Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Study CP-MGD019-03 is an open-label study of lorigerlimab in participants with platinum-resistant ovarian cancer (PROC) or clear cell gynecologic cancer (CCGC). Approximately 80 participants will be enrolled. The study will assess the efficacy and safety of lorigerlimab in participants with PROC or CCGC.
Participants will receive lorigerlimab by intravenous (IV) infusion on Day 1 of every 21-day treatment cycle. Treatment cycles will continue until progression of cancer, unacceptable side effects, withdrawal of consent by the participant, or the study ends.
Participants will be monitored closely for side effects by physical exam and routine laboratory tests every cycle. Tumor status will be checked approximately every 9 weeks for the first year, then every 12 weeks for the duration of treatment. Participants will have a safety followup performed within 30 days after treatment discontinuation. Participants who discontinue study treatment for reasons other than progression of cancer, will continue CA-125 and tumor assessments every 12 weeks. Participants who discontinue study treatment for progression of cancer will enter the 6-month survival follow up portion of the study.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A (PROC) high dose | Experimental | Lorigerlimab 6 mg/kg IV every 21 days |
|
| Cohort A (PROC) low dose | Experimental | Lorigerlimab 3 mg/kg IV every 21 days |
|
| Cohort B (CCGC) | Experimental | Lorigerlimab 6 mg/kg IV every 21 days |
|
| Cohort C (CCGC) | Experimental | Lorigerlimab 3 mg/kg IV every 21 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lorigerlimab | Biological | Bispecific DART protein binding PD-1 and CTLA-4 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria as determined by the investigator | The ORR, is defined as the percentage of patients in the response evaluable population who achieve a best overall response of complete response (CR) or partial response (PR), per RECIST, version 1.1 criteria. CR is defined as disappearance of all target and non-target lesions. PR is defined as at least a 30% decrease from baseline in the sum of diameters of target lesions. | Throughout the study up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and severity of adverse events (AEs), serious AEs (SAEs), immune-related AEs (irAEs), and AEs leading to dose modifications or treatment discontinuation. | Throughout the study, up to approximately 2 years | |
| Median duration of response (DoR) per RECIST 1.1 criteria |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Global Trial Manager | Contact | 301-251-5172 | info@macrogenics.com |
| Name | Affiliation | Role |
|---|---|---|
| Pepi Pencheva | MacroGenics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA | Recruiting | Los Angeles | California | 90095 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
The DoR will be calculated per RECIST v1.1 criteria, as determined by the investigator, from the date of initial tumor response (CR or PR) to the date of first documented progressive disease (PD) or death from any cause, whichever occurs first.
| Throughout the study, up to approximately 2.5 years |
| Median progression free survival (PFS) per RECIST 1.1 criteria | PFS is defined as the time from the first dose of study treatment to the date of documented PD or death from any cause, whichever occurs first. | Throughout the study, up to 2.5 years |
| Percent change from baseline in tumor size | Tumor size is defined as the sum of diameters of the target lesions. | Throughout the study, up to 2.5 years |
| Best percent change from baseline in tumor size | Tumor size is defined as the sum of diameters of the target lesions. | Throughout the study, up to 2.5 years |
| Disease control rate (DCR) | DCR, per RECIST v1.1 criteria, as determined by the investigator, is defined as the proportion of participants in the response evaluable population who achieve a CR, PR or stable disease for at least 3 months. | Throughout the study, up to 2.5 years |
| Ochsner MD Anderson Cancer Center | Recruiting | New Orleans | Louisiana | 70115 | United States |
|
| START Midwest | Recruiting | Grand Rapids | Michigan | 49546 | United States |
|
| West Penn Allegheny Health | Recruiting | Pittsburgh | Pennsylvania | 15224 | United States |
|
| The University of Texas MD Anderson Cancer Center, Gynecologic Oncology Center | Recruiting | Houston | Texas | 77030 | United States |
|
| START San Antonio | Recruiting | San Antonio | Texas | 78229 | United States |
|
| Wisconsin Institute Medical Research- UW Cancer Connect | Recruiting | Madison | Wisconsin | 53705 | United States |
|
| Princess Margaret Cancer Center | Recruiting | Toronto | Ontario | M5G 2M9 | Canada |
|
| McGill University | Recruiting | Montreal | Quebec | H4A3J1 | Canada |
|
| National Cancer Center | Recruiting | Goyang-si | Gyeonggi-do | 410-763 | South Korea |
|
| Seoul National University Hospital Bundang Hospital | Recruiting | Seongnam-si | Gyeonnggi-Do | 463-707 | South Korea |
|
| Yonsei University Health System Severance Hospital | Recruiting | Seoul | 03722 | South Korea |
|
| Gangnam Severance Hospital | Recruiting | Seoul | 06273 | South Korea |
|
| Korea University Guro Hospital | Recruiting | Seoul | 08308 | South Korea |
|
| Seoul National University Hospital | Recruiting | Seoul | 110-74 | South Korea |
|
| Samsung Medical Center | Recruiting | Seoul | 135-710 | South Korea |
|
| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
Not provided
Not provided