Description:
This is a phase 1b/2 study to assess the safety, tolerability, and preliminary anti-tumor
activity of IMGN853 when administered with chemotherapy. Patients will be assigned to one of
five regimens: IMGN853 administered with bevacizumab, IMGN853 administered with carboplatin,
IMGN853 administered with pegylated liposomal doxorubicin, IMGN853 administered with
pembrolizumab, or IMGN853 administered with bevacizumab+carboplatin
Title
- Brief Title: Study of Mirvetuximab Soravtansine in Comb. With Bevacizumab, Carboplatin, PLD, Pembrolizumab, or Bevacizumab + Carboplatin in Adults With FRa + Adv. EOC, Primary Peritoneal or Fallopian Tube Cancer
- Official Title: 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
Clinical Trial IDs
- ORG STUDY ID:
IMGN853-0402
- SECONDARY ID:
KEYNOTE PN409
- NCT ID:
NCT02606305
Conditions
- Epithelial Ovarian Cancer
- Primary Peritoneal Cancer
- Fallopian Tube Cancer
Interventions
Drug | Synonyms | Arms |
---|
IMGN853 | | Regimen A |
Bevacizumab | | Regimen A |
Carboplatin | | Regimen B |
Pegylated Liposomal Doxorubicin | | Regimen C |
Pembrolizumab | | Regimen D |
Bevacizumab+Carboplatin | | Regimen E |
Purpose
This is a phase 1b/2 study to assess the safety, tolerability, and preliminary anti-tumor
activity of IMGN853 when administered with chemotherapy. Patients will be assigned to one of
five regimens: IMGN853 administered with bevacizumab, IMGN853 administered with carboplatin,
IMGN853 administered with pegylated liposomal doxorubicin, IMGN853 administered with
pembrolizumab, or IMGN853 administered with bevacizumab+carboplatin
Detailed Description
The dose escalation part of the study will assess safety and tolerability and determine the
maximum tolerated dose (MTD) for each regimen. The dose expansion of the MTD will assess
safety, tolerability and preliminary anti-tumor activity.
Trial Arms
Name | Type | Description | Interventions |
---|
Regimen A | Experimental | Dose escalation and dose expansion with IMGN853 and bevacizumab | |
Regimen B | Experimental | Dose Escalation with IMGN853 and carboplatin | |
Regimen C | Experimental | Dose Escalation with IMGN853 and pegylated liposomal doxorubicin | - IMGN853
- Pegylated Liposomal Doxorubicin
|
Regimen D | Experimental | Dose escalation and dose expansion with IMGN853 and pembrolizumab | |
Regimen E | Experimental | Dose expansion with IMGN853 and bevacizumab+carboplatin | - IMGN853
- Bevacizumab+Carboplatin
|
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with advanced epithelial ovarian cancer, primary peritoneal cancer, or
fallopian tube cancer
- Folate receptor alpha positive tumor expression as defined in the protocol
- Willing to undergo tumor biopsy
- Measurable disease
Exclusion Criteria:
- Primary platinum-refractory EOC
- Diagnosis of clear cell, low grade ovarian cancer or mixed tumors
- Serious concurrent illness or clinically relevant active infection, including known
diagnosis of HIV and hepatitis B or C, as defined in the protocol
- Active autoimmune disease requiring systemic therapy in past 2 years (IMGN853 and
pembrolizumab only)
- Women who are pregnant or breastfeeding
- Male patients
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Female |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Incidence of TEAEs, SAEs, adverse events, clinically significant changes in laboratory/clinical tests and dose-limiting toxicities (DLTs) as a measure of safety and tolerability [dose escalation] |
Time Frame: | Up to 2.5 years |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Duration of response (DOR); the time from first objective response until progressive disease, will be calculated for all patients who achieve a confirmed objective response (PR or CR) |
Time Frame: | Up to 2.5 years |
Safety Issue: | |
Description: | |
Measure: | Progression-free survival (PFS); the time from date of first dose until the date of objective disease progression or death by any cause as defined by RECIST 1.1. |
Time Frame: | Up to 2.5 years |
Safety Issue: | |
Description: | |
Measure: | PK parameters: maximum plasma concentration (Cmax) of IMGN853, bevacizumab, carboplatin and PLD |
Time Frame: | Up to 2.5 years |
Safety Issue: | |
Description: | |
Measure: | PK parameters: area under the time-concentration curve (AUC) of IMGN853, bevacizumab, carboplatin and PLD |
Time Frame: | Up to 2.5 years |
Safety Issue: | |
Description: | |
Measure: | PK parameters: terminal half-life (t½) of IMGN853, bevacizumab, carboplatin and PLD |
Time Frame: | Up to 2.5 years |
Safety Issue: | |
Description: | |
Measure: | PK parameters: clearance (Cl) of IMGN853, bevacizumab, carboplatin and PLD |
Time Frame: | Up to 2.5 years |
Safety Issue: | |
Description: | |
Measure: | PK parameters: volume of distribution at steady state (Vss) of IMGN853, bevacizumab, carboplatin and PLD |
Time Frame: | Up to 2.5 years |
Safety Issue: | |
Description: | |
Measure: | PK parameters: maximum time (Tmax) of IMGN853, bevacizumab, carboplatin and PLD |
Time Frame: | Up to 2.5 years |
Safety Issue: | |
Description: | |
Measure: | Immunogenicity: Presence of Anti-Drug Antibody (ADA) |
Time Frame: | Up to 2.5 years |
Safety Issue: | |
Description: | |
Measure: | Number of patients with CA125 clinical response. |
Time Frame: | Up to 2.5 years |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | ImmunoGen, Inc. |
Trial Keywords
- Epithelial ovarian cancer
- Fallopian tube cancer
- Primary peritoneal cancer
- IMGN853
- ADC
- Antibody drug conjugate
- ImmunoGen
- Antibody
- Phase 1
- Folate receptor alpha
Last Updated
September 10, 2019