Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess safety and tolerability of IMGN151 when given as monotherapy and in combination with other anti-cancer therapies in adult participants with gynecologic cancers. IMGN151 is an investigational drug being developed for the treatment of gynecologic cancers. Participants are placed in 1 of 4 groups, called treatment arms. Each group receives a different treatment. Around 377 participants with gynecologic cancers will be enrolled in the study at approximately 50 sites worldwide. Participants will receive intravenous infusions of IMGN151 as monotherapy or in combination with anti-cancer therapies according to their assigned study arm. In Arm A, participants will receive IMGN151 in combination with carboplatin on Day 1 of each cycle. In Arm B, participants will receive IMGN151 in combination with olaparib, twice a day (BID) on Day 1 of each cycle. In Arm C, participants will receive IMGN151 in combination with bevacizumab on Day 1 of each cycle. In Arm D, participants will receive IMGN151 as monotherapy on Day 1 of each cycle. In Arm E, participants will receive IMGN151 as monotherapy on Day 1 of each cycle. In Arm F, participants will receive IMGN151 as monotherapy on Day 1 of each cycle. The total study duration will be approximately 3 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
377
Intravenous (IV) infusion
Intravenous (IV) infusion
Intravenous (IV) infusion
Oral Tablet
The Chaim Sheba Medical Center /ID# 275997
Ramat Gan, Tel Aviv, Israel
RECRUITINGTel Aviv Sourasky Medical Center /ID# 275852
Tel Aviv, Tel Aviv, Israel
RECRUITINGRambam Health Care Campus /ID# 276004
Haifa, Israel
RECRUITINGShaare Zedek Medical Center /ID# 275854
Jerusalem, Israel
RECRUITINGHyogo Cancer Center /ID# 276940
Akashi-shi, Hyōgo, Japan
RECRUITINGNational Cancer Center Hospital /ID# 276715
Chuo-Ku, Tokyo, Japan
RECRUITINGThe Cancer Institute Hospital Of JFCR /ID# 276711
Koto-ku, Tokyo, Japan
RECRUITINGNumber of Participants With Dose-limiting Toxicities (DLTs)
Dose limiting toxicities (DLTs) of IMGN151 when given as monotherapy and in combination with other anti-cancer therapies DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications.
Time frame: Up to approximately 3 years
Percentage of Participants with Adverse Events (AE)
An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug.
Time frame: Up to approximately 3 years
Objective Response (OR)
Defined as achieving confirmed response (complete response \[CR\] + partial response \[PR\]) assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1.
Time frame: Up to approximately 3 years
Duration of response (DOR)
Defined as the time from initial response of CR or PR until investigator assessed radiographical PD per RECIST v1.1 or death of any cause, whichever occurs first.
Time frame: Up to approximately 3 years
Progression-free survival (PFS)
Defined as the time from the first dose of study treatment until investigator-assessed radiographical PD per RECIST v1.1 or death of any cause, whichever occurs first.
Time frame: Up to approximately 3 years
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