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Study Name: GOG-3078

Status:

Recruiting

Disease Site:

Ovarian

Phase:

Phase III

Official Title:

GOG-3078 PHASE III, OPEN-LABEL, RANDOMIZED STUDY OF MIRVETUXIMAB SORAVTANSINE IN COMBINATION WITH BEVACIZUMAB VERSUS BEVACIZUMAB ALONE AS MAINTENANCE THERAPY FOR PATIENTS WITH FOLATE-POSITIVE RECURRENT PLATINUM-SENSITIVE OVARIAN CANCER WHO HAVE NOT PROGRESSED AFTER SECOND LINE PLATINUM-BASED CHEMO PLUS BEVACIZUMAB

NCT ID:

NCT#05445778

Link to Full Details:

clinicaltrials.gov/show/NCT05445778

Description:

GLORIOSA is a Phase 3 multicenter, open label study designed to evaluate the safety and efficacy of mirvetuximab Soravtansine as maintenance therapy in participants with platinum-sensitive ovarian, primary peritoneal or fallopian tube cancers with high folate receptor-alpha (FRα) expression.

Eligibility:

Female – 18 years and older

Inclusion Criteria:

  • High-grade serous epithelial ovarian, fallopian tube or peritoneal origin
  • Folate positive based on central testing
  • BRCA testing required to be completed locally, somatic or germline; somatic or germline BRCA positive patients must have received prior tx with PARPi in maintenance following first-line treatment
  • Must have relapsed after 1 line of platinum-based chemotherapy and have platinum- sensitive disease
  • Must have received no less than 4 and no more than 8 cycles of platinum-based triplet tx, to include no less than 3 cycles of bevacizumab in combination with chemo. If the number of cycles received is less than 6 due to toxicity, this must be documented and toxicity assessed as unlikely r/t bevacizumab
  • Taxol, Gemzar, and PLD acceptable as second line chemo options
  • Must be in CR, PR, or SD after completion of triplet therapy in second line
  • Must be randomized no later than 8 weeks from the last dose of triplet therapy in second line

Exclusion Criteria:

  • Endometrioid, clear cell, mucinous, or sarcomatous histology; mixed tumors containing any of the previous histologies; low-grade or borderline
  • PD while on or following platinum-based triplet tx in second line
  • Pts who receive an intervening dose of bevacizumab after the last dose of triplet therapy before rando
  • Greater than grade 1 peripheral neuropathy