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New treatment option for Platinum-resistant Ovarian Cancer
Official title A Study of Lorigerlimab in Participants With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT06730347
What this study is testing
What is Lorigerlimab?
Lorigerlimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for platinum-resistant ovarian cancer.
Also referred to as MGD019.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Histologically confirmed high-grade serous epithelial ovarian cancer, including primary peritoneal, or fallopian tube cancer, resistant to platinum...
- Histologically confirmed clear cell carcinoma of the ovary (including primary peritoneal and fallopian tube), endometrium, vagina, vulva, or cervix.
- Persistent or recurrent disease with documented disease progression.
- Participants with PROC must have received at least 1 but not more than 3 prior lines of therapy for PROC.
- Participants with CCGC must have received at least 1 prior line of therapy for CCGC.
You likely can't join if
- Any underlying medical or psychiatric condition impairing participant's ability to receive, tolerate, or comply with the planned treatment or study...
- Primary platinum-refractory disease, defined as disease that did not respond to (CR or PR) or has progressed within 3 months of the last dose of...
- Prior treatment with a checkpoint inhibitor (e.g., anti-PD-1/PD-L1, anti-PD-L2, anti-CTLA-4). Prior use of immune checkpoint inhibitors (e.g...
- Active brain metastases or leptomeningeal metastases.
- Prior stem cell, tissue, or solid organ transplant.
- Paracentesis (removal of fluid from the abdomen) within 4 weeks prior to initiation of study treatment.
See the full eligibility criteria
- Histologically confirmed high-grade serous epithelial ovarian cancer, including primary peritoneal, or fallopian tube cancer, resistant to platinum based chemotherapy. OR
- Histologically confirmed clear cell carcinoma of the ovary (including primary peritoneal and fallopian tube), endometrium, vagina, vulva, or cervix.
- Persistent or recurrent disease with documented disease progression.
- Participants with PROC must have received at least 1 but not more than 3 prior lines of therapy for PROC.
- Participants with CCGC must have received at least 1 prior line of therapy for CCGC.
- Participants with a known breast cancer (BRCA) mutation (germline or somatic) must have received a Poly ADP-ribose polymerase (PARP) inhibitor, if locally approved and available, and experienced disease progression or...
- Participants must have at least one lesion that meets the definition of measurable disease by RECIST v1.1.
- Participants must have an available archival or formalin-fixed paraffin-embedded tumor tissue, or be willing to undergo a biopsy procedure to obtain a fresh tumor sample.
- Participants have acceptable physical condition and laboratory values.
- Participants of childbearing potential must agree to use highly effective methods of birth control.
- Participants must not be pregnant, planning to be pregnant, or breastfeeding.
- Any underlying medical or psychiatric condition impairing participant's ability to receive, tolerate, or comply with the planned treatment or study procedures.
- Primary platinum-refractory disease, defined as disease that did not respond to (CR or PR) or has progressed within 3 months of the last dose of first-line platinum- containing chemotherapy.
- Prior treatment with a checkpoint inhibitor (e.g., anti-PD-1/PD-L1, anti-PD-L2, anti-CTLA-4). Prior use of immune checkpoint inhibitors (e.g., anti-PD-1, anti-PD-L1, anti-CTLA-4) is allowed for clear cell endometrial...
- Active brain metastases or leptomeningeal metastases.
- Prior stem cell, tissue, or solid organ transplant.
- Paracentesis (removal of fluid from the abdomen) within 4 weeks prior to initiation of study treatment.
- Another hematologic or solid tumor ≥ stage 1 malignancy that completed surgery, last dose of radiotherapy, or last dose of systemic anti-cancer therapy ≤ 3 years from first dose of study treatment. Participants with...
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- New Orleans, Louisiana, United States
- Grand Rapids, Michigan, United States
- Pittsburgh, Pennsylvania, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- Madison, Wisconsin, United States
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
- Goyang-si, Gyeonggi-do, South Korea
- Seongnam-si, Gyeonnggi-Do, South Korea
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; New Orleans, Louisiana, United States; Grand Rapids, Michigan, United States; Pittsburgh, Pennsylvania, United States; Houston, Texas, United States; San Antonio, Texas, United States and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.