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NCT02606305 · ClinicalTrials.gov registry record · Phase 1
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 1 study, sponsored by ImmunoGen.
- Completed
- Registry status
- Phase 1
- Development phase
- 264
- Enrollment target
NCT02606305 is a Phase 1 study that has completed, run by ImmunoGen. The registered enrollment target is 264 participants.
The verdict
NCT02606305, a Phase 1 study, has completed, sponsored by ImmunoGen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 264 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Pembrolizumab
- DRUG Bevacizumab
- DRUG Carboplatin
- DRUG Mirvetuximab soravtansine
- DRUG Pegylated Liposomal Doxorubicin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 264 participants |
| Start Date | 2016-03-02 |
| Est. Completion | 2021-03-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02606305
The ClinicalTrials.gov registry entry for NCT02606305 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 264 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ImmunoGen, which has 15 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT02606305 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02606305 about?
NCT02606305 is a clinical study titled "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". 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 t...
What is the current status of trial NCT02606305?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 264 participants. The study started on 2016-03-02. Estimated completion is 2021-03-12.
What interventions are being tested in trial NCT02606305?
The interventions under investigation include: Pembrolizumab (DRUG), Bevacizumab (DRUG), Carboplatin (DRUG), Mirvetuximab soravtansine (DRUG), Pegylated Liposomal Doxorubicin (DRUG).
Who is sponsoring clinical trial NCT02606305?
This trial is sponsored by ImmunoGen, which has 15 total clinical trials registered on ClinicalTrials.gov.
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