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| ID | Type | Description | Link |
|---|---|---|---|
| GOG-3124 | Other Identifier | GOG |
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| Name | Class |
|---|---|
| GOG Foundation | NETWORK |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: IMGN151 + Carboplatin (For PSOC) | Experimental | Participants will receive IMGN151 in combination with Carboplatin on Day 1 of a 21-day cycle. |
|
| Arm B: IMGN151 + Olaparib (For PSOC) | Experimental | Participants will receive IMGN151 in combination with Olaparib twice a day (BID) on Day 1 of a 21-day cycle. |
|
| Arm C: IMGN151 + Bevacizumab (For PSOC or PROC) | Experimental | Participants will receive IMGN151 in combination with Bevacizumab Day 1 of a 21-day cycle. |
|
| Arm D: IMGN151 Monotherapy (For PSOC) | Experimental | Participants will receive IMGN151 Day 1 of a 21-day cycle. |
|
| Arm E: IMGN151 Monotherapy (For PROC in China) | Experimental | Participants will receive IMGN151 Day 1 of a 21-day cycle. |
|
| Arm F: IMGN151 Monotherapy (For PROC in Japan) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMGN151 | Drug | Intravenous (IV) infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number 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. | 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. | Up to approximately 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to approximately 3 years |
| Duration of response (DOR) |
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Inclusion Criteria:
ECOG performance status of 0 or 1
Participants (except for platinum-sensitive ovarian, fallopian tube, and primary peritoneal cancer (PSOC) participants without disease progression after platinum combination standard of care therapy in Arms B and D) will have ≥ 1 lesion that meets the definition of measurable disease by RECIST v1.1 (radiographically measured by the investigator).
Participants will have high-grade serous epithelial ovarian, fallopian tube, and primary peritoneal cancers (EOC).
Participant has completed prior therapy within the specified times below:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ABBVIE CALL CENTER | Contact | 844-663-3742 | abbvieclinicaltrials@abbvie.com |
| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Holy Name Medical Center /ID# 279017 | Recruiting | Teaneck | New Jersey | 07666 | United States | |
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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| Experimental |
Participants will receive IMGN151 Day 1 of a 21-day cycle. |
|
| Carboplatin | Drug | Intravenous (IV) infusion |
|
| Bevacizumab | Drug | Intravenous (IV) infusion |
|
| Olaparib | Drug | Oral Tablet |
|
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. |
| Up to approximately 3 years |
| Progression-free survival (PFS) | Defined as the time from the randomization date for randomized phase or the first dose of study treatment for non-randomized phase until investigator-assessed radiographical PD per RECIST v1.1 or death of any cause, whichever occurs first. | Up to approximately 3 years |
| University of Cincinnati Medical Center. /ID# 278925 |
| Recruiting |
| Cincinnati |
| Ohio |
| 45219 |
| United States |
| OU Health - Stephenson Cancer Center /ID# 277656 | Recruiting | Oklahoma City | Oklahoma | 73104 | United States |
| Providence Portland Medical Center /ID# 277727 | Recruiting | Portland | Oregon | 97213 | United States |
| Women & Infants Hospital /ID# 277930 | Recruiting | Providence | Rhode Island | 02905 | United States |
| SCRI Oncology Partners /ID# 279733 | Recruiting | Nashville | Tennessee | 37203 | United States |
| Texas Oncology-Austin North /ID# 279958 | Recruiting | Austin | Texas | 78758 | United States |
| Next Virginia /ID# 279684 | Recruiting | Fairfax | Virginia | 22031 | United States |
| Rabin Medical Center /ID# 279142 | Recruiting | Petah Tikva | Central District | 4941492 | Israel |
| The Chaim Sheba Medical Center /ID# 275997 | Recruiting | Ramat Gan | Tel Aviv | 5265601 | Israel |
| Tel Aviv Sourasky Medical Center /ID# 275852 | Recruiting | Tel Aviv | Tel Aviv | 6423906 | Israel |
| Rambam Health Care Campus- Haifa /ID# 276004 | Recruiting | Haifa | 3109601 | Israel |
| Shaare Zedek Medical Center /ID# 275854 | Recruiting | Jerusalem | 9103102 | Israel |
| Hyogo Cancer Center /ID# 276940 | Recruiting | Akashi-shi | Hyōgo | 673-8558 | Japan |
| National Cancer Center Hospital /ID# 276715 | Recruiting | Chuo-Ku | Tokyo | 104-0045 | Japan |
| The Cancer Institute Hospital Of JFCR /ID# 276711 | Recruiting | Koto-ku | Tokyo | 135-8550 | Japan |
| ID | Term |
|---|---|
| D005185 | Fallopian Tube Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D005184 | Fallopian Tube Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D000068258 | Bevacizumab |
| C531550 | olaparib |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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