Trial · NCT02606305
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
NCT02606305, Phase 1, Phase 2, Completed, ImmunoGen, Inc.; results first posted 2024-02-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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. Trials, record NCT02606305. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02606305
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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
- NCT number
- NCT02606305
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 264 participants, actual
- Lead sponsor
- ImmunoGen, Inc.
- Conditions
- Epithelial Ovarian Cancer, Primary Peritoneal Cancer, Fallopian Tube Cancer
- Interventions
- Mirvetuximab soravtansine, Bevacizumab, Carboplatin, Pegylated Liposomal Doxorubicin, Pembrolizumab
- First posted
- 2015-11-17
- Last updated
- 2024-06-14
- Results first posted
- 2024-02-14
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) | 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. |
| Primary | 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 | From first dose of study drug until first CR or PR (maximum exposure: 238.3 weeks) | 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. |
| Secondary | Dose Escalation (Regimens A Through D): ORR; Percentage of Participants With Confirmed Response, as Assessed by RECIST Version 1.1 | From first dose of study drug until first CR or PR (maximum exposure: 238.3 weeks) | 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. |
| Secondary | 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 | From first dose of study drug until the date of PD or death by any cause (maximum exposure: 238.3 weeks) | 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. |
| Secondary | Duration of Response (DOR) Per RECIST v1.1 by Investigator Assessment | From the date of first objective response to the time of PD (maximum exposure: 238.3 weeks) | 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. |
| Secondary | Gynecologic Cancer Intergroup (GCIG) Cancer Antigen (CA)-125 Clinical Response Rate by Investigator Assessment | From first dose of study drug until first CR or PR (maximum exposure: 238.3 weeks) | 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. |
| Secondary | Pharmacokinetics (PK) Parameter: Maximum Plasma Concentration (Cmax) of Mirvetuximab Soravtansine and Total Antibody | Cycles 1 and 3: Day 1 (pre-infusion, within 10 minutes of end of infusion [EOI], and 6 hours post-infusion); Days 2 and 3 (24- and 48-hours post-infusion); Days 8 and 15 (additionally at Day 22 for Regimen C) | 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). |
| Secondary | PK Parameter: Cmax of N2'-[4-[(3-carboxypropyl)Dithio]-4-methyl-1-oxo-2-sulfopentyl]-N2'-Deacetylmaytansine (DM4) and S-methyl DM4 (SmDM4) | Cycles 1 and 3: Day 1 (pre-infusion, within 10 minutes of end of infusion [EOI], and 6 hours post-infusion); Days 2 and 3 (24- and 48-hours post-infusion); Days 8 and 15 (additionally at Day 22 for Regimen C) | 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. |
| Secondary | PK Parameter: Area Under the Time-Concentration Curve From Time 0 To Infinite Time (AUCinf) of Mirvetuximab Soravtansine and Total Antibody | Cycles 1 and 3: Day 1 (pre-infusion, within 10 minutes of EOI, and 6 hours post-infusion); Days 2 and 3 (24- and 48-hours post-infusion); Days 8 and 15 (additionally at Day 22 for Regimen C) | 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. |
| Secondary | PK Parameter: AUCinf of Intact DM4 and SmDM4 | Cycles 1 and 3: Day 1 (pre-infusion, within 10 minutes of EOI, and 6 hours post-infusion); Days 2 and 3 (24- and 48-hours post-infusion); Days 8 and 15 (additionally at Day 22 for Regimen C) | 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. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) | 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | 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 | From first dose of study drug until first CR or PR (maximum exposure: 238.3 weeks) | 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. | percentage of participants | NUMBER |
| SECONDARY | Dose Escalation (Regimens A Through D): ORR; Percentage of Participants With Confirmed Response, as Assessed by RECIST Version 1.1 | From first dose of study drug until first CR or PR (maximum exposure: 238.3 weeks) | 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. | percentage of participants | NUMBER |
| SECONDARY | 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 | From first dose of study drug until the date of PD or death by any cause (maximum exposure: 238.3 weeks) | 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. | months | MEDIAN |
| SECONDARY | Duration of Response (DOR) Per RECIST v1.1 by Investigator Assessment | From the date of first objective response to the time of PD (maximum exposure: 238.3 weeks) | 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. | months | MEDIAN |
| SECONDARY | Gynecologic Cancer Intergroup (GCIG) Cancer Antigen (CA)-125 Clinical Response Rate by Investigator Assessment | From first dose of study drug until first CR or PR (maximum exposure: 238.3 weeks) | 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. | percentage of participants | NUMBER |
| SECONDARY | Pharmacokinetics (PK) Parameter: Maximum Plasma Concentration (Cmax) of Mirvetuximab Soravtansine and Total Antibody | Cycles 1 and 3: Day 1 (pre-infusion, within 10 minutes of end of infusion [EOI], and 6 hours post-infusion); Days 2 and 3 (24- and 48-hours post-infusion); Days 8 and 15 (additionally at Day 22 for Regimen C) | 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. | µg/mL | GEOMETRIC_MEAN |
| SECONDARY | PK Parameter: Cmax of N2'-[4-[(3-carboxypropyl)Dithio]-4-methyl-1-oxo-2-sulfopentyl]-N2'-Deacetylmaytansine (DM4) and S-methyl DM4 (SmDM4) | Cycles 1 and 3: Day 1 (pre-infusion, within 10 minutes of end of infusion [EOI], and 6 hours post-infusion); Days 2 and 3 (24- and 48-hours post-infusion); Days 8 and 15 (additionally at Day 22 for Regimen C) | 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. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | PK Parameter: Area Under the Time-Concentration Curve From Time 0 To Infinite Time (AUCinf) of Mirvetuximab Soravtansine and Total Antibody | Cycles 1 and 3: Day 1 (pre-infusion, within 10 minutes of EOI, and 6 hours post-infusion); Days 2 and 3 (24- and 48-hours post-infusion); Days 8 and 15 (additionally at Day 22 for Regimen C) | 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. | mg*h/mL | GEOMETRIC_MEAN |
| SECONDARY | PK Parameter: AUCinf of Intact DM4 and SmDM4 | Cycles 1 and 3: Day 1 (pre-infusion, within 10 minutes of EOI, and 6 hours post-infusion); Days 2 and 3 (24- and 48-hours post-infusion); Days 8 and 15 (additionally at Day 22 for Regimen C) | 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. | ng*h/mL | GEOMETRIC_MEAN |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group969
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Mirvetuximab Soravtansine 5 mg/kg + Bevacizumab 15 mg/kg | Any TEAE | 3 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Mirvetuximab Soravtansine 6 mg/kg + Bevacizumab 15 mg/kg | Any TEAE | 126 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC4 | Any TEAE | 4 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC5 | Any TEAE | 4 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Mirvetuximab Soravtansine 6 mg/kg + Carboplatin AUC5 | Any TEAE | 10 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Mirvetuximab Soravtansine 5 mg/kg + PLD 30 mg/m^2 | Any TEAE | 4 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Mirvetuximab Soravtansine 5 mg/kg + PLD 40 mg/m^2 | Any TEAE | 4 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Mirvetuximab Soravtansine 6 mg/kg + PLD 40 mg/m^2 | Any TEAE | 7 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Mirvetuximab Soravtansine 5 mg/kg + Pembrolizumab 200 mg | Any TEAE | 4 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg | Any TEAE | 56 | Participants |
1 to 10 of 969Source ClinicalTrials.gov
See all 969 results by groupParticipant flow180
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Dose Escalation: Regimens A, B, C and D | STARTED | Regimen A Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Bevacizumab 15 mg/kg | 3 | |
| Dose Escalation: Regimens A, B, C and D | STARTED | Regimen A Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Bevacizumab 15 mg/kg | 11 | |
| Dose Escalation: Regimens A, B, C and D | STARTED | Regimen A Dose Expansion Cohort 1: Bevacizumab-naïve | 0 | |
| Dose Escalation: Regimens A, B, C and D | STARTED | Regimen A Dose Expansion Cohort 2: Bevacizumab Pre-treated | 0 | |
| Dose Escalation: Regimens A, B, C and D | STARTED | Regimen A Dose Expansion Cohort 3: Pt-agnostic: | 0 | |
| Dose Escalation: Regimens A, B, C and D | STARTED | Regimen B Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC4 | 4 | |
| Dose Escalation: Regimens A, B, C and D | STARTED | Regimen B Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC5 | 4 | |
| Dose Escalation: Regimens A, B, C and D | STARTED | Regimen B Dose Escalation: Mirvetuximab Soravtansine 6 mg/kg + Carboplatin AUC5 | 10 | |
| Dose Escalation: Regimens A, B, C and D | STARTED | Regimen C Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + PLD 30 mg/m^2 | 4 | |
| Dose Escalation: Regimens A, B, C and D | STARTED | Regimen C Dose Escalation: Mirvetuximab Soravtansine 5 mg/kg + PLD 40 mg/m^2 | 5 |
1 to 10 of 180Source ClinicalTrials.gov
See all 180 participant flowAdverse events7,557
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Mirvetuximab Soravtansine 5 mg/kg + Bevacizumab 15 mg/kg | 1 | 3 | |
| other | Diarrhoea | Gastrointestinal disorders | Mirvetuximab Soravtansine 6 mg/kg + Bevacizumab 15 mg/kg | 85 | 126 | |
| other | Diarrhoea | Gastrointestinal disorders | Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC4 | 4 | 4 | |
| other | Diarrhoea | Gastrointestinal disorders | Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC5 | 3 | 4 | |
| other | Diarrhoea | Gastrointestinal disorders | Mirvetuximab Soravtansine 6 mg/kg + Carboplatin AUC5 | 5 | 10 | |
| other | Diarrhoea | Gastrointestinal disorders | Mirvetuximab Soravtansine 5 mg/kg + PLD 30 mg/m^2 | 3 | 4 | |
| other | Diarrhoea | Gastrointestinal disorders | Mirvetuximab Soravtansine 5 mg/kg + PLD 40 mg/m^2 | 4 | 5 | |
| other | Diarrhoea | Gastrointestinal disorders | Mirvetuximab Soravtansine 6 mg/kg + PLD 40 mg/m^2 | 4 | 7 | |
| other | Diarrhoea | Gastrointestinal disorders | Mirvetuximab Soravtansine 5 mg/kg + Pembrolizumab 200 mg | 2 | 4 | |
| other | Diarrhoea | Gastrointestinal disorders | Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg | 32 | 56 |
1 to 10 of 7,557Source ClinicalTrials.gov
See all 7,557 adverse eventsAdverse event totals33
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Mirvetuximab Soravtansine 5 mg/kg + Bevacizumab 15 mg/kg | 0 | 3 |
| Total, all-cause mortality | Mirvetuximab Soravtansine 6 mg/kg + Bevacizumab 15 mg/kg | 5 | 126 |
| Total, all-cause mortality | Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC4 | 0 | 4 |
| Total, all-cause mortality | Mirvetuximab Soravtansine 5 mg/kg + Carboplatin AUC5 | 0 | 4 |
| Total, all-cause mortality | Mirvetuximab Soravtansine 6 mg/kg + Carboplatin AUC5 | 0 | 10 |
| Total, all-cause mortality | Mirvetuximab Soravtansine 5 mg/kg + PLD 30 mg/m^2 | 0 | 4 |
| Total, all-cause mortality | Mirvetuximab Soravtansine 5 mg/kg + PLD 40 mg/m^2 | 0 | 5 |
| Total, all-cause mortality | Mirvetuximab Soravtansine 6 mg/kg + PLD 40 mg/m^2 | 0 | 7 |
| Total, all-cause mortality | Mirvetuximab Soravtansine 5 mg/kg + Pembrolizumab 200 mg | 0 | 4 |
| Total, all-cause mortality | Mirvetuximab Soravtansine 6 mg/kg + Pembrolizumab 200 mg | 4 | 56 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40700855 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
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