Lorigerlimab for advanced platinum‑resistant and clear‑cell gynecologic cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open‑label Phase 2 study enrolling about 60 participants to receive lorigerlimab by intravenous infusion on Day 1 of a 21‑day cycle. Treatment continues until cancer progression, unacceptable side effects, withdrawal, or study end, with a safety follow‑up within 30 days of stopping treatment. Participants will have routine labs and physical exams each cycle and tumor imaging about every 9 weeks for the first year then every 12 weeks thereafter. Eligible patients must have histologically confirmed specified gynecologic cancers with measurable disease and meet prior‑therapy requirements.

Why it matters

Who can join: the full rules

Inclusion 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 intolerance on the PARP inhibitor.
* 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.

Exclusion Criteria:

* 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 and clear cell cervical cancer.
* 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 another tumor that has a negligible risk for metastasis or death such as, adequately controlled basal-cell carcinoma or squamous-cell carcinoma of the skin, or carcinoma in situ of the cervix or breast are eligible.

Where it's running

• UCLA
  Los Angeles, California, United States Recruiting
• Ochsner MD Anderson Cancer Center
  New Orleans, Louisiana, United States Recruiting
• START Midwest
  Grand Rapids, Michigan, United States Recruiting
• West Penn Allegheny Health
  Pittsburgh, Pennsylvania, United States Recruiting
• The University of Texas MD Anderson Cancer Center, Gynecologic Oncology Center
  Houston, Texas, United States Recruiting
• START San Antonio
  San Antonio, Texas, United States Recruiting

Study contacts

• Study coordinator: Global Trial Manager
• Email: info@macrogenics.com
• Phone: 301-251-5172

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.