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Study of Lorigerlimab for Platinum-Resistant Ovarian or Clear Cell Gynecologic Cancers

This study is testing a drug called lorigerlimab in about 80 women with advanced solid tumors. Specifically, it's for those with ovarian, fallopian tube, or peritoneal cancer that has not responded to platinum-based chemotherapy, or certain clear cell gynecologic cancers. Lorigerlimab is a type of immunotherapy that works by targeting specific proteins (PD-1 and CTLA-4) to help your body's immune system fight cancer. Researchers want to see how many participants respond to the treatment (Objective Response Rate) over about two years. The study is currently unclear on its recruitment status.

Study design
This is an open-label study, meaning you and your doctors will know you are receiving lorigerlimab. Approximately 80 participants will be enrolled.
What's involved
You will receive lorigerlimab through an IV infusion on Day 1 of every 21-day cycle. Treatment continues until your cancer progresses, side effects are too severe, or you choose to stop.
Compensation
Not stated in the trial record.
Follow-up
Your response to treatment will be measured throughout the study for up to approximately 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06730347

A Study of Lorigerlimab in Participants With Advanced Solid Tumors

Recruiting
PHASE2Ages 18+InterventionalTreatment
MacroGenics
~80 participants
Updated 2026-06-02 on ClinicalTrials.gov
What's tested:Lorigerlimab

At a glance

Recruiting sites
16 of 16 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria as determined by the investigator
Measured over Throughout the study up to approximately 2 years

Conditions

Platinum-resistant Ovarian Cancer
Platinum-Resistant Fallopian Tube Carcinoma
Platinum-Resistant Primary Peritoneal Carcinoma
Clear Cell Adenocarcinoma of Ovary
Clear Cell Adenocarcinoma of Vulva
Clear Cell Adenocarcinoma of Vagina
Clear Cell Adenocarcinoma of Cervix
Clear Cell Adenocarcinoma of Uterus
Clear Cell Adenocarcinoma of Fallopian Tube
Clear Cell Adenocarcinoma of Peritoneum
Endometrial Cancer

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Where it's being run

16 sites across 11 states
South Korea5
Texas2
California1
Louisiana1
Michigan1
Pennsylvania1
Wisconsin1
Ontario1

Study leadership

  • Pepi Pencheva · STUDY_DIRECTOR · MacroGenics

Who to contact

Global Trial Manager
[email protected]
301-251-5172
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria as determined by the investigatorThroughout the study up to approximately 2 years

    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.