 or 2.
  • Be judged by the investigator and/or treating physician to be an appropriate candidate to receive chemotherapy.
  • Diagnosis of -confirmed high-grade, serous epithelial ovarian, fallopian tube or primary peritoneal cancer.
  • Participant meets the following disease criteria:

    • Stage III or IV disease by the Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) staging system, and
    • Folate Receptor Alpha (FRα) expression positivity as defined by immunohistochemical staining of >= 75% of viable tumor cells with moderate >= 2+ membrane staining by the Ventana Folate Receptor Alpha (VENTANA FOLR1) assay, FOLR1 Eligibility Testing - Ventana FOLR1 (FOLR1-2.1) RxDx - Commercial or Central, and
    • by (RECIST) Version 1.1 criteria.

Exclusion criteria

Exclusion Criteria:

  • Endometrioid, clear cell, mucinous, or sarcomatous tumor histology; mixed tumors containing any of the above histologies; or low-grade/borderline ovarian tumor.
  • Previous clinical diagnosis of noninfectious interstitial lung disease, including noninfectious pneumonitis.
  • Previously treated with anticancer therapy including chemotherapy, radiation therapy, immunotherapy, or biologic agent for current cancer, with the exception of one cycle of single agent carboplatin
  • Participants with the following ocular history and/or concurrent disorders:

    • History of corneal transplantation;
    • Undergoing active postoperative management for refractive surgery, cataract surgery, corneal cross-linking, or corneal complications of surgery;
    • Confluent superficial punctate keratopathy (SPK) not expected to resolve to non-confluence or better within the screening window with standard of care (SOC) intervention;
    • Active or chronic (>= Grade 3) corneal dystrophy (e.g., Fuchs dystrophy);
    • Active ocular conditions requiring ongoing treatment/monitoring, such as glaucoma, which is not adequately controlled with medication or surgery, wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, macular degeneration, presence of papilledema or an ocular condition with high risk of retinal detachment;
    • Monocular vision with visual acuity in the worse eye, worse than 20/200 or visual fields less than 20 degrees (i.e., functional blindness in at least one eye).
  • History of other within 3 years prior to signing study consent. -- Note: Participants with tumors with a negligible risk for 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.
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
140 participants (estimated)

Study arms

  • Experimental
    Carboplatin + Mirvetuximab Soravtansine

    Participants will receive carboplatin in combination with mirvetuximab soravtansine on Day 1 of a 21-day cycle per dose +/- Bevacizumab per investigator's discretion.

    Drug: Carboplatin · Drug: Mirvetuximab Soravtansine · Drug: Bevacizumab

Interventions

06

What researchers measure

Primary outcomes

  1. Objective Response (OR) by Independent Central Review (ICR)

    OR is defined as the best overall response of radiographic complete response (CR) or partial response (PR) as assessed by ICR using RECIST Version 1.1 criteria, prior to any subsequent anticancer therapy, including interval debulking surgery (IDS).

    Time frame: Up to Approximately 3 years

Secondary outcomes

  1. Percentage of Participants with Adverse Events (AE)

    An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug.

    Time frame: Up to Approximately 3 years

  2. Percentage of Participants with AEs leading to study drug discontinuation or dose modification

    An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug.

    Time frame: Up to Approximately 3 years

  3. Objective Response (OR) by Investigator

    OR is defined as the best overall response of radiographic CR or PR as assessed by investigator using RECIST Version 1.1 criteria, prior to any subsequent anticancer therapy, including IDS.

    Time frame: Up to Approximately 3 years

  4. Disease Control by ICR

    Disease control defined as CR, PR, or stable disease (SD) as assessed by ICR per RECIST Version 1.1 prior to subsequent anticancer therapy including IDS.

    Time frame: Up to Approximately 3 years

  5. Disease control by Investigator

    Disease control defined as CR, PR, or stable disease (SD) as assessed by investigator per RECIST Version 1.1 prior to subsequent anticancer therapy including IDS.

    Time frame: Up to Approximately 3 years

  6. Percentage of Participants With CA-125 Confirmed Response Per Gynecologic Cancer Intergroup (GCIG) Criteria

    The GCIG CA-125 response was defined as at least 50% reduction in CA-125.

    Time frame: Up to Approximately 3 years

  7. Progression-Free Survival (PFS) by investigator

    PFS by investigator, defined as the time from the date of C1D1 until PD per RECIST v1.1 as assessed by investigator or death from any cause, whichever occurs first.

    Time frame: Up to Approximately 3 years

  8. Percentage of Participants that Underwent Interval debulking surgery (IDS)

    Percentage of participants that underwent IDS during the course of the study treatment

    Time frame: Up to Approximately 3 years

  9. Percentage of participants with complete tumor cytoreduction at IDS

    Complete tumor cytoreduction is defined as the absence of macroscopically visible residual disease at the end of the surgery

    Time frame: Up to Approximately 3 years

  10. Percentage of participants with Incomplete Tumor Cytoreduction at IDS

    Defined as macroscopically visible residual tumor (≤ 1 cm or \> 1cm) at the end of surgery.

    Time frame: Up to Approximately 3 years

  11. Change from baseline in disease-related symptoms as measured by the NCCN-FACT Ovarian Symptom Index (NFOSI-18) disease symptom subscale - physical (DRS-P)

    The NFOSI-18 provides a total score that sums all 18 items, plus 2 multi-item scales that assess physical disease-related symptoms (DRS-P; 9 items) and general function/well-being (F/WB; 3 items).

    Time frame: Up to Approximately 3 years

07

Study locations

71 of 73 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

Supporting information: Study protocol, Statistical analysis plan

Time frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/

Access criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Data sharing details ↗ · vivli.org

No publications or documents are linked to this record.

09

Timeline

4 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2025 (actual). Primary completion is estimated for Feb 2030, 51 months after the start.

Of 51 phase 2 interventional studies under Carcinoma, Ovarian Epithelial, half reached primary completion within 72 months of starting (the median), counting those still running; a quarter within 45 and three quarters within 92. This study's planned 51 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 20, 2025
First posted
Mar 24, 2025
StartActual
Nov 21, 2025
Primary completionEst.
Feb 2030
CompletionEst.
Feb 2030
Last update
Oct 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
5 sites added, 2 sites removed. Mount Sinai Medical Center /ID# 274868 is now Completed
Show 5 added (5 United States)
  • UCLA - University of California Los Angeles Medical Center /ID# 274566 · Los Angeles, United States
  • Columbia University Irving Medical Center /ID# 276156 · New York, United States
  • West Penn Hospital /ID# 276028 · Pittsburgh, United States
  • Kaiser Permanente - Irvine /ID# 276924 · Irvine, United States
  • Willis-Knighton Medical Center /ID# 274310 · Shreveport, United States
Show 2 removed
  • University of California Los Angeles Medical Center /ID# 274566 · Los Angeles, United States
  • Trials 365 /ID# 274310 · Shreveport, United States
across 4 updates, Sep 29, 2026 – Oct 20, 2026
Site contacts
Changed at 1 site. See the sites
Show the site
  • Mount Sinai Medical Center /ID# 274868 · Miami Beach, United StatesContact removed (no phone or email listed)
Oct 16, 2026
Show all 4 updates
  1. Oct 20, 2026
    2 sites added, 1 site removed
    Show 2 added (2 United States)
    • Kaiser Permanente - Irvine /ID# 276924 · Irvine, United States
    • Willis-Knighton Medical Center /ID# 274310 · Shreveport, United States
    Show 1 removed
    • Trials 365 /ID# 274310 · Shreveport, United States
  2. Oct 16, 2026
    Mount Sinai Medical Center /ID# 274868 is now Completed
    Site contacts Changed at 1 site. See the sites
    Show the site
    • Mount Sinai Medical Center /ID# 274868 · Miami Beach, United StatesContact removed (no phone or email listed)
  3. Oct 6, 2026
    2 sites added
    Show 2 added (2 United States)
    • Columbia University Irving Medical Center /ID# 276156 · New York, United States
    • West Penn Hospital /ID# 276028 · Pittsburgh, United States
    + 1 other change: verification date
  4. Sep 29, 2026
    1 site added, 1 site removed
    Show site
    • UCLA - University of California Los Angeles Medical Center /ID# 274566 · Los Angeles, United States
    Show 1 removed
    • University of California Los Angeles Medical Center /ID# 274566 · Los Angeles, United States

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06890338
Lead sponsor
AbbVie
Collaborators
GOG Foundation
Responsible party
Sponsor
First posted
Mar 24, 2025
Start date
Nov 21, 2025
Primary completion
Feb 2030 (estimated)
Completion
Feb 2030 (estimated)
Last update
Oct 20, 2026

Study contacts

ABBVIE CALL CENTER
Contact
abbvieclinicaltrials@abbvie.com
844-663-3742
ABBVIE INC.
study director · AbbVie

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Carboplatin · Mirvetuximab soravtansine

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