Clinical Trial: NCT02606305 - My Cancer Genome

NCT02606305

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

Related Conditions:

Fallopian Tube Carcinoma
Ovarian Carcinoma
Primary Peritoneal Carcinoma

Recruiting Status:

Active, not recruiting

Phase:

Phase 1/Phase 2

URL:

https://clinicaltrials.gov/show/NCT02606305

Trial Eligibility

Document

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

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	IMGN853 Bevacizumab
Regimen B	Experimental	Dose Escalation with IMGN853 and carboplatin	IMGN853 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	IMGN853 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

Clinical Trials /

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