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All Conditions

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Genital Diseases

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Female Urogenital Diseases

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Female Urogenital Diseases and Pregnancy Complications

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Urogenital Neoplasms

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Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Fallopian Tube Diseases

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Pembrolizumab

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Liposomal doxorubicin

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Immunoglobulins

Mirvetuximab soravtansine

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Antineoplastic Agents, Immunological

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Antibiotics, Antitubercular

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Vitamin B9

Mirvetuximab soravtansine + Bevacizumab administered on Day 1 of each 21-day cycle in Dose Escalation and Dose Expansion phase.

Mirvetuximab soravtansine + Carboplatin administered on Day 1 of each 21-day cycle in Dose Escalation phase.

Mirvetuximab soravtansine + Pegylated liposomal doxorubicin administered on Day 1 of each 28-day cycle in Dose Escalation Phase.

Mirvetuximab soravtansine + Pembrolizumab administered on Day 1 of each 21-day cycle in Dose Escalation and Dose Expansion phase.

Mirvetuximab soravtansine + Bevacizumab + Carboplatin administered on Day 1 of each 21-day cycle in Dose Expansion phase.

Pegylated Liposomal Doxorubicin

This study comprises a Dose Escalation phase followed by a Dose Expansion phase. Dose Escalation part of the study will assess the safety and tolerability and determine the maximum tolerated dose (MTD) as the recommended Phase 2 (RP2D) dose for each regimen. Participants will be assigned to one of the 4 regimens in Dose Escalation phase: Regimen A: mirvetuximab soravtansine administered with bevacizumab; Regimen B: mirvetuximab soravtansine administered with carboplatin; Regimen C: mirvetuximab soravtansine administered with pegylated liposomal doxorubicin; or Regimen D: mirvetuximab soravtansine administered with pembrolizumab. Dose Expansion of the study will further assess safety, tolerability and preliminary anti-tumor activity of mirvetuximab soravtansine. A Dose Expansion phase is planned for Regimen A and Regimen D and will open pending Sponsor decision; participants enrolled in the Dose Expansion phase will receive study treatment at the MTD or RP2D determined during Dose Escalation. For Regimen A, participants in the Dose Expansion phase may be enrolled according to prior exposure to bevacizumab into 3 Dose Expansion Cohorts as follows: 1) Dose Expansion Cohort 1: bevacizumab naïve; 2) Dose Expansion Cohort 2: bevacizumab pretreated; and 3) Dose Expansion Cohort 3: one to three prior treatments, one of which could have been bevacizumab. A triplet Regimen (Regimen E: mirvetuximab soravtansine + bevacizumab + carboplatin) will be opened to evaluate the safety and tolerability and to assess any early signs of activity in participants dosed with the combination regimen. All mirvetuximab soravtansine doses were calculated according to adjusted ideal body weight.

Participants will continue to receive mirvetuximab soravtansine and/or the combination agent until progressive disease (PD), unacceptable toxicity, or withdrawal of consent, whichever comes first, or until the Sponsor terminates the study.

Study of Mirvetuximab Soravtansine in Combination With Bevacizumab, Carboplatin, Pegylated Liposomal Doxorubicin, Pembrolizumab, or Bevacizumab + Carboplatin in Participants With Folate Receptor Alpha (FRα) Positive Advanced Epithelial Ovarian Cancer, Primary Peritoneal, or Fallopian Tube Cancer

A Phase 1b/2 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Mirvetuximab Soravtansine (IMGN853) in Combination With Bevacizumab, Carboplatin, Pegylated Liposomal Doxorubicin, Pembrolizumab, or Bevacizumab + Carboplatin, in Adults With Folate Receptor Alpha Positive Advanced Epithelial Ovarian Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer

Adverse events (AEs) were any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function that developed or worsened during the clinical study, not necessarily having a causal relationship to study drug. Severity was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03: Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life-threatening, Grade 5=death. Serious AEs included death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes previously listed. TEAEs were any AE that emerged on or after the first dose, and within 30 days of the last dose. Serious and other non-serious AEs regardless of causality are reported in the AE module.

ORR was defined as percentage of participants with confirmed response (complete response \[CR\] + partial response \[PR\]). CR: Disappearance of all target or non-target lesions. All pathological or non-pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 millimeters (mm). PR: At least 30 percent (%) decrease in the sum of the longest diameters (SLD) of target lesions, taking as reference the baseline SLD. The 95% confidence interval (CI) was based on binomial distribution.

ORR was defined as percentage of participants with confirmed response (CR + PR). CR: Disappearance of all target or non-target lesions. All pathological or non-pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: At least 30% decrease in the SLD of target lesions, taking as reference the baseline SLD.

PFS was defined as the time from the date of the first dose of study drug until the date of PD or death from any cause, whichever occurred first, estimated using the Kaplan-Meier method. PFS was defined based on radiological assessments and determined by the investigator. PD was defined as at least a 20% increase in the SLD of target lesions, taking as reference the smallest (nadir) SLD since and including baseline. In addition to the relative increase of 20%, the SLD must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of non-target lesions and appearance of new lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.

DOR was defined as the time from the date of the first response (CR or PR), to the date of PD or death from any cause, whichever occurred first. DOR was only defined for patients who had a best overall response of CR or PR, estimated using the Kaplan-Meier method. The response-evaluable population included all patients with radiographic assessment at baseline, who received at least 1 dose of combination treatment and had at least 1 post-dose radiographic tumor assessment or who died within 105 days of first dose.

A CA-125 response was defined as a ≥ 50% reduction in CA-125 levels from baseline. GCIG CA125 response rate was defined as the number of participants with a CA-125 confirmed response divided by the number of participants in the CA-125 response-evaluable population multiplied by 100. The CA-125 evaluable population included all participants whose pretreatment sample was ≥2.0 times the upper limit of normal, within 2 weeks prior to the first dose of combination treatment, and who had at least 1 post-baseline CA-125 evaluation.

Blood samples from participants were analyzed to characterize the PK of mirvetuximab soravtansine when administered in 3- or 4-week cycles. Results are reported in micrograms/milliliter (µg/mL).

Blood samples from participants were analyzed to characterize the PK of mirvetuximab soravtansine when administered in 3- or 4-week cycles. Results are reported in nanograms (ng)/mL.

Blood samples from participants were analyzed to characterize the PK of mirvetuximab soravtansine when administered in 3- or 4-week cycles. Results are reported in mg\*hours (h)/mL.

Blood samples from participants were analyzed to characterize the PK of mirvetuximab soravtansine when administered in 3- or 4-week cycles. Note that '9999' is used because AUCinf cannot be calculated for n\<3.

Blood samples from participants were analyzed to characterize the PK of mirvetuximab soravtansine when administered in 3- or 4-week cycles. PK parameters were calculated using standard non-compartmental methods.

The terminal t½ is an estimate (extrapolation) of the time it takes for the concentration or amount in the body of that drug to be reduced by exactly one-half (50%). If extrapolated AUC was greater than 20% (due to insufficient number of participants with data samples) the upper range of t½ was not reported.

Blood samples from participants were analyzed to characterize the PK of mirvetuximab soravtansine when administered in 3- or 4-week cycles.

Blood samples from participants were analyzed to characterize PK when administered in 3- or 4-week cycles.

Blood samples from participants were analyzed to characterize the PK of mirvetuximab soravtansine when administered in 3- or 4-week cycles.

PK parameters were derived using non-compartmental PK analysis.

Blood samples from participants at the end of infusion were analyzed to characterize the PK of mirvetuximab soravtansine when administered in 3- or 4-week cycles.

Blood samples were collected to measure the presence of ADAs for mirvetuximab soravtansine. Seronegative is defined as a participant that tests negative at all visits. Treatment-emergent ADA is defined as a participant that is seronegative prior to dosing on Day 1 of Cycle 1 and tests positive in both screening and confirmatory assays at one or more subsequent visits. Treatment-unaffected ADA is defined as a participant test positive in both screening and confirmatory assays prior to dosing on Day 1 of Cycle 1 with a post-dose titer increase of less than or equal to 4-fold (based on a 2-fold sample dilution). Treatment-boosted ADA is defined as a participant test positive in both screening and confirmatory assays prior to dosing on Day 1 of Cycle 1 with a post-dose titer increase of more than a 4-fold increase (based on a 2-fold sample dilution).

ImmunoGen, Inc.

Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.

Participants were administered mirvetuximab soravtansine 5 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.

Mirvetuximab Soravtansine 5 mg/kg + Bevacizumab 15 mg/kg

All participants who were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle in the dose escalation and dose expansion phases.

Mirvetuximab Soravtansine 6 mg/kg + Bevacizumab 15 mg/kg

Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC4 on Day 1 of each 21-day cycle.

Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC4

Participants were administered mirvetuximab soravtansine 5 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.

Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC5

Participants were administered mirvetuximab soravtansine 6 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.

Mirvetuximab Soravtansine 6 mg/kg + Carboplatin AUC5

Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 30 mg/m\^2 on Day 1 of each 28-day cycle.

Mirvetuximab Soravtansine 5 mg/kg + PLD 30 mg/m^2

Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 40 mg/m\^2 on Day 1 of each 28-day cycle.

Mirvetuximab Soravtansine 5 mg/kg + PLD 40 mg/m^2

Participants were administered mirvetuximab soravtansine 6 mg/kg + PLD 40 mg/m\^2 on Day 1 of each 28-day cycle.

Mirvetuximab Soravtansine 6 mg/kg + PLD 40 mg/m^2

Participants were administered mirvetuximab soravtansine 5 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.

Mirvetuximab Soravtansine 5 mg/kg + Pembrolizumab 200 mg

All participants who were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle in the dose escalation and dose expansion phases.

Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg

Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg + carboplatin AUC5 on Day 1 of each 21-day cycle.

Mirvetuximab Soravtansine + Bevacizumab + Carboplatin

Regimen A Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Bevacizumab 15 mg/kg

Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.

Regimen A Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Bevacizumab 15 mg/kg

Participants not previously treated with bevacizumab (bevacizumab naïve) were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.

Regimen A Dose Expansion Cohort 1: Bevacizumab-naïve

Participants who were pre-treated with bevacizumab were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg on Day 1 of each 21-day cycle.

Regimen A Dose Expansion Cohort 2: Bevacizumab Pre-treated

Participants with at least 1 but no more than 3 prior systemic treatment regimens, where prior regimens may have included bevacizumab were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg.

Regimen A Dose Expansion Cohort 3: Pt-agnostic:

Regimen B Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC4

Regimen B Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC5

Regimen B Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Carboplatin AUC5

Regimen C Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + PLD 30 mg/m^2

Regimen C Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + PLD 40 mg/m^2

Regimen C Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + PLD 40 mg/m^2

Regimen D Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Pembrolizumab 200 mg

Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg on Day 1 of each 21-day cycle.

Regimen D Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg

Regimen D Dose Expansion: Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg

Regimen E: Mirvetuximab Soravtansine + Bevacizumab + Carboplatin

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

All participants who were enrolled and received at least 1 dose of study drug.

CMO, ImmunoGen

Any TEAE

SAEs

Grade >=3 TEAEs

Participants were administered mirvetuximab soravtansine 5 mg/kg + PLD 40 mg/m\^2 administered on Day 1 of each 28-day cycle.

All participants who were enrolled and received at least 1 dose of study drug. Data were reported by dose group and where applicable the dose-escalation and expansion phases were combined to report data by dose group.

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

Response-Evaluable Population: All participants who received at least 1 dose of study treatment, had radiographic assessment at baseline received at least 1 dose of combination treatment, and at least 1 post-dose radiographic tumor assessment or have died within 105 days of first dose.

Dose Expansion (Regimens A and D) and Triplet (Regimen E): Objective Response Rate (ORR); Percentage of Participants With Confirmed Response, as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

Participants were administered mirvetuximab soravtansine 6 mg/kg + PLD 40 mg/m\^2 administered on Day 1 of each 28-day cycle.

Dose Escalation (Regimens A Through D): ORR; Percentage of Participants With Confirmed Response, as Assessed by RECIST Version 1.1

Participants were administered mirvetuximab soravtansine 6 mg/kg + bevacizumab 15 mg/kg administered on Day 1 of each 21-day cycle.

Progression-Free Survival (PFS); Time From the Date Of First Dose Until The Date Of Progressive Disease (PD) Or Death By Any Cause, As Defined By RECIST Version 1.1

Participants were administered mirvetuximab soravtansine 6 mg/kg + carboplatin AUC5 administered on Day 1 of each 21-day cycle.

Response-Evaluable Population: All participants who received at least 1 dose of study treatment, had radiographic assessment at baseline received at least 1 dose of combination treatment, and at least 1 post-dose radiographic tumor assessment or have died within 105 days of first dose. Only participants who had best overall response of CR or PR were analyzable.

Duration of Response (DOR) Per RECIST v1.1 by Investigator Assessment

CA125 Evaluable Population: All participants whose pretreatment sample is ≥ 2.0 times the upper limit of normal (ULN), within 2 weeks prior to the first dose of combination treatment, and who have at least 1 post-baseline CA125 evaluation.

Gynecologic Cancer Intergroup (GCIG) Cancer Antigen (CA)-125 Clinical Response Rate by Investigator Assessment

Mirvetuximab Soravtansine: Cycle 1

Mirvetuximab Soravtansine: Cycle 3

Total Antibody: Cycle 1

Total Antibody: Cycle 3

Participants were administered mirvetuximab soravtansine 6 mg/kg + pembrolizumab 200 mg administered on Day 1 of each 21-day cycle.

Response-Evaluable Population: All participants who received at least 1 dose of study treatment, had radiographic assessment at baseline received at least 1 dose of combination treatment, and at least 1 post-dose radiographic tumor assessment or have died within 105 days of first dose. The 'Number Analyzed' signifies participants evaluable for the specified categories.

Spots Global Cancer Trial Database for mirvetuximab

Every month we try and update this database with for mirvetuximab cancer trials from around the world to help patients and their families find trials that might be right for them.
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