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

Part of paid clinical trials in Los Angeles, California.

Sponsor
ImmunoGen, Inc.
Study ID
NCT02606305
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Mirvetuximab soravtansine — DRUG
  • Bevacizumab — DRUG
  • Carboplatin — DRUG
  • Pegylated Liposomal Doxorubicin — DRUG
  • Pembrolizumab — DRUG

Study Details

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.

Key Dates

First listed
Nov 17, 2015
Start date
Mar 2, 2016
Status verified
Jun 2024
Primary completion
Mar 12, 2021
Completion
Mar 12, 2021

Study Design

Enrollment
264 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Regimen A (Mirvetuximab soravtansine + Bevacizumab)
    Mirvetuximab soravtansine + Bevacizumab administered on Day 1 of each 21-day cycle in Dose Escalation and Dose Expansion phase.
  • Experimental: Regimen B (Mirvetuximab soravtansine + Carboplatin)
    Mirvetuximab soravtansine + Carboplatin administered on Day 1 of each 21-day cycle in Dose Escalation phase.
  • Experimental: Regimen C (Mirvetuximab soravtansine + Pegylated liposomal doxorubicin)
    Mirvetuximab soravtansine + Pegylated liposomal doxorubicin administered on Day 1 of each 28-day cycle in Dose Escalation Phase.
  • Experimental: Regimen D (Mirvetuximab soravtansine + Pembrolizumab)
    Mirvetuximab soravtansine + Pembrolizumab administered on Day 1 of each 21-day cycle in Dose Escalation and Dose Expansion phase.
  • Experimental: Regimen E (Mirvetuximab soravtansine + Bevacizumab + Carboplatin)
    Mirvetuximab soravtansine + Bevacizumab + Carboplatin administered on Day 1 of each 21-day cycle in Dose Expansion phase.

Primary Outcome Measure

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 238.3 weeks) ]

Locations (7)

FacilityCityStateZIPSite coordinators
University of California at Los AngelesLos AngelesCalifornia--
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
City of HopeRenoNevada--
The Ohio State UniversityHilliardOhio43026-
Peggy and Charles Stephenson Oklahoma Cancer CenterOklahoma CityOklahoma73104-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-

Find similar trials in Los Angeles, CA

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
University of California at Los Angeles· Los Angeles, CADana-Farber Cancer Institute· Boston, MAMassachusetts General Hospital· Boston, MACity of Hope· Reno, NVThe Ohio State University· Hilliard, OHPeggy and Charles Stephenson Oklahoma Cancer Center· Oklahoma City, OK

Related Studies