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
| Status: | Recruiting |
|---|---|
| Conditions: | Ovarian Cancer, Cervical Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Endometrial Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/9/2018 |
| Start Date: | December 2015 |
| End Date: | July 2021 |
| Contact: | ImmunoGen Clinical Operations |
| Email: | IMGN0402@immunogen.com |
| Phone: | 781-895-0600 |
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
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
four 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
activity of IMGN853 when administered with chemotherapy. Patients will be assigned to one of
four 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
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.
maximum tolerated dose (MTD) for each regimen. The dose expansion of the MTD will assess
safety, tolerability and preliminary anti-tumor activity.
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
- Diagnosis of clear cell or low grade ovarian cancer
- 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
We found this trial at
6
sites
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